Process lifecycle management method and system

Abstract

Process knowledge creation, development and management techniques allow and enable creation of a universal process definition (UPD) for an industrial process, automatic conversion or transformation of the UPD into different venue-specific process definitions, and implementation of the venue-specific process definitions at different manufacturing, production and / or automation venues. Generally, the UPD is venue and equipment independent, and the transformations may generate and provide a set of venue-specific process definition implementation files or routines to configure and / or manage behaviors of various venue-specific execution systems, e.g., as venue-specific operational instances of the UPD. The techniques may utilize feedback and information generated by venue-specific operation instances to generate learned knowledge and update the UPD accordingly such that subsequent instantiations of the UPD may incorporate the learned knowledge (and obtain benefits of the learned knowledge). The technique may automatically select the most suitable venue for a particular instantiation of the UPD.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 301,434, filed on January 20, 2022, entitled “Process Lifecycle Management Methods and Systems,” the entire disclosure of which is hereby expressly incorporated herein by reference. Technical Field

[0003] The present patent application generally relates to the management of the life cycle of an industrial or manufacturing process over time (eg, from research to development to manufacturing and release) across various industrial and manufacturing execution processes and systems. Background Art

[0004] Industrial or manufacturing processes, such as those used in chemical, petroleum, pharmaceutical, paper, or other industrial process plants to produce physical products from source materials, typically include one or more process controllers communicatively coupled to one or more field devices via an analog, digital, or combined analog / digital bus or via a wireless communication link or network. These field devices, which may be, for example, valves, valve positioners, switches, and transmitters (e.g., temperature, pressure, level, and flow rate sensors), are located within the process environment and typically perform physical or process control functions such as opening or closing valves, measuring process parameters, etc., to control one or more processes performed within the process plant or system. Smart field devices, such as those that conform to the well-known Field devices that use the Fieldbus protocol may also perform control calculations, alarm functions, and other control functions that are typically implemented in a controller. - These process controllers (which may be centrally located in a plant environment or may be located in a distributed manner in a plant environment) receive signals indicating process measurements made by field devices and / or other information related to field devices, and execute controller applications that run, for example, different control modules that make process control decisions based on the received information, generate control signals, and communicate with field devices (such as and The control module in the controller sends control signals to the field devices through communication lines or links, thereby controlling the operation of at least a portion of the process plant or system.

[0005] Information from field devices and controllers is usually provided from the controller through a data highway to one or more other hardware devices, such as an operator workstation, a personal computer or computing device, a data historian, a report generator, a centralized database, or other centralized management computing devices that are usually placed in a control room or other locations away from a harsher plant environment. Each of these hardware devices is usually concentrated on a process plant or a part of a process plant. These hardware devices execute application programs, which can, for example, enable engineers to configure parts of the process or enable operators to perform functions related to the control process and / or operation of the process plant, such as changing the settings of the process control routine, modifying the operation of the control module in the controller or field device, viewing the current state of the process, viewing the alarms generated by the field device and controller, simulating the operation of the process for the purpose of training personnel or testing process control software, maintaining and updating the configuration database, etc. The data highways utilized by the hardware devices, controllers, and field devices may include a wired communication path, a wireless communication path, or a combination of wired and wireless communication paths.

[0006] For example, the DeltaV sold by Emerson TMThe control system includes a plurality of applications stored in different devices located at different locations in the process plant and executed by these different devices. The configuration application (which resides in one or more workstations or computing devices) enables users to create or change process control modules and download these process control modules to dedicated distributed controllers via data highways. Typically, these control modules are composed of communication interconnected function blocks, which are objects in object-oriented programming protocols that perform functions within the control scheme based on their inputs and provide outputs to other function blocks within the control scheme. The configuration application may also allow the configuration designer to create or change an operator interface, which is used by the viewing application to display data to the operator and enable the operator to change settings within the process control routine, such as set points. Each dedicated controller, and in some cases one or more field devices, stores and executes a corresponding controller application that runs the control modules assigned and downloaded thereto to implement the actual process control functions. Viewing applications (which may be executed on one or more operator workstations (or on one or more remote computing devices in communication with the operator workstations and the data highway)) receive data from the controller applications via the data highway and display the data to a process control system designer, operator or user using a user interface and may provide any of a number of different views, such as an operator's view, an engineer's view, a technician's view, etc. A data historian application is typically stored in and executed by a data historian device that collects and stores some or all of the data provided via the data highway, while a configuration database application may be run in another computer attached to the data highway to store the current process control routine configuration and data associated therewith. Alternatively, the configuration database may be located in the same workstation as the configuration application.

[0007] Although an instance of an industrial or manufacturing process may be executed and controlled by a process control system at a specific plant site to produce a final product or commodity, the instance is typically only one of multiple instances of the process that can be implemented over the life cycle of the process. The "life cycle" of an industrial or manufacturing process, as used herein, typically includes multiple stages of process maturity, for example, from the initial concept validation of the process, to the design of the process, to the development of the process, to the testing, adjustment and refinement of the process, to the expansion of the process to support commercial manufacturing and production of the final product, etc. Therefore, an instance of a process may be implemented and executed at a site early in the life cycle of the process (such as during the concept validation or trial phase of the process), and another instance of the process may be implemented and executed at a different site later in the life cycle of the process (such as during the process phase corresponding to the commercial production of the final product). In addition, due to plant or site-specific constraints such as equipment type and availability, plant capabilities, environmental conditions, etc., different instances of a process within the same stage of the process life cycle may require a plant or site-specific execution system to be configured differently. Furthermore, implementation of a particular instance of an industrial or manufacturing process at a plant or site requires not only that the plant's process control system be specifically configured to support the particular process instance, but also typically requires that other execution systems at the plant be specifically configured to support the particular process instance. Such other execution systems may include, for example, a manufacturing operations management system (MOM), a manufacturing execution system (MES), an enterprise resource planning system (ERP), a modeling system, a data management system, an electronic laboratory notebook, a laboratory information system, an audit system, an asset management system (AMS), other types of record management systems, and / or other systems that provide and / or consume data and information related to the particular plant or site where the particular instance of the industrial or manufacturing process will be implemented and executed.

[0008] Historically, the transfer of process lifecycle information from earlier stages to later stages of its lifecycle (e.g., "technical transfer" or "technology transfer" from one process stage to another) has been largely manual, where personnel familiar with earlier process stages provide key process, material, equipment, and procedural knowledge and information to personnel implementing later stages, such as via paper, pdf files, spreadsheets, etc. As a result, the accuracy and completeness of the process lifecycle knowledge information transferred is susceptible to compromise, which not only increases the overall time to move a process from early stages through the various stages of its lifecycle to support mass production, but also introduces risks into the products produced by the process. Unfortunately, such risks can lead to life safety issues for both plant personnel and users of the final product, and in some cases, such as when risks are introduced into processes used to produce pharmaceuticals, chemicals, and other potentially hazardous and / or lethal products, can result in injury or death. Exacerbating these problems, manual technology transfers make it difficult for product manufacturers to record and accurately report data necessary to find causes and contributors to product safety and quality, as well as to comply with jurisdictional regulatory requirements. Furthermore, this manual technology transfer inevitably involves many different people with different skills and knowledge bases associated with different facilities or plant equipment used at various times during the process development lifecycle, which also increases the testing and deployment time of the process.

[0009] Several digital tools have attempted to address these issues, however, these attempts have shortcomings and drawbacks. For example, product (vs. process) lifecycle management tools ("PLM") address the lifecycle phase of the physical end product and are not easily adaptable and / or optimized for aspects unique to the lifecycle phase of the industrial and manufacturing processes that produce the physical end product. Furthermore, PLM is not easily customized, extended into, and / or integrated with site-specific execution systems (if any).

[0010] Recently, some process knowledge management systems or tools ("PKA") have attempted to allow engineers and / or other process personnel to define processes a priori in a manner similar to those used in object-oriented techniques (e.g., objects, classes, modules, instances, etc.). Such PKA tools provide a user interface and database to enable users to define and store a set of related process definitions (from broad expressions down to specific implementation values, such as experimental process definitions, general process definitions, site process definitions, control process definitions) and site-specific parameter values ​​that can be transferred from the tool to a specific site for implementation at the specific site. However, these tools not only require manual definition of process objects and parameters a priori at the tool for various object levels (e.g., objects, classes, modules, instances, etc.), but also these tools rely heavily on a set of target equipment at a fixed plant and cannot be easily or flexibly converted (if at all) between sites with different equipment and / or equipment types (whether between less mature and more mature process stages, or between locations that are differently assembled during the same process stage). Summary of the invention

[0011] The novel process knowledge creation and management systems, methods and techniques disclosed herein allow and enable the creation and definition of generic process formulas (also interchangeably referred to herein as "universal process definition files," "process descriptor files," or "generic process recipes") for industrial or manufacturing processes, wherein these systems and / or methods can automatically convert the generic or universal process definition, process formula or descriptor file into corresponding site-specific production facility instruction sets for various different execution systems associated with different sites, whether these different sites are for different maturity stages of the process or for differently equipped sites at the same stage of the process. The universal process definition file may include, for example, a set of process inputs for manufacturing a product, a set of process steps or operations for manufacturing a product, an order or sequence (e.g., of execution) of these process steps or operations, one or more times or durations associated with one or more of these process steps or operations, categories and / or types of process equipment required to implement one or more of these process steps, data to be collected before, during and after a site operates the process, scaling or relative quantitative information that provides a way to scale the operation of the process to different sizes or throughputs, etc. Typically, the ubiquitous process definition or descriptor file is site and equipment independent. Additionally, execution systems associated with a specific industrial or manufacturing plant or site and into which site-specific production facility instructions may be incorporated include, for example, manufacturing operations management systems (MOM), manufacturing execution systems (MES), enterprise resource planning systems (ERP), modeling systems, data management systems, electronic laboratory notebooks, laboratory information systems, other types of record management systems, asset management systems (AMS), historians, audit systems such as supervisory systems, and / or other systems that provide and / or consume data and information related to a specific plant or site.

[0012] In one embodiment, at least a portion of the universal process definition or descriptor file is manually created, for example, it can be defined via one or more user interfaces of a process knowledge and creation management system, method and / or technology. Additionally or alternatively, at least a portion (and in some cases, all) of the universal process description or descriptor file can be automatically created by the disclosed technology based on an industrial or manufacturing process that has been implemented and is being executed at a specific process or manufacturing plant. That is, the universal process definition can be automatically and at least partially defined based on an actual, implemented instance of the process. For example, the system can receive one or more control routines, configuration files, and other process information and knowledge from an experimental system that executes the process at a proof of concept life cycle stage or at a small batch production stage, and the system can automatically generate a universal process definition or descriptor file based on the received information (and in some cases, also based on additional stage or site-specific data and / or information). In one embodiment, the disclosed technology includes: receiving one or more control routines for manufacturing, productizing, or packaging a product in a specific process plant using a specified set of equipment; receiving data related to the physical configuration of the process plant; and automatically creating a pervasive process description, a universal process formula, or a universal process descriptor file based on the received routines and the received data related to the physical configuration of the process plant. In addition, and advantageously, in an embodiment, the disclosed technology may include verifying that the pervasive process description or universal process formula is buildable and deployable to various sites.

[0013] The created or defined universal process definition or universal process formula can be stored at a process knowledge creation and management system, and the disclosed technology can convert the universal process description into different site-specific production facility instructions, each of which can be implemented in different factories or sites or in different execution systems at the same factory or site. In one embodiment, the disclosed technology may include: selecting a first production facility having at least a first process execution system (e.g., a control, audit, material handling, or sequencing system) coupled to a first set of process equipment; using a computer processor to convert the universal process definition file or universal process formula as stored in the management system into a set of site-specific production facility instructions for implementation by the first process execution system on the first set of process equipment at the first production facility to manufacture a product; selecting a second production facility having at least a second process execution system (e.g., a control, audit, material handling, or sequencing system) coupled to a second set of process equipment different from the first set of process equipment; and using a computer processor to convert the universal process definition or universal process formula as stored in the management system into a set of site-specific production facility instructions for implementation by the process execution system on the second set of process equipment at the second production facility to manufacture a product. In one embodiment, the disclosed technology may include: selecting a first production facility having a first process execution system (e.g., a control, audit, material handling, or sequencing system) coupled to a first set of process equipment and having a second process execution system coupled to the first set of process equipment; using a computer processor to convert a generic process formula as stored in a management system into a set of site-specific production facility instructions for implementation by the first process execution system on the first set of process equipment at the first production facility to manufacture a product; and using a computer processor to convert a universal process definition or generic process formula as stored in the first management system into a set of site-specific production facility instructions for implementation by the second process execution system on the first set of process equipment at the first production facility to manufacture a product.

[0014] To implement or facilitate the transformation of a pervasive process definition or a generic process formula, and to support other aspects of process knowledge creation and management techniques, a process knowledge creation and management system may include a technology delivery layer or platform that provides an interface between other portions of the process knowledge creation and management system and site-specific execution systems at various plants, for example, for creating, implementing / executing, and refining industrial or manufacturing processes throughout various lifecycle phases and across various different plants, and for tracking information related thereto. The technology delivery layer or platform may include: a delivery component for receiving a pervasive process definition or a generic process formula; a communication link or system coupled to each of a plurality of process plant execution systems; a plurality of analysis routines, each of which is configured to analyze data received from one or more of the plurality of process plant systems; and a transformation routine configured to receive the pervasive process definition or the generic process formula and coupled to the output of one or more of the plurality of analysis routines, and to configure an instance of a process for execution in one or more execution systems of a process plant. Advantageously, via a technology delivery layer platform, the disclosed technology can transform a pervasive process definition or generic process formula into a site-specific, operational instance of a process via one or more execution systems associated with a site and within site-specific constraints.

[0015] In addition, in some embodiments, the disclosed technology can transfer information and knowledge from the execution system of the process or manufacturing site to the process knowledge creation and management system, and transform such information and knowledge to be incorporated into a universal process definition or a universal process formula. For example, an embodiment of the method may include: receiving process data collected during the execution of a process in the process plant from a process plant; receiving a universal process definition or process formula or descriptor file that specifies a series of equipment-independent processing steps corresponding to the process; and associating various received process plant data with a processing step or a series of processing steps. Advantageously, the information provided to the process knowledge management and creation system from the execution system may include execution, calibration and performance data and records to support audit trails.

[0016] Thus, and advantageously, embodiments of the disclosed process knowledge creation and management systems, methods, and techniques allow not only automatic or manual generation of a universal process definition or a generic process formula or descriptor file, but also automatic transformation and instantiation of the universal process definition, generic process formula, or descriptor file into corresponding one or more execution systems associated with multiple processes or manufacturing plants or sites. In some cases, the disclosed techniques may transform an instance of a process executed at a plant site back to a universal process definition or a generic process formula, such as for verification purposes. In embodiments, the systems, methods, and / or techniques may include transforming any modifications to the process and / or other types of feedback, information, and knowledge gathered from the operation of the process at a process or manufacturing plant or site to be easily (and in some cases, automatically) rolled back to or otherwise incorporated into the universal process definition or a generic process formula or descriptor file, such that subsequent instantiations of the universal process definition, generic process formula, or descriptor file in other plants may include these modifications, feedback, or gathered knowledge. That is, processes, materials, equipment, and procedural knowledge and information can be easily and automatically transformed from a universal process definition or a generic process formula or definition into a site-specific, operational instance of the process, and additional processes, materials, equipment, and procedural knowledge and information gathered from the site-specific, operational instance of the process can be incorporated or added to the universal process definition, generic process formula or definition, for example, so that future instantiations of the universal process definition or generic process formula are based on the incorporated process knowledge and information.

[0017] In addition, novel process knowledge creation and management systems, methods and techniques may be utilized to provide other novel and useful aspects, advantages and benefits of process management. For example, the disclosed techniques may verify that various candidate sites or plants have or do not have the capabilities required to implement instances of processes defined by a pervasive process definition or a general process recipe, where the capabilities may be associated with equipment type and / or availability, equipment usage and / or scheduling of required personnel, site throughput and / or performance, etc. In one embodiment, a method for managing a process plant may include: receiving a pervasive process descriptor file that describes a series of equipment-independent processing steps that define a process for producing a product; generating an indication of one or more plant requirements for performing each of the processing steps based on the process descriptor file that describes the equipment-independent sequence; and receiving plant configuration data regarding various aspects of the physical configuration of one or more candidate process plants. Additionally, the method may include: identifying matches between the one or more plant requirements and plant configuration data for each of the one or more candidate process plants; and generating a suitability indicator for each of the one or more candidate process plants based on the matches, wherein the suitability indicator for each candidate process plant indicates the suitability of various aspects of the physical configuration of the candidate process plant for performing the process. Examples of plant aspects that may be considered for suitability may include: quality and performance parameters; availability, status, and / or scheduling of equipment, resources, and / or personnel; the time and location at which a product can be manufactured at a particular plant given the current manufacturing status of the particular plant; and / or other factors that may affect regulatory, compliance, and / or business objectives. Furthermore, the method may include selecting one or more production plants from the candidate process plants to perform a process for producing a product based on the suitability indicators; and causing the one or more production plants to perform a series of equipment-specific processing steps corresponding to the process to produce the product. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 is a flow chart illustrating a general process development and management approach that is typically manually established in the prior art.

[0019] Figure 2 Illustrated is a process development and management method that uses a process development and management system and method as described herein to make process development and deployment faster and easier than traditional prior art methods and systems.

[0020] Figure 3 An example process development and management system as described in more detail herein is illustrated including a process knowledge management layer, a transformation layer, and an execution or site layer.

[0021] Figure 4 Illustrated by Figure 2 and Figure 3An example of a Universal Process Definition (UPD) used by a system.

[0022] Figure 5A Example transform layers are illustrated in more detail.

[0023] Figure 5B Examples include Figure 5A A first example of a transform module in a transform layer is depicted in FIG.

[0024] Figure 5C Examples include Figure 5A A second example of a transform module in a transform layer is depicted in FIG.

[0025] Figure 5D Depicts example site configuration data in more detail.

[0026] FIG. 5E to FIG. 5I An example transformation module and associated input and output data are depicted.

[0027] Figure 5J An example inverse transform module is depicted.

[0028] Figure 6 is a flow chart depicting a method of configuring a process plant using a received pervasive process description.

[0029] Figure 7 is a flow chart depicting a method for creating a pervasive process description from data of a site-specific implementation of the process.

[0030] Fig. 8A is a flow chart of an example method for developing a process based on a site-specific implementation of an industrial process.

[0031] Figure 8B is a flow chart of an example method for developing a process based on a site-specific implementation of an industrial process.

[0032] Fig. 9 is a flow chart of an example method for validating and / or selecting development or production sites based on a pervasive process description. DETAILED DESCRIPTION

[0033] Figure 1A flowchart illustrating a typical process development life cycle associated with the creation and management of a specific process (such as a drug formulation and manufacturing process, a chemical manufacturing process, etc.) is depicted. As will be understood, a "process" as used, described, and referred to herein can be any type of process that produces any type of product in any quantity or recipe. Such a process can generally take the form of a batch process for creating a drug or other chemical substance from a set of raw materials or intermediate materials using a method commonly referred to as a recipe. However, the term "process" as used herein is not limited to such use. Therefore, as used herein, a "process" may include any batch or continuous process that can be used to manufacture any product (including but not limited to drugs, chemicals, petroleum products, etc.), a process implemented by a set of steps and equipment implemented by any type of manual implementation, a process implemented in any semi-automatic manner (including both automated and manual steps and / or equipment), and a process implemented using any automated system (such as a factory automation system, a process automation system, an automated manufacturing system, etc.) to produce a product. In addition, a "process" as used herein can produce an end-use product (e.g., a commercial product sold commercially) or an intermediate product used in other processes to produce a commercial product. Furthermore, as used herein, a "process" may be any set of operations performed on equipment to create or formulate a product in elemental form, such as a drug, any set of operations to change a product (such as a drug or other material) into a formulated product to be sold or used (such as formulating a drug into a pill form or a liquid form in a syringe, dosing a drug or other product, etc.), or any set of operations to package a product, such as a drug or chemical packaging process. Of course, while the example processes described herein are drug or chemical manufacturing processes, the processes described and referred to herein may be processes for manufacturing products other than drugs or chemicals, such as chip manufacturing processes, factory automation processes, etc., for manufacturing, manipulating, or packaging any type of product. Furthermore, a "process," as used, described, and referred to herein, may manufacture a product at any scale using any type or set of appropriate equipment, and includes methods implemented at a laboratory scale, at a development scale, at a small production or testing scale, or at a commercial manufacturing scale. In addition, the equipment used, described and referred to herein for performing a "process" may be automated equipment (such as process equipment typically found at large commercial manufacturing plants), may be semi-automated equipment having a certain degree of automation and a certain degree of non-automated control (such as manual control or specific implementation), or may be manually implemented equipment (such as equipment typically found or used in a laboratory environment), or may be any combination of automated, semi-automated and manually operated equipment.

[0034] refer to Figure 1 , a typical process development life cycle10 includes Figure 1The multiple stages illustrated from left to right in FIG. 1 include one or more development stages, in which a basic or preliminary process is created and refined to produce a desired product (usually on a small scale), and one or more production stages, in which the basic process is refined for implementation on a larger scale or using more advanced commercial production equipment. Thus, as Figure 1 As shown, a typical process development life cycle begins in a laboratory environment or stage 12 where the basic steps for formulating or creating a product (such as a pharmaceutical formulation) are typically developed manually to create a laboratory template 24 that defines the basic steps of the process. As will be appreciated, the systems and process equipment used in the laboratory 12 may be basic, may require a significant amount of manual operation, and may actually have minimal or no automated control systems associated therewith. In any case, at some point, based on feedback from the laboratory 12 (in Figure 1 16), a process developer creates a general or overarching process template 18 that, in the examples described herein, can be used to create a recipe 14 for a drug. The recipe 14 may include a description of raw materials used to prepare the drug, a set of steps to be performed on the materials, and the order of steps to be performed to manufacture the drug.

[0035] At some point, a recipe 14 may be developed at the laboratory stage 12 so that it is ready for further testing and / or use at another stage of the process development lifecycle, such as at a larger scale plant, which may be a development or test plant 20. This development stage is typically used to refine the recipe 14 so that it can be used in a more automated or larger scale production system, and to ensure that the process works to produce the desired product in those systems. Here, the recipe 14 is provided or used to generate a site recipe 22 that can be used at a specific development plant or site 20. The process developer typically manually creates a site recipe 22 from the overall recipe 14 by considering factors or conditions at the selected development plant 20, such as the class and type of equipment present at the plant 20, the amount or size of the test runs to be performed at the plant 20, etc. The site recipe 22 is then provided to the development plant 22, or used to create a master recipe 24 for the process to be implemented at the site 20. As will be appreciated, the development plant 20 may use some automated equipment for implementation of the master recipe 24, and may, for example, use a PLC control system (which uses a basic programmable logic controller) to control the process equipment at the development plant 20 to implement the process using the master recipe 24. At this stage, typically, personnel at the plant 20 must review the site recipe 22 and program or set up the actual equipment at the plant 20 to create and implement the master recipe 24. Of course, the actual programming of the equipment at the plant 20 requires time and specific knowledge of personnel at the plant 20 who are familiar with the specific equipment at the plant 20 and the type and nature of the automation system (if any) at the plant 20. The creation of the master recipe 24 and the programming and setting up of the plant 20 to implement the master recipe 24 typically takes a significant amount of time because it requires a significant amount of manual programming and testing to set up the plant 20 to implement the process defined by the site recipe 22. In addition, when implementing the master recipe 24, personnel at the plant 20 need to review and record data that defines the operation of the plant 20. Such a review requires personnel at the plant 20 to program the plant equipment to capture the desired data, such as plant and process operation data, quality data, and the like. Furthermore, such review requires personnel at the plant 20 to review the data and provide significant feedback that may be needed to refine or change the site recipe 22 to make it more applicable to the plant 20 and usable at the plant (actually using plant equipment at the development plant 20). This feedback, which is usually manual in nature, is Figure 1 This is shown using dashed line 26. Of course, it may be necessary to run a process or general site recipe 22 at the plant 20 multiple times using the master recipe 24 to perform adequate testing and refinement of the recipe for the plant 20.

[0036] At some point, such as after one or more runs of the master recipe 24 at the plant 20, the process developer may use feedback 26 from the plant 20 (typically provided manually by plant personnel at the plant 20) to create a new version 30 of the process recipe. Figure 1 2.0), which is suitable for and refined based on the implementation of the recipe 14 at the development plant 20. Generally speaking, in the examples provided herein, the laboratory site 12 and the development plant site 20 are used in the process development phase to develop a recipe (process) for a product (e.g., a drug) and to produce a process recipe 30 that is generally suitable for implementation at one or more production plants. However, although Figure 1 The process development phase is illustrated as including a laboratory phase 12 and a development plant phase 20, but other types of process sites may be used in the process development phase, and process development may include more or less than Figure 1 1 and 20. In addition, process development may use multiple different sites of the same type (e.g., a laboratory site and a development plant site), and in some cases, larger or commercial-scale plants or sites may be used during the process development phase.

[0037] In any case, the recipe 30 may then be applied to or used in one or more production stages of the process where the process is refined or altered or modified for implementation at one or more production facilities. Figure 1 In the example of FIG. 1 , a process recipe 30 is first used to produce a site recipe 32, which is used as a master recipe 34 in a pilot plant 36 to refine the process recipe for commercial or larger scale production. Figure 1As shown, the pilot plant 36 may be larger in size than the development plant 20, and may, for example, use a distributed control system (DCS) to implement the process using automated process control equipment. Therefore, the pilot plant 36 may use equipment and execution systems that are very different from the development plant 20 or the laboratory site 12. Therefore, the site recipe 32 may need to be refined or configured to use equipment of different categories and types from the equipment used in the laboratory site 12 or the development plant site 20. In addition, other automated systems at the pilot plant 36, such as data historians, process control configuration systems, audit systems, data collection systems, asset management systems, etc., may need to be programmed to implement the process at the pilot plant site 36. Similarly, such programming and site-specific implementation of the site recipe 32 as the master recipe 34 takes time and a lot of knowledge of individuals or plant personnel who understand the specific equipment at the pilot plant 36. In addition, when implementing the recipe 32, personnel at the plant 36 need to review and record data that defines the operation of the plant 36. This review requires personnel at the plant 36 to program the plant equipment to capture expected data, such as plant and process operation data, quality data, etc. In addition, such review requires personnel at the plant 36 to examine the data and provide significant feedback (as indicated by dashed line 38), which may be necessary to refine or change the site recipe 32 to make the recipe more suitable for and usable in or prior to deployment at a commercial-scale production facility. Of course, it may be necessary to run the process at the plant 36 multiple times using the master recipe 34 to perform adequate testing and refinement of the recipe for larger-scale production. In addition, the process developer may use feedback from the plant 36 (again, typically provided in manual form by plant personnel at the plant 36) to create a new version 40 of the process recipe. Figure 1 0), which is suitable for the implementation of recipe 30 at pilot plant 36 and is refined based on this implementation.

[0038] Next, if Figure 1As shown, formula 40 can be used for developing one or more site formulas 42A and 42B for various different commercial-grade production plants 50A and 50B. Formula 42A and 42B can be changed to consider the operation of various scales and sizes to be performed at the specific equipment of production sites 50A and 50B and these factories, and can be used to produce master formulas 52A and 52B for sites 50A and 50B. However, once again, site formula 42A and 42B need to be refined or changed or adapted to use the equipment of different categories and / or types used in pilot plant 36. For example, production plant 50A and 50B may include another or other automation systems or execution systems that need to be programmed or set, such as data history library, process control configuration system, audit system, data collection system, manufacturing execution system etc. Similarly, various audits or regulatory test systems need to be set to allow the government or industry supervision of the product manufactured on the commercial level to the process or by the process. Likewise, such programming and site-specific implementation of site recipes 42A and 42B takes time and significant knowledge by other individuals or plant personnel who understand the specific equipment at plants 50A and 50B.

[0039] like Figure 1 As shown, the typical process development method occurs continuously, so that the development of the process or formulation passes through each of a set of different development and production stages in sequence, requiring one stage to be completed before starting the next stage. In addition, typically, very different types, sizes, and configurations of process equipment are used at each different stage of the development cycle, which requires personnel with different skills and knowledge bases to participate in each different stage of the development and production cycle to implement the process in different stages. These factors mean that a lot of time and effort need to be invested to complete the entire process development life cycle of the product. In fact, due to the time spent through each of these development stages, and the time required to implement the formulation at each different stage on different plant equipment at different scales, new drug formulation and production roll-out may take several years to execute. Therefore, as shown in FIG. Figure 1 As will be appreciated from the description, a typical process development lifecycle for, for example, a new drug can take a significant amount of time and typically requires iterative development of a process recipe through various different process plants or process sites during different stages of process development in order to create and test the recipe and develop the recipe in a manner that enables it to be used for commercial scale production. Because these operations must be performed continuously, typically first in a laboratory, then in a small scale development plant, then in a small production plant such as a pilot plant, and then in a commercial scale plant, it can take a significant amount of time to develop a process recipe for a commercial grade product.

[0040] A process development and management system (PDMS) as described herein operates to provide Figure 1 The process development lifecycle described provides a specific structure to reduce the overall time spent advancing through the lifecycle. Specifically, the PDMS described herein enables more flexible creation and refinement of processes for implementation and testing at various different stages of the process development lifecycle in order to reach commercial scale production, reduces or eliminates some or most of the manual integration and implementation steps required or used during a typical process development lifecycle, reduces reliance on personnel at various different plants with specialized knowledge for implementing processes at various different stages of the process development lifecycle, and thus significantly reduces the amount of time spent executing process development cycles. Figure 2 A process development and management system (PDMS) 60 as described herein is illustrated and may be used to manage a process development lifecycle through or with respect to various different process development, implementation, and production stages, including various development stages such as a laboratory-based development stage 62 and a small-scale development plant stage 64, and various production stages such as a pilot plant stage 66 and a large commercial-scale production plant stage 68.

[0041] Generally speaking, Figure 2 The PDMS 60 of the present invention operates to enable one or more users to create and manage one or more universal process definitions (UPDs) that can then be used to implement the processes described or associated with the UPDs at various plants or sites in any desired order and at any desired time. In general, the PDMS 60 includes management of one or more UPDs 72 (in Figure 272 as stored in a database 73). Generally speaking, each different UPD 72 defines the process to be implemented in a very general way, so that the defined process can be universally applied or used to control the operation of different plants or production facilities (sites) to a certain extent, and these different plants or production facilities (sites) may differ in the size, capacity, category or type of equipment available, the execution system used to control or manage the process equipment, the feedback or data collection system used to monitor the process equipment or process, etc. Generally speaking, each UPD 72 will include a description of or a list of the following items: a set of operations to be performed as part of the defined process, a set of materials to be used in the defined process, the order or sequencing of the set of steps for the defined process, and relative quantitative or sizing information such as ratios of different materials to be used in the defined process or a set of example material quantities for a specific size of operation or throughput of the defined process. In addition, each UPD may include data about or in some way define the equipment for implementing the defined process and important data associated with the defined process, such as control data including control values, limits, ratios, amounts, etc. used in controlling the defined process, feedback variables or measurements to be collected before, during or after the operation of the defined process, audit or regulatory variables to be collected or obtained for the defined process before, during or after the operation of the defined process, etc. Of course, these are just some of the components of the universal process definition. As will be understood, the process definition information in the UPD is usually equipment-independent, and therefore does not usually (although in some cases) specify the specific equipment to be used in the implementation of the defined process. Therefore, the UPD is not particularly specific about the specific equipment to be run on it or about the specific size or throughput of the process. Therefore, the UPD is not uniquely bound to any specific plant, site or plant equipment that can be used to implement the defined process during the actual operation or implementation of the defined process, but on the contrary, the UPD can be run or used to implement various different sizes or throughputs and various different types of plants and plant equipment at different stages of the process creation and management life cycle.

[0042] like Figure 2As shown, the PDMS 60 includes a transformation engine 74 that, in general, uses the UPD 72 managed at the PKA system 70 to create files, instructions, or programming to be used in a specific plant or site associated with one or more of the process development phases 62, 64, 66, or 68. As will be appreciated, the transformation engine 74 uses a specific UPD 72 to create instructions or files that can be deployed to a variety of different process facilities, plants, or sites and can be used in a variety of different process facilities, plants, or sites at any time and in any order to implement the process defined by the converted UPD 72. Thus, in conjunction with the PKA 70, the transformation engine 74 operates solely on the UPD to transform the UPD into site-specific information or files, which are referred to herein as process definition implementation files (PDIFs), which can be used by a specific site or facility 62, 64, 66, 68 to implement the process defined by the UPD. Thus, the transformation engine 74 creates or helps create site-specific technology that can be sent to a specific site, more easily implemented or used at a specific site to initiate, run, test, and collect data about a process as defined by a specific UPD 72. Information from the site's operation of the process defined by the UPD can then be provided back to the transformation engine 74, which interprets the feedback data to produce more generic feedback data associated with the UPD, and the generic feedback data can be used at the PKA system 70 to modify or change the UPD to make the UPD more applicable to the specific site or specific type of site where the process operation occurs, to take into account scale changes in the process defined by the UPD, to take into account equipment or execution system differences or characteristics at the site where the process is operated, etc.

[0043] Importantly, the PDMS 60 can implement a particular UPD 72 at various different plants or sites, such as plants or sites associated with different development facilities (e.g., a laboratory 62 and a small-scale development plant 64) and plants or sites associated with different production facilities or sites 66 and 68, in any order and even simultaneously if necessary, to accelerate the process development life cycle. In addition, the PDMS 60 operates to automate some (if not many) of the steps or activities required to deploy or implement a generally defined process at a specific site or plant, including, for example, the steps required to set up a control system, data collection system, audit system, etc. at various different plants or sites, thereby making the deployment to the different sites faster, more seamless, and involving less plant personnel interaction or supervision. In addition, the PDMS 60 can automatically acquire or execute the deployment of the process to various different plant sites or facilities in a manner that defines, automates, and ensures the collection of feedback data required for monitoring and analyzing the implementation of the process at the different plants or sites, thereby enabling faster review and analysis of the process as implemented at the site or facility, which leads to faster changes and development of the overall process.

[0044] Reference again Figure 2 , PKA 70 enables one or more users to create, manage, change, and store one or more UPDs 72. In addition, PKA 70 enables a user to select a specific UPD 72 and deploy the UPD at one or more specific sites, such as a laboratory site 62, a development plant site 64, a pilot plant site 66, or a commercial plant site 68. Of course, here, a user may select a specific site or a specific type of site, for example, based on the development stage of the process being developed and managed. Figure 2As shown, the same UPD 72 may be provided to any number of different sites or factory facilities at the same time or at different times. In this case, the transformation manager 76, which may be part of the transformation engine 74, may interface with or spawn (e.g., create) one or more site transformation modules 80, which are executed on one or more computer processors to perform various activities related to deploying the selected UPD to a specific site or a group of specific sites. In this case, the first site transformation module 80A is associated with or interfaced with, for example, a laboratory facility 62 having mainly manually implemented equipment. In addition, the second site transformation module 80B is associated with or interfaced with a development factory facility 64 that may have small-scale equipment for implementing a process using some but possibly limited automation systems. The third site transformation module 80C is associated with or interfaced with a pilot or test plant 66 that may have some automation equipment and testing and data capture capabilities together with more advanced automation and execution systems. In addition, the fourth site transformation module 80D is associated with and / or interfaced with a commercial-grade manufacturing facility or factory 68 suitable for full-scale commercial production that may have more automation systems, test facilities, audit systems, and other execution systems. Although in Figure 2 Only four site transformation modules 80 are illustrated in the figure, but it should be understood that each site transformation module 80 can be interfaced with more than one specific site, or additional transformation modules can be used to interface with any type of additional site. Therefore, multiple different site transformation modules 80 within the PDMS 60 can be interfaced with specific sites associated with the same process development stage, such as multiple laboratories, multiple pilot plants, multiple commercial production plants, etc. In addition, the same site transformation module 80 can be interfaced with multiple sites that allow or are suitable for the same process development stage. In addition, the same site transformation module 80 can be interfaced with multiple different sites that allow or are suitable for different process development stages. In addition, it should be understood that "site" or "facility" as used herein may include any logical or physical grouping of plant equipment, and may include equipment at the same or different physical locations. In addition, different sites or facilities may be at the same physical location, and may, for example, represent equipment lines at a plant, buildings at a plant, areas of a plant, logical groupings of similar equipment located at the same or different physical plant locations, etc. In addition, Figure 2 The four sites 62, 64, 66, 68 to which the PDMS 60 is connected are for exemplary purposes only, and the PDMS 60 may be connected to more or fewer sites, other types of plant facilities or sites, multiple plant facilities or sites of the same type of plant facilities or sites having the same or different sizes, the same or different types of equipment, the same or different execution systems, etc. In addition, the PDMS 60 may be connected to and disconnected from the various sites 62, 64, 66, 68 at any time, may be connected to any combination of these sites simultaneously or in an overlapping manner, and so on.

[0045] As noted above, the PKA system 70 of PDMS 60 manages or supervises the creation, storage, manipulation, change and download or deployment of UPD 72, for execution at or on any one of venue 62,64,66,68 at the same or different times. Generally speaking, the user of PKA system 70 will create a specific UPD 72 and store the UPD in memory 73. In some cases, as described below, the UPD development module can be executed to develop one or more UPDs for the process based on the feedback from the laboratory, factory or other facilities implementing the process. In any case, at this level, the PKA system 70 enables the user to create, view, change, modify and otherwise manipulate a specific UPD by adding data fields to a specific UPD or deleting data fields from a specific UPD, by adding, deleting or changing the data in one or more data fields in the data fields of the UPD 72, by changing and tracking the version of a specific UPD, etc. In addition, when ready, the PKA system 70 enables the user to deploy or apply a specific UPD to a specific site, such as a site in site 62, 64, 66, 68, for implementation at the selected site. As part of this deployment, the PKA system 70 can enable the user to select or specify a specific site (e.g., a site in site 62, 64, 66, 68) for deployment. However, in some cases, the user can instruct the transformation engine 74 to select a specific site for deployment based on the standards in the UPD and / or based on the stage of process development. In other cases, the user can instruct the transformation engine 74 to determine one or more sites where deployment can occur based on the standards in the UPD and / or based on the stage of process development and provide a group of potential sites to the user, and the user can select from this group of potential sites to deploy. In the latter two cases, the transformation engine 74 may analyze data from or about each site in a group of sites to determine the suitability of each site for implementing the process, such as whether the sites include appropriate or necessary plant equipment for implementing the process defined by the UPD, whether the site is suitable for the development stage at which the process development cycle exists, whether the site includes or has available specific materials required in the process, or has a specific type of execution, testing, or data collection system or equipment required to implement the process and provide the desired feedback of the process operation, etc. In some cases, the transformation engine 74 may rank different sites based on each site's suitability for implementing the process at the current development stage and / or based on details of the equipment at the site.

[0046] In any case, when a particular site is selected for deployment, the transformation manager 76 provides the particular UPD to one of the site modules 80 associated with the selected site (or spawns the site module 80). The site module 80 then performs one or more transformations on the UPD to generate one or more site-specific instructions or files that define specific techniques, programming, and / or steps to be implemented at the site as part of implementing the process defined by the UPD. In order to perform the transformations, the site module 80 stores or has access to various site-specific information or data, including, for example: categories and types and details of plant equipment at the site (including, for example, size, specification, and connectivity information about the plant equipment, such as process instrumentation diagrams (PI&Ds) at the site), details about execution and automation systems located at the site and how these execution systems are connected to the equipment at the site and control or monitor the equipment, data collection systems or capabilities at the site, test facilities and equipment at the site, communication and control protocols used at the site, etc. Of course, the execution system at the site may include control systems, configuration systems, management execution systems, manufacturing operation management systems, audit systems, asset management systems, historical library systems, etc. that exist or are available at the site. During the transformation operation as explained in more detail below, the site transformation module 80 analyzes the UPD and determines the factory equipment required to be used to implement the UPD at the site. The transformation module 80 then determines one or more instructions, programming files, configuration files, data collection instructions, execution system configurations or instruction sets, etc. that are to be used to set up, program, or use the actual equipment at the selected site to implement the process defined by the UPD at the selected site. These instructions, configuration files, etc. (which are generally referred to as process definition implementation files (PDIFs) in this article) can take any desired form and may include or may be any desired combination of complete instructions that can enable the site or the equipment at the site to operate to automatically implement the process, or may be smaller in nature (such as basic building blocks such as programs or instructions such as control modules, PLC logic, execution system flow charts, etc.), which can be used by personnel at the site to program or set up the equipment at the site to perform the process defined by the UPD. In addition, these instructions or documents may include a list of standard operating procedures (SOPs) that should or need to be implemented to perform the process defined by the UPD at the site and / or definitions of manual operations or any other manual, semi-automated or automated steps. Of course, the PDIF may include instructions of other types or natures that can be implemented directly by factory equipment or execution systems at the site, can be used or modified by personnel at the site to program or set up equipment or execution systems at the site to perform manually implemented steps at the site before, during or after the process is performed at the site, etc.

[0047] In any case, the site change module 80 then provides the PDIF (which may be in the form of real-time instructions, downloadable files, or any other data stream or variable type) to the site where they were created, and these files or instructions are used to program, control, or otherwise operate the equipment at the site or the personnel at the site (or any combination of both) to implement the process at the site. Figure 2 As shown, in response to the execution management system providing the UPD 90 to the site change module 80A, the site change module 80A creates a set of PDIFs 90A and provides it to the laboratory facility or site 62. As noted above, the UPIF 90A, which may include many different sets of programs or instructions for different plant equipment and execution systems, may be used to program, instruct, cause or facilitate the setup and operation of some or all of the process equipment and execution systems (if any) at the laboratory facility 62 (or personnel at the laboratory facility 62) to implement the process defined by the UPD 90. The PDIF 90A may include a description of feedback data and / or instructions for obtaining, collecting and providing feedback data, as specified in the UPD 90. This feedback data may then be collected during the operation of the process defined by the UPD 90 at the laboratory facility 62 and provided back to the site change module 80A, which may associate the collected data with specific data or portions of the UPD 90 that are relevant to the collected data. The feedback data may then be provided to the transformation manager 76, which may present the data to a user (e.g., via the PKA system 70) for review and analysis by one or more process developers. Additionally, or alternatively, the site transformation module 80A or the transformation manager 76 may perform some analysis of the feedback data to assist the process developers in analyzing the operation of the process at the site 62.

[0048] At this point, the process developer may modify or change the UPD 90 to change the definition of the process, expand the definition, specify additional or different data to be collected or tests to be performed, etc. The modified UPD (which may be referred to herein as a different version of the UPD) may be provided back to the transformation engine 74, which then uses the transformation manager 76 and transformation module 80A to create a new set of PDIFs or instructions 90B (or to modify a previously created PDIF or instruction based on the changes made to the UPD 90) and sends the new PDIF 90B to the site (in this case the laboratory site 62) for implementation. The site facility then executes the new process as defined by the modified or new version of the UPD 90, and provides more feedback data for further analysis, as well as enabling further changes to the UPD 90 based on the additional feedback data. Thus, as described above, the process developer may modify or change the UPD 90 to improve the process quality and to improve the process quality of the process. Figure 2As shown, for a laboratory facility or site 62, multiple UPDs or versions of a UPD 90 may be used to create multiple PDIFs 90A to 90N to be implemented at the same facility 62. Of course, various versions of the UPD 90 may be implemented continuously or iteratively at the facility 62, so that feedback from the implementation of one version of the UPD 90 may be used to create the next or subsequent version of the UPD 90. Alternatively, however, multiple different versions of a particular UPD 90 may be implemented simultaneously at a facility (e.g., at the laboratory site 62), or sent to a facility to be implemented before feedback from the runs of those implementations is available to the transformation manager 76 or the PKA system 70. For example, a process developer may create different versions of a particular UPD and implement them at a facility such as a laboratory or development plant using the transformation engine 74, then compare the output or results of the two runs (and therefore the two UPD versions) to determine which UPD version produces the best performance or observe the advantages and disadvantages of each UPD to help create yet another version of the UPD. Such concurrent implementation of different versions of a UPD (at the same or different sites or facilities) can result in faster honing of a final UPD for implementation at production scale.

[0049] In addition, if Figure 2 As shown, the process developer may repeat or implement deployment of the UPD at other or different sites (e.g., Figure 2The process developer may send a UPD 92 to a transformation module 80B, which converts or transforms the UPD 92 into one or more PDIFs 92A to 92N (using site equipment data defining the equipment at the site 64), which are used to run or implement the equipment at the site 64 and provide feedback to the process developer. Additionally, the process developer may send a UPD 94 to a transformation module 80C, which converts or transforms the UPD 94 into one or more PDIFs 94A to 94N (using site equipment data defining the equipment at the site 66), which are used to run or implement the equipment at the site 66 and provide feedback to the process developer for this stage of process development. Likewise, the process developer may send a UPD 96 to a transformation module 80D, which converts or transforms the UPD 96 into one or more PDIFs 96A to 96N (using site equipment data defining the equipment at the site 68), which are used to run or implement the equipment at the site 68 for this stage of process development and provide feedback to the process developer. It should be understood that the UPDs 90, 92, 94, and 96 described herein may be the same UPD or may be different versions of the same UPD, such that the UPD 94 may be a later version of the UPD 92 and a later version of the UPD 90. However, if the process developer wants to send the same UPD (e.g., the same version of the UPD) to different sites at the same time or at different times, the system 60 supports the developer. In this way, the process developer may implement the same UPD simultaneously on different process equipment to implement different process development stages simultaneously. In addition, process developers can implement different versions of the same UPD simultaneously on the same facility or site, on the same type of facility or site (for example, at different pilot plants or at different development plants at the same time) or even at different types of facilities or sites at the same time, thereby accelerating or shortening the process development life cycle. In addition, if necessary, process developers can use system 60 to change the typical sequencing (and therefore specific UPD) of the development of process by skipping one or more typical process stages. For example, process developers can use system 60 to generate UPD at the laboratory site, and then directly deploy the UPD in the pilot plant site, skipping the development plant test stage. Similarly, process developers can implement the different stages of the process development life cycle in any desired order except the typical order described herein. In addition, process developers can make system 60 automatically propagate the changes made to UPD (for example, based on development plant testing) to other sites where the UPD is being implemented.In this case, for example, a new version of the UPD created using feedback from the development site can be provided to and deployed at a pilot plant that is also executing a process based on the original UPD to change the implementation of the process to implement the new version of the UPD.

[0050] Thus, as will be appreciated, the same UPD or different versions of the same UPD may be downloaded and deployed at different ones of the sites 62 to 68 for implementation at different times, may be sent to different ones of the sites 62 to 68 for implementation at the same time or at overlapping times, etc. In addition, the system 60 may enable a user to view feedback from various sites in the form of data collected from the various sites when the UPD is running or implemented, and use that data to change the UPD as stored in the database 73. If desired, the user may then provide the changed or updated UPD to the same site for implementation, or to another site currently in the process of implementing the UPD to update the operation of the UPD at the second site.

[0051] Thus, the PDMS 60 described herein functions and operates to enable a significant reduction in the development time of a process because the PDMS provides for faster development of a process by enabling various activities of the development cycle to be automated or semi-automated (e.g., at the transformation engine 74) in order to accelerate the implementation of the process being developed at different sites or facilities, which may be of different sizes, may use very different process equipment and automation systems, and may be associated with different stages of process development. The PDMS 60 also facilitates the implementation of a particular UPD at any particular site or facility by providing some automated conversion of the UPD to data, files, instructions, etc. that can be used at the site to program the equipment and systems at the site to implement the process, thereby reducing the need to involve personnel with highly specialized site knowledge.

[0052] Figure 3 Illustrate an example process development and management system PDMS (and methods associated therewith) that can be used to accelerate (reduce) the time frame in which a process can be developed and deployed in different sites or plants or facilities, such as Figure 2 PDMS 60. Specifically, the process development and management system PDMS 100 includes a process knowledge management layer 102, a transformation layer 104, and a process plant or site layer 106, which are communicatively connected to each other through any desired communication system or technology (such as using a wired or wireless WAN, LAN, public or private Internet, telephone communication system, etc.).

[0053] In general, the process knowledge management layer 102 provides a development environment for process developers to create, store and manage one or more universal process definitions (UPDs), and also enables process developers to deploy UPDs at any time and in any order or sequencing at a specific process site or facility. As noted above, the UPD defines the process in a generic or process equipment-independent manner, and therefore does not typically specify the specific process equipment to be used, the specific process size or throughput, etc. Therefore, the UPD can be used at different plants, facilities or sites, such as at development and production facilities of different sizes, at plants or sites with equipment of different types and layouts, at sites with different control mechanisms or infrastructures, at sites with different data collection systems or methods, etc. The process knowledge management layer 102 provides the UPD to the transformation layer 104 at different times.

[0054] Generally speaking, the transformation layer 104 (which may be implemented to include Figure 2 The transformation manager 76 and the transformation module 80 Figure 2The transformation engine 74 of the present invention is operated to receive the UPD and convert the UPD into one or more groups of data files or instructions (PDIF), which are then provided to a specific plant or site facility in the site layer 106. As described in more detail herein, the transformation layer 104 applies one or more transformation modules or analysis routines to the information in the UPD to create various different groups of instructions, data files, programming files or other PDIFs, which are then provided to a specific plant or facility. These process implementation files can be used to guide or program the controller, data collection system, management execution system or other manual or automated system at the plant or site to implement the process defined by the UPD for the specific equipment at the plant or site, or to help the operator or other personnel at the site configure, set, program and / or run the equipment at the site to achieve the process. As noted above, the transformation layer 104 can operate the same UPD to provide different instructions or different groups of implementation files to different plants or sites in the site layer 106, so as to implement the process defined by the UPD in different plant settings (using, for example, different plant equipment to run the process at different scales). The different plants or sites may be different types of plants, such as development plants, laboratories, small or large-scale manufacturing plants, commercial-grade manufacturing plants, etc., or may be the same type of plants. As will be appreciated, these different plants or sites may use the same or may use different types, sizes, and configurations of equipment to implement the process. In addition, the transformation layer 104 may provide different implementation instructions or files for different types of systems at a particular plant or site, such as for different execution systems within a particular plant. Thus, the transformation layer 104 may provide a type of file or set of instructions for programming a manufacturing execution system at a plant or for use by a manufacturing execution system at a plant, a second set of programming or configuration instructions for use by a control system at the same plant or facility, another set of instructions or programming for a historical library at the same plant or site, and one or more sets of yet further instructions for programming a batch scheduler, an audit system, or other type of execution system used at a plant.

[0055] also, Figure 3 The transformation layer 104 is shown providing the created implementation file (PDIF) to the venue layer 106 via one or more communication systems such as one or more application programming interfaces (APIs). Figure 3As shown, PDIF (implementation file) can be provided to a specific plant or site, and these files or instructions can be used to program or control the equipment at the site at a specific site in the site layer 106, or can instruct users or otherwise help users at the site to implement the process defined by UPD on specific equipment at the site. As noted above, different implementation files or different groups of these implementation files can be provided to different execution systems in the plant or site, such as real-time control execution systems, MOM or MEM execution systems, configuration systems for configuring one or more controllers or creating control modules for one or more controllers, scheduling systems at the site (such as batch schedulers), historical libraries for data collection at the site, audit systems for collecting FDA or other required audit data from the operations of the plant or site, asset management systems at the site, etc.

[0056] In addition, the data collected at each site in the site layer 106 during one or more operations of the process at the site is returned to the transformation layer 104, where the data is processed to convert site-specific feedback data into more general data associated with the UPD, so as to align those feedback variables with variables or other data defined by the UPD, for example. This inverse transformation performed at the transformation layer 104 can be performed to provide the process developer with the ability to view or understand how and in what manner the converted UPD operates under a specific site background. This feedback may include any desired type of data, such as quality variables, timing variables, control variables or values ​​(e.g., set points, limits, etc.) associated with the process or the product produced by the process, changes made to the process at the site layer 106 in order to implement the process at the site, different types and / or specificity of the equipment used in the process at the site, and any other feedback variables that can be considered as being beneficial to understanding or analyzing the operation of the process in the specific environment of the site where the process is implemented or affecting the operation of the process in the specific environment of the site where the process is implemented. Of course, different types of variables can be implemented or provided from different types of sites or from different types of processes running at specific sites. In addition, the information provided back from the site layer 106 is transformed into a variable or difference list or other feedback data associated with the various components of the UPD at the transformation layer 104, and the transformed data is provided to the process knowledge management layer 102 for one or more process developers at the PKA layer 102 to review and potential actions. The transformed feedback data can then be used by the process developer to change, update or further refine the UPD. This ability to provide and review feedback from the process running at a specific factory in a more general way enables the process developer to modify the UPD more quickly to better operate in various different environments, to manufacture higher quality products (not only based on the actual steps of the process, but also based on the basic process equipment or elements of the factory where the UPD is deployed, the size and scale of the process implemented at the site, the actual materials used at the site, etc.). In addition, the feedback data can be provided to one or more analysis engines, which can be, for example, difference engines, engines based on artificial intelligence, etc. The analysis engine can operate on feedback data from a specific plant, from multiple different plants running the same UPD, from processes running at different sizes or scales at the same or different sites, etc., to help process developers modify, expand or otherwise refine the UPD.

[0057] like Figure 3As more particularly shown in FIG. 1 , the process knowledge management layer 102 includes a process knowledge management (PKA) engine 110 having access to one or more UPDs 112 that may be stored, for example, in a database 114. Additionally, the process knowledge management layer 102 includes one or more user interfaces 116 that may be coupled to the PKA engine 110. Generally speaking, the PKA engine 110 is programmed to interact with one or more users via the one or more user interfaces 116 (using wired or wireless communications) to create, develop, manipulate, and deploy UPDs 112 as stored in the database 114. Figure 3 As shown, the database 114 may store any number of UPDs (eg, UPD1, UPD2, ..., UPD N ), where each UPD X Associated with or defined by different processes. In addition, each UPD X One or more versions thereof may be included (e.g., UPD1 version 1, UPD1 version 2, ..., UPD1 version N), wherein each version generally defines the same process, but represents a different development phase or development sub-phase or other contextual variables within the process development lifecycle. Thus, for example, different versions of the UPD may be deployed for different development and production phases, for different types of plants or sites at the same development or production phase, for different scales or sizes of operations of the process, or for any other reason.

[0058] The various components of the process knowledge management layer 102, including the PKA engine 110, the database 114, the user interface 116, etc., can be implemented on one or more processors (the one or more processors can be, for example, processors of a single computer or multiple computers, processors executed in the cloud or at a specific user site) or in any other processing environment using any desired type of computer programming. As noted above, the PKA engine 110 includes programming instructions that provide information to one or more users through a user interface 116 (these user interfaces can be any desired type of interface, including, for example, a computer user interface, a mobile phone or mobile device interface, a laptop or surface interface, a wearable interface, etc.) when executed on a computer processor, and enables a user or process developer to interact with the user interface 116 to enable the PKA engine 110 to establish, create, modify, view, deploy one or more UPDs in the UPD 112 or take any other action about the one or more UPDs. The PKA engine 110 can also enable a user to view feedback data from one or more sites where the UPD is deployed to view and understand the operation of the UPD as currently configured.

[0059] When being instructed to deploy UPD, PKA engine 110 sends one or more UPDs in UPD 112 to transformation layer 104 via communication interface 120. Communication interface 120 can be any type of communication interface such as Internet-based communication system, LAN, WAN, telephone communication interface, etc., and can use any desired type of wired or wireless communication infrastructure, or a combination of the two. In addition, during deployment activities, process developers can provide instructions to transformation layer 104 for specific sites or facilities where UPDs are to be deployed. In some cases, users can use KM system 112 to instruct transformation layer 104 to determine the suitability of one or more process facilities or sites for implementing UPD.

[0060] like Figure 3As shown, the transformation layer 104 includes a transformation manager 130 and a set of site information files or data 140. The site information files 140 include data related to each site in the site layer 106, and specifically, each site information file or data set 140 includes information about or defines the following: process equipment at the site (such as the category and type of process equipment at the site, the manufacturer and / or model and / or size of the equipment at the site, the configuration name or label of the equipment at the site, the model and / or serial number of the equipment at the site, the communication protocol used by the equipment at the site, etc.), the execution system at the site (e.g., MOM, MEM, control, configuration, batch scheduling, audit, historian, AMS, etc. systems at the site), the testing and data collection capabilities and equipment at the site, the way the process equipment at the site is configured, laid out, or connected together (e.g., PI&D diagrams or other connectivity information from the site), information about the programming and configuration of the equipment at the site and the communication setup and capabilities, and any other site-specific information required to understand and / or configure and / or operate the equipment at the site. Site information can be very specific in that it can define process equipment and other execution systems at or associated with a site down to the manufacturer and model and even serial number in order to specifically define the equipment and execution systems and any subsystems thereof at a particular site. Furthermore, site information can define the equipment and systems associated with a site as any specific logical or physical grouping of equipment in any manner, such as specific equipment within a specific plant facility at a single location, equipment associated with physical equipment at different physical locations, similar arrays of equipment within the same or different plants or plant locations, equipment associated with a specific plant area or plant building or plant line, similar equipment located at different physical locations or areas in a plant or even at different plants, etc. Likewise, site information can be completely specific as to the types of execution systems at or associated with a site that operate to provide control, data collection, scheduling, configuration, etc. at the site. Likewise, site information can specify or define one or more application programming interfaces (APIs) required to interact with the site or with any equipment at the site. Additionally, venue information files 140 may be collected from each venue prior to use in transformation layer 104 and may be stored in database 142 in transformation layer 104, may be provided to transformation layer 104 in real time from the venue or a database associated with the venue in venue layer 106 in response to a request for information from one or more of transformation modules 130, or any combination of the two.

[0061] As will be appreciated, the transformation engine 130 manages and launches various different modules that can be executed at the transformation layer 104 on one or more computer processors at any desired location. The transformation modules may be implemented or executed in whole or in part at the same computer device at a single location (such as on the same computer processing device that executes any of the components of the process knowledge management layer 102 or any other computer processor device), may be implemented on one or more computer processor devices in the cloud, may be implemented or executed on one or more computer processor devices at a site in the site layer 106, or any combination of these. Thus, in some cases, different transformation modules may operate or execute at various different locations or computer processors (such as at different plant facilities) to perform the operations described herein as being associated with the transformation layer 104.

[0062] like Figure 3 As shown, the transformation modules of the transformation manager 130 may include a site suitability module 160 and various site or equipment specific transformation modules 170. The site or equipment specific transformation modules 170 generally include transformation modules associated with different types of equipment and execution systems located at one or more sites in the site layer 106. The transformation modules 170 (which may be composed of Figure 2The transformation modules 80 used or spawned by the transformation manager 76 of the site layer 106 can be or include various types of analysis modules related to different execution systems at the site in the site layer 106, including, for example, MOM transformation modules 172, control system transformation modules 174, configuration system transformation modules 176, scheduler system transformation modules 178, audit system transformation modules 180, historical library or data collection system transformation modules 182, asset management system (AMS) transformation modules 183, etc. In addition, each type of transformation module 170 may include different specific modules for performing transformations with respect to each of various or different types of execution systems or process equipment at one or more sites. For example, the set of control transformation modules 174 may include different control transformation modules for operating on a PLC control system, on a distributed process control system, on a manually executed control system, etc. In addition, there may be other different but more specific control transformation modules for different kinds of distributed controllers, such as control transformation modules for DeltaV control systems, control transformation modules for Honeywell control systems, control transformation modules for ABB control systems, etc. Likewise, there may be various different MOM transformation modules for manufacturing operation management systems 170 of different types, kinds, brands, manufacturers, and the like. Furthermore, different configuration transformation modules 176 may exist or be created for factory configuration systems of different types, kinds, and the like. Furthermore, a variety of different scheduler, audit, history library, AMS, and the like transformation modules 178, 180, 182, 183 may be created for these various execution systems of different types, kinds, brands, manufacturers, and the like. Furthermore, the transformation engine 130 may store or propagate different transformation modules for each specific site or for a group of related or similar sites. Thus, the control transformation module 174 may include different control-related transformation modules for use at two different sites, and thus the transformation modules may be site-specific, equipment-specific, equipment-type-specific (e.g., for use on a PLC controller or on a distributed controller, etc.). Thus, Figure 3 The transformation module 170 may be associated with transformations of any level or specificity, including site-specific, execution system-specific, site-type-specific, or any combination of these.

[0063] In any case, the site suitability module 160 operates to receive the UPD and potentially other information from the PKA 110 (e.g., an indication of the development stage at which the UPD exists, the expected size of the UPD operation, etc.), and determines the suitability of one or more sites for implementing the UPD. Generally speaking, the site suitability module analyzes the data in the UPD and uses the site information data 140 from one or more sites to determine whether the specific site being analyzed is suitable for implementing the UPD for the desired purpose and the size or scale of the operation of the process associated with the UPD. The site suitability module 160 can operate on any information in or provided with the UPD (and / or specified by the process developer at the PKA 110), and can select a specific site to be analyzed based on the information (e.g., whether the site meets the development stage information associated with the UPD). Alternatively, a user or process developer can indicate the name of one or more sites to be analyzed for suitability or provide an identifier of one or more sites to be analyzed for suitability.

[0064] In any case, the site suitability module 160 analyzes the site information 140 for each of the potential or selected sites with respect to the UPD to determine (1) whether the site is capable of implementing the UPD, and (2) how suitable the site is for implementing the UPD. Specifically, the site suitability module 160 may first determine whether the site includes appropriate or necessary equipment for performing the steps or operations defined by the UPD, whether the site has access to materials specified by the UPD, whether the site has necessary testing or data collection facilities specified by the UPD, whether the equipment at the site is capable of implementing the process at the scale specified for the UPD, and so on. If the site suitability module 160 determines that the site is capable of implementing the UPD at the desired scale and for the desired purpose, the site suitability module 160 may then determine how suitable the site is for implementing the UPD. This activity may require determining a suitability factor for the site based on a comparison of the site equipment and capabilities with information within the UPD regarding necessary, alternative, and preferred steps, materials, data collection, testing facilities, and the like. The site suitability module 160 may determine the suitability factors or suitability information using, for example, a weighting algorithm that provides or uses weights to determine the relative importance of different factors in the suitability determination. Of course, the site suitability module 160 may use other algorithms to determine the suitability of each analyzed site, and may send the suitability information back to the process developer at the process knowledge management layer 102 for analysis and selection of sites. The suitability information may include, for example, a ranking of sites based on one or more calculated suitability factors, a list of advantages and disadvantages associated with each site, or any other information that may be helpful in determining a site to use.

[0065] In any case, when a site has been selected, either automatically by the site suitability module 160 or via feedback or guidance from a process developer at the PKA layer 102, the transformation layer 104 (or a process implemented in the transformation layer 104) Figure 2The transformation manager 76 of the transformation module 170 may join, create or multiply one or more transformation modules in the transformation module 170 to create one or more PDIFs or one or more sets of instructions for sending to the site in the site layer 106. Of course, depending on the site at which the UPD is to be implemented, one or more transformation modules in the transformation module 170 operate the UPD using the site information 140 of the selected site to generate a PDIF including one or more sets of programming instructions, configuration instructions, scheduling instructions, etc. for each of the different execution systems and process equipment at the site. For example, the configuration transformation module 176 may analyze the information at the site (including the process equipment at the selected site, the specific type of control system at the site, etc.), and may determine or generate one or more control programs, control modules, template control modules, PLC logic, etc. to be used in or by the control system at the site to implement the UPD at the site. The configuration PDIF or the group of instructions may also include or alternatively include information or instructions to be used by the configuration engineer at the site to create one or more control programs, configuration equipment, information or instructions to specify what equipment (e.g., controller, valve, transmitter, measuring device, etc.) to be used for those instructions, SOPs to be implemented before, during, or after the process of running the process using the UPD, etc. For example, the MOM transformation module 172 may create instructions, flow charts, or other programming data that will be used by a specific MOM system at the site or at a specific MOM system at the site to help program the MOM to manage the operation of the process using the UPD. The data may include flow charts, user interface instructions, phase change information, interruptions, alarms, and warnings, etc. that will be managed and implemented by the MOM system to create a management process routine or a group of user interfaces, interlocks, etc., which will be used by the MOM system or at the MOM system when the equipment at the control site is used to implement the process defined by the UPD. In addition, the historian transformation module 182 may include program instructions for the historian at the site, which program instructions may be used to configure one or more historians at the site regarding what data is to be collected and stored, how often the data is to be collected and stored, alarms and warnings that should be set based on the data collection, etc. Similarly, the scheduler transformation module 178 may interact with a scheduling system at the site, such as a batch scheduler at the site, to actually schedule one or more runs of a process at the site using specific site equipment, or to provide information to a user at the site to set up a specific schedule using the scheduler at the site. As will be understood, the audit system transformation module 180 may develop files or instructions for one or more audit or other data collection systems at the site or to be used to set up one or more audit or other data collection systems at the site, including tests to be performed on the final or any intermediate products produced by the process, data to be collected and stored for audit purposes, etc.In addition, the AMS transformation module 183 may develop files or instructions for configuring the AMS system to perform the following operations: configuring factory equipment, testing or replacing equipment required for running a process using the UPD, changing equipment settings, and the like.

[0066] As will be appreciated, the transformation module 170 may use data about the site, such as data specifying specific equipment and execution systems at the site, to create actual interaction or programming instructions for the equipment, or other information used by personnel at the site to set up, run and / or analyze the operation of the process at the site. The transformation models 170 may be automatic in nature, in that they may automatically create sufficient information or instructions to program or set up the execution system at the site; may be manual in nature, in that the transformation module may provide data or instructions to a user or operator at the site to program or set up one or more execution systems at the site; or may be any combination of the two. In any case, the transformation module 170 greatly enables and accelerates the configuration, setup and operation of specific equipment at the site by providing at least some building blocks or information to personnel at the site to set up and implement the operation of the process defined by the UPD. In this way, the transformation module 170 may be operable to significantly reduce the time spent setting up and operating different equipment at different facilities or sites to implement the process.

[0067] The PDIF or implementation files or instructions generated by the transformation module 170 may be provided to a particular site via the communication system 184, which may include one or more APIs that enable different transformation modules 170 to communicate with different sites or even with different equipment at different sites in order to provide the PDIF or other implementation files or instructions to the sites and the equipment at the sites. In general, the various APIs in the communication system 184 are used to convert or provide the information in the PDIF as created by the transformation module 170 into instructions, commands, and information that are readable and usable by different execution systems at the actual site. Figure 3 As shown, PDIFs or instructions 186 for various execution systems of "site 1" (190) are provided to site 190 and may be used at the facility or site to program, implement, or instruct personnel at site 190 regarding the manner and nature of programming, configuring, and / or running processes on equipment at site 190. As noted above, PDIF 186 may be sent as a file via the API of communication system 184 or sent in real time as real-time instructions to site 190 for use by equipment or personnel at site 190.

[0068] In addition, if Figure 3As shown, data collected before, during, or after operation of a site 190 (which data may be specified by the UPD and programmed to be collected in the UPD as feedback data) may be sent back to the transformation layer 104 via the communication system 184 as site process / feedback data 192. This data, which may be collected by the site and stored at the site, may be provided back to the transformation layer 104 during real-time operation of the plant or as one or more separate data files sent at the same or different times.

[0069] like Figure 3 As shown, one or more inverse transformation modules 194 may receive site process / feedback information 192 and may operate as described in further detail herein to convert site-specific data back into more general data associated with a UPD used to generate a PDIF for running a process defined by the UPD and running at the site. The inverse transformation module 194 may analyze the received or converted data so as to relate the received or converted data to various portions or sections of the UPD used to generate the site process / feedback data so as to enable the operation of the equipment at the site to be correctly attributed to the UPD. The feedback data may be analyzed manually or automatically within the inverse transformation module 194 or using one or more analysis routines. The transformed feedback data and any analysis performed thereon may then be provided by the inverse transformation module 194 back to the PKA system 110 for review by the process developer. In addition, as Figure 3 As shown, the field process / feedback data 192 can be sent directly to the PKA system 110 via the communication system 120 for analysis by the process developer. In addition, the field process / feedback data 192 can be provided directly to one or more analysis engines 196, in which any desired analysis routines can be used to analyze the field process / feedback data, and the output of these analysis engines 196 can be provided back to the PKA system 110 via the communication system 120 for review and use by the process developer at the PKA system 110. It should be understood that the process developer can use the PKA system 110 (and the user interface 116 associated therewith) to view, analyze and use the field process / feedback data, the transformed field process / feedback data, and any analysis information from any analysis performed on the field process / feedback data or the transformed field process / feedback data to modify, expand and change the information within the UPD used to create the field process / feedback data 192. The process developer can, for example, use the feedback data to create a new version of the UPD with different or changed data. Of course, although Figure 3 The use of transformation module 170 is shown to create a PDIF for use at venue 190, but it should be understood that transformation module 170 can also be used to create PDIFs for use at other venues (such as at the same time or at a different time) in a similar manner. Figure 3 PDIF of venue 2, venue 3, …, venue N).

[0070] As you will see, Figure 3 The overall system shown provides an effective platform and method for developing, testing, creating and deploying processes that can be implemented at the same or different times at very different sites or plants or facilities. In addition, it should be understood that Figure 3 Each of the components of the PKA layer 102 and the transformation layer 104 may be implemented separately or at different locations, may be implemented in the cloud or at different distributed locations, and / or may be implemented in whole or in part at a single location or at multiple different locations, including at one or more of the sites of the site layer 106. In some cases, it may be beneficial to implement the transformation layer 104 or portions of the transformation layer 104 at a specific site in order to protect proprietary or confidential information of the site.

[0071] Figure 4 An example of a universal UPD 200 is illustrated, which can be created and stored in Figure 3 The PKA layer 102 of the present invention is used to initiate the execution of the process at various sites or facilities in the manner described herein. Figure 4 The example UPD 200 is provided to provide example details about what information may enter the UPD. However, Figure 4 The information within UPD 200 is exemplary in nature and is intended to illustrate only some of the categories, types, and specific information that may be stored as part of a UPD. Figure 4 The UPD information shown and described is not limiting and is not necessary in some cases. In addition, different UPDs for different types of processes may include different information or different information groups.

[0072] Generally speaking, Figure 4 The UPD 200 includes different categories of data or information, and each of these information categories may have different types or details of information stored therefor. In addition, as will be understood, Figure 4 The various categories, fields, subfields, etc. of data within the UPD 200 may be populated, added, augmented, expanded, removed, etc. during the development process of the UPD based on various different operations of the UPD at the same or different sites or facilities. Generally speaking, as the UPD advances through the entire development life cycle, more fields of the UPD and more specific data within each field will be added because more information about implementing the UPD is typically needed when the defined process is implemented on larger and more complex equipment that is typically associated with the later development and production stages of the process development life cycle.

[0073] More specifically, UPD 200 may include version field 202 indicating a version of the UPD. Versioning may be performed in any desired manner, and thus version field 202 may have any number of version fields, including, for example, a value field and a stage assignment field (e.g., there may be multiple version numbers associated with a particular development stage). Of course, version numbers may be based on a particular stage, a particular size, a particular type of site or equipment at a site, etc., or may be incremented and associated with a particular stage, a particular size, a particular type of site or equipment at a site, etc., and thus in addition to Figure 4 Other version fields may be used in addition to or in place of the version fields shown.

[0074] In addition, UPD 200 may include any other number of data fields for defining a process, including, for example, a step or operation field 204, a sequence field 206, a material field 208, a relative amount field 210, an equipment field 212, and an important operating parameter / data field 214. Generally speaking, a step or operation field 204 includes data associated with or defining various steps or operations performed as a part of a defined process. These steps or operations may define specific activities or subprocesses that need to be performed as a part of a defined process. A step or operation field 204 may include an operation list, such as mixing, heating, stirring, drying, cleaning, moving, rotating, filling, emptying, measuring, etc., or any other process steps to be implemented at a certain point in the process so that the production process is designed to produce the product. A step or operation field 204 may indicate whether any one of the steps therein must be implemented in a batch process or a continuous process or can be implemented in any one of a batch process or a continuous process. Step or operation field 204 may indicate that some steps or operations may be necessary or necessary steps, which means that these steps or operations must be performed or implemented during the process or may be indicated as preferred steps or alternative steps. Therefore, the field of UPD 200 may specify the condition of a value (such as a step or operation in this case), and such condition may include specifying whether the value is necessary or necessary, in which case, the process implemented on the equipment at the site must include the value. Alternatively, the field may indicate whether the value is preferred but not necessary (and therefore indicates that the value or parts are preferably used, but if necessary, the process may use an alternative value). In addition, the field may indicate that the value is an alternative value, which means that the value may be used as an alternative value of another value (such as a preferred value). This necessary, preferred, alternative condition assignment will be referred to as N / P / A value or condition in this article. Step or operation field 204 may also include one or more initial conditions, qualifiers, such as for the transition requirements for one or more steps to be transformed between steps, etc., associated with or defining the subfields of the one or more initial conditions, these qualifiers. Field 204 may also include information that specifies one or more ways in which a step or operation may or must be performed, such as whether the materials in the step must be processed together in one unit or may be separated and implemented in multiple different units. Of course, other types of information defining a step or operation or data associated with a defined step or operation may be stored in field 204 or as part of the field.

[0075] Additionally, the sequence field 206 stores information indicating the sequencing or timing to be applied to the steps or operations defined in the step field 204. This information may specify the order of steps, the overlap of steps, the timing of steps, whether different steps may be performed simultaneously or must be performed before or after other steps, the interconnection between the output of one step and the input of another step, etc. The sequence field 206 may specify whether the implementation of one or more steps is fixed in a particular order or is adjustable to some extent, whether steps must or may be performed serially or in parallel, transition conditions or data associated with the sequencing, etc.

[0076] The material field 208 lists or defines the ingredients, materials, and / or material properties associated with the materials used in the process, including raw materials, starting materials, ending materials, intermediate materials, etc. In some cases, the material field 208 may store data indicating N / P / A conditions for one or more materials or material properties or any other information about the materials to be used in the process or produced by the process. The material properties may specify values ​​or one or more ranges of values ​​for one or more material properties, and whether these values ​​or ranges are required, preferred, or alternative. The material properties or materials defined by the field 208 may specify the material in any manner, such as by name, type, composition, manufacturer, material selection, etc.

[0077] In addition, the relative quantitative or relative quantification information field 210 specifies the relative amounts of materials, sequences, etc. of the UPD so that the process implemented using the UPD can be correctly scaled to different scales or manufacturing volumes. In some cases, the scaling information or relative amount information may include the ratio of different materials to be added or used, the limit of the amount of materials, the limit of the size applicable to the UPD (upper and / or lower limit manufacturing size), etc. In other cases, the relative amount information field 210 may specify an example process (such as a specific throughput of the process), and may specify the amount of each material in the materials used in the example process, timing, etc., from which the ratio and other scaling information can be determined. When scaling up or down the UPD to be implemented at different throughputs or batch sizes, the relative amount information enables one or more transformation modules described herein to determine the amount of materials, timing, limitations, etc. Of course, the relative amount information can be defined in any desired manner.

[0078] Likewise, equipment field 212 may specify or define equipment that may or must be used in the process of implementing the UPD definition. Field 212 may define equipment at any level of specificity, including the category of equipment (e.g., mixer), the specific type of the category of equipment (e.g., mixer with a stirrer, or a mixer combining two stream inputs, etc.), the brand of equipment, the manufacturer of equipment, the model of equipment, etc. Field 212 may specify or define any equipment field value in the equipment field value as a necessary, preferred, or alternative equipment value. Equipment field 212 may also specify the size of equipment (such as the upper and / or lower limits of the size of a tank), the initial conditions of various equipment (e.g., heated to a specific value, cleaned using a specific cleaning agent or cleaning method or standard, etc.), whether the equipment can be extended using multiple items, such as using two units instead of one unit, etc. Equipment field 212 may also define the necessary, preferred, or alternative properties of equipment, such as whether the equipment must be able to handle corrosive materials, whether the equipment must be able to be used in a hazardous environment, whether the equipment is rated as intrinsically safe, etc.

[0079] In addition, the important operation field 214 may define important parameters associated with the operation of the process, the monitoring of the process, and the collection of feedback data from the process. Important parameters may include, for example, times, ramp rates, limits, etc. associated with one or more of the steps or operations in the operation field 204, or one or more sequences in the sequence field 206. The important parameter field 214 may define various control parameters and / or specific control values ​​associated with these control parameters (e.g., set points, limits, times, flow rates, control system execution rates, etc.) and whether these values ​​are necessary, preferred, or alternative. In addition, the important parameter field 214 may include values ​​associated with testing of one or more variables, products, intermediates, etc. produced by the process, such as the type of test, the frequency of the test, and / or the necessary, preferred, or alternative values ​​required for the test, etc.

[0080] In addition, if Figure 4 As shown, the important parameter data field 214 may include audit-related or regulatory data that needs to be measured, collected, or stored for the process, the frequency of collection, the type or nature of measurement equipment to be used to perform the test or measurement, and any other information about the data to be collected before, during and / or after the process is run for audit purposes.

[0081] Additionally, the important parameters field 214 may include parameters that need to be measured and / or collected to be provided back to the process developer for analysis of the process operation (e.g., as Figure 3The feedback data may specify or identify, for example, control parameters, process variable parameters, equipment type, size and configuration used during operation of the process at the plant, throughput, material inputs, instructions for changes made at the process by site personnel in order to run or implement the process, tests to be performed, quality measurements associated with the output (or any input) of the process or with the output (or input) of an intermediate stage of the process, manual notes made by a process operator or implementer, environmental conditions at the process, timing information, etc. The feedback data may include any data that a process developer or process operator may wish to see or record for the purpose of analyzing the process as it is running at the site and that a process developer may use to change, expand, modify, etc. the UPD. Of course, the important parameters field 214 may include or specify any other type of data that is considered useful or necessary for running the process or for collecting data from the process for regulatory, auditing or feedback purposes.

[0082] Of course, not Figure 4 All data or data fields shown must be included in the UPD. However, if Figure 4 As indicated by the * in , the step or operation field 204, the sequence field 206, the material field 208, and the relative quantity information field 208 are generally considered to be the most important and are generally necessary in any process definition. However, any and all of the information in the UPD and its various fields can be used by the transformation module described herein to create implementation documents or instructions (PDIF) for one or more sites, collect feedback data from one or more sites, and help analyze the feedback information to further develop the UPD as it moves through the development and production cycle.

[0083] Now turn to Figure 5A , depicting the transformation platform 300 in more detail. At a high level, the transformation platform 300 operates across multiple levels of the architecture, and therefore, and as described above, the transformation platform 300 may have elements that operate with or in each of the layers of the PDMS 100 (including the PKA layer 102, the transformation layer 104, and the field layer 106).

[0084] like Figure 5A, the transformation platform 300 includes a transformation layer 302. Generally speaking, the transformation layer 302 can be operated at the business unit level of the organization and / or at the site level of the organization, and can even be divided between multiple levels of the organization. The transformation layer 302 is usually operated as a PKA 102 that can generate and / or edit one or more universal process descriptions (UPD) associated with the manufacture, productization and / or packaging of the product and one or more development or production sites that can produce, productize and / or package products therein. The transformation layer 302 includes the various elements of the process description interface file (PDIF) of the specific or equipment-specific process described below to transform one or more equipment-independent UPDs into site-specific or equipment-specific. Then, the PDIF can be sent to one or more site operating systems 304 or used by the one or more site operating systems to implement necessary programs and operations at the development or production site to manufacture, productize or package projects, and can be used by the transformation layer 302 in various embodiments to actually program some or all of the site operations 304 to manufacture, productize or package projects.

[0085] Each of the site operating systems 304 may correspond to an aspect of the operation of a particular development or production site. Thus, a given development or production site may include Figure 5A Zero, one, a plurality of, or all of the field operating systems depicted in the field operating system, and may include Figure 5A Additional site operating systems not depicted in FIG. By way of example, Figure 5A The depiction shows that data may be collected from it for use by the transformation layer 302, data generated by the transformation layer 302 may be sent to it, and / or it may be explicitly programmed by the transformation layer 302 to perform a specific process. Therefore, and in view of the foregoing and following descriptions, it should be understood that at any given point, data from the field operating system 304 may be consumed by the transformation layer 302, or provided to the field operating system 304 by the transformation layer 302. Additionally, although the field operating system 304 is depicted as a separate system, Figure 5A The functions contemplated by the systems depicted in the 304 may be combined or further depicted. In addition, as will be readily appreciated, the functions associated with the systems depicted in the venue operating system 304 may operate independently or in concert.

[0086] in short, Figure 5AThe site operating system 304 depicted in the figure includes a control automation system 334, a manufacturing operation management (MOM) system or a manufacturing execution system (MES) 336, a historical library system 338, a batch execution system 340, an inventory / material management system 342, a control configuration system 344, an asset management system 346, and a supervision / compliance system 348. As will be understood, these site operating systems 304 may be different between various development and production sites. For example, a small development site such as a laboratory is unlikely to have many (if any) of these site operating systems 304, but may instead only have a system for saving electronic laboratory notebooks. For another example, a large continuous process site is unlikely to have a batch execution system 340 because it does not perform batch processing. Other sites may not have a control automation system 334 or a control configuration system 344 because these sites are not automated, as in the case of a small development site. Additionally, site operating systems associated with a particular industrial or manufacturing plant or site may include, for example, enterprise resource planning systems (ERP), modeling systems, data management systems, electronic laboratory notebooks, laboratory information systems, other types of record management systems, and / or other systems that provide and / or consume data and information related to the particular plant or site. Figure 5A The field operation system 304 depicted in is exemplary. However, it is broadly contemplated that: control automation systems 334 are those systems that actively control a set of process equipment to execute a process; control configuration systems 344 are those systems used to perform configuration of control automation systems; manufacturing operations management systems 336 are those systems that manage or direct processes and procedures in a process plant by, for example, arranging manually executed process execution steps, maintaining and specifying the performance of various standard operating procedures, etc.; historical library systems 338 are those systems that historicalize (i.e., store in an organized manner) parameters, variables, and other data associated with the execution of a process; batch execution systems 340 are those systems that execute batch procedures, coordinate communications between stages, and allocate equipment and other resources required for batch processing of batch processes; inventory / material management systems 342 are those systems that track, order, move various input materials to a process; asset management systems 346 are those systems that control or track the availability, status, maintenance, and other aspects of equipment in a process; and regulatory / compliance systems 348 are those systems that track data specifically needed for regulatory or compliance purposes. (Relatedly, other systems such as audit systems ( Figure 5A (not shown) can track data specifically needed for auditing of internal processes. For example, the audit system can ensure that internal standards are achieved / maintained, can ensure that specific parameters are not changed without authorization, can track authorization for changes, etc.).

[0087] The communication layer 332 serves as an interface between the transformation layer 302 and the field operating systems 304. The communication layer 332 includes a plurality of application programming interfaces (APIs) 350 that facilitate the communication of information between the transformation layer 302 and respective ones of the field operating systems 304. Of course, the communication layer 332 may include a plurality of types of APIs 350 for any category of field operating systems 304. For example, the APIs 350 may include an API for communicating with a control automation system sold by a first manufacturer (e.g., a DeltaV sold by Emerson). TM The communication layer 332 may include a first API for communicating with a first type of field operating system (e.g., a first API for communicating with a control automation system sold by a second manufacturer), a second API for communicating with a first type of programmable logic controller (PLC), a third API for communicating with a second type of PLC, and so on. That is, the communication layer 332 may include APIs 350 for the various different field operating systems 304 for each field operating system 304. As will be explained in further detail below, in various embodiments, the communication layer 332 may also include routines 352 for parsing data (e.g., PDIF) to determine which data should be transmitted to each of the field operating systems 304.

[0088] Returning to the transformation layer 302, the transmission module 306 is operable to receive one or more UPDs from the PKA layer 102 via the communication interface 120. In some examples and embodiments, the transmission module 306 is also operable to send one or more UPDs, process data, analysis outputs, and other data generated in the site operating system 304 or received by the transformation layer 302 from the site operating system to the PKA layer 102. Therefore, the transmission module 306 acts as a logical interface between the PKA layer 102 and the transformation module 302, and operates to receive, retrieve and / or request UPDs from the PKA layer 102. The transmission module 306 itself may include a parsing routine 308, which is used to parse the UPD to determine what data exists in the UPD. For example, the parsing routine 308 can find the title or other tags of the structured format of the UPD, and these titles or tags can be used to identify data about materials, operations, sequences, and quantitative information about materials, as well as any optional data present in the UPD. The transfer component can store the data extracted from the UPD as process definition data 322 in the data repository 310 for use by other modules and routines. In an alternative embodiment, the UPD can be parsed or analyzed by one of the plurality of analysis modules 328 of the transformation layer 302, wherein the process definition is similarly stored as process definition data 322.

[0089] In addition to the process definition data 322, the data repository 310 may also include a variety of other data. Site configuration data 320 may include data and information about the configuration of one or more development or production sites, which may be used by the transformation module 330 to transform the equipment-independent UPD into a site-specific PDIF, determine which development or production site in multiple development or production sites is acceptable, suitable or preferred for a specific process, and perform other analyses as described herein. Site configuration data 320 may be retrieved from each site operating system in the site operating system 304 via the communication layer 332. For example, the asset management system 346 may provide data about which equipment exists in its associated development or production site. The control automation system 334 may provide information directly about the configuration of various equipment in the associated development or production site (e.g., how the equipment is connected, what automation system exists, the capabilities of various system components, etc.), or may provide control routines, control modules, function blocks or other control objects from which one or more analysis modules in the analysis module 328 may derive the configuration of various equipment in the associated development or production site. The batch execution system 340 may provide data about which equipment is currently available (or available at a particular time) to run a desired batch. The inventory / material management system 342 may provide information about what input materials are available on the site (and in what quantities) or may be ordered (and when received). In this manner, the site operations system 304 provides information about each site in the site, which may be stored in the transformation layer 302 as site configuration data 320.

[0090] Site process and / or feedback data 324 may also be stored in the data repository 310. Site process and / or feedback data 324 may be data received from one or more of the site operating systems 304 after a process is executed at an associated development or production site. For example, site process and / or feedback data 324 may be data stored at an associated development or production site by a historian system 338 and received and / or retrieved from the historian system 338 via the communication layer 332. Although contemplated herein as being stored in the same historian system, it should be clear that process data (all data generated by a process and stored for later analysis, review, or other consumption) and feedback data (data specifically requested by the PDMS 100 for updating, validating, analyzing, etc. processes according to the specific implementation of the UPD and corresponding PDIF) may be stored in the same or different data repositories between site operating systems 304 and / or may be stored in the same or different data repositories when retrieved or received by the transformation layer 302.

[0091] The output of each of the transform modules 330 may be stored in the data repository 310 as transform output 326. The transform output 326 may include the PDIF and any other files or data generated by the transform module 330.

[0092] The data repository 310 may also include a variety of transformation data 312. The transformation data 312 includes data used by the transformation module 330 to generate the transformation output 326. One category of the transformation data 312 is the operation data 314. The operation data 314 includes information related to the transformation of the equipment-independent operation of the UPD into the equipment or site-specific PDIF. By way of example, the operation data 314 may include data associated with various equipment classes, types, brands and / or models that can be used to perform the equipment-independent operation specified in the UPD. For example, the UPD may specify the operation of "mixing" components A and B. The operation data 314 may generally indicate that for the operation "mixing", there are several types of equipment that can perform mixing: two pipes that merge the flow into a single flow; a container with a stirring element; a container with a stirrer; etc. The operation data 314 may indicate different types of equipment required or preferred for various types of input materials to be mixed based on viscosity, volume, whether the input material is wet or dry, etc. Thus, for any operation (mixing, heating, cooling, drying, extruding, etc.), the operational data may indicate the class of equipment, the type of equipment, information about the specific equipment, and related information for determining whether the operation (and, by extension, all operations of the process) can be performed on the equipment specified for a particular development or production site by the site configuration data 320. Thus, the operational data 314 may also include, for any class or type of mixing equipment, manufacturer or model information of the mixing equipment, volume / capacity data for the specific model, and other relevant data for the mixing equipment, so that the transformation module can determine from the site configuration data 320 and the process definition data 322 (no matter how specific the latter may be) how to configure the equipment in the development or production site, whether the production or development site is capable of manufacturing the product (or is capable of manufacturing the product) at a particular desired scale, whether one development or production site is better than another production or development site, etc.

[0093] As mentioned, the operational data 314 may also include information about the properties of various input materials that may be specified by the UPD. For example, the operational data 314 may include data about whether common input materials are corrosive, explosive, etc. (and therefore may require special handling or special equipment), the viscosity of the material, whether the material is wet or dry, the maximum temperature of the material, the freezing point and melting point of the material, etc.

[0094] Additionally, the transformation data 312 may include scaling data 316. The scaling data 316 may indicate various scaling parameters for different materials and / or operations. For example, the scaling data 316 may indicate for various materials whether they scale linearly for different processes, and / or may indicate how certain operating parameters change as the process is scaled up. With respect to the latter, for example, the scaling data 316 may indicate that for a heating operation, the time requirement for heating to a certain temperature or for achieving a desired reaction scales exponentially rather than linearly.

[0095] Other data 318 may also be included in the transformation data 312. By way of example and not limitation, such other data may include libraries of control routines and / or function blocks for various specific equipment, various specific equipment types, various specific control automation systems, various PLCs, etc. This other data 318 may further facilitate the transformation of the UPD into a PDIF, and specifically into a PDIF that may be used by personnel at a specific development or production site to configure a process at that site, and further in an embodiment may be used directly by the transformation layer 302 to configure a specific development or production site to perform a process.

[0096] It should be understood that in some embodiments, part or all of the transformation platform 300 may be located in a cloud computing environment. However, it is not required that all components of the transformation platform 300 reside in the cloud, and therefore, some components may be located at individual workstations or servers at development or production sites, business operation centers, etc. Additionally, the components of the transformation platform 300 may be executed on different systems or the same system, and the system on which the components are executed may vary according to a specific embodiment. That is, the platform considered and disclosed herein is a logical arrangement of components, rather than a physical arrangement of components. For example, the transformation module 330 may be executed at the development or production site, or executed at the central facility responsible for managing UPD and PDIF, and the associated data (transformation output 326, site configuration data 322, process definition data 322) may be stored locally to the transformation module 330, or remotely stored from the transformation module.

[0097] Each of the transformation modules 330 is responsible for performing a transformation of the data. The transformation modules 330 may transform the data from the equipment-independent UPD to a site-specific PDIF, may transform the data from the UPD to an intermediate form for later transformation by another transformation module in the transformation module 330, may transform the data between intermediate forms, and / or may transform the data from the intermediate form to a site-specific PDIF. Thus, the transformation modules 330 may be specific to the type of transformation in some embodiments, and / or may be specific to a specific development or production site in other embodiments.

[0098] Figure 5BAn example implementation of a transformation layer 302 is depicted in which a plurality of transformation modules 330 each perform a specific transformation. Figure 5B In an embodiment of the invention, transformation module 354 performs a scaling transformation, transformation module 356 performs a site suitability transformation, transformation module 358 performs a process specification transformation, transformation module 360 ​​performs a control automation transformation, and transformation module 362 performs a control configuration transformation. In contrast, Figure 5C An example implementation of a transformation layer 302 is depicted, wherein each of a plurality of transformation modules 330 is configured to perform operations related to Figure 5B 354 to 362. That is, each of the transformation modules 330 includes a scaling routine 364, a site suitability routine 366, a process specification routine 368, a control automation routine 370, and a control configuration routine 372. Figure 5C In the depicted embodiment, each of the N transformation modules 330 corresponds to a specific development or production site 1 to N. Of course, it should be understood that the Figure 5B In the example embodiments depicted, some implementations may omit certain of the transform modules, some implementations may combine the functionality of the transform modules, and some implementations may include additional transform modules. Figure 5C In the example embodiment depicted, each of the transformation modules 330 may include only those routines that are necessary or appropriate for the particular development or production site to which it is applied. For example, in the absence of control automation in a laboratory environment, a transformation module for a laboratory development site may not include control automation or control configuration routines. These various example transformations will be described with respect to FIG. 5E to FIG. 5I Described in further detail.

[0099] The site configuration data 320 may be stored at a corresponding development or production site in an implementation scheme, in the cloud in an implementation scheme, and / or on a server or workstation executing the transformation module 330, as long as the site configuration data can be accessed by various transformation modules 330 and analysis modules 328 when necessary. Figure 5D A set of example venue configuration data 320 is depicted, including venue data 3741 to 374N for each venue in a set of N venues 1 to N. Just as each venue may have a set of venue-specific venue operating systems, and each venue may vary in which venue operating systems are implemented, so each set of venue data may also have a corresponding set of data, and each venue may vary in which data is available and / or stored. The following exemplary data types are provided by way of example and not limitation to illustrate the types of data that may be stored in venue configuration data:

[0100] Control automation data 376: data defining the type and arrangement of the control automation system, including, for example, system manufacturer, hardware, hardware version, software, software version;

[0101] Control configuration data 378: data defining the logical and / or physical configuration of the process control system, including what equipment is present, what transmitters are present, device tags or registers corresponding to each equipment parameter and / or transmitter, I / O configuration, configured control loops;

[0102] Batch execution data 380: data defining batch-specific automation parameters, including configured phases, units, processes, etc.;

[0103] Manufacturing operations management data 382: higher level data including standard operating procedures (SOPs) for performing certain operations and / or operations that must be performed manually, overall site facility information (location, shift data, operation schedules, open capabilities, etc.);

[0104] Inventory / materials management data 384: data indicating what input materials are available at the site, can be readily obtained, can be ordered within various time frames, and the quantities associated with the input materials;

[0105] Asset management data 386: data indicating available equipment assets, the manufacturer, make and model of the equipment, the capacity / size of the equipment, the calibration and / or maintenance status of the equipment;

[0106] Historian data 388: data defining parameters that are routinely or currently programmed to be historized, the frequency with which data is to be historized, the type of historization system, and the storage capacity;

[0107] Regulatory / Compliance Data 390: Data defining parameters that are routinely or currently programmed to be tracked for regulatory compliance, the frequency with which data is collected, the types of systems that track regulatory / compliance data, and regulatory certifications achieved and / or maintained;

[0108] Audit data 392: data indicating the audit software employed at the site, data required by the site operator to conduct an audit, data available to site users for conducting an audit;

[0109] Scheduler data 394: data indicating the current schedule of a development or production site, including what resources are available and when;

[0110] Other Data 396: Any other type of data from the site's operational systems, such as log data (whether manual or electronic).

[0111] Of course, the description of each of the sets 376 - 396 of venue data 374 is merely exemplary, and each type, if present, may include less or more information than described above.

[0112] Now go to FIG. 5E to FIG. 5I , various example transformation modules 330 are illustrated with corresponding example inputs and outputs. Figure 5E Describe the scaling transformation module (or the scaling routine of the transformation module) 400. In an embodiment, the scaling transformation module 400 may be configured to consume some or all of the process definition data 322 for specifying the UPD (and generating from the specified UPD). In other embodiments, the scaling transformation module 400 may be configured to receive the UPD itself as input, and the data may be parsed as part of its routine. In any case, the UPD or process definition data 322 may explicitly or implicitly include an indication of the scale for which it is designed. For example, in an embodiment, the UPD may specify that the UPD produces a 5L batch of products, may include a total of 5L of combined input materials, or may specify that the UPD is valid for a range of 0L to 5L. Alternatively, in some cases, the UPD or process definition data 322 may not have an indication of scale, wherein the UPD only indicates the relative amount of input materials (e.g., 1 part X, 3 parts Y, etc.). In these cases, it may be assumed that the UPD is valid for all scales.

[0113] As reference Figure 4 As described, the UPD (and therefore the process definition data 322) specifies at least a minimum set of information about the process, including input materials, amounts or ratios of the input materials, operations performed on the input materials, and the order of the operations. The UPD may also include parameters of the operation (e.g., heating to X degrees Celsius, heating for Y minutes), properties of the input materials (e.g., material Z with 5% salinity), etc. The scaling transformation 400 may take into account any information included in the UPD that may be relevant to the change in scaling.

[0114] The module or routine 400 also receives information 402 regarding the scale of the desired transformation. The scale information 402 may be received from the management execution engine 76 or from any other element of the PDMS 60 that requests scaling of the transformation. In any case, the scaling module 402 receives the UPD or process definition data 322 and the scale information 402 and uses both along with the transformation data 312 to produce a scaled UPD 404 and / or a set of scaled process definition data 406, either of which includes a scale adjustment relative to an unscaled UPD. Adjustments to scale may include replacing relative quantitative information (e.g., 1 part X, 2 parts Y) with absolute quantitative information (e.g., 5 L of X, 10 L of Y), correcting relative quantitative information (e.g., 2 parts X, 3.8 parts Y), correcting parameters associated with input materials (e.g., from a first scale where 10% salinity is necessary to a second scale where 5% salinity is necessary), correcting parameters associated with operations (e.g., from a first scale where heating for 5 minutes is sufficient to a second scale where heating for 10 minutes is necessary), or making any other corrections to account for the change in scale.

[0115] The revised, scaled UPD may be stored, transmitted to the PKA system 70 , transmitted to a development or production site (eg, to allow engineers to set up a process), etc. Alternatively or additionally, the scaled process definition data 406 may be stored in the data repository 310 .

[0116] Fig. 5F An example site suitability transformation module 410 is shown that can determine whether one or more sites are suitable or desirable for producing a given product. In an embodiment, the module 410 can receive or retrieve the scaled UPD 404 or the scaled process definition data 406. However, while in Fig. 5F 404 or the process definition data 406 being scaled, the module 410 may also receive information about specific requirements for production, which may partially determine whether a given development or production site is suitable. Depending on the embodiment, the requirement information may include some or all of the required level (e.g., complete) or type (e.g., PLC) of automation 412, the required production area 414, the deadline or other timing information 416 (e.g., the date by which the process must be completed), and various other information 418. Other information 418 may include the required product volume, the specification of preferred or required equipment, the required regulatory certification, etc. Module 410 may also receive or retrieve transformation data 312.

[0117] Module 410 considers the indicated requirements and preferences, compares this information to the site configuration data 320, and determines the suitability of one or more sites for production, as will be described in more detail below.

[0118] Once a development or production site has been identified and / or selected, the user may invoke the process specification transformation module 420, such as Figure 5G Depicted. The process specification transformation module 420 is operable to specify a set of site-specific procedures for completing a process using the equipment at the selected site. Site-specific procedures can specify any type of information for executing a process, and can be relatively more or less specific in various embodiments or examples. For a given development or production site with a given set of equipment, the process specification transformation module 420 can generate one or more PDIFs specifying various parameters for executing a process at the site. These PDIFs can provide the manufacturing operation management system 336 of the site with information on how to use the equipment at the site to execute a process. For example, these PDIFs can specify that before rinsing a 500L tank and the input pipeline to the tank with distilled water, the tank and the pipelines should first be rinsed with a cleaning solution that keeps in contact with the tank and the pipelines for 15 minutes. These PDIFs can then specify that the first input pipeline and the second input pipeline are connected to the supply source of the corresponding first input material and the second input material, and the first input material and the second input material are added to the tank in equal portions (total volume is 400L), wherein the pressure for the second input material does not exceed 100psi and the pressure for the second input material does not exceed 50psi. These PDIFs may indicate that the mixing element in the tank should be engaged at 100 RPM and the heating element should be concurrently turned on to heat the mixture at 5°C / hour to a set point temperature of 30°C, and once the set point temperature is reached, the mixture should be maintained at that temperature for three hours while adding a third input material at a rate of 1 L / hr per 100 L of mixture.

[0119] In embodiments or examples, these PDIFs may also specify the standard operating procedures (SOPs) for one or more steps in the steps of the execution process. These PDIFs may specify that SOP AA should refer to the steps for connecting the input pipeline to the cleaning solution supply source, SOP BB should refer to the steps for rinsing the tank with distilled water, and SOP CC should refer to the steps for engaging the mixing element, etc. As should be understood, each SOP may be site and / or equipment and / or product specific, and may specify any details about the step (e.g., how tight the torque of the input coupling is, the maximum ramp rate for making the mixing element reach speed, etc.). In other embodiments, the PDIF may specify additional data for the execution process, including, for example, what data must be tracked for management and / or compliance purposes (and the frequency of tracking and at what point tracking), what data must be tracked for internal audit purposes (and the frequency of tracking and at what point tracking), scheduling information for the process, and any other data that may be relevant to the execution process, which depends in part on the UPD404 or process definition data 406 provided to the process specification transformation module 420. These other data may include data such as: whether operations can be performed in parallel or must be performed serially; constraints on sequence parameters; specifications related to transitions between operations; initial conditions of equipment; initial conditions of materials; material properties of one or more input materials; equipment type; equipment size; equipment model; equipment capabilities; important parameters, including time / duration, ramp rate, and / or limits for various operations, sequences, control parameters, and test / sampling values; feedback data capture parameters, audit and regulatory data parameters; and more. Any of the above data may be designated as required, preferred, and / or alternative values.

[0120] As described above, the process specification transformation module 420 may output one or more PDIFs 422. The one or more PDIFs may include information in a single file or in multiple files (each file relating to one of the site operating systems 304). Although the PDIF output by the process specification transformation module 420 will typically include manufacturing operations management data 422A (e.g., specified processes, SOPs, etc., as described above), the PDIF output by the module 420 may also include regulatory / compliance information 422B, audit information 422C, and / or scheduler information 422D in a single file or separate files. The PDIF may be communicated to the site or, in an embodiment, directly to the corresponding site operating system 304 (e.g., system 336, 348, etc.).

[0121] Alternatively (or, conceivably, additionally), instead of invoking the process specification transformation module 420, the control automation transformation module 424 may be invoked, such as Figure 5H. In contrast to the module 420 that specifies operations, SOPs, and other information that can be used to manually perform a process and / or develop a control routine for performing a process, the contemplated control automation transformation module 424 operates to develop control automation logic that can be used at the site. The operation of the control automation transformation module 424 is similar in many respects to the operation of the module 420. However, in the case of the module 424, in addition to the type of process equipment present at the site, the module may also receive data indicating the availability and type of control automation equipment at the site from the site configuration data 320. The site configuration data 320 may also include data indicating what function blocks and / or control modules are configured at the site (e.g., from the control automation data 376 or the control configuration data 378), or may include a library of function blocks and / or control modules available at the site. Additionally or alternatively, the transformation data 312 may include various libraries 318A, 318B, etc. of function blocks and / or control modules that can be used with various equipment to perform various operations. Based on the available function blocks and control modules received from either or both of the transformation data 312 and the site configuration data 320, the control automation transformation module 424 may create site-specific control automation logic for the site. That is, the module 424 may be operable to create function blocks and control modules for operating one or more process controllers that are bound to specific equipment in the development or production site (e.g., by device tags), may be operable to create ladder logic for programming one or more PLCs that is bound to specific equipment in the development or production site (e.g., by specific register values), and so on. The site-specific control automation logic for the site may be output as PIDF data 422 and may be used by personnel at the development or production site to program hardware and software to perform some or all of the process.

[0122] Therefore, in addition to the data 422A to 422D described above about module 420, PDIF data 422 may also include control routine 422E and / or batch execution information 422F. In view of this description, it should be apparent that control routine 422E and / or batch execution information 422F do not need to promote the automation of each step, operation or program of process. In embodiments, it is expected that, although control automation can promote the part of the process in given development or production site, some steps, operation or program may not be automated in the site due to equipment limitation, automation limitation, regulatory limitation etc. As only one example, the process specified by UPD can be to use control automation to be implementable at a specific site, and therefore, module 424 can develop and output control modules and routines for many steps in the step of performing the process. However, the example process may include one or more manual sampling and test steps, wherein the sample of product is obtained and analyzed in the laboratory, and the sample analysis result is manually recorded. Therefore, the process implemented at the site may also include manual steps except the step of automation. Thus, in an embodiment, control of the process may be passed back and forth between a control automation system 334 (programmed to operate process equipment to perform portions of the process based on the output of module 424) and a manufacturing operations management system 336 (programmed to direct, verify, validate, etc., the manual portions of the process based on the output of module 424). Of course, the PDIF 422 output by module 424 may be used to configure other aspects and systems of a development or production site, including programming a regulatory / compliance system 348 based on regulatory / compliance system PDIF data 422B, programming an audit system based on audit system PDIF data 422C, programming a scheduler system based on scheduler system PDIF data 422D, programming a historian system 338 based on historian system PDIF data 422G, and programming any other system based on corresponding PDIF data.

[0123] In yet another alternative, the control configuration transformation module 430 may be called, such as Fig.5I. Unlike the control automation transformation module 424 that operates to develop control automation logic that can be used at the site, the contemplated control configuration transformation module 430 actually operates to configure some or all of the site operating system 304 in addition to developing control automation logic. That is, the module 430 can output one or more PDIFs 422 (the data from which corresponds to the selected site operating system 304), and can direct the programming of the site operating system 304 via the API 350 in the communication layer 332. In a specific embodiment, a PDIF parsing routine 352 disposed in the communication layer, in the transformation module 430, or elsewhere can parse the one or more PDIFs 422 and direct the data therein to the corresponding site operating system 304. Thus, the module 430 can configure one or more process automation resources within a development or production site so that a user, by calling the transformation module 430, can obtain an equipment-independent UPD (e.g., the scaled UPD 404), transform it into a site-specific process specification, and configure the process plant to perform the process with minimal manual intervention.

[0124] In various embodiments, various transformation modules or their corresponding functions in the transformation module 330 may be combined and / or omitted, and other transformation modules for performing other transformations may be added. In addition, in various embodiments, specific data within the PDIF 422 may be replicated among multiple PDIFs (where the PDIF data is split into multiple files), each of which may correspond to a different one of the field operating systems 304, or when only a single PDIF is present, the specific data may be used to program multiple field operating systems in the field operating system 304. For example, PDIF data related to input materials may be present in each of the manufacturing operations management PDIF data 422A and the inventory / materials management PDIF data 422I, and / or may be sent to both the manufacturing operations management system 336 and the inventory / materials management system 342.

[0125] In an embodiment, the transform module 330 may also include one or more inverse transform modules 450. One such inverse transform module 450 may be Figure 5J 4. In general, the inverse transformation module 450 operates to acquire data from a development or production site and create from that data a universal process definition that can be used by other transformation modules to become site-specific for other sites. This can be useful, for example, for creating a UPD from a laboratory bench or small-scale development plant for later transformation for use at other development or production sites. The inverse transformation module 450 can also be used to create a UPD from a well-established production facility for analysis purposes and / or to transfer a process program to other facilities.

[0126] The inverse transformation module 450 receives site-specific data 320 from a development or production site. Depending on the type of site (e.g., a laboratory bench versus a large-scale commercial production plant), site-specific data may differ in form, substance, and / or source. For example, for a laboratory bench, site-specific data may include an electronic laboratory notebook, while for a large-scale commercial production plant, site-specific data may include a complete set of data from each of the various site operating systems 304, control routines, and process data generated during process execution. The inverse transformation module 450 (or its various versions) is configured to receive site-specific data and generate a UPD that includes at least minimally basic input material information 208, basic operating information 204, basic sequence information 208, and basic relative quantitative information 210. Of course, when the site from which the UPD is generated by the inverse transformation module 450 is a laboratory bench, the UPD may include only minimal information, and a more detailed UPD may be generated from a complete set of site-specific data 320 received from an operating commercial production plant.

[0127] The inverse transformation module 450 can extrapolate usable UPD data from any data input into it. Thus, if the module 450 receives data from an electronic lab notebook software, the data may include a set of simple operations performed on a set of input materials in a particular order. There may or may not be operational parameter data associated with the data from the electronic lab notebook. In such an instance, the module 450 can easily create a UPD from the electronic lab notebook data because there is typically less data to parse.

[0128] In contrast, when provided with site-specific data from a commercial production site, the inverse transform module 450 may have significantly more data to parse, although concomitantly, the UPD may be more detailed. Figure 5J is an example of this. Figure 5J In FIG. 4 , the inverse transformation module 450 receives the control routine 452 and the manufacturing operation management data 454 as part of the site specific data 320. Figure 5AUnlike the control automation data 334 and the manufacturing operations management data 336 in the 312 (which do not include programmed processes), the data 452 and 454 include the programming of the process and may include SOPs, manufacturing execution instructions, control routines, PLC ladder logic, batch execution data, etc. In some cases, the inverse transformation module 450 may additionally receive process data 324 generated during the execution of the process and stored by the historian system 338, the regulatory / compliance system 348, the audit system, etc. The inverse transformation module 450 can use the site-specific data 320, the process data 324, and other data together with the transformation data 312 to "reverse engineer" the UPD. For example, the inverse transformation module 450 can calculate the relative amount of input materials based on the measured flow rate and the duration of the flow (e.g., the valve is open for 20 seconds, allowing a flow rate of 5 L / s), based on the measured volume in the tank, etc. The inverse transformation module 450 can determine the input materials themselves based on data in the inventory / material management system, based on manufacturing operations management information, etc. The operations and sequence of operations may be determined, for example, by viewing the order in which the operations occur in a batch control environment, by reviewing manufacturing operations management information, etc. Various control parameters may likewise be determined by reviewing control routines 452, process data 324, historian data 338, etc. In an embodiment, transformation data 312 may aid in this analysis by providing context for the types of operations performed by different equipment (e.g., operation data 314), while scaling data 316 may facilitate distillation of the implemented processes into basic ratios of input materials for UPD.

[0129] In any case, the inverse transformation module 450 may output a set of scaled process definition data in an embodiment, or may output a new UPD 456 based on the implemented process. The UPD 456 may be compared with a previous version of the UPD to determine differences in products, processes, equipment employed, etc. The UPD 456 may also be sent to the PKA layer 102 for review and / or editing. In addition, the UPD 456 may be used as input to a transformation module (e.g., modules 400, 410, 420, 424, 430, 450) for further transformation.

[0130] Figure 6At a high level, a method 460 of configuring a development or production site to manufacture, productize, or package a product is depicted. For simplicity, manufacturing, productization, and packaging will be collectively referred to as "manufacturing." However, it should be recognized that between raw materials and a product that is marketed for sale, there may be multiple processes, each of which may require different facilities, sequences of operations, and / or sets of equipment. As just one example, a pharmaceutical product may go through a first process of turning raw ingredients into active ingredients, a second process of turning the active ingredients into a product (a pill or suspension or capsule, etc.), and a third process of packaging the product (e.g., placing it into a blister pack, bottle, etc. and placing it in its final sales package), etc. Thus, with respect to Figure 6 The described order of operations may encompass some or all of the manufacturing processes in any given embodiment.

[0131] Figure 6 The method 460 depicted in FIG. 4 includes receiving a UPD specifying a series of equipment-independent processing steps for manufacturing a product (block 462 ). Figure 6 The method 460 depicted in FIG. 4 also includes receiving data related to the configuration of the development or production site (block 464). The method 460 also includes automatically transforming the series of equipment-independent processing steps into data specifying one or more routines for performing the series of processing steps to manufacture a product using the equipment at the development or production site (block 466). The transformation may be performed by one or more transformation modules in the transformation layer. In an embodiment, each of the transformation modules corresponds to a different one of the site operating systems and is programmed to configure the corresponding site operating system based in part on the site configuration data and the process definition data.

[0132] As should now be understood, one or more routines for performing a sequence of processing steps may include one or more manual processing steps, one or more automated processing steps, or a combination of one or more manual processing steps and one or more automated processing steps. Method 460 may also include programming one or more systems at a development or production site to coordinate a combination of automated actions and manual actions to perform a sequence of processing steps, and may include specifying an automated portion of a sequence of processing steps and a manually performed portion of a sequence of processing steps. Automatic transformation of a sequence of equipment-independent processing steps may include generating one or more control modules or control routines (the one or more control modules or control routines are operable to control equipment at a development or production site to perform one or more automated steps of the one or more routines), and in embodiments, may include programming one or more automated systems at a development or production site to perform the one or more routines, programming one or more programmable logic controllers at a development or production site to perform a sequence of processing steps, and / or programming one or more batch controllers at a development or production site to perform a sequence of processing steps. The received data related to the configuration of the development or production site may include: equipment tag information; automation equipment type information; process control equipment information; I / O configuration data; and / or skid configuration information.

[0133] As described elsewhere, the received UPD includes at least data related to input materials, data related to the ratio or amount of input materials and / or intermediate products, data related to operations on input materials and / or intermediate products, and data related to the order in which operations are performed, and may include duration data related to corresponding operations in the operation, parameter data of corresponding operations in the operation, constraint data of corresponding parameter data, required initial state data of equipment performing corresponding operations, required feedback parameters to be collected, required audit data to be collected, preferred range data of corresponding parameter data, and preferred equipment type data for one or more operations in the corresponding operation. Method 460 may also include identifying one or more types of equipment corresponding to each corresponding operation based at least on the data related to the operation. Method 460 may also include comparing data related to the configuration of the development or production site, and determining whether the development or production site has at least one type of equipment in one or more types of equipment corresponding to each corresponding operation so that a series of processing steps can be performed at the development or production site.

[0134] In an embodiment, automatically transforming a series of equipment-independent processing steps into one or more routines for performing the series of processing steps includes automatically scaling input materials according to the ratios or amounts and adjusting operations to manufacture, productize, or package the product using the equipment at the development or production site. In addition, the method may include receiving an indication of an amount of the product to be manufactured, productized, or packaged at the development or production site, determining capabilities of one or more equipment at the development or production site, and determining whether the equipment at the development or production site can produce the indicated amount.

[0135] In some embodiments, automatically transforming a series of equipment-independent processing steps into one or more routines for performing the series of processing steps includes automatically scaling input materials according to the ratios or amounts and adjusting operations to manufacture, productize, or package a specific amount of product using equipment at the development or production site. In these embodiments, method 460 may also include receiving inventory information related to input materials available at the development or production site, comparing the inventory information to the scaled input materials, and determining whether the development or production site can produce the specific amount of product using the input materials available at the development or production site.

[0136] In an embodiment, automatically transforming a series of equipment-independent processing steps into one or more routines for performing the series of processing steps includes automatically scaling input materials according to these ratios or amounts and adjusting operations to manufacture, productize or package a specific amount of product using the equipment of the development or production site within a specified time. In such embodiments; method 460 may also include receiving equipment availability scheduling information related to the development or production site, determining the total time required to produce the specific amount of product using the equipment of the development or production site, and determining whether the development or production site can produce the specific amount of product within the specified time based on the equipment availability scheduling information and the total time required.

[0137] Figure 7 A method 470 for creating a UPD is depicted. The method 470 includes receiving data specifying the execution of a set of process steps for manufacturing, productizing, or packaging a product using a set of specified equipment in the development or production site from one or more site operating systems of the development or production site (block 472). The method 470 also includes receiving data related to the physical configuration of the development or production site (block 474). In addition, the method 470 includes automatically creating a UPD based on the received files specifying the execution of the set of process steps and the received data related to the physical configuration of the development or production site.

[0138] In various embodiments, the data specifying the execution of this group of process steps include one or more automated control routines, one or more manual processing steps, or both. In embodiments, the data specifying the execution of this group of process steps include electronic laboratory notebook data. In embodiments, UPD includes a group of input materials, a group of operations performed on the input materials, the order of operation execution, and quantitative information about the amount of corresponding input materials. UPD may also include one or more of the following: equipment for the necessary type of one or more operations in operation, equipment for the preferred type of one or more operations in operation, initial conditions of equipment for one or more operations in operation, necessary material properties of one or more input materials in input materials, preferred material properties of one or more input materials in input materials, alternative materials of one or more input materials in input materials, constraints for one or more parameters, parameters to be stored in the supervision tracking system, and parameters to be stored by the data history library system.

[0139] The method 470 may also include transforming the created universal process definition into second data specifying the execution of a set of process steps for manufacturing, productizing, or packaging a product using a different set of equipment and / or at a different process plant, and / or comparing the created universal process definition with a second universal process definition and indicating differences between the two. When implemented in software, any of the applications, modules, routines, managers, layers, engines, services, virtual devices, virtual machines, virtual entities, etc. described herein may be stored in any one or more tangible non-transitory computer-readable memories, such as stored on a magnetic disk, a laser disk, a solid-state memory device, a molecular memory storage device, or other storage medium, stored in a RAM or ROM of a computer or processor, etc. Although the example systems disclosed herein are disclosed as including software and / or firmware and other components executed on hardware, it should be noted that such systems are merely illustrative and should not be considered limiting. For example, it is contemplated that any or all of these hardware, software, and firmware components may be embodied exclusively in hardware, exclusively in software, or in any combination of hardware and software. Thus, while the example systems described herein are described as being implemented in software executing on processors of one or more computer devices, persons of ordinary skill in the art will readily appreciate that the examples provided are not the only way to implement such systems.

[0140] Now go to Fig. 8A , Fig. 8A A flow chart of an example method 800 for developing an industrial process based on a site-specific implementation of the industrial process is depicted. In an embodiment, the method 800 may be performed in whole or in part by Figure 2 Process Development and Management System (PDMS) 60 and / or by Figure 3For example, at least a portion of method 800 may be performed by Figure 2 The transformation manager 76 and one or more transformation modules 80 are implemented or executed, and / or at least a portion of the method 800 may be implemented or executed by Figure 3 The process knowledge management layer 102 and the transformation layer 104 are implemented or executed. Therefore, the method 800 can be saved to one or more memories as one or more sets of computer executable instructions, which can be executed by one or more computing devices of the PDMS 60 and / or PDMS 100. In an embodiment, the method 800 may include additional or alternative blocks other than those discussed in the present disclosure. In an embodiment, the method 800 may be combined with other methods described herein (such as Figure 6 In addition, for the purpose of explanation and not for the purpose of limitation, Fig. 8A Also refer to the description of Figures 2 to 4 , FIG. 5A to FIG. 5J and Figure 6 Additionally, Fig. 8A Optional blocks of method 800 are indicated using dashed lines.

[0141] At block 802, method 800 includes receiving, at one or more computing devices, collected site data. The collected site data corresponds to data collected by one or more execution systems at an industrial process site during execution of a site-specific implementation of an industrial process at the industrial process site. For example, method 800 may include receiving, via one or more computing devices of PDMS 60, data associated with an industrial process at a site-specific implementation of an industrial process. Figure 2 One of venues 62 to 68, Figure 3 At least some of the collected site data may correspond to data collected by one or more site-specific execution or operating systems, such as site process / feedback data 192 generated and / or collected by one or more of the site operating systems 304 of the site 190 where the industrial process is executed. The collected site data may include, for example: process data generated by the execution of the industrial process at the site; configuration data and values; other values ​​of parameters and / or settings; site historian information; data that can be used for regulatory, audit and / or compliance purposes; notes, photos / images, etc. generated by operators or personnel; site environmental data; feedback data; and the like. In general, the collected site data may include any data corresponding to the execution of the industrial process at the site 190 and provided by the site 190 to the PDMS 100.

[0142] In some cases, at least some of the collected site data received at block 802 includes data indicative of corresponding equipment specific to the industrial process site 190. For example, at least some of the collected site data may include site process / feedback data 192, 324, at least some of which includes data indicative of site-specific equipment. In these cases, method 800 may include (at Fig. 8A ), after receiving the collected field data, the collected field data indicating field-specific equipment is transformed into corresponding or corresponding equipment-independent data by one or more computing equipment. For example, one or more of the inverse transformation modules 194, 450 may operate on the field process / feedback data 192, 324 received via one or more communication APIs 184 to transform the received field data into corresponding equipment-independent data.

[0143] In some cases, at least some of the collected site data received at block 802 may have been transformed from data indicative of site-specific equipment to equipment-independent data prior to being received at block 802. For example, one or more of the site-specific execution systems 304, the communication layer 332, and / or one or more of the communication APIs 184, 332 may have operated on data corresponding to execution of an industrial process at the site 190 and indicative of site-specific equipment to transform such data to equipment-independent data. In such cases, the inverse transformation module 194, 450 may not operate on (e.g., may simply pass through) the equipment-independent data received via the API 184, or the equipment-independent data may bypass the inverse transformation module 194, 450.

[0144] At block 805, method 800 includes obtaining, by one or more computing devices, a universal process definition (UPD) for the industrial process from a data repository, wherein the universal process definition specifies a sequence of equipment-independent process operations (and optionally may specify other components) corresponding to the industrial process. For example, block 805 may include obtaining the universal process definition 72 for the industrial process executed at one of sites 62 to 68 from database 73 of PDMS 60, and / or block 805 may include obtaining the universal process definition 112 for the industrial process executed at site 190 from database 114 of PDMS 100.

[0145] At block 808, the method 800 includes associating, by one or more computing devices, the collected site data with one or more components of a pervasive process definition of an industrial process executed at an industrial process site 190 (e.g., one of the sites 62 to 68). That is, various different collected site data may be associated with different sets (e.g., one or more) of components of the pervasive process definition. Figure 4With reference to the UPD 200 of the industrial process, at block 808, the collected site data may be associated with one or more process steps or operations 204 defined by the UPD 200 of the industrial process, one or more characteristics of one or more sequences 206 of the industrial process defined by the UPD 200, and relative quantitative or sizing information 210 corresponding to one or more input materials 208 defined by the UPD 200, one or more characteristics of equipment 212 defined by the UPD 200, one or more parameters 214 defined by the UPD 200, and / or other components 214 of the UPD 200 of the industrial process. For example, the collected site data may indicate that field devices of a particular manufacturer were utilized in a particular control loop during execution of the industrial process at the site 190, and thus an indication of this may be stored with the equipment information 212 defined by the UPD 200 of the industrial process. In another example, an additional constraint on the execution of a portion of the sequence of the industrial process may have been implemented on the fly by an operator of the plant site 190 during the execution of the process at the site 190, and the additional constraint may be added to the definition of the sequence 206 of the UPD 200 of the industrial process. In yet another example, data indicating an adjustment of the ratio of two input materials at the site 190 may be associated with both the definition of the relative quantitative information 210 of the UPD 200 and one or more aspects 214 of the UPD 200 of the industrial process indicating the scale or size (e.g., throughput, quantity, etc.) of the site 190. In yet another example, feedback data corresponding to the industrial process executed at the site 190 (such as quality measurements, changes, configurations, etc.) may be associated with corresponding other components 214 of the UPD 200 of the industrial process. Of course, these are only a few of the many examples of collected site data that may be associated with one or more components of the UPD 200 of the industrial process executed at the industrial process site.

[0146] In an embodiment, associating 808 the collected site data with one or more components of a ubiquitous process definition of an industrial process executed at the industrial process site 190 may include associating data that has been generated and / or provided by the site 190 and has not yet been transformed (e.g., data indicative of site-specific equipment). Additionally or alternatively, associating 808 the collected site data with one or more components of a UPD of an industrial process may include associating data that has been generated and / or provided by the site 490 and has been transformed to be equipment-independent (e.g., by an inverse transformation module 194, one or more of the site-specific execution or operating systems 304, the communication layer 332, one or more of the communication APIs 184, 322, etc.).

[0147] At block 810, the method 800 includes storing an indication of an association between the collected site data and one or more components of the pervasive process definition. For example, the indication of the association may be stored with the pervasive process definition 72 in a Figure 2 The database 73 is stored together with the universal process definition 112. Figure 3 114 and / or stored with the process definition data 322 Figure 5A Additionally or alternatively, the indication of the association may be stored as historical data corresponding to UPD 72 and / or UPD 112 in data repository 73 and / or data repository 114, and / or as site process / feedback data 324. Figure 5A The method 800 includes obtaining approval of an association between the collected site data and one or more components of the pervasive process definition 200, and storing 810 an indication of the association is based on the obtained approval. For example, the indication of the association may be presented at the user interface 116 of the PDMS 100 and / or transmitted to a device or account of a user, and after obtaining the user's approval of the association, the indication of the association may be stored 810.

[0148] At box 812, method 800 includes updating the ubiquitous process definition based on the stored indication of the association between the collected site data and one or more components of the UPD of the industrial process. In embodiments where the indication of the association is stored 810 in or in conjunction with the UPD definition 72, 112, the storage 810 of the indication of the association in or in conjunction with the UPD definition 72, 112 may thus generate 812 an updated UPD. The updated UPD may replace the initial UPD 200, such as when the process is in its early stages of maturity 62, 64. However, for more mature processes, a typical (but not exclusive) scenario may include storing the updated UPD definition as a different version 202 of the UPD definition 200 for the industrial process. For example, as previously described with respect to Figure 4 As discussed, the UPD 200 for an industrial process may include multiple different versions, each of which may include a corresponding indication of a version and / or development stage of the industrial process 202. As desired, the different versions 202 of the UPD 200 for an industrial process may correspond to different maturity stages and / or different site configurations for implementing the industrial process at the same maturity stage or maturity level.

[0149] In some embodiments, storing 810 an indication of an association between the collected site data of a site-specific implementation of an industrial process and one or more components of a UPD of the industrial process includes storing 810 the indication in a historical data repository or database 73, 114. Thus, updating 812 the ubiquitous process definition based on the stored indication of the association may include updating 812 the UPD based on the contents of the historical data repository. Generally speaking, the historical data repository 73, 114 may store data and information corresponding to (and indicating) various site-specific implementations of the UPD 200 of the industrial process at multiple different process sites at possibly different maturity stages (and / or the same maturity stage), as well as data and information corresponding to (and indicating and / or generated from) different runs or executions of the implemented process at multiple different process sites. As previously discussed, each site-specific implementation of the UPD 200 may correspond to a corresponding set of site-specific process definition interface files generated from the ubiquitous process definition 200 (e.g., may be implemented according to the corresponding set of site-specific process definition interface files). For example, each set of corresponding site-specific process definition interface files may include an indication of equipment specific to a corresponding industrial process site in the plurality of industrial process sites. Thus, the contents of the historical data repository 73, 114 generally include data and information corresponding to the implementation of the site-specific process definition corresponding to the ubiquitous process definition 200 for the industrial process, as well as data and information corresponding to the execution of the site-specific process definition.

[0150] Conveniently, the historization data repository 73, 114 may be queried manually and / or automatically to obtain information and / or data generated by an instance of an executed industrial process and required for audit purposes, for purposes of determining and / or verifying the fidelity of an executed process instance relative to an intended (e.g., defined) industrial process, for jurisdictional and / or regulatory compliance purposes, etc. Thus, in one embodiment, the method 800 may include obtaining a subset of the contents of the historization repository in response to an audit or compliance query.

[0151] In any case, as previously mentioned, the historical data repository 73, 114 (when used with Fig. 8AWhen relevant, they store 810 an indication of the association between the collected site data and one or more components of the UPD 200) that the content can be used to generate 812 an updated pervasive process definition 200 for the industrial process. For example, the method 800 may include analyzing the content of the historical data repository 73, 114 to thereby generate additional knowledge corresponding to the pervasive process definition, and the additional knowledge can be used to update 812 the pervasive process definition. Specifically, one or more of the analysis modules or routines 196, 328 can be applied to at least a subset of the content of the historical data repository 73, 114, and the output of the application of the analysis modules 196, 328 can include the learned or discovered knowledge, such as, for example, correlations between various components of the UPD 200 and / or their specific values, classification of at least some of the collected site information corresponding to the execution of the industrial process at the site 190, segmentation of different components of the UPD 200 and / or different values ​​of these components, etc. In an embodiment, one or more of the analysis modules or routines 196, 328 may include statistical, artificial intelligence and / or machine learning modules and / or other types of analysis modules.

[0152] In some cases, additional knowledge (e.g., discovered or learned correlations, classifications, segmentations, etc.) may correspond to one or more execution goals of an industrial process. Execution goals may generally be measurable and / or quantifiable, and may correspond to desired or target behaviors (e.g., goals, requirements, etc.) for executing an industrial process, such as quality levels, compliance levels, throughput, time limits or durations (e.g., maximum or minimum time limits or durations) or costs, for example. Each execution goal may be applied to the overall execution of an industrial process, and / or may be applied only to a portion of an industrial process. Some execution goals may correspond to universal process definitions. For example, an execution goal of the UPD 200 for the manufacture of a specific drug may be a target range for the percentage of active ingredients included in a batch output, regardless of the site where the UPD 200 is implemented. Some execution goals may correspond to site-specific process definitions corresponding to the UPD 200. For example, an execution goal of a site-specific process definition corresponding to the UPD 200 may be a target throughput of units manufactured per unit time at a specific site. Thus, the additional knowledge may include information indicating the effects or impacts (e.g., quantitative and / or statistical effects or impacts) of various implemented site-specific process definition components (and / or their values) on one or more execution objectives, some of which may be previously unknown. The effects or impacts may be positive effects or impacts (e.g., they cause the industrial process to execute closer to one or more of its execution objectives), or may be negative effects or impacts (e.g., they cause the industrial process to execute further away from one or more of its execution objectives).

[0153] Furthermore, in embodiments where the method 800 generates additional knowledge based on analysis of the contents of the historical data repository 73, 114, block 812 may include updating the pervasive process definition 200 based on the additional knowledge. For example, the additional knowledge (or indications thereof) may be added to and / or stored with corresponding components of the UPD 200, such as as a replacement UPD 200 and / or as a version of the UPD 200, such as in a manner similar to that discussed elsewhere herein. If desired, updates to the UPD 200 may be based on manual or automatic approval of the additional knowledge.

[0154] Thus, as described above, updating 812 the UPD 200 for an industrial process based on stored indications of associations between collected site data and one or more components of the UPD 200 may include incorporating the indications of the collected site data into the UPD 200, thereby generating an updated UPD. Additionally or alternatively, updating 812 the UPD 200 for an industrial process based on stored indications of associations may include incorporating additional knowledge that has been learned or discovered based on the collected site data and other historical data into the UPD 200, thereby generating an updated UPD. Of course, other techniques for updating the UPD 200 based on stored indications of associations between collected site data and one or more components of the UPD 200 are also possible.

[0155] At box 818, method 800 may optionally include applying the updated ubiquitous process definition 200 to another industrial process site. For example, at box 818, method 800 may include transforming the updated ubiquitous process definition into one or more site-specific process definition interface files for the second industrial process site based on site-specific information of the second industrial process site, wherein the site-specific information of the second industrial process site includes instructions for equipment specific to the second industrial process site. Additionally, at box 818, method 800 may include enabling one or more site-specific process definition interface files to be utilized at the second industrial process site, thereby implementing a site-specific process definition corresponding to the updated ubiquitous process definition at the second industrial process site. For example, applying the updated UPD 200 of an industrial process to another industrial process may include executing Figure 6 At least a portion of an embodiment of method 460 depicted in, and / or may include other techniques for applying UPD 200 to a particular process site discussed elsewhere herein.

[0156] Now go to Figure 8B , Figure 8B A flow chart of an example method 830 for developing an industrial process based on a site-specific implementation of the industrial process is depicted. In an embodiment, the method 830 may be performed in whole or in part by Figure 2Process Development and Management System (PDMS) 60 and / or by Figure 3 For example, at least a portion of method 830 may be performed by Figure 2 The transformation manager 76 and one or more transformation modules 80 are implemented or executed, and / or at least a portion of the method 830 may be implemented or executed by Figure 3 The process knowledge management layer 102 and the transformation layer 104 are implemented or executed. Therefore, the method 830 can be saved to one or more memories as one or more sets of computer executable instructions, which can be executed by one or more computing devices of the PDMS 60 and / or PDMS 100. In an embodiment, the method 830 may include additional or alternative boxes in addition to those boxes discussed in the present disclosure. In an embodiment, the method 830 can be combined with other methods described herein (such as Figure 6 Method 460 and / or Fig. 8A Additionally, Figure 8B Dashed lines are used to indicate optional boxes. In addition, for the convenience of explanation and not for the purpose of limitation, Figure 8B Also refer to the description of Figures 2 to 4 , FIG. 5A to FIG. 5J and Figure 6 various parts.

[0157] In a manner similar to that described for method 800, method 830 includes receiving 802 collected site data corresponding to execution of a site-specific implementation of an industrial process at an industrial process site (e.g., one of sites 62 to 68, or site 190). That is, the implementation of the industrial process at the industrial process site is in accordance with a site-specific process definition. The site-specific process definition may correspond to both a universal process definition (e.g., UPD 72, 112, 200) and site-specific information of the industrial process site (e.g., site information file 140 and / or site configuration data 320), wherein the site-specific information 140, 320 includes an indication of equipment specific to the industrial process site 190. In an example, the site-specific process definition may be implemented at the industrial process site 190 according to one or more (e.g., a set of) site-specific process definition interface files and / or routines (e.g., interface files or routines 422) corresponding to the industrial process site 190. One or more site-specific process definition interface files and / or routines 422 corresponding to the process site 190 may have been generated by transforming the universal process definition 72, 112, 200 of the industrial process based on the site-specific information 140, 320 of the process site 190. For example, the site-specific process definition interface files and / or routines 422 may have been generated by the transformation layer 302 and provided to one or more site operating systems 304 of the industrial process site via the communication layer 332. Additionally or alternatively, Figure 6 Embodiments of the method 460 may generate at least a portion of the set of site-specific process definition interface files and / or routines 422 for the site 190. Additionally or alternatively, Fig. 8A Embodiments of the method 800 may have generated at least a portion of the set of site-specific process definition interface files and / or routines 422 and caused such generated interface files and / or routines to be provided to the industrial process site 190 and / or utilized at the industrial process site to support implementation of the site-specific process definition (e.g., in a manner as described with respect to block 818). Thus, receiving 802 data collected during execution of the industrial process at the industrial process site may include receiving collected site data, wherein the collected site data includes data collected during execution of the industrial process at the industrial process site according to the site-specific process definition at the industrial process site.

[0158] like Figure 8B As shown, method 830 may also include obtaining a pervasive process definition for an industrial process (block 805), associating the collected site data with one or more components of the UPD (block 808), and storing an indication of the association (block 810). In general, blocks 802, 805, 808, and 810 of method 830 may be similar to blocks 802, 805, 808, and 810 as described for method 800.

[0159] At block 832, the method 830 includes evaluating the site-specific process definition based on the (stored) associations between the collected site data and one or more components of the ubiquitous process definition. Evaluating 832 the site-specific process definition may include, for example, evaluating the accuracy of the site-specific process definition (block 835), evaluating the effectiveness of the site-specific process definition (block 838), and / or evaluating one or more other aspects of the site-specific process definition. The output (e.g., results) of the evaluation performed at block 832 and / or other information gathered from the evaluation may be stored in the historical data repository 73, 114, and may optionally be provided to a user, for example, via the user interface 116 and / or via other suitable electronic devices.

[0160] Evaluating 835 the accuracy of the site-specific process definition based on the association between the collected site data and one or more components of the universal process definition may include: determining whether the corresponding classification of various collected site data into the corresponding one or more components of the universal process definition (e.g., the species-genus relationship between the collected site data and the components of the UPD) is correct or acceptable, determining whether various collected site data has or has not been able to be associated with any component of the universal process definition, determining whether various components of the universal process definition have or have not been able to be associated with at least some of the collected site data, etc. In general, evaluating the accuracy of the site-specific process definition determines the level or measure of compliance of the site-specific process definition of the industrial process with the universal process definition of the industrial process. In an embodiment in which the site-specific process definition was previously transformed from the universal process definition, evaluating 835 the accuracy of the site-specific process definition can provide a measure of the quality and / or accuracy of the transformation.

[0161] Evaluating 838 the effectiveness of the site-specific process definition based on the association between at least some of the collected site data and the corresponding components of the universal process definition may include evaluating 838 the effectiveness of the site-specific process definition relative to one or more execution goals of the industrial process. As previously discussed, the execution goals of the industrial process may involve product quality levels, process execution compliance levels (e.g., how commensurate the implemented process is with the designed process), product and / or process compliance levels, throughput goals (e.g., units of product per unit time), time-related goals (e.g., duration, time limit, etc.), costs, etc. The execution goals may apply to the entire industrial process, or may only apply to a portion of the industrial process (e.g., measuring the quality of the output of the tank that provides the intermediate material to the next process step). The execution goals may correspond to the universal process definition (e.g., the output product will have a percentage of active ingredients within a certain percentage range), and thus apply to all sites where the UPD is implemented. The execution goals may specifically correspond to site-specific process definitions (e.g., target throughput at a specific site, target maximum level of byproduct emissions at a specific site, etc.).

[0162] In an embodiment, at optional block 840, the method 830 may include generating, by one or more computing devices, additional knowledge corresponding to the pervasive process definition based on the evaluation 832. As previously discussed, the output (e.g., results) of the evaluation 832 and / or other information gathered from the evaluation 832 may be stored in the historical data repository 73, 114. Thus, at block 840, the method 830 may include analyzing the contents of the historical data repository 73, 114 to generate additional knowledge corresponding to the pervasive process definition. For example, one or more of the analysis modules or routines 196, 328 may be applied to at least a subset of the contents of the historical data repository 73, 114, and the output of the application of the analysis modules 196, 328 may include learned or discovered knowledge, such as, for example, correlations, classifications, segmentations, predictions, and the like. For example, the learned or discovered knowledge (which may be previously unknown) may include discovered correlations between various components of UPD 200, their specific values, and / or their specific combinations and corresponding effects (which may be positive or negative) on various execution goals, some of which may be previously unknown. In one embodiment, one or more analysis modules or routines 196, 328 may include statistical, artificial intelligence and / or machine learning modules, and / or other types of analysis modules.

[0163] At optional block 842, method 830 may include updating the ubiquitous process definition based on the additional knowledge generated based on the evaluation 832, thereby generating an updated ubiquitous process definition. For example, an indication of the additional knowledge and / or data corresponding to the additional knowledge may be stored in or with one or more corresponding components of the UPD 200, thereby updating the UPD. In an embodiment, method 830 includes obtaining approval of the additional knowledge, and updating 842 the ubiquitous process definition based on the additional knowledge is based on the approval of the additional knowledge. For example, an indication of the additional knowledge may be presented at the user interface 116 of the PDMS 100 and / or transmitted to a device or account of a user, and upon obtaining the user's approval of the additional knowledge, the ubiquitous process definition may be updated 842.

[0164] In one embodiment, at optional box 845, method 830 may include applying the updated universal process definition (e.g., generated at box 842) to another industrial process site. For example, at box 845, method 830 may include transforming the updated universal process definition into one or more site-specific process definition interface files for a fourth industrial process site based on site-specific information of a fourth industrial process site, wherein the site-specific information of the fourth industrial process site includes an indication of equipment specific to the fourth industrial process site. At box 845, method 830 may also include causing one or more site-specific process definition interface files to be utilized at the fourth industrial process site, thereby implementing a site-specific process definition corresponding to the updated universal process definition at the fourth industrial process site. For example, applying 845 the updated UPD 200 of an industrial process to another industrial process may include executing Figure 6 At least a portion of an embodiment of method 460 depicted in, and / or may include other techniques for applying UPD 200 to a particular process site discussed elsewhere herein.

[0165] Thus, in view of the above, method 832 may be particularly useful when a site-specific implementation of an industrial process generates a "golden batch" of a product, where the golden batch meets most, if not all, of its execution objectives. Thus, by executing method 832, site data corresponding to the golden batch may be collected, associated with corresponding components of the ubiquitous process definition, and evaluated to discover specific factors (e.g., components of the UPD implemented at the site, their values, combinations of components, combinations of component values, etc.) that have the strongest effect or impact on the various execution objectives of the batch. The ubiquitous product definition may be updated based on the discovered information so that future site-specific implementations of the UPD may incorporate the discovered factors and gain their benefits.

[0166] Fig. 9 An example method 900 is depicted for verifying and / or selecting a development or production site with capabilities required by a general recipe based on information from the site, which may be automatically obtained directly from the site, such as may be performed by the site suitability module 160, site suitability routine 366, and / or site suitability module 410 described above. Verification may include determining availability or scheduling future availability. Sites may be automatically selected or recommended based on meeting general recipe criteria and availability, which may include availability of specific preferred equipment types (e.g., equipment types known to produce superior output).

[0167] Fig. 9The depicted method 900 includes receiving (step 902) a universal process definition that specifies a series of equipment-independent processing steps for manufacturing, productizing, or packaging a product. For example, in some examples, the universal process definition may include data related to input materials, data related to ratios or amounts of input materials and / or intermediate products, data related to operations on input materials and / or intermediate products, and / or data related to the order in which operations are performed. Additionally, in some examples, the universal process definition may include duration data related to corresponding operations in the operation, parameter data for the corresponding operations in the operation, constraint data for the corresponding parameter data, required initial state data for the equipment performing the corresponding operation, required feedback parameters to be collected, required audit data to be collected, preferred range data for the corresponding parameter data, and / or preferred equipment type data for one or more operations in the corresponding operation.

[0168] Method 900 also includes generating (step 904) an indication of one or more site requirements for performing a series of equipment-independent processing steps for manufacturing, productizing, or packaging products based on the universal process definition. For example, in some examples, generating an indication of one or more site requirements may include identifying (and / or otherwise receiving or obtaining) one or more required properties of equipment corresponding to each corresponding operation associated with a series of equipment-independent processing steps for manufacturing, productizing, or packaging products based on the universal process definition. For example, as described above, a series of equipment-independent processing steps for manufacturing, productizing, or packaging products may include one or more operations to be performed, such as, for example, mixing operations, heating operations, cooling operations, etc. Although a given operation may not require any particular piece of equipment, the operation may require the equipment to have certain properties. For example, the required properties of equipment performing a mixing operation may include the ability of the equipment to combine input materials together. For another example, the required properties of equipment performing a heating operation may include the ability of the equipment to provide heat.

[0169] Furthermore, in some examples, generating an indication of one or more site requirements may include identifying (and / or otherwise receiving or obtaining) one or more required properties of input materials, equipment, and / or personnel corresponding to each respective operation associated with a series of equipment-independent processing steps for manufacturing, productizing, or packaging a product based on a pervasive process definition.

[0170] For example, in some examples, certain ratios or amounts of input materials and / or intermediates may be required. That is, the desired properties of the input materials for a given operation may be a specific minimum amount of one or more input materials, or a specific ratio of one input material to another input material. In addition, the desired properties of the input materials for a given operation may include the desired properties of the components of the input materials (e.g., a range of percentage values ​​for each component of the input materials). In other examples, the desired properties of the input materials may specify a specific input material (e.g., having a specific percentage value for each component of the input material). In addition, in other examples, the desired properties of the input materials may specify a specific brand or manufacturer of the input materials. Additionally, in other examples, the desired properties of the input materials may specify a maximum price for the input materials (e.g., per volume or per weight).

[0171] Similarly, in some examples, the desired properties of a piece of equipment for a given operation may include a desired type of equipment (e.g., a heater, agitator, etc.), a desired brand or manufacturer of the equipment, a desired price of the equipment (or a price per use), a desired material composition of the equipment, etc. Additionally, as described above, the desired properties of a piece of equipment to perform a given operation may be the ability of the piece of equipment to perform the operation, such as the ability to mix materials, heat materials, move materials from one location to another, etc. Further, the desired properties of a piece of equipment to perform a given operation may include the scope or limitations of the performance of the operation by the piece of equipment. To name a few, the desired properties of equipment to perform a given operation may include the ability of the equipment to heat to a specific temperature (e.g., a minimum temperature or temperature range), the ability of the equipment to maintain a specific temperature for a specific amount of time (e.g., a minimum amount of time, a time period range, etc.), the speed at which the equipment can reach a specific temperature, the ability of the piece of equipment to mix at a specific speed (e.g., a minimum speed, a speed range, etc.), the ability of the equipment to hold, mix, store, transport, heat, or otherwise operate on input materials (e.g., a minimum capacity or a possible range of capacities), etc.

[0172] Additionally, in some examples, the required properties of personnel may include the number of personnel required to perform a given operation (e.g., a minimum number of personnel, or a minimum ratio of personnel to equipment and / or input materials). Further, in some examples, the required properties of personnel may include the qualification level of personnel required to perform a given operation (e.g., the required degree, education level, certification, training, etc. required of personnel to perform a given operation). Further, in some examples, the required properties of personnel may include the required minimum size, strength, or other physical property of one or more personnel to perform a given operation.

[0173] Additionally, in some examples, generating an indication of one or more site requirements may include identifying (or otherwise obtaining) one or more properties of a site size required for each respective operation associated with a sequence of equipment-independent processing steps for manufacturing, productizing, or packaging a product, or for the sequence of equipment-independent steps as a whole. For example, the required properties of the site size may include a required size (such as a required area, a required ceiling height, a required depth below ground, a required distance from other sites, etc.) of a site in which the sequence of equipment-independent steps is performed, or a portion of a site in which each operation is performed.

[0174] In addition, in some examples, generating an indication of one or more site requirements may include identifying (and / or otherwise receiving or obtaining) one or more required properties of operations that are performed to perform a series of equipment-independent processing steps for manufacturing, productizing, or packaging a product based on a universal process definition. For example, one or more operations may need to be performed in a specific order. For another example, one or more operations may need to be performed simultaneously. In addition, one or more operations may need to be performed manually, or one or more operations may need to be performed automatically.

[0175] Additionally, in some examples, generating an indication of one or more site requirements may include identifying (and / or otherwise receiving or obtaining) additional requirements based on the ubiquitous process definition, such as a date or time (e.g., a latest possible date and / or time) by which a series of equipment-independent processing steps for manufacturing, productizing, or packaging a product must be performed, a maximum cost associated with performing the series of equipment-independent processing steps for manufacturing, productizing, or packaging a product, and / or a minimum quantity of product that ultimately must be manufactured, produced, or productized.

[0176] The required properties (and / or any other requirements) of the input materials, equipment, and / or personnel corresponding to each respective operation and / or the sequence of operations as a whole may range from general to specific. In addition, a given operation may, for example, have required properties to be performed on a very specific amount of a given input material manufactured by a specific manufacturer, but may have relatively fewer or less specific equipment or personnel requirements (e.g., an operation must be performed by a certain piece of equipment capable of heating to a specific temperature, but there are no required properties for the personnel performing the operation). As another example, a given operation may, for example, have required properties to be performed by a person with a Ph.D., but may only require that the input material be any material with a composition range of specific components, and that the equipment be any equipment capable of mixing at a specific speed.

[0177] Additionally, method 900 includes receiving (step 906) site configuration data related to the configuration of one or more candidate development or production sites. The one or more candidate development or production sites may include, for example, laboratories, development plants, pilot plants, and / or large-scale production plants.

[0178] For example, in some examples, the site configuration data may include equipment tag information, automation equipment type information, process control equipment information, I / O configuration data, and / or skid configuration information for each of the plurality of candidate development or production sites. Additionally, in some examples, the site configuration data may include an indication of one or more properties of input materials, equipment, and / or personnel available at each of the candidate development and / or production sites, and / or an indication of one or more properties of the size of each of the candidate development and / or production sites.

[0179] For example, the site configuration data may include an indication of which input materials are available at each of the candidate development and / or production sites, including an indication of the amount of each input material, an indication of the specific composition of the input materials, an indication of the brand or manufacturer associated with each input material, etc. Similarly, the site configuration data may include an indication of which equipment is available at each of the candidate development and / or production sites, including an indication of the amount of each type of equipment, an indication of the capabilities of each piece of equipment, an indication of the specifications and capabilities of each piece of equipment, an indication of the brand or manufacturer of each piece of equipment, etc. In addition, the site configuration data may include an indication of which personnel are available at each of the candidate development and / or production sites, including an indication of the number of available personnel, an indication of their qualifications, an indication of their physical properties, an indication of their ability to manually perform various operations, etc. Additionally, in some examples, the site configuration data may include an indication of the size of each of the candidate development and / or production sites or indications of the sizes of various areas of each of the candidate development and / or production sites.

[0180] In addition, in some examples, the site configuration data may include (or method 900 may otherwise include obtaining and / or receiving) indications of other factors associated with each of the candidate development and / or production sites, such as an indication of the geographic location of each of the candidate development and / or production sites, an indication of the costs associated with each of the candidate development and / or production sites, an indication of the scheduling availability of each of the candidate development and / or production sites, an indication of the efficiency or speed with which each of the candidate development and / or production sites can perform various operations, and the like.

[0181] In addition, method 900 includes identifying (step 908) one or more candidate development or production sites as a match based at least in part on comparing one or more site requirements for performing a series of equipment-independent processing steps for manufacturing, productizing, or packaging a product with site configuration data associated with each of the one or more candidate development or production sites. For example, one or more required properties of input materials, equipment, and / or personnel for manufacturing, productizing, or packaging a product may be compared with corresponding properties of input materials, equipment, and / or personnel associated with each of the one or more candidate development or production sites (e.g., based on site configuration data) to identify the one or more candidate development or production sites as a match. Similarly, one or more properties of site size required for each corresponding operation associated with a series of equipment-independent processing steps for manufacturing, productizing, or packaging a product or for the series of equipment-independent steps as a whole may be compared with corresponding properties of site size associated with each of the one or more candidate development or production sites (e.g., based on site configuration data) to identify the one or more candidate development or production sites as a match.

[0182] For another example, identifying a candidate development or production site as a match may include determining (and / or otherwise receiving or obtaining) capabilities of one or more of the equipment at each of the one or more candidate development or production sites based on the site configuration data, and determining whether each of the one or more candidate development or production sites is a match based at least in part on whether each of the one or more candidate development or production sites can produce a required (e.g., minimum) amount of a product to be manufactured, productized, or packaged based on site requirements. For another example, identifying a candidate development or production site as a match may include determining (and / or otherwise receiving or obtaining) inventory information related to input materials available at each of the one or more candidate development or production sites based on the site configuration data, and determining whether each of the one or more candidate development or production sites is a match based at least in part on whether each of the one or more candidate development or production sites can produce a required (e.g., minimum) amount of a product to be manufactured, productized, or packaged based on site requirements using input materials available at the development or production site.

[0183] As another example, identifying a candidate development or production site as a match may include determining (and / or otherwise receiving) an indication of a required quantity of a product and a required time by which the product must be manufactured, productized, or packaged based on the site requirements. In this example, method 900 may include receiving equipment availability scheduling information associated with each of the one or more candidate development or production sites, and determining the total time required to produce the required quantity of the product (as indicated by the site configuration data) using the equipment of each of the one or more candidate development or production sites. In this example, it may be determined based on the equipment availability scheduling information and the total time required whether each of the one or more candidate development or production sites can produce the required quantity of the product within the required time, and the candidate development or production site may be identified as a match based on whether each of the candidate development or production sites can produce the required quantity of the product within the required time.

[0184] In some examples, identifying a candidate development or production site as a match may include determining whether each candidate development or production site has at least one (or a minimum number) of one or more types of equipment corresponding to each corresponding operation so that a series of processing steps can be performed at the development or production site. In some examples, a given operation may be able to be performed by a single piece of equipment or by multiple pieces of equipment. For example, an operation may require that a given amount of a specific input material can be heated to a specific temperature. In some examples, a candidate development or production site that includes a single piece of equipment that can heat the entire amount of a specific input material to a specific temperature may be identified as a match, and a candidate development or production site that includes multiple pieces of equipment that can collectively heat the amount of specific input materials to a specific temperature may also be identified as a match. In addition, in some examples, a single candidate development or production site that meets all of the requirements for manufacturing, productization, or packaging products may be identified as a match. In addition, in some examples, multiple candidate development or production sites that collectively meet all of the requirements for manufacturing, productization, or packaging products may be identified as a match. For example, for a plurality of candidate development or production sites that match, one or more operations may be performed by a first candidate or production site, while other operations may be performed by a second candidate or production site, assuming other requirements are met (e.g., geographic proximity). For another example, for a plurality of candidate development or production sites that match, some amount of input material may be operated by a first candidate or production site, while additional amount of input material may be performed by a second candidate or production site (i.e., in some cases, the input material may be divided among several candidate development or production sites).

[0185] In any case, method 900 also includes selecting (step 910) one or more development or production sites from the matching one or more candidate development or production sites to perform a series of processing steps for manufacturing, productizing, or packaging the product.

[0186] In an example, selecting one or more development or production sites from the matching one or more candidate development or production sites may include generating (and / or otherwise receiving or obtaining) an indication of one or more site preferences for performing a sequence of equipment-independent processing steps for manufacturing, productizing, or packaging a product based on the pervasive process definition, and generating a suitability indicator associated with each of the one or more matching candidate development or production sites based at least in part on comparing the one or more site preferences to the site configuration of each of the one or more matching candidate development or production sites. For example, site preferences may be generally similar to site requirements, but may include indications of preferred properties or qualities of the site, input materials, equipment, personnel, or other preferred properties of the site's operational performance, which may be different from or more specific than the site requirements.

[0187] For example, in some examples, generating an indication of one or more site preferences may include identifying one or more preferred properties of equipment corresponding to each respective operation associated with a series of equipment-independent processing steps for manufacturing, productizing, or packaging a product based on a pervasive process definition. Further, in some examples, generating an indication of one or more site preferences may include identifying (and / or otherwise receiving or obtaining) one or more preferred properties of input materials, equipment, and / or personnel corresponding to each respective operation associated with a series of equipment-independent processing steps for manufacturing, productizing, or packaging a product based on a pervasive process definition. Further, in some examples, generating an indication of one or more site preferences may include identifying (and / or otherwise receiving or obtaining) one or more properties of site size preferred for each respective operation associated with a series of equipment-independent processing steps for manufacturing, productizing, or packaging a product or for the series of equipment-independent steps as a whole. Furthermore, in some examples, generating an indication of one or more site preferences may include identifying (and / or otherwise receiving or obtaining) based on the ubiquitous process definition one or more preferred properties of input materials associated with an equipment-independent sequence of processing steps for manufacturing, productizing, or packaging a product, one or more preferred properties of ratios or quantities of input materials and / or intermediate products associated with an equipment-independent sequence of processing steps for manufacturing, productizing, or packaging a product, one or more preferred properties of operations on input materials and / or intermediate products associated with an equipment-independent sequence of processing steps for manufacturing, productizing, or packaging a product, and / or one or more preferred properties of operations in which operations are preferably performed in order to perform an equipment-independent sequence of processing steps for manufacturing, productizing, or packaging a product.

[0188] For example, a site requirement may include any equipment capable of heating an input material to a certain minimum temperature, while a site preference may include a specific type or brand of equipment, or a preferred temperature to which the equipment can heat the input material. For another example, a site requirement may simply include a certain minimum number of personnel, while a site preference may include a preferred higher number of personnel or a general preference for a higher number of personnel, or specific training completed by one or more personnel. For another example, a site requirement may include a latest date or time by which an operation must be completed, and a site preference may include a preference for an earlier date or time, or a general preference for the earliest possible date or time by which an operation must be completed.

[0189] The suitability indicator may include a numerical score or rating for each of the one or more matching candidate development or production sites based on comparing the one or more site preferences to the site configuration of each of the one or more matching candidate development or production sites. For example, matching candidate development or production sites that meet more of the site preferences based on the site configuration data may be associated with a higher ranking or higher rating suitability indicator, while matching candidate development or production sites that meet fewer of the site preferences based on the site configuration data may be associated with a lower ranking or lower rating suitability indicator. In some examples, the suitability indicator may be weighted based on specific site preferences that may be indicated by a user (e.g., based on importance or other considerations associated with each of the site preferences).

[0190] In this example, one or more development or production sites may be selected from the matching candidate development or production sites to perform a series of processing steps for manufacturing, productizing, or packaging a product based at least in part on a suitability indicator associated with each of the matching candidate development or production sites.

[0191] In some examples, selecting a development or production site from the matching candidate development or production sites may include selecting only the matching candidate development or production sites associated with a suitability indicator that is greater than a suitability indicator threshold. Additionally, in some examples, selecting a development or production site from the matching candidate development or production sites may include automatically selecting one or more of the matching candidate development or production sites that are associated with the highest suitability indicator. Furthermore, in some examples, selecting a development or production site from the matching candidate development or production sites may include presenting, via a user interface, an indication of the suitability indicator associated with each of the one or more matching candidate development or production sites (e.g., in a ranked order based on their suitability indicators) and receiving, via the user interface, an indication of a selection of the one or more matching candidate development or production sites.

[0192] Once one or more development or production sites are selected, in some examples, method 900 may include automatically transforming a series of equipment-independent processing steps into one or more routines for executing the series of processing steps to manufacture, productize, or package a product using equipment at the selected one or more development or production sites, for example, as described above with respect to Figure 6 Discussed.

[0193] Some aspects of the invention include:

[0194] 1. A method of managing a production system to implement and lifecycle management processes to create a product, the method comprising:

[0195] Creating a process definition for manufacturing the product, wherein the process definition is not limited to process equipment at a single process facility, the process definition comprising:

[0196] A set of process materials used to manufacture said product,

[0197] a set of process operations to be applied to the material used to manufacture the product, the sequence of the process operations, and

[0198] information regarding the relative amounts of said materials used in said process;

[0199] storing the process definition in a management system;

[0200] selecting a first production site having at least a first process execution system coupled to a first set of process equipment;

[0201] obtaining first process site data including execution system and process equipment data defining the first process execution system and the first set of process equipment;

[0202] using a computer processor, creating a first set of site-specific production facility instructions using the process definition and the first process site data for implementation by or on the first process execution system using the first set of process equipment at the first production site to manufacture the product, the first set of site-specific production facility instructions being specific to the first process execution system using the first set of process equipment at the first production site;

[0203] selecting a second production site having at least a second process execution system coupled to a second set of process equipment different from the first set of process equipment;

[0204] obtaining second process site data including execution system and process equipment data defining the second process execution system and the second set of process equipment; and

[0205] Using a computer processor, the process definition and the second process site data are used to create a second set of site-specific production facility instructions for implementation by or on the second process execution system using the second set of process equipment at the second production site to manufacture the product, the second set of site-specific production facility instructions being specific to the second process execution system using the second set of process equipment at the second production site.

[0206] 2. A method according to claim 1, wherein using the process definition and the first process site data to create the first set of site-specific production facility instructions for implementation by the first process execution system using the first set of process equipment at the first production site to manufacture the product includes: generating one or more process control routines to be implemented by the control system at the first production site, and wherein using the process definition and the second process site data to create the second set of site-specific production facility instructions for implementation by the second process execution system using the second set of process equipment at the second production site to manufacture the product includes: generating one or more process control routines to be implemented by the control system at the second production site.

[0207] 3. A method according to claim 1, wherein using the process definition and the first process site data to create the first set of site-specific production facility instructions for implementation by the first process execution system using the first set of process equipment at the first production site to manufacture the product includes: generating one or more audit system instructions to be implemented by the audit execution system at the first production site, and wherein using the process definition and the second process site data to create the second set of site-specific production facility instructions for implementation by the second process execution system using the second set of process equipment at the second production site to manufacture the product includes: generating one or more audit execution system instructions to be implemented by the audit execution system at the second production site.

[0208] 4. The method of claim 1, further comprising collecting data related to operation of the first process execution system using the first set of process equipment at the first production site to manufacture the product, and storing the collected data at the management system.

[0209] 5. The method according to claim 4 further includes: using the collected data related to the operation of the first process execution system using the first set of process equipment at the first production site to manufacture the product to change the process definition; and storing the changed process definition as the process definition in the management system, and then using the process definition to create a set of site-specific production facility instructions for implementation by the process execution system on the second set of process equipment at the second production site to manufacture the product.

[0210] 6. The method of claim 1, wherein the first production facility is a development production facility that performs development runs of the process, and wherein the second production facility is a commercial manufacturing facility that manufactures commercial-grade products.

[0211] 7. The method of claim 1, wherein the first production facility is a development production site that performs development runs of the process, and wherein the second production site is a clinical trial site that manufactures the product for use in a clinical trial.

[0212] 8. The method of claim 1, wherein the first production site is a test production facility that performs a test run of the process, and wherein the second production site is one of a development facility that performs a development run of the product and a commercial manufacturing facility that manufactures a commercial-grade product.

[0213] 9. A method according to claim 1, wherein using the process definition and the first process site data to create the first set of site-specific production facility instructions for implementation by the first process execution system using the first set of process equipment at the first production site to manufacture the product includes: using the relative quantity information to scale the process definition for a first production scale at the first production site, and wherein using the process definition and the second process site data to create the second set of site-specific production facility instructions for implementation by the second process execution system using the second set of process equipment at the second production site to manufacture the product includes: using the relative quantity information to scale the process definition for a second production scale at the second production site, wherein the first production scale is different from the second production scale.

[0214] 10. The method of claim 1, wherein the process definition specifies a process for manufacturing a product.

[0215] 11. The method of claim 1 , wherein the process definition specifies a process for packaging a product.

[0216] 12. The method of claim 1, wherein the process definition specifies a process for compounding a medication.

[0217] 13. A method of managing a production system to implement a process to create a product, the method comprising:

[0218] Creating a process definition for manufacturing the product, wherein the process definition is not limited to process equipment at a single process facility, the process definition comprising:

[0219] A set of process materials used to manufacture said product,

[0220] a set of process operations to be applied to the material used to manufacture the product, the sequence of the process operations, and

[0221] information regarding the relative amounts of said materials used in said process;

[0222] storing the process definition in a management system;

[0223] selecting a production site having at least a first process execution system coupled to one or more sets of process equipment at the production site and a second process execution system coupled to the one or more sets of process equipment at the production site;

[0224] obtaining process site data including execution system and process equipment data defining the first process execution system and the second process execution system and the one or more sets of process equipment;

[0225] analyzing, using a computer processor, the process definition and the process site data associated with the first process execution system and the one or more sets of process equipment to create a first set of site-specific production facility instructions for implementation by or on the first process execution system using at least some of the one or more sets of process equipment at the production site to manufacture the product, the first set of site-specific production facility instructions being specific to the first process execution system using the at least some of the one or more sets of process equipment at the production site; and

[0226] Using a computer processor, the process definition and the process site data associated with the second process execution system and the one or more sets of process equipment are analyzed to create a second set of site-specific production facility instructions for implementation by or on the second process execution system using at least some of the one or more sets of process equipment at the production site to manufacture the product, the second set of site-specific production facility instructions being specific to the second process execution system using at least some of the one or more sets of process equipment at the production site.

[0227] 14. The method of claim 13, wherein the first process execution system is a process equipment control system that implements a process to manufacture the product, and wherein the second process execution system is an audit system that implements one or more audit functions during operation of the process to manufacture the product at the production facility.

[0228] 15. The method of claim 13, wherein the first process execution system is a process equipment control system that implements a process to manufacture the product, and wherein the second process execution system is a scheduling system that implements one or more scheduling functions during operation of the process to manufacture the product at the production facility.

[0229] 16. A method according to claim 13, wherein the first process execution system is a process equipment control system that implements a process to manufacture the product, and wherein the second process execution system is a manufacturing operations management system that uses the process equipment control system to implement one or more management control functions during operation of the process to manufacture the product at the production facility.

[0230] 17. A method according to claim 13, wherein the first process execution system is a manufacturing operation management system that uses a set of process control equipment to implement one or more management control functions during operation of a process for manufacturing the product at the production facility, and the second process execution system is a data collection system that collects data from the process equipment during operation of the process.

[0231] 18. The method of claim 13, further comprising collecting data related to the operation of the first process execution system and the second process execution system during operation of the process for manufacturing the product, and storing the collected data at the management system.

[0232] 19. The method according to claim 18 further includes changing the process definition using the collected data related to the operation of the first process execution system and the second process execution system during the operation of the process for manufacturing the product, and storing the changed process definition as the process definition in the management system in advance.

[0233] 20. A method of configuring a development or production site to manufacture, productize or package a product, the method comprising:

[0234] receiving a universal process definition specifying a sequence of equipment-independent processing steps for manufacturing, productizing, or packaging the product;

[0235] receiving data related to the configuration of said development or production site;

[0236] The equipment-independent series of process steps is automatically transformed into data specifying one or more routines for executing the series of process steps to manufacture, productize or package the product using equipment at the development or production site.

[0237] 21. The method of claim 20, wherein the one or more routines for performing the series of processing steps include one or more manual processing steps.

[0238] 22. The method of claim 20, wherein the one or more routines for performing the series of processing steps include one or more automated processing steps.

[0239] 23. The method of claim 20, wherein the one or more routines for performing the series of processing steps include one or more manual processing steps and one or more automated processing steps.

[0240] 24. The method of claim 20, wherein automatically transforming the series of equipment-independent processing steps into one or more routines for performing the series of processing steps comprises programming one or more automation systems at the development or production site to execute the one or more routines.

[0241] 25. The method of claim 20, wherein automatically transforming the series of equipment-independent processing steps into one or more routines for performing the series of processing steps includes generating one or more control modules or control routines operable to control the equipment at the development or production site to perform one or more automated steps of the one or more routines.

[0242] 26. The method of claim 20, further comprising programming one or more systems at the development or production site to coordinate a combination of automated and manual actions to perform the series of process steps.

[0243] 27. The method of claim 20, wherein transforming the series of equipment-independent processing steps into one or more routines for performing the series of processing steps comprises specifying an automated portion of the series of processing steps and a manually performed portion of the series of processing steps.

[0244] 28. The method of claim 20, wherein receiving data related to the configuration of the development or production site comprises receiving one or more of: device tag information; automation equipment type information; process control equipment information; I / O configuration data; and skid configuration information.

[0245] 29. The method of claim 20, wherein receiving the pervasive process definition comprises receiving at least:

[0246] Data related to input materials;

[0247] data relating to the ratios or amounts of said input materials and / or intermediate products;

[0248] Data relating to operations on said input materials and / or intermediate products; and data relating to the order in which said operations are to be performed.

[0249] 30. The method of claim 29, wherein receiving the pervasive process definition further comprises receiving one or more of:

[0250] duration data associated with respective ones of the operations;

[0251] parameter data of a corresponding operation in the operations;

[0252] Constraint data of corresponding parameter data;

[0253] Required initial state data of the equipment to perform the corresponding operation;

[0254] The desired feedback parameters to be collected;

[0255] The required audit data to be collected;

[0256] Preferred range data of corresponding parameter data;

[0257] Preferred equipment type data for one or more of the respective operations.

[0258] 31. A method according to claim 20, wherein automatically transforming the series of equipment-independent processing steps into one or more routines for performing the series of processing steps includes: automatically scaling the input materials according to the ratio or amount and adjusting the operation to manufacture, productize or package the product using equipment at the development or production site.

[0259] 32. The method of claim 20, wherein receiving the universal process definition comprises receiving at least: data related to input materials; data related to ratios or amounts of the input materials and / or intermediate products; data related to operations on the input materials and / or intermediate products; and data related to the order in which the operations are performed; and

[0260] And the method further includes: identifying one or more types of equipment corresponding to each respective operation based at least on the data associated with the operation.

[0261] 33. The method according to claim 32 further includes comparing the data related to the configuration of the development or production site, and determining whether the development or production site has at least one type of equipment of the one or more types of equipment corresponding to each corresponding operation so that the series of processing steps can be performed at the development or production site.

[0262] 34. A method according to claim 33, further comprising determining whether the one or more routines for performing the series of processing steps to manufacture, productize or package the product using the equipment at the development or production site will require one or more of the series of processing steps to be performed manually.

[0263] 35. The method of claim 33, further comprising:

[0264] receiving an indication of an amount of said product to be manufactured, productized or packaged at said development or production site;

[0265] determining a capability of one or more of the equipment at the development or production site; and

[0266] A determination is made as to whether the equipment at the development or production site is capable of producing the indicated quantity.

[0267] 36. The method of claim 20, wherein automatically transforming the series of equipment-independent processing steps into one or more routines for performing the series of processing steps comprises: automatically scaling the input materials according to the ratio or amount and adjusting the operation to manufacture, productize or package a specific amount of the product using equipment at the development or production site; the method further comprising:

[0268] receiving inventory information related to said input materials available at said development or production site;

[0269] comparing the inventory information to the scaled input material;

[0270] A determination is made as to whether the development or production site is capable of producing the specific quantity of the product using the input materials available at the development or production site.

[0271] 37. The method of claim 20, wherein automatically transforming the series of equipment-independent processing steps into one or more routines for performing the series of processing steps comprises: automatically scaling the input materials according to the ratio or amount and adjusting the operation to manufacture, productize or package a specific amount of the product within a specified time using equipment at the development or production site; the method further comprising:

[0272] receiving equipment availability scheduling information associated with the development or production site;

[0273] determining the total time required to produce said specified quantity of said product using said equipment at said development or production site;

[0274] Based on the equipment availability scheduling information and the required total time, it is determined whether the development or production site can produce the specific amount of the product within the specified time.

[0275] 38. The method of claim 20, wherein automatically transforming the series of equipment-independent processing steps into one or more routines for executing the series of processing steps comprises programming one or more programmable logic controllers at the development or production site to execute the series of processing steps.

[0276] 39. The method of claim 20, wherein automatically transforming the series of equipment-independent processing steps into one or more routines for executing the series of processing steps comprises programming one or more batch processing controllers at the development or production site to execute the series of processing steps.

[0277] 40. The method of claim 20, wherein the development or production site is a laboratory.

[0278] 41. The method of claim 20, wherein the development or production site is a development plant.

[0279] 42. The method of claim 20, wherein the development or production site is a pilot plant.

[0280] 43. The method of claim 20, wherein the development or production site is a large-scale production plant.

[0281] 44. A method comprising:

[0282] Receive a general process definition that specifies a series of equipment-independent processing steps for manufacturing, productizing, or packaging a product;

[0283] receiving data related to the configuration of said development or production site;

[0284] One or more equipment-specific implementation files are automatically generated from the series of equipment-independent process steps for executing the series of process steps to manufacture, productize or package the product using equipment at the development or production site.

[0285] 45. A technology delivery platform, comprising:

[0286] a delivery module that receives a universal process definition that specifies a series of equipment-independent processing steps for manufacturing, productizing, or packaging a product;

[0287] a communication layer coupled to each of a plurality of development or production site operating systems and comprising a plurality of communication interface protocols, each communication interface protocol configured to facilitate communication between the delivery platform and a respective one of the plurality of development or production site operating systems;

[0288] one or more analysis modules, each analysis module configured to analyze data received from one or more development or production site operating systems of the plurality of development or production site operating systems;

[0289] One or more transformation modules are configured to receive the pervasive process definition and outputs of one or more of the plurality of analysis modules and generate one or more outputs that configure one or more of the field operating systems.

[0290] 46. ​​The technology delivery platform of claim 45, wherein one or more of the transformation modules configure a corresponding one of the field operating systems.

[0291] 47. The technology delivery platform of claim 45, wherein one of the transformation modules outputs data to configure a process for execution in an instance at a development or production site.

[0292] 48. The technology delivery platform of claim 47, wherein the data output by the one of the transformation modules is used by the transformation module to configure the instance of the development or production site.

[0293] 49. The technology delivery platform of claim 48, wherein the data output by the one of the transformation modules comprises configuration data for an automation system.

[0294] 50. The technology delivery platform of claim 49, wherein the data output by the one of the transformation modules comprises a control module for execution by a controller of the automation system.

[0295] 51. The technology delivery platform of claim 49, wherein the data output by the one of the transformation modules comprises ladder logic for execution by a programmable logic controller of the automation system.

[0296] 52. The technology delivery platform of claim 49, wherein the data output by the one of the transformation modules includes data for implementing a plurality of control loops present in the automation system.

[0297] 53. The technology delivery platform of claim 48, wherein the data output by the one of the transformation modules comprises configuration data for an operations management system.

[0298] 54. The technology delivery platform of claim 49, wherein the data output by the one of the transformation modules includes configuration data for manually executing some of the processing steps and automatically executing other of the processing steps.

[0299] 55. The technology delivery platform of claim 45, wherein the plurality of communication interface protocols include application programming interfaces (APIs) for corresponding development or production site operating systems among the plurality of development or production site operating systems.

[0300] 56. The technology delivery platform of claim 45, wherein the plurality of development or production site operating systems include a control automation system.

[0301] 57. The technology delivery platform of claim 45, wherein the plurality of development or production site operating systems include a control configuration system.

[0302] 58. The technology delivery platform of claim 45, wherein the plurality of development or production site operating systems include a system for tracking regulatory compliance data.

[0303] 59. The technology delivery platform of claim 45, wherein the plurality of development or production site operating systems include an inventory or sequencing system.

[0304] 60. The technology delivery platform of claim 45, wherein the plurality of development or production site operating systems comprises an operations management system.

[0305] 61. The technology delivery platform of claim 45, wherein the plurality of development or production site operating systems include a data historian.

[0306] 62. The technology delivery platform of claim 45, wherein one of the transformation modules is configured to scale the processing steps for execution in a development or production site.

[0307] 63. The technology delivery platform of claim 62, wherein the one of the transformation modules is configured to scale the processing step at least according to a ratio in the pervasive process definition.

[0308] 64. The technology delivery platform of claim 62, wherein the one of the transformation modules is configured to scale the processing step according to at least an equipment specification of equipment in the development or production site.

[0309] 65. The technology delivery platform of claim 62, wherein said one of said transformation modules is configured to scale said processing step based at least on an indication of a desired output volume for said product.

[0310] 66. The technology delivery platform of claim 45, wherein the one or more outputs configure a process automation system by associating the processing steps with specific equipment in the development or production site and defining control modules or routines for the process plant.

[0311] 67. The technology delivery platform according to claim 45 further comprises a delivery module, wherein the delivery module is configured to receive process data from a development or production site and output a universal process definition corresponding to the received process data, wherein the universal process definition specifies a series of equipment-independent processing steps performed at the development or production site to generate the process data.

[0312] 68. The technology delivery platform of claim 45, wherein the pervasive process definition specifies:

[0313] A set of input materials;

[0314] a set of operations to be performed on the input material;

[0315] the order in which the operations are to be performed; and

[0316] Quantitative information about the amount of the respective input material.

[0317] 69. A technology delivery platform according to claim 68, further comprising equipment category information specifying common equipment associated with each operation in the set of operations, wherein the technology delivery platform is operable to determine a minimum set of common equipment necessary to perform the set of operations from the pervasive process definition.

[0318] 70. The technology delivery platform of claim 69, wherein the pervasive process definition further specifies one or more preferred equipment types for at least one of the operations.

[0319] 71. The technology delivery platform of claim 45, further comprising stored information of a plurality of development or production sites, the stored information specifying, for each of the development or production sites, at least one set of process equipment available at the development or production site.

[0320] 72. A technology delivery platform according to claim 45, wherein the communication layer is coupled to each of a plurality of development or production sites, and wherein the technology delivery platform receives via the communication layer at least one set of process equipment available at the development or production site for each of the development or production sites.

[0321] 73. The technology delivery platform of claim 69, wherein the pervasive process definition further specifies a set of parameter data to be collected for regulatory purposes, and wherein the one or more transformation modules generate outputs that configure a regulatory system at a development or production site.

[0322] 74. The technology delivery platform of claim 69, wherein the pervasive process definition further specifies a set of parameter data to be collected by a data historian, and wherein the one or more transformation modules generate outputs that configure the data historian at a development or production site.

[0323] 75. A technology delivery platform according to claim 69, wherein the ubiquitous process definition also specifies a set of parameter data to be collected for feedback to the technology delivery platform, and wherein the one or more transformation modules generate a site operating system in the site operating system at a configuration development or production site to collect the parameter data during the execution of a site-specific series of processing steps generated from the ubiquitous process definition and provide the parameter data to an output of the technology delivery platform after the execution of the site-specific series of processing steps.

[0324] 76. The technology delivery platform of claim 69, wherein the pervasive process definition further specifies one or more constraints on one or more properties of input materials.

[0325] 77. The technology delivery platform of claim 69, wherein the pervasive process definition further specifies one or more constraints on one or more parameters of an operation.

[0326] 78. The technology delivery platform of claim 69, wherein the pervasive process definition further specifies one or more constraints on one or more parameters of the sequence.

[0327] 79. The technology delivery platform of claim 45, wherein the delivery component is operable to parse the pervasive process definition to extract and store process definition data.

[0328] 80. A method of creating a pervasive process definition that specifies a series of equipment-independent processing steps for manufacturing, productizing, or packaging a product, the method comprising:

[0329] receiving, from one or more site operating systems at a development or production site, data specifying the performance of a set of process steps for manufacturing, productizing, or packaging the product using a specified set of equipment at the development or production site;

[0330] receiving data related to the physical configuration of the development or production site;

[0331] The pervasive process definition is automatically created based on the received file specifying execution of the set of process steps and the received data related to the physical configuration of the development or production site.

[0332] 81. The method of claim 80, wherein the data specifying execution of the set of process steps comprises one or more automated control routines.

[0333] 82. The method of claim 80, wherein the data specifying performance of the set of process steps comprises one or more manual processing steps.

[0334] 83. The method of claim 80, wherein the data specifying execution of the set of process steps comprises one or more automated control routines and one or more manual processing steps.

[0335] 84. The method of claim 80, wherein the pervasive process definition specifies:

[0336] A set of input materials;

[0337] a set of operations to be performed on said input material;

[0338] the order in which the operations are performed; and

[0339] Quantitative information about the amount of the respective input material.

[0340] 85. The method according to claim 80 further includes transforming the created universal process definition into second data, wherein the second data specifies the execution of a set of process steps for manufacturing, productizing or packaging the product using a different set of equipment and / or at a different process plant.

[0341] 86. The method of claim 80, further comprising comparing the created pervasive process definition to a second pervasive process definition and indicating differences therebetween.

[0342] 87. The method of claim 80, wherein the data specifying performance of the set of process steps comprises electronic laboratory notebook data.

[0343] 88. The method of claim 84, wherein the pervasive process definition further specifies one or more of the following:

[0344] equipment of the necessary type for one or more of the operations described;

[0345] preferred types of equipment for one or more of the operations;

[0346] initial conditions of equipment for one or more of the operations;

[0347] essential material properties of one or more of the input materials;

[0348] preferred material properties of one or more of the input materials;

[0349] Alternative materials to one or more of the input materials;

[0350] constraints on one or more parameters;

[0351] Parameters to be stored in the regulatory tracking system;

[0352] Parameters to be stored by the data historian system.

[0353] 89. The method of claim 80, further comprising receiving process data generated during execution of the set of process steps from the one or more site operating systems of the development or production site.

[0354] 90. The method of claim 89, further comprising analyzing the received process data to determine one or more process improvements relative to an earlier generated pervasive process definition.

[0355] 91. The method of claim 90, further comprising adjusting the earlier generated pervasive process definition based on the one or more process improvements to create a revised pervasive process definition.

[0356] 92. The method of claim 91 further comprising automatically transforming the modified universal process definition into data specifying the execution of the set of process steps for manufacturing, productizing or packaging the product using a specified set of equipment in different development or production sites.

[0357] 93. A method for developing an industrial process, the method comprising:

[0358] receiving, at one or more computing devices, collected site data corresponding to data collected by one or more execution systems at an industrial process site during execution of a site-specific implementation of an industrial process at the industrial process site;

[0359] Obtaining, by the one or more computing devices, a pervasive process definition of the industrial process from a data repository, the pervasive process definition specifying a process associated with the industrial process

[0360] A corresponding series of equipment-independent process operations; and

[0361] The collected site data is combined with the

[0362] One or more components of a pervasive process definition are associated;

[0363] storing, by the one or more computing devices, an indication of the association between the collected site data and the one or more components of the pervasive process definition;

[0364] and

[0365] The pervasive process definition is updated, by the one or more computing devices, based on the stored indication.

[0366] 94. The method of claim 93, wherein:

[0367] The collected site data corresponding to the execution of the industrial process at the industrial process site includes data indicative of equipment specific to the industrial process site.

[0368] data;

[0369] The method further includes, after receiving the collected site data, transforming, by the one or more computing devices, at least a portion of the data indicative of the equipment specific to the industrial process site into equipment-independent data; and

[0370] Wherein associating the collected site data with the one or more components of the pervasive process definition includes associating the equipment-independent data with the one or more components of the pervasive process definition.

[0371] 95. A method according to any one of claims 93 to 94, wherein receiving collected site data corresponding to the execution of the industrial process at the industrial process site includes receiving equipment-independent data, which is a transformation of data indicating equipment specific to the industrial process site and corresponding to the execution of the industrial process at the industrial process site.

[0372] 96. The method of any one of claims 93 to 95, wherein associating the collected site data with the one or more components of the pervasive process definition comprises associating respective portions of the collected site data with one or more of:

[0373] The series of equipment-independent process operations;

[0374] a set of input materials for said industrial process; or

[0375] Relative quantitation or sizing information corresponding to the set of input materials.

[0376] 97. A method according to any one of claims 93 to 96, wherein storing the indication of the association between the collected site data and the one or more components of the ubiquitous process definition includes storing the indication of the association in conjunction with the ubiquitous process definition, thereby generating an updated ubiquitous process definition.

[0377] 98. The method according to claim 97,

[0378] The method further includes obtaining, by the one or more computing devices, approval of the association between the collected site data and the one or more components of the pervasive process definition, and

[0379] Generating the updated pervasive process definition is based on the approval.

[0380] 99. The method of any one of claims 97 to 98, wherein:

[0381] Obtaining the pervasive process definition for the industrial process includes obtaining a first version of the pervasive process definition; and

[0382] Generating the updated pervasive process definition includes generating a second version of the pervasive process definition.

[0383] 100. The method of any one of claims 93 to 99, wherein the industrial process site is a first industrial process site, and the method further comprises applying the updated pervasive process to a second industrial process site.

[0384] 101. The method of claim 100, wherein applying the updated pervasive process to the second industrial process site comprises:

[0385] transforming, by the one or more computing devices, the updated pervasive process definition into one or more site-specific process definition interface files for the second industrial process site based on site-specific information of the second industrial process site, the site-specific information of the second industrial process site including an indication of equipment specific to the second industrial process site; and

[0386] The one or more site-specific process definition interface files are enabled to be utilized at the second industrial process site by the one or more computing devices, thereby implementing a site-specific process definition corresponding to the updated pervasive process definition at the second industrial process site.

[0387] 102. A method according to any one of claims 93 to 101, wherein the received

[0388] The indication of the association between the collected site data and the one or more components of the pervasive process definition includes storing the indication of the association between the collected site data and the one or more components of the pervasive process definition in a historization data repository corresponding to the pervasive process definition.

[0389] 103. The method according to claim 102 further comprises:

[0390] A computing device obtains a subset of the contents of the historization repository in response to an audit or compliance query.

[0391] 104. The method according to any one of claims 102 to 103,

[0392] Also included is analyzing, by the one or more computing devices, the contents of the historical data repository to generate additional knowledge corresponding to the pervasive process definition; and

[0393] Wherein updating the pervasive process definition based on the stored indication comprises updating the pervasive process definition based on the additional knowledge.

[0394] 105. The method of claim 104, wherein:

[0395] The contents of the historization data repository correspond to data collected from a plurality of industrial process sites executing respective industrial processes according to respective sets of site-specific process definition interface files generated from the pervasive process definition; and

[0396] Each respective set of site-specific process definition interface files includes indications of equipment specific to a respective industrial process site of the plurality of industrial process sites.

[0397] 106. The method according to any one of claims 104 to 105, wherein the historical

[0398] Historizing the contents of the repository includes applying one or more analysis modules or routines to at least a subset of the contents of the historizing data repository.

[0399] 107. The method of claim 106, wherein generating a process definition corresponding to the pervasive process definition

[0400] The corresponding additional knowledge includes at least one of discovering correlations, classifications, or segmentations corresponding to the at least a subset of the content of the historical data repository based on applying the one or more analysis modules or routines to the at least a subset of the content of the historical data repository.

[0401] 108. A method according to claim 107, wherein discovering at least one of the correlations, classifications, or segmentations corresponding to at least some of the subset of the content of the historical data repository includes discovering at least one of the correlations, classifications, or segmentations of at least one of different components of the universal process definition or different values ​​of the different components.

[0402] 109. A method according to any one of claims 107 to 108, wherein discovering at least one of the correlations, classifications, or segmentations corresponding to at least some of the subset of the content of the historical data repository includes discovering at least one of the associations, classifications, or segmentations of at least some of the subset of the content of the historical data repository relative to one or more execution objectives of the industrial process.

[0403] 110. The method of claim 109, wherein the one or more execution goals of the industrial process include at least one of: quality level, compliance level, throughput, time limit or duration, or cost.

[0404] 111. The method of any one of claims 109 to 110, wherein at least some of the one or more execution goals of the industrial process correspond to the pervasive process definition.

[0405] 112. The method of any one of claims 109 to 111, wherein at least some of the one or more execution targets of the industrial process specifically correspond to the industrial process site.

[0406] 113. The method of any one of claims 93 to 112, further comprising obtaining, by the one or more computing devices, approval of the additional knowledge, and wherein updating the pervasive process definition is based on the approval.

[0407] 114. The method of any one of claims 93 to 113, wherein the industrial process site is a first industrial process site, and the method further comprises applying the updated pervasive process to a third industrial process site.

[0408] 115. The method of claim 114, wherein applying the updated pervasive process to the third industrial site comprises:

[0409] The one or more computing devices transform the updated universal process definition into one or more site-specific process definition interface files for the third industrial process site based on site-specific information of the third industrial process site, wherein the site-specific information of the third industrial process site includes information specific to the third industrial process site.

[0410] Instructions for equipment at the process site; and

[0411] The one or more site-specific process definition interface files are caused to be implemented at the third industrial process site by the one or more computing devices, thereby implementing a site-specific process definition corresponding to the updated pervasive process definition at the third industrial process site.

[0412] 116. The method of any one of claims 93 to 115, wherein:

[0413] The industrial process site implements a site-specific process definition corresponding to the ubiquitous process definition and site-specific information for the industrial process site, the site-specific information including an indication of equipment specific to the industrial process site; and

[0414] Receiving data collected during the execution of the industrial process at the industrial process site includes receiving data collected during execution of an industrial process at the industrial process site according to the site-specific process definition.

[0415] 117. The method of claim 116, further comprising:

[0416] The one or more computing devices transform the universal process definition into a process for the industrial process based on the site-specific information of the industrial process site.

[0417] One or more site-specific process definition interface documents for the site; and

[0418] The one or more site-specific process definition interface files are enabled to be utilized at the industrial process site by the one or more computing devices to implement the site-specific process definition at the industrial process site.

[0419] 118. The method according to any one of claims 116 to 117, further comprising

[0420] The site-specific process definition is evaluated by the one or more computing devices based on the association between the collected site data and the one or more components of the ubiquitous process definition.

[0421] 119. The method of claim 118, wherein based on the collected site data and the

[0422] Evaluating the site-specific definition based on the association between the one or more components of the ubiquitous process definition includes evaluating the accuracy of the site-specific process definition relative to the ubiquitous process definition based on the association between the collected site data and the one or more components of the ubiquitous process definition.

[0423] 120. A method according to any one of claims 118 to 119, wherein evaluating the site-specific definition based on the association between the collected site data and the one or more components of the universal process definition includes evaluating the effectiveness of the site-specific process definition relative to one or more objectives of the execution of the industrial process based on the association between the collected site data and the one or more components of the universal process definition.

[0424] 121. The method of claim 120, wherein the one or more objectives for the execution of the industrial process include at least one of: quality level, compliance level, throughput, time limit or duration, or cost.

[0425] 122. The method of any one of claims 120 to 121, wherein at least some of the one or more objectives of the execution of the industrial process correspond to the pervasive process definition.

[0426] 123. The method of any one of claims 120 to 122, wherein at least some of the one or more objectives of the execution of the industrial process specifically correspond to the industrial process site.

[0427] 124. The method of any one of claims 118 to 123, further comprising generating, by the one or more computing devices, additional knowledge corresponding to the pervasive process definition based on the evaluation.

[0428] 125. The method of claim 124, wherein generating the additional knowledge comprises applying one or more analysis modules or routines to the collected site data or the association of the collected site data with the one or more components of the pervasive process definition to discover the additional knowledge.

[0429] 126. The method of any one of claims 123 to 124, wherein generating the additional knowledge comprises generating information corresponding to at least one of different components of the pervasive process definition or different values ​​of the different components.

[0430] 127. The method according to any one of claims 124 to 126, further comprising updating, by the one or more computing devices, the pervasive process definition according to the additional knowledge generated based on the evaluation, thereby generating an updated pervasive process definition.

[0431] 128. A method according to claim 127, the method also includes obtaining approval of the additional knowledge generated based on the evaluation through the one or more computing devices, and wherein updating the pervasive process definition based on the additional knowledge is based on the approval of the additional knowledge generated based on the evaluation.

[0432] 129. The method of any one of claims 127 to 128, wherein the industrial process site is a first industrial process site, and the method further comprises:

[0433] transforming, by the one or more computing devices, the updated pervasive process definition into one or more site-specific process definition interface files for a fourth industrial process site based on site-specific information of the fourth industrial process site, the site-specific information of the fourth industrial process site including an indication of equipment specific to the fourth industrial process site; and

[0434] The one or more site-specific process definition interface files are caused to be implemented at the fourth industrial process site by the one or more computing devices, thereby implementing a site-specific process definition corresponding to the updated pervasive process definition at the fourth industrial process site.

[0435] 130. The method of any one of claims 93 to 129, wherein the one or more computing devices are included in a technology delivery platform of any one of claims 45 to 79.

[0436] 131. The method of any one of claims 93 to 130, wherein at least a portion of the one or more computing devices is included in a process development and management system.

[0437] 132. The method of claim 130, wherein the process development and management system corresponds to a plurality of industrial process sites including the industrial process site at which the industrial process is performed.

[0438] 133. A method for managing a process plant, the method comprising:

[0439] Receive a general process definition that specifies a series of equipment-independent processing steps for manufacturing, productizing, or packaging a product;

[0440] generating, based on the pervasive process definition, an indication of one or more site requirements for performing the series of equipment-independent process steps for manufacturing, productizing, or packaging the product;

[0441] receiving site configuration data associated with a configuration of one or more candidate development or production sites;

[0442] identifying one or more candidate development or production sites as a match based at least in part on comparing the one or more site requirements for performing the series of equipment-independent processing steps for manufacturing, productizing, or packaging the product to the site configuration data associated with each of the one or more candidate development or production sites; and

[0443] One or more development or production sites are selected from the matching one or more candidate development or production sites to perform the series of process steps for manufacturing, productizing or packaging the product.

[0444] 134. The method of claim 133, wherein receiving the pervasive process definition comprises

[0445] Receive at least:

[0446] Data related to input materials;

[0447] data relating to the ratios or amounts of said input materials and / or intermediate products;

[0448] Data relating to operations on said input materials and / or intermediate products; and data relating to the order in which said operations are to be performed.

[0449] 135. The method of claim 133, wherein receiving the pervasive process definition further comprises receiving one or more of:

[0450] duration data associated with respective ones of the operations;

[0451] parameter data of a corresponding operation in the operations;

[0452] Constraint data of corresponding parameter data;

[0453] Required initial state data of the equipment to perform the corresponding operation;

[0454] The desired feedback parameters to be collected;

[0455] The required audit data to be collected;

[0456] Preferred range data of corresponding parameter data;

[0457] Preferred equipment type data for one or more of the respective operations.

[0458] 136. The method of claim 133, wherein generating

[0459] The indication of one or more site requirements for performing the series of equipment-independent processing steps for manufacturing, productizing, or packaging the product also includes identifying one or more required properties of equipment corresponding to each respective operation based on the pervasive process definition.

[0460] 137. The method of claim 133, wherein generating

[0461] The paired indications of one or more site requirements for performing the series of equipment-independent processing steps for manufacturing, productizing, or packaging the product also include identifying one or more required properties of personnel used to perform the series of equipment-independent processing steps for manufacturing, productizing, or packaging the product based on the universal process definition.

[0462] 138. A method according to claim 133, wherein generating an indication of one or more site requirements for performing the series of equipment-independent processing steps for manufacturing, productizing or packaging the product based on the universal process definition also includes identifying one or more required properties of the size of a site for performing the series of equipment-independent processing steps for manufacturing, productizing or packaging the product based on the universal process definition.

[0463] 139. A method according to claim 133, wherein generating an indication of one or more site requirements for performing the series of equipment-independent processing steps for manufacturing, productizing or packaging the product based on the universal process definition also includes identifying one or more required properties of the following based on the universal process definition: input materials; ratios or amounts of the input materials and / or intermediates; operations on the input materials and / or intermediates; and / or the order in which the operations are performed.

[0464] 140. A method according to claim 133, wherein receiving site configuration data related to the configuration of the one or more candidate development or production sites includes receiving one or more of the following: equipment tag information; automation equipment type information; process control equipment information; I / O configuration data; and skid configuration information.

[0465] 141. A method according to claim 133, wherein receiving site configuration data related to the configuration of the one or more candidate development or production sites includes receiving indications of one or more properties of equipment available at each of the one or more candidate development or production sites.

[0466] 142. A method according to claim 133, wherein receiving site configuration data related to the configuration of the one or more candidate development or production sites includes receiving an indication of one or more properties of input materials available at each of the one or more candidate development or production sites.

[0467] 143. A method according to claim 133, wherein receiving site configuration data related to the configuration of the one or more candidate development or production sites includes receiving indications of one or more properties of personnel available at each of the one or more candidate development or production sites.

[0468] 144. The method of claim 133, wherein receiving

[0469] The site configuration data associated with the configuration of the development or production sites includes receiving an indication of one or more properties of a site size at each of the one or more candidate development or production sites.

[0470] 145. The method of claim 133, wherein one or more candidate development or production

[0471] Identifying a production site as a match also includes comparing one or more desired properties of personnel used to manufacture, productize, or package the product to one or more properties of personnel associated with each of the one or more candidate development or production sites.

[0472] 146. The method of claim 133, wherein one or more candidate development or production

[0473] Identifying a production site as a match also includes comparing one or more desired properties of a site size for manufacturing, productizing, or packaging the product to one or more properties of a site size at each of the one or more candidate development or production sites.

[0474] 147. The method of claim 133, wherein one or more candidate development or production

[0475] Identifying the production site as a match also includes comparing the data associated with the configuration of the development or production site, and determining, for each of the one or more candidate development or production sites, whether each candidate development or production site possesses at least one of the one or more types of equipment corresponding to each corresponding operation so that the series of processing steps can be performed at the development or production site.

[0476] 148. The method of claim 133, wherein one or more candidate development or production

[0477] The production site identification also includes:

[0478] Determine one or more of the equipment at each of the one or more candidate development or production sites based on the site configuration data

[0479] Multiple equipment capabilities; and

[0480] Determining whether each of the one or more candidate development or production sites is a match is based at least in part on whether each of the one or more candidate development or production sites is capable of producing a required quantity of the product to be manufactured, produced or packaged based on requirements of the site.

[0481] 149. The method of claim 133, wherein one or more candidate development or production

[0482] The production site identification also includes:

[0483] Determining the input material available at each of the one or more candidate development or production sites based on the site configuration data

[0484] Related inventory information;

[0485] Determining whether each of the one or more candidate development or production sites is a match based at least in part on whether each of the one or more candidate development or production sites is capable of producing a required quantity of the product to be manufactured, produced or packaged utilizing the input materials available at the development or production site based on the site requirements.

[0486] 150. The method of claim 133, wherein one or more candidate development or production

[0487] The production site identification also includes:

[0488] determining, based on the site requirements, an indication of the required quantity of the product and the required time by which the product must be manufactured, productized, or packaged;

[0489] Receive information related to each candidate of the one or more candidate development or production sites

[0490] Equipment availability scheduling information related to development or production sites;

[0491] determining a total time required to produce the required quantity of the product using the equipment at each of the one or more candidate development or production sites;

[0492] Determine, based on the equipment availability scheduling information and the required total time, whether each of the one or more candidate development or production sites is capable of producing the required quantity of the product within the required time; and determine whether each of the one or more candidate development or production sites is a match based at least in part on whether each of the one or more candidate development or production sites is capable of producing the required quantity of the product within the required time.

[0493] 151. The method of claim 133, wherein the first and second candidates are selected from the first and second candidates.

[0494] Selecting one or more development or production sites to perform the series of processing steps for manufacturing, productizing or packaging the product includes:

[0495] generating, based on the universal process definition, one or more instructions for executing the series of equipment-independent process steps for manufacturing, productizing, or packaging the product;

[0496] indication of multiple venue preferences;

[0497] generating a matching candidate development or production site for each of the one or more matching candidate development or production sites based at least in part on comparing the one or more site preferences for performing the series of equipment-independent process steps for manufacturing, productizing, or packaging the product with the site configuration of each of the one or more matching candidate development or production sites;

[0498] Suitability indicators associated with selected development or production sites; and

[0499] One or more development or production sites are selected from the matching one or more candidate development or production sites based on the suitability indicators to perform the series of processing steps for manufacturing, productizing, or packaging the product.

[0500] 152. The method of claim 151, wherein generating

[0501] The indication of one or more site preferences for performing the series of equipment-independent processing steps for manufacturing, producti...

Claims

1. A method of managing a production system to implement and lifecycle management processes to create a product, the method comprising: Creating a process definition for manufacturing the product, wherein the process definition is not limited to process equipment at a single process facility, the process definition comprising: A set of process materials used to manufacture said product, a set of process operations to be applied to the material used to manufacture the product, the sequence of the process operations, and information regarding the relative amounts of said materials used in said process; storing the process definition in a management system; selecting a first production site having at least a first process execution system coupled to a first set of process equipment; obtaining first process site data including execution system and process equipment data defining the first process execution system and the first set of process equipment; using a computer processor, creating a first set of site-specific production facility instructions using the process definition and the first process site data for implementation by or on the first process execution system using the first set of process equipment at the first production site to manufacture the product, the first set of site-specific production facility instructions being specific to the first process execution system using the first set of process equipment at the first production site; selecting a second production site having at least a second process execution system coupled to a second set of process equipment different from the first set of process equipment; obtaining second process site data including execution system and process equipment data defining the second process execution system and the second set of process equipment; and Using a computer processor, the process definition and the second process site data are used to create a second set of site-specific production facility instructions for implementation by or on the second process execution system using the second set of process equipment at the second production site to manufacture the product, the second set of site-specific production facility instructions being specific to the second process execution system using the second set of process equipment at the second production site.

2. The method of claim 1 , wherein using the process definition and the first process site data to create the first set of site-specific production facility instructions for implementation by the first process execution system using the first set of process equipment at the first production site to manufacture the product comprises: Generating one or more process control routines to be implemented by a control system at the first production site, and wherein using the process definition and the second process site data to create the second set of site-specific production facility instructions for implementation by the second process execution system using the second set of process equipment at the second production site to manufacture the product includes: generating one or more process control routines to be implemented by the control system at the second production site.

3. The method of claim 1 , wherein using the process definition and the first process site data to create the first set of site-specific production facility instructions for implementation by the first process execution system using the first set of process equipment at the first production site to manufacture the product comprises: Generating one or more audit system instructions to be implemented by an audit execution system at the first production site, and wherein using the process definition and the second process site data to create the second set of site-specific production facility instructions for implementation by the second process execution system using the second set of process equipment at the second production site to manufacture the product includes: generating one or more audit execution system instructions to be implemented by the audit execution system at the second production site.

4. The method of claim 1, further comprising collecting data related to operation of the first process execution system using the first set of process equipment at the first production site to manufacture the product, and storing the collected data at the management system.

5. The method according to claim 4, further comprising: using the collected data related to the operation of the first process execution system using the first set of process equipment at the first production site to manufacture the product to change the process definition; and storing the changed process definition as the process definition in the management system, and then using the process definition to create a set of site-specific production facility instructions for implementation by the process execution system on the second set of process equipment at the second production site to manufacture the product.

6. The method of claim 1, wherein the first production facility is a development production facility that performs development runs of the process, and wherein the second production facility is a commercial manufacturing facility that manufactures commercial-grade products.

7. The method of claim 1, wherein the first production site is a test production facility that performs a test run of the process, and wherein the second production site is one of a development facility that performs a development run of the product and a commercial manufacturing facility that manufactures a commercial-grade product.

8. The method of claim 1 , wherein using the process definition and the first process site data to create the first set of site-specific production facility instructions for implementation by the first process execution system using the first set of process equipment at the first production site to manufacture the product comprises: The process definition is scaled using the relative quantity information for a first production scale at the first production site, and wherein the process definition and the second process site data are used to create the second set of site-specific production facility instructions for implementation by the second process execution system using the second set of process equipment at the second production site to manufacture the product, including: scaling the process definition using the relative quantity information for a second production scale at the second production site, wherein the first production scale is different from the second production scale.

9. A method of managing a production system to implement a process to create a product, the method comprising: Creating a process definition for manufacturing the product, wherein the process definition is not limited to process equipment at a single process facility, the process definition comprising: A set of process materials used to manufacture said product, a set of process operations to be applied to the material used to manufacture the product, the sequence of the process operations, and information regarding the relative amounts of said materials used in said process; storing the process definition in a management system; selecting a production site having at least a first process execution system coupled to one or more sets of process equipment at the production site and a second process execution system coupled to the one or more sets of process equipment at the production site; obtaining process site data including execution system and process equipment data defining the first process execution system and the second process execution system and the one or more sets of process equipment; analyzing, using a computer processor, the process definition and the process site data associated with the first process execution system and the one or more sets of process equipment to create a first set of site-specific production facility instructions for implementation by or on the first process execution system using at least some of the one or more sets of process equipment at the production site to manufacture the product, the first set of site-specific production facility instructions being specific to the first process execution system using the at least some of the one or more sets of process equipment at the production site; and Using a computer processor, the process definition and the process site data associated with the second process execution system and the one or more sets of process equipment are analyzed to create a second set of site-specific production facility instructions for implementation by or on the second process execution system using at least some of the one or more sets of process equipment at the production site to manufacture the product, the second set of site-specific production facility instructions being specific to the second process execution system using at least some of the one or more sets of process equipment at the production site.

10. The method of claim 9, wherein the first process execution system is a process equipment control system that implements a process to manufacture the product, and wherein the second process execution system is an audit system that implements one or more audit functions during operation of the process to manufacture the product at the production facility.

11. The method of claim 9, wherein the first process execution system is a process equipment control system that implements a process to manufacture the product, and wherein the second process execution system is a scheduling system that implements one or more scheduling functions during operation of the process to manufacture the product at the production facility.

12. The method of claim 9, wherein the first process execution system is a process equipment control system that implements a process to manufacture the product, and wherein the second process execution system is a manufacturing operations management system that uses the process equipment control system to implement one or more management control functions during operation of the process to manufacture the product at the production facility.

13. The method of claim 9, wherein the first process execution system is a manufacturing operations management system that uses a set of process control equipment to implement one or more management control functions during operation of a process for manufacturing the product at the production facility, and the second process execution system is a data collection system that collects data from the process equipment during operation of the process.

14. The method according to claim 9 further includes collecting data related to the operation of the first process execution system and the second process execution system during the operation of the process for manufacturing the product, and storing the collected data at the management system; and the method further includes using the collected data related to the operation of the first process execution system and the second process execution system during the operation of the process for manufacturing the product to change the process definition, and pre-storing the changed process definition as the process definition in the management system.

15. A production management system for managing a production system to implement a process to create a product, the production management system comprising: a definition module, the definition module being configured to be executed on a computer processor, the definition module being adapted to create a process definition for manufacturing the product, wherein the process definition is not limited to process equipment at a single process facility, the process definition comprising: A set of process materials used to manufacture said product, a set of process operations to be applied to the material used to manufacture the product, the sequence of the process operations, and information regarding the relative amounts of said materials used in said process; a database for storing the process definition; and An execution module, the execution module is used to execute on one or more computer processors, the execution module enables a user to perform the following operations: selecting a first production site having at least a first process execution system coupled to a first set of process equipment, obtaining first process site data including execution system and process equipment data defining the first process execution system and the first set of process equipment, creating a first set of site-specific production facility instructions using the process definition and the first process site data for implementation by or on the first process execution system using the first set of process equipment at the first production site to manufacture the product, the first set of site-specific production facility instructions being specific to the first process execution system using the first set of process equipment at the first production site, selecting a second production site having at least a second process execution system coupled to a second set of process equipment different from the first set of process equipment, obtaining second process site data including execution system and process equipment data defining the second process execution system and the second set of process equipment, and A second set of site-specific production facility instructions is created using the process definition and the second process site data for implementation by or on the second process execution system using the second set of process equipment at the second production site to manufacture the product, the second set of site-specific production facility instructions being specific to the second process execution system using the second set of process equipment at the second production site.

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