Technology used to generate and execute analytical methods

Abstract

The present invention describes a technique and apparatus for generating and executing an analysis method. In one embodiment, for example, the apparatus may include at least one memory and logic coupled to the at least one memory. The logic may be configured to: perform an analysis service on a primary analysis device; receive an acceptance of the analysis service; and generate an analysis service package for the analysis service, the analysis service package being configured to facilitate performing the analysis service on a client analysis device. The present invention describes other embodiments.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 62 / 733,941, filed on September 20, 2018, the entire contents of which are incorporated by reference. Technical Field

[0003] Embodiments herein relate generally to management processes for analytical devices, and more particularly, to processes for generating methods configured to be performed by analytical devices. Background Art

[0004] Mass spectrometry (MS) is an effective tool for characterizing compounds in a wide range of disciplines, including proteomics, toxicology, food and environment (F&E), pharmaceuticals, and clinical research. The combination of chromatographic techniques and mass spectrometry combines the resolving power of chromatography with the detection specificity of MS. For example, a liquid chromatography-MS (LC-MS) system combines a liquid chromatography (LC) system with a mass analyzer (i.e., a mass spectrometer (MS) and / or an ion mobility spectrometer (IMS)).

[0005] Conventional MS systems require experienced users with technical knowledge of specific instruments and analytical techniques. In addition, MS analysis results generally require long turnaround times. Therefore, MS analysis is generally limited to a specialized operating environment. Therefore, although MS provides effective and accurate analysis, conventional MS systems have not been widely used, especially for routine applications in time-sensitive and / or high-yield environments such as in vitro diagnostics (IVD) or other clinical applications. Summary of the invention

[0006] According to various aspects of the embodiment, an apparatus is provided, which may include at least one memory and logic coupled to the at least one memory. The logic is operable to: perform an analysis service on a primary analysis device; receive an acceptance of the analysis service; and generate an analysis service package for the analysis service, the analysis service package being configured to facilitate performing the analysis service on a client analysis device.

[0007] In some embodiments of the device, at least a portion of the analysis service package is immutable. In various embodiments of the device, the main analysis device may include a liquid chromatography (LC) device. In some embodiments of the device, the main analysis device may include a mass spectrometer (MS) device. In some embodiments of the device, the analysis service package may include the status of the analysis service. In an exemplary embodiment of the device, the analysis service package may include the security level of the operator allowed to run the analysis service. In various embodiments of the device, the logic is operable to: access the analysis service package; and provide the analysis service package to the client analysis device for performing the analysis service on the client device. In some embodiments of the device, the logic is operable to set the acceptance variable of the analysis service package to an acceptance value in response to the acceptance of the analysis service package. In various embodiments of the device, the logic is operable to associate the analysis service package with a regulatory certificate. In some embodiments of the device, the analysis service package may include an analysis method and processing information associated with executing the analysis method.

[0008] According to some aspects of the embodiment, a method is provided, which may include: performing an analysis service on a primary analysis device; receiving an acceptance of the analysis service; and generating an analysis service package for the analysis service, the analysis service package being configured to facilitate performing the analysis service on a client analysis device.

[0009] In some embodiments of the method, at least a portion of the analysis service package is immutable. In some embodiments of the method, the primary analysis device may include a liquid chromatography (LC) device. In some embodiments of the method, the primary analysis device may include a mass spectrometer (MS) device. In some embodiments of the method, the analysis service package may include the status of the analysis service. In some embodiments of the method, the analysis service package may include the security level of the operator who is allowed to run the analysis service. In some embodiments of the method, the method may include: accessing the analysis service package; and providing the analysis service package to the client analysis device for performing the analysis service on the client device. In some embodiments of the method, the method may include: setting the acceptance variable of the analysis service package to an acceptance value in response to the acceptance of the analysis service package. In some embodiments of the method, the method may include: associating the analysis service package with a regulatory certificate. In some embodiments of the method, the analysis service package may include an analysis method and processing information associated with performing the analysis method. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1 An embodiment of a first operating environment is shown.

[0011] Figure 2 An embodiment of a second operating environment is shown.

[0012] Figure 3 An embodiment of a third operating environment is shown.

[0013] Figure 4 An embodiment of a fourth operating environment is shown.

[0014] Figure 5 A first logic flow is shown according to some embodiments.

[0015] Figure 6 A second logic flow is shown according to some embodiments.

[0016] Figure 7 A third logic flow is shown according to some embodiments.

[0017] Fig. 8A An embodiment of a fifth operating environment is shown.

[0018] Figure 8B An implementation of a sixth operating environment is shown.

[0019] FIG. 9A to FIG. 9S Depicted are illustrative screen images from an analytics service application according to some embodiments.

[0020] Fig.10 An embodiment of a computing architecture is shown. DETAILED DESCRIPTION

[0021] Various embodiments may be integrally related to systems, methods and / or devices for generating, controlling, processing, operating or otherwise managing analysis services for analysis systems. In some embodiments, analysis services may be generated using the primary analysis system used on the client analysis system. In an exemplary embodiment, analysis services may include processes and any process information (e.g., parameters, settings, thresholds, limits, etc.) required for the execution of processes, methods, analysis, tests, etc. by analysis equipment. In some embodiments, analysis services may be developed, refined, adjusted, etc. using the primary analysis system. The primary analysis system may be used to determine the correct method, steps, sequence, parameters, etc. for analysis services. Once the analysis service is correctly (otherwise as required) operated on the primary analysis system, an analysis service package for use by the client analysis system may be generated. In various embodiments, at least a portion of the analysis service package may be immutable or unmodifiable. The client analysis system may access and execute ("run" or "play") the analysis service package to execute the analysis service as specified by the analysis process package.

[0022] For example, in some embodiments, the analysis system may include a liquid chromatography (LC)-mass spectrometry (MS) system. LC-MS services may be developed and refined in the main LC-MS system. Once the correct service parameters are determined and the performance of the service is established, the service may be exported as an analysis service package or process package. For example, the service may include performing LC-MS on a particular class of compounds. When exporting, many common settings (e.g., plate size, sample position order, which plates to use at runtime, etc.) may be specified, and the service may be packaged for routine use by the client LC-MS system. In some embodiments, the client LC-MS system may include or may be operably coupled to a computing device. The computing device may execute an analysis service application, which operates to perform the services specified by the analysis service package. In various embodiments, the analysis service application may be operable to execute the analysis service package as a read-only (or at least partially read-only) package. Therefore, the analysis service application may be operable as a package "player", which operates to "run" or "play" the services specified in the analysis service package using the client LC-MS and associated computing hardware / software. In some embodiments, an analytical service package may include a status characteristic, such as a status characteristic indicating its approval status (e.g., approved by a regulatory agency (e.g., the Food and Drug Administration (FDA)) for performance evaluation only, for clinical use, for research use only).

[0023] In various embodiments, the client analysis system can be a basic version of an analysis system optimized for running the same method multiple times, improving user experience, reducing usage errors, reducing data input, user interaction, and touch time, etc. (e.g., compared to a mature main analysis system). For example, the client analysis system and / or the client analysis service application may not have the same number of options or configurations as a mature main analysis system. In some embodiments, the client analysis service application may be or may include a web application ("web app" or "app"), a remote web client, etc. Therefore, in some embodiments, the client analysis system can take advantage of the fact that many parameters are preset during the generation of the analysis service package to optimize the workflow, minimize operator interaction, and thus reduce the scope of operator error. In some embodiments, the client analysis system may be or may include operating characteristics different from the main analysis system. For example, the client analysis system may require different reagent volumes, parameter volumes, sample run times, etc. In some embodiments, the analysis service package may include information that allows its process to be performed on different client analysis systems. For example, the analysis service package may include information that converts the method from the main analysis system to various types of client analysis systems.

[0024] Compared with conventional systems and methods, analysis services according to some embodiments can provide multiple technical advantages and technical features, including improvements to computing technology. For example, some embodiments may allow non-expert users to use analytical equipment that must be performed by expert operators using conventional techniques to perform analysis. For example, the use of LC-MS for applications associated with clinical diagnosis (CDX) has steadily increased. However, the expansion of LC-MS outside highly specialized fields has been limited. Therefore, some embodiments can provide new processes, software tools and analytical equipment systems that will meet the core application needs of clinical diagnostic laboratories and deliver enhanced user experience (UX), to further adopt LC-MS. For example, some embodiments can provide a user interface that focuses on the execution of analytical tests, and will be designed to provide intuitive, simplified workflows, which means that non-expert users therein will be able to operate analytical systems, such as LC-MS systems.

[0025] The expansion of LC-MS in clinical settings has been limited because the clinical diagnostic environment places specific demands on LC-MS products and the software tools associated with them that have not been met by conventional systems. Specifically, conventional LC-MS is widely considered to be a complex technology to operate in clinical laboratories due to the need for skilled operators, which is a major barrier to widespread adoption. Therefore, some embodiments can provide effective interfaces and services to facilitate the use of LC-MS in conventional experimental settings.

[0026] For example, the need for non-expert users can be addressed by the LC-MS system being able to generate and report results with no or reduced technical expertise. In another example, modern clinical laboratories are highly automated environments, so some embodiments can facilitate the integration of LC-MS with laboratory information (management) systems (LIS or LIMS) and a variety of sample processing tools to improve the overall efficiency of analysis and reduce the error rates associated with manual transcription of data or sample processing.

[0027] In addition, some embodiments may support additional requirements that must be considered for in vitro applications. For example, when LC-MS systems, whether used alone or in combination, are intended to be used by manufacturers for in vitro examination of samples to provide information for generating data that will affect treatment decisions for diagnostic, monitoring or compatibility purposes, they are classified as in vitro diagnostic (IVD) medical devices. Therefore, these systems are subject to regulatory controls that are intended to protect the health and safety of patients, users, and other personnel by ensuring that manufacturers of IVD medical devices meet certain standards during design, manufacture, use, and / or marketing (e.g., the FDA in the United States, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and the European Medicines Agency (EMA) in the European Union).

[0028] As described in detail below, some embodiments may provide analytical equipment, applications, processes, etc. that can be used as components of IVD medical equipment (such as LC-MS IVD medical equipment). For example, some embodiments may allow clinical laboratories (e.g., hospitals, contract trials, etc.) to develop their own laboratory developed tests (LDTs) using LC-MS IVD equipment. In another example, research organizations, third parties and / or other entities may use analytical equipment, applications, processes, etc. according to some embodiments to use LC-MS IVD medical equipment to implement their own Class II medical devices, obtain regulatory approval, commercialize, etc. (e.g., using the documents provided by the processes according to some embodiments). In another example, some embodiments may allow entities (e.g., laboratories) to develop diagnostic tests and commercialize them, which can be run on client instruments on site or as part of a reagent rental program. The embodiments are not limited to this context. Specifically, although IVD medical equipment (and specifically LC-MS IVD medical equipment) is described in some examples, the embodiments are not limited thereto, because any application that can be operated according to some embodiments is contemplated herein. For example, some embodiments may provide analytical devices, applications, processes, etc. for use in pharmaceuticals, food and environment (F&E), toxicology (eg, forensic toxicology), and the like.

[0029] In this description, many specific details, such as components and system configurations, may be set forth in order to provide a more thorough understanding of the described embodiments. However, those skilled in the art will appreciate that the described embodiments may be practiced without such specific details. In addition, some well-known structures, elements, and other features are not shown in detail to avoid unnecessarily obscuring the described embodiments.

[0030] In the following description, references to "one embodiment," "an embodiment," "an example embodiment," "various embodiments," etc., indicate that an embodiment of the described technology may include a particular feature, structure, or characteristic, but more than one embodiment may, and not every embodiment must, include the particular feature, structure, or characteristic. Furthermore, some embodiments may have some, all, or none of the features described for other embodiments.

[0031] As used in this specification and the claims, unless otherwise stated, the use of ordinal adjectives "first", "second", "third", etc. to describe elements merely refers to a specific instance of the referenced element or different instances of similar elements, and is not meant to imply that the elements so described must be in a specific order in time, space, order, or in any other manner.

[0032] Figure 1An example of an operating environment 100 is shown that may represent some embodiments. Figure 1 As shown, the operating environment 100 may include an analysis system 105 that operates to manage analysis data associated with analysis devices 115a-115n. In some embodiments, the analysis devices 115a-115n may be or may include a chromatography system, a liquid chromatography (LC) system, a gas chromatography (GC) system, a mass analyzer system, a mass spectrometer (MS) system, an ion mobility spectrometer (IMS) system, a high performance liquid chromatography (HPLC) system, an ultra high performance liquid chromatography (ULHPLC) system, or a high performance liquid chromatography (ULHPLC) system. Systems, ultra-high performance liquid chromatography (UHPLC) systems, solid phase extraction systems, sample preparation systems, heaters (e.g., column heaters), sample managers, solvent managers, in vitro devices (IVDs), combinations thereof, components thereof, variations thereof, and the like. Although LC, MS, and LC-MS are used in the examples in this detailed description, the embodiments are not limited thereto, as other analytical devices capable of operating according to some embodiments are contemplated herein. In various embodiments, one or more analytical devices in the analytical devices 115a-115n may include a primary analytical device. In some embodiments, one or more analytical devices in the analytical devices 115a-115n may include a client analytical device. In some embodiments, the primary analytical device and the client analytical device may have the same or substantially the same hardware and / or software configurations. In various embodiments, the hardware and / or software configurations of the primary analytical device and the client analytical device may have sufficient similarity so that the analytical service developed on the primary analytical device can be fully executed on the client analytical device.

[0033] In various embodiments, the analysis system 105 may include a computing device 110 communicatively coupled to the analysis devices 115a-115n. The computing device 110 is operable to communicate, control, monitor, manage, or otherwise process the various operating functions of the analysis devices 115a-115n. In some embodiments, the computing device 110 may be or may include an independent computing device, such as a personal computer (PC), a server, a tablet computing device, a cloud computing device, etc. In some embodiments, the computing device 110 may be a device separate from the analysis devices 115a-115n. In other embodiments, the computing device 110 may be a part of the analysis devices 115a-115n, such as an integrated controller.

[0034] like Figure 1 As shown, computing device 110 may include processing circuit 120, memory unit 130, and transceiver 160. Processing circuit 120 may be communicatively coupled to memory unit 130 and / or transceiver 160.

[0035] The processing circuit 120 may include and / or access various logics for performing processing according to some embodiments. For example, the processing circuit 120 may include and / or access analysis service logic 122, service generation logic 124 and / or service execution logic 126. The processing circuit and / or analysis service logic 122, service generation logic 124 and / or service execution logic 126 or parts thereof may be implemented in hardware, software or a combination thereof. As used in this application, the terms "logic", "component", "layer", "system", "circuit", "decoder", "encoder" and / or "module" are intended to refer to computer-related entities, which may be hardware, a combination of hardware and software, software or software in execution, examples of which are provided by the exemplary computing architecture 1000. For example, logic, circuits, or layers may be and / or may include, but are not limited to, a process running on a processor, a processor, a hard drive, multiple storage drives (optical and / or magnetic storage media), an object, an executable program, an execution thread, a program, a computer, a hardware circuit, an integrated circuit, an application specific integrated circuit (ASIC), a programmable logic device (PLD), a digital signal processor (DSP), a field programmable gate array (FPGA), a system on a chip (SoC), a memory cell, a logic gate, a register, a semiconductor device, a chip, a microchip, a chipset, a software component, a program, an application, firmware, a software module, computer code, any combination of the foregoing, and the like.

[0036] although Figure 1 120, but embodiments are not limited thereto. In addition, while service generation logic 124 and service execution logic 126 are depicted as logic of analysis service logic 122, embodiments are not limited thereto, as service generation logic 124 and service execution logic 126 may be separate logic and / or may not be separate logic, but part of analysis service logic 122. For example, analysis service logic 122, service generation logic 124, service execution logic 126, and / or any components thereof may be located within an accelerator, a processor core, an interface, a separate processor chip, fully implemented as a software application (e.g., analysis service application 136), etc.

[0037] The memory unit 130 may include various types of computer-readable storage media and / or systems in the form of one or more higher-speed memory units, such as read-only memory (ROM), random access memory (RAM), dynamic RAM (DRAM), double data rate DRAM (DDRAM), synchronous DRAM (SDRAM), static RAM (SRAM), programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), flash memory, polymer memory (such as ferroelectric polymer memory, bidirectional memory, phase change or ferroelectric memory), silicon-oxide-nitride-oxide-silicon (SONOS) memory, magnetic card or optical card, device array (such as independent disk redundant array (RAID) drive), solid-state memory device (e.g., USB memory, solid-state drive (SSD), and any other type of storage medium suitable for storing information. In addition, the memory unit 130 may include various types of computer-readable storage media in the form of one or more lower-speed memory units, including internal (or external) hard disk drives (HDD), magnetic floppy disk drives (FDD), optical disk drives for reading or writing removable optical disks (e.g., CD-ROM or DVD), solid-state drives (SSD), etc.

[0038] According to some embodiments, the memory unit 130 may store an analysis service application 136 that may operate alone or in combination with the analysis service logic 122 to perform various analysis functions. In various embodiments, the analysis service application 136 may interact with the analysis devices 115a-115n and / or components thereof through various drivers 132 (which may include application programming interfaces (APIs) or the like).

[0039] In various embodiments, the analysis service application 136 operates to access, generate, export, modify, provide, etc. an analysis service package 142. In various embodiments, the application service application 136 may provide an interface to include and / or modify a script, code, or other structure associated with the analysis service package 142. Thus, the analysis service package 142 may be or may include a script component, or may include analysis device information indicating the performance or characteristics of the analysis device 115a-115n. Such analysis device information may include, but is not limited to, spectral information, retention time information, performance characteristics, collision cross section (CCS) information, drift time information, chromatographic information, instrument accuracy, resolution, sensitivity or precision information, mass range, acquisition rate, dynamic range, error tolerance information, solvent capacity, maximum operating pressure, sample capacity, etc.

[0040] In some embodiments, the analysis service application 136 is operable to generate an analysis service for one or more analysis devices in the analysis device. For example, the analysis device 115a can be or can include a main analysis device, instrument, system, etc., such as a main LC-MS system. Analysis services or processes such as services for analyzing a specific class of compounds ("sample analysis") can be performed using an LC-MS system. The execution of the service can generate process information 134 and / or analysis data 138. The process information 134 may include information required for performing the service using the LC-MS system. Non-limiting examples of the process information 134 may include process steps, process step sequences, settings, parameters, etc. The analysis data 138 may include data associated with the analysis results of performing the service using the LC-MS system. Non-limiting examples of the analysis data 138 may include spectral information, retention time information, collision cross section (CCS) information, drift time information, chromatographic information, etc.

[0041] The analysis service may be performed using the primary analysis equipment 115a-115n until it has been accepted. For example, in some embodiments, the analysis service package may include an acceptance mark or variable or be associated with an acceptance mark or variable to indicate whether the analysis service package and / or the related analysis service has been accepted. For example, the sample analysis performed using LC-MS may be repeated, for example, refined, modified, etc. until acceptable. In some embodiments, acceptance may be based on acceptance factors, including but not limited to acceptance by the operator, acceptance based on a regulatory process (e.g., FDA), etc. In some embodiments, the analysis service package 142 may include one or more regulatory certificates or may be associated with one or more regulatory certificates, such as including a data structure of a regulatory certificate or an indication of an associated regulatory certificate in the analysis service package (e.g., so that the unmodified method of the analysis service package complies with the associated regulatory certificate). In some embodiments, the qualification information 140 may be used for the qualification or acceptance of the analysis service. For example, the qualification information 140 may include but is not limited to threshold values, calibration requirements, blank plate requirements, reagent requirements, tolerances, error information, etc. that may be used for the qualification analysis service. For example, an analytic process may be accepted (or partially accepted) if the analytic data for a particular number of runs of the analytic process satisfies the qualification information 140. The embodiments are not limited in this context.

[0042] In various embodiments, the analysis service application 136 (alone or in combination with the service generation logic 124) can generate an analysis service package 142 for the analysis service. For example, if the sample analysis performed on the primary LC-MS device is acceptable, the analysis service application 136 can generate a sample analysis package for the sample analysis service. The analysis service package 142 can provide information for the analysis service to be performed on the client analysis device 115a-115n. For example, the analysis device 115n can be a client LC-MS device. The computing device 110 can provide an interface for operating the client LC-MS device.

[0043] In some embodiments, the analysis service package 142 may include an analysis method (e.g., a proteomics sample analysis method) and information associated with performing the method, such as safety information (e.g., the user safety level required to run the method), validation requirements (e.g., the method is intended for use with FDA-validated LC-MS equipment), method status (e.g., for internal use only, non-FDA-approved, under development, for research purposes, approved for clinical research, approved for IVD, etc.), analysis equipment information, etc.

[0044] In some embodiments, although Figure 1 Only one computing device 110 is depicted in the figure, but there may be separate computing devices for operating a primary analysis device (e.g., a primary computing device) and a client analysis device (e.g., a client computing device), which may be located at separate locations. In various embodiments, the primary computing device and the client computing device may include and / or operate different versions of analysis service logic and / or analysis service applications. For example, the client computing device 110 may include service execution logic 126, but not service generation logic 124. In another example, the client computing device may not be able to run a full version of an analysis service application that is capable of modifying analysis services and / or analysis service packages (beyond authorized modifications). The embodiments are not limited to this context.

[0045] In various embodiments, the client computing device 110 may receive an analysis service package 142. For example, a client computing device for a client LC-MS system may access a sample analysis package. In some embodiments, the analysis service package may be stored in a data source 154a-154n accessible via a network 150. An analysis service application 136 (e.g., together with the service execution logic 126) may perform analysis services for the analysis service package. For example, the sample analysis package may include information, instructions, etc., so as to perform sample analysis on the client LC-MS system. In some embodiments, the analysis service application 136 may generate various reports 144 in response to the analysis device 115a-115n performing the analysis service.

[0046] Thus, in some embodiments, the analytical services application 136 may provide a user interface to the client analytical devices 115a-115n, such as LC-MS IVD medical devices, to allow the user to execute (or "just play"), process data, and report results, for example, as part of validation training, routine laboratory services, etc. In some embodiments, the client analytical services application 136 may allow the user to start and shut down the client analytical devices 115a-115n, select analytical services packages to execute associated methods, determine the client analytical device 115a-115n status and / or prepare to identify, correct, and resolve any system errors before performing diagnostic tests, define a set of samples (a batch of samples) to be analyzed, execute or "play" a method for analyzing a set of samples to acquire analytical data, process raw data collected by the client analytical devices 115a-115n, review the processed data to ensure laboratory-defined analytical data quality metrics are met, and / or generate reports for dissemination to test requesters, archival purposes, and / or other stakeholders.

[0047] In addition, as described in detail herein, according to some embodiments, the client analysis devices 115a-115n can provide a process for defining access rights on a per-user basis to ensure that users are only allowed to perform functions (and / or tests) for which they are qualified. The administrator level can, for example, define the functions and parameters that subsequent users are allowed to view, edit, delete, access, etc. Some embodiments can provide a process for identifying analysis services that have been developed and are suitable for the client environment and preventing access to analysis services that are not suitable for this analysis service (e.g., analysis services designed for different hardware configurations). In various embodiments, the client analysis service application 136 can be configured to log system errors and monitor and record experimental conditions during the collection of analysis data 138, indicating that the performance of the client analysis system is sufficient (e.g., via system suitability testing, etc.) to perform a specific test. The embodiments are not limited to this context.

[0048] Additionally, the analysis services application 136 may be configured to compare the analysis device information within the analysis services package 142 with information indicative of or otherwise associated with analysis devices 115a-115n that are communicatively coupled to or otherwise executing the analysis services application 136. The analysis services application 136 may be configured to present to the user data (e.g., any errors, incompatibilities, warnings, out of tolerance data, failures, etc.) that indicates that the selected analysis services package 142 will be suitable for execution with the coupled analysis devices 115a-115n.

[0049] Additionally or alternatively, the analysis service application 136 may be configured to convert analysis data 138 and / or process information 134 received during or after execution of the analysis service application 136 based on differences between analysis device information embedded within the analysis service package 142 and analysis device information of the analysis devices 115a-115n used to communicate with the analysis service application 136.

[0050] Additionally or alternatively, the analysis service package may include data indicating the performance of the original (or main) analysis device 115a-115n, which is used to create the analysis service package when the analysis service application analyzes a reference or standard analyte. The data indicating the performance of the new or different analysis device 115a-115n can be collected by analyzing the same reference or standard analyte. The difference between the data indicating the performance of the original analysis device and the new or different analysis device can be maintained as a conversion filter. In some embodiments, a conversion filter can be applied to convert the analysis data 138 and / or the processing information 134 received during or after the execution of the analysis service application 136 for such new or different analysis devices to ensure the consistency of the results on different analysis devices. For example, the difference between the spectrum of the reference standard collected on the LC-MS device used to create the analysis service package and the spectrum of the same reference standard collected on the new or different LC-MS device can be applied to all results collected on the new or different LC-MS device. In some embodiments, the transformation filter may include and / or have access to a library, database, or other data repository of transformation information that can be used to transform the performance of a process associated with the analysis service package 142 from a first machine (e.g., an originating machine used to generate the analysis service package) to a second machine (e.g., a different machine used to execute the analysis service package).

[0051] In some embodiments, the analysis services application 136 is operable to convert a process associated with the analysis services package 142 to a different type of analysis device. For example, a first analysis device may require different reagents, reagent volumes, reagent sequences, parameters, parameter values, calibrations, sample processing times, sample volumes, etc. The analysis services application 136 is operable to determine, for example, via device information, conversion tables, etc., the different requirements for converting the process of the analysis services package. In some embodiments, the different requirements for converting the process may be determined during execution of the process on an analysis device. For example, the analysis services application 136 may determine that a particular type, manufacturer, etc. of analysis device requires different parameter values ​​in order for the analysis to run successfully.

[0052] Figure 2 An example of an operating environment 200 is shown that may represent some embodiments. Figure 2As shown, operating environment 200 may include controller 230 that operates to perform analysis service 232 on analysis device 215. Controller 230 may include various processors, logic, etc. In some embodiments, controller 230 may be part of a computing device (e.g., computing device 110). In various embodiments, controller 230 may be part of analysis device 215, such as an embedded controller or a computing system. The embodiments are not limited to this context. In some embodiments, controller 230 may be or may include a data acquisition controller.

[0053] The analysis device 215 may include a plurality of analysis components 240a-240n. For example, the analysis device 215 may include an LC-MS device, and the analysis component 240a may include an LC component and 240n may include an MS component. In another example, the analysis device 215 may include an MS device, and the component 240a may include a sample introduction device and the component 240n may include a detector. The embodiments are not limited to this context.

[0054] In various embodiments, the controller 230 may receive a request to run a batch of samples (e.g., from a batch submitter, a result reviewer, etc.). The controller 230 may, for example, use drivers 234a-234n to execute analysis services 232 on the analysis device 215 to control operational aspects of the analysis components 240a-240n. The analysis services 232 may come from analysis service packages generated by a method developer using the primary analysis device 215. The controller 230 may execute or "play" the method specified in the analysis service 232. The results of the execution of the analysis service 232 on the analysis device 215 may be provided to a data consumer, such as a LIMS.

[0055] Figure 3 An example of an operating environment 300 is shown that may represent some embodiments. Figure 3 As shown, the operating environment 300 may include a healthcare system 305, which is operably coupled to an analysis system 310 via an interface engine 310 through a network 335. The healthcare system 305 may include a plurality of point-of-care devices 320a-320n and / or healthcare information sources 325a-325n operably coupled to a hospital information system (HIS) 315. In various embodiments, the HIS 315 may be operably coupled to the LIS of the analysis system 310 via an interface engine 330. A device manager 355 may be operable to manage, interact, support or otherwise control various operational aspects of a plurality of analysis devices 360a-360n. In some embodiments, at least a portion of the analysis devices 360a-360n may be client analysis devices. In various embodiments, at least a portion of the analysis devices 360a-360n may be primary analysis devices.

[0056] The analysis service device 345 may include a computing device that operates to generate analysis service packages using the main analysis devices 360a-360n and / or provides analysis service packages to the client analysis devices 360a-360n. In some embodiments, the analysis system 310 may include a plurality of LIS workstations 350a-350n that operate to monitor the main analysis devices 360a-360n. In various embodiments, the LIS workstations 350a-350n may execute a version of an analysis service application to view, generate, modify analysis service packages from the analysis service device 345, and load analysis service packages to the analysis service device, etc. In an exemplary embodiment, the analysis system 310 may include a sample preparation device 365 that may provide samples to the analysis devices 360a-360n during the generation and / or execution of analysis services.

[0057] Figure 4 An example of an operating environment 400 that may represent some embodiments is shown. Figure 4 As shown, the operating environment 400 may include a computing device 410 executing, hosting, or otherwise implementing an analysis service application 420 and an analysis service platform 430. In some embodiments, the analysis service application 420 may include a platform application that communicates with a portal service 424 and an identity service 430. The portal service 424 may include various APIs 426a-426n and applications 428a-428n. The portal service 424 may communicate with an application core service 436 having APIs 438a-438n, applications 440a-440n, and job information 442.

[0058] The analysis service platform 450 may include various services including, but not limited to, batch services 452a, method services 452b, system event services 452c, reporting services 452d, and result services 452e to provide information to the document information 454. The processing service 470 may communicate with the processing queue 460 and the raw data storage device 480. The collection service 464 may receive events from the collection event 462 data repository in communication with the application core service 436.

[0059] This article includes one or more logic flows representing exemplary methods for performing novel aspects of the disclosed architecture. Although one or more methods shown herein are shown and described as a series of actions for the purpose of simplifying the description, it will be understood and appreciated by those skilled in the art that these methods are not limited by the order of actions. Therefore, some actions may occur in different orders and / or occur simultaneously with other actions shown and described herein. For example, it will be understood and appreciated by those skilled in the art that the method may alternatively be represented as a series of related states or events, such as in a state diagram. In addition, not all behaviors shown in the method may be necessary for the novel implementation.

[0060] The logic flow may be implemented in software, firmware, hardware, or any combination thereof. In software and firmware embodiments, the logic flow may be implemented by computer executable instructions stored on a non-transitory computer readable medium or machine readable medium, such as an optical, magnetic, or semiconductor storage device. The embodiments are not limited in this context.

[0061] Figure 5 An embodiment of a logic flow 500 is shown. The logic flow 500 may represent some or all of the operations performed by one or more embodiments described herein, such as the analysis system 105 and / or the computing device 410. In some embodiments, the logic flow 500 may represent some or all of the operations of determining a device state of, for example, a client analysis device.

[0062] like Figure 5 As shown, candidate analysis equipment scheme test 505 may include candidate equipment method 510. For example, candidate LC-MS scheme test may include candidate method (or service) that can be run on specific LC-MS equipment. At box 515, the analysis equipment scheme may be verified by logic flow 500. At box 520, logic flow 500 may determine whether the analysis equipment has passed the system suitability test. For example, when in use, the suitability of the analysis equipment to perform diagnostic tests (such as verified analysis equipment schemes) may be evaluated. The system suitability test may be based on various factors, such as the passing of quality control tests, verification according to regulatory schemes, etc. If the analysis equipment has passed the system suitability test, the analysis equipment may be used at box 530 for diagnostic use of the analysis scheme. If the analysis equipment has not passed the system suitability test or the analysis equipment has been otherwise designated as removed from diagnostic use, the logic flow 500 may cause the analysis equipment to enter maintenance mode 525 or otherwise be unavailable for performing the analysis scheme. In some embodiments, if the analytical device is removed from diagnostic use for any test, the device must be shown to pass the system suitability for that test before being used for any further tests. In various embodiments, the device status may also change when the device is used to develop a new LDT, undergoes maintenance, or is taken out of service for any other reason.

[0063] Figure 6 An embodiment of a logic flow 600 is shown. The logic flow 600 may represent some or all of the operations performed by one or various embodiments described herein, such as the analysis system 105 and / or the computing device 410. In some embodiments, the logic flow 600 may represent some or all of the operations during the acquisition and processing of a batch of an LC-MS system.

[0064] For example, when a batch is submitted for acquisition, a job entity consisting of (at least) the selected method and batch may be created. The core application service of the analysis service application may submit the batch for conversion into an injection task sequence. In some embodiments, the injection data may be sent back and stored on disk. The core application service may use the acquisition events to coordinate processing operations and submit processing jobs to the processing service, for example, via a shared queue. The processing service may read the injection data, generate results, and store the results via the result service of the analysis service application. In various embodiments, the processing service may publish status notifications to the requesting service.

[0065] like Figure 6 As shown, at block 610, the logic flow may receive input A from a user interface at a portal service at block 615. For example, input A may include batch information, a method identifier, etc. In some embodiments, the portal service may provide information B for display at the user interface. At block 620, the core application service of the analysis service application may receive input C from the portal service. In various embodiments, input C may be or may include information from input A (e.g., batch information, a method identifier, etc.). At block 620, the core application service may provide batch id D to the batch service, and may receive a batch E matching batch id D from the batch service. At block 630, the logic flow may provide method id F to the method service, and the method service may provide method G.

[0066] At box 635, the logic flow 600 may receive an acquisition method batch H from the core application service at the acquisition service. At box 640, the logic flow 600 may provide injection data J from the acquisition controller in response to the acquisition method task list I. At box 645, the logic flow 600 may receive injection data L at an analysis information component (e.g., a sample repository). At box 650, the logic flow 600 may receive a processing job (e.g., a processing method, injection data id, etc.) at a job queue. At box 655, the logic flow 600 may receive a processing job O from a job queue at the processing service and injection data M from the analysis information component. The job may be processed, for example, by a client analysis device. At box 660, the logic flow 600 may receive a result set N at a result service.

[0067] Figure 7 700. Logic flow 700 may represent some or all of the operations performed by one or more embodiments described herein, such as analysis system 105 and / or computing device 410. In some embodiments, Figure 7 Can represent data flows associated with the flow of information during acquisition and processing of batches in an LC-MS system.

[0068] At block 715, the batch 705 and the method 710 may be provided to create a job. At block 720, the logic flow 700 may provide job A to create an injection sequence. At block 725, the injection sequence B may be provided to the acquisition service. At block 730, the acquisition service may provide injection data C to an auxiliary process data component (e.g., injection data). At block 735, the acquisition event D may be provided to the process acquisition event service. At block 740, process information E (e.g., channel ID, processing settings, etc.) may be provided to the process data service. At block 745, the analysis device may execute the process to generate analysis information.

[0069] Fig. 8A An example of an operating environment 800A is shown that may represent some embodiments. Fig. 8A As shown, operating environment 800A may include an analysis exchange platform (or analysis equipment platform) 805 associated with analysis service application 838. In some embodiments, analysis exchange platform 805 is operable to provide exchange of analysis information between interested entities. In various embodiments, analysis exchange platform 805 may include an application platform that operates to provide data exchange services between nodes 840a-840n and 850a-850n. In an exemplary embodiment, analysis exchange platform 805 may be a software platform, a suite, a solution set, etc. provided to consumers by a manufacturer, a product source, and / or a developer ("developer") associated with an analytical instrument. A non-limiting example of a developer may be Waters Corporation (Waters Corporation, Milford, Massachusetts, United States of America) in Milford, Massachusetts, USA. For example, a developer may provide analysis exchange platform 805 as a data exchange interface for analytical instruments such as LC, MS, LC-MS provided to entities by a developer. According to some embodiments, entities that use analytical instruments provided by developers (such as pharmaceutical manufacturers, research organizations, product suppliers, food supply chain entities, environmental testing entities, etc.) can use the analytical exchange platform 805 to implement analytical service applications 838. Other entities can access the analytical exchange platform 805 via a GUI (such as a client application, a web interface, a mobile application, etc.) to perform functions associated with the analytical service applications 838. In some embodiments, at least a portion of the analytical exchange platform 805 can be hosted in a cloud computing environment.

[0070] For example, in some embodiments, a developer or another entity can develop an analysis service package, method, test, verification scheme, etc. The developer can provide the analysis service package to the client analysis device via the analysis exchange platform.Node 840a-840n can be a data producer for analysis service application 838, and node 850a-850n can be a data consumer of analysis service application 838. Entity can be both data producer and data consumer. For example, node 840a can be a clinic operating client LC-MS IVD equipment. Node 850a can be a regulatory agency (e.g., FDA) operating to generate an analysis service package for verifying LC-MS IVD equipment, and node 850b can be an equipment manufacturer operating to generate a test method for analyzing a sample in a clinical setting using LC-MS IVD equipment. In some embodiments, analysis exchange platform 805 can be operated according to a cloud-based model and / or "as a service" model. In this way, analysis exchange platform 805 can provide services, and this service provides a single central platform that will allow entities to access the analysis service package.

[0071] In some embodiments, the analysis results and / or portions thereof (e.g., any errors, out-of-tolerance data, failures, etc.) may be provided from the user to the analysis package developer. In this way, the developer may be aware of the status of the analysis package and make corrections, pass / fail the analysis package, etc.

[0072] Figure 8B An example of an operating environment 800B is shown that may represent some embodiments. Figure 8B As shown, operating environment 800B may include a specific implementation of an analysis service platform 810, which may include a platform package 820 and a platform service 825. Non-limiting examples of platform package 820 may include a user interface (e.g., a web service, a client application user interface, etc.), a data model, analysis task management, etc. Non-limiting examples of platform services may include batch services, result services, method services, acquisition services, processing services, etc.

[0073] The analysis service platform 810 may include various service providers and / or may communicate with various service providers, such as analysis application 860a, analysis device driver 860b and / or information system 860c. The analysis application 860a may include a method development application with clinical input. The analysis device driver 860b may include drivers for various components of the analysis device (e.g., LC driver and MS driver for LC-MS system). The information system 860c may include various databases, including third-party databases, such as LIS, LIMS, HIS, etc. The embodiment is not limited to this context. The analysis service platform 810 may provide various applications, such as clinical application 870a, F&E application 870b, toxicology application 870c, etc. In this way, a set of public platform packages 820 and platform services 825 may be configured to provide services in a wide range of applications.

[0074] FIG. 9A to FIG. 9S Depicted are illustrative screen images from an analysis services application according to some embodiments. In various embodiments, the analysis services application can be used with an LC-MS system. Fig.9A Depicts an exemplary startup screen 905A showing that the LC-MS system is not in use. Selecting "System Startup" causes the display of Fig. 9B Screen 905B. Screen 905B may be or may include a user selection screen. In some embodiments, certain actions within the analysis service application may require user login or verification. In various embodiments, the user performing the action may be recorded in a log, a timestamp, a database, etc. In some embodiments, each user may belong to a security level, a role, a group, etc. For example, an analyst role may be allowed to collect and prepare samples to prepare LC-MS samples to be analyzed on the device, perform tests using the device, perform basic troubleshooting and routine maintenance on the device, etc. A super analyst role may be allowed to execute all analyst licenses and generate LDTs ​​for use on the device, perform more professional equipment settings, such as hardware configuration, advanced troubleshooting and advanced user maintenance of the device, review and approve data that has been subjected to qualification certification / training, and data entrusted by a supervisor, etc. The supervisor role may be allowed to supervise the use and execution of the device, and review / approve data for reporting (as entrusted by the laboratory supervisor), coordinate communications with third parties for service, installation, etc. Other roles may include operators, laboratory supervisors, third-party integrators, supplier service representatives, etc. The implementation scheme is not limited to this context. In some embodiments, the analysis service package may include designated roles for one or more aspects of the analysis service. For example, the analysis service package may specify roles that can view the analysis service, run the analysis service, exit the analysis results, etc.

[0075] Fig. 9CDepicted is screen 905C showing analysis services or methods 910 that the LC-MS system may be prepared for. A user may select the appropriate service 910 for operating the LC-MS for a particular run. Fig.9D Screen 905D is depicted after the user has selected a service 910 (e.g., a therapeutic drug monitoring service) on screen 905C. Fig.9D As shown, the analytical service application may provide the status of various system components 915. For example, the mass spectrometer and sample manager are online and ready, while the column manager is not yet available. Fig.9E Once the column manager becomes available (and therefore all monitored systems are indicated as ready), screen 905E may indicate that the system is ready to run.

[0076] See also Fig.9F , depicting screen 905F showing a graphical representation of a sample plate that may be displayed in response to selecting "Enter Samples" on screen 905E. Samples (including blanks, solvents, calibrators, etc.) may be manually entered or loaded via locally stored electronic files in a remote data system (e.g., a LI MS system), etc. Figure 9G Screen 905G depicts a sample plate loaded via a LIMS file. Once the sample plate is loaded, selecting "Next Step" on screen 905G causes the display to Figure 9H 905H, which depicts the instructions for physically loading the board into the system. Fig.9I Screen 905I of FIG. 10 may be displayed after the first plate is loaded. After all plates to be analyzed are loaded, the following may be displayed: Figure 9J The reagent check is performed as depicted in screen 905J. Figure 9K As shown in screen 905K of FIG. 1 , the operator may need to confirm solvents, lot numbers, etc. associated with reagents used in the analytical method.

[0077] See also Figure 9L , which depicts screen 905L showing an analysis service being performed on the LC-MS device, which shows, among other things, samples and time remaining for the analysis service. In response to completion of the analysis service, a Figure 9M Screen 905M indicates that the associated data is ready for review. Figure 9M As shown, an indicator 920 associated with the data associated with the analytical service may be provided, indicating, for example, that there may be a problem with the corresponding calibration. Figure 9N Screen 905N of FIG. 1 depicts the calibrators corresponding to the analytical service, including the calibrators outside of tolerance 925. In some embodiments, the calibrators may be respectively as follows: Fig.9O The screen 905O and Figure 9PThe screen 905P of illustratively provides a screen depicting the analysis data of the blank plate and the solvent and / or internal standard. An operator with appropriate authorization can view and modify the peak integration of the analysis data, such as Figure 9Q In various embodiments, any modifications made via screen 905Q may be recorded in a record associated with the performance of the analysis service. Figure 9R Screen 905R and Figure 9S As shown in screen 905S of , an operator with appropriate authorization can enter and / or generate his own calibrators. Calibrators can be associated with various methods that can be generated and / or executed on the LC-MS instrument.

[0078] Exemplary and non-limiting use cases

[0079] Use Case I :

[0080] Description: The laboratory provides testing services using LC-MS (MRM) to separate, identify, and quantify organic compounds contained in a human biological fluid sample matrix (such as blood or urine) using manual sample information entry and reporting using paper reports transcribed to the LIS. Trigger: The laboratory supervisor implements routine LC-MS testing in the lab. Prerequisites: The LC-MS protocol and sample preparation methods have been developed according to the laboratory SOP. Steps: 1. The analyst verifies that the equipment is being used; 2. The analyst selects the appropriate test; 3. The analyst prepares the LC-MS system for use; 4. The analyst performs system suitability testing and obtains a pass; 5. The analyst collects patient samples to be analyzed using a worklist and assembles them together with any blanks, QCs, and calibrators used in the batch; 6. The analyst provides the LC-MS sample information to the LC-MS system by completing the run list using a barcode scanner to enter the container ID of the patient sample; 7. The analyst performs sample run analysis on the patient sample, blanks, QCs, and calibrators. 1. Analyst prepares sample to produce LC-MS sample in sample carrier; 2. Analyst loads LC-MS sample into sample carrier and places in LC-MS system; 3. Analyst performs analysis of LC-MS sample by starting injection sequence; 4. Analyst processes data from LC-MS injection sequence; 5. Super analyst reviews data and makes adjustments to integration as needed; 6. Supervisor approves / rejects results and issues report; 7. Analyst prepares paper report for lab record; 8. Analyst manually enters results into LIS to report to person who ordered test. Acceptance criteria: Successful completion of summary usability testing and achievement of target completion and error rates for the above workflow.

[0081] Use Case II :

[0082] Description: The laboratory provides high volume testing services using LC-MS (MRM) to separate, identify and quantify organic compounds contained in a human biological fluid sample matrix (such as blood or urine) using automated sample preparation, electronic import of sample information and export of results to the LIS. Trigger: The laboratory supervisor implements routine high volume LC-MS testing in the laboratory. Prerequisites: LC-MS protocols and sample preparation methods have been developed according to laboratory SOPs. Data transfer between sample preparation equipment and LIS has been established. Steps: 1. The analyst collects and assembles patient samples that may be targeted for a work list generated by the LIS; 2. The analyst prepares the automated sample preparation device for use; 3. The analyst places patient samples including blanks, QCs, and calibrators on the liquid handler according to the laboratory SOP; 4. The analyst starts the sample preparation device to prepare the LC-MS sample, and the sample preparation device generates a work list for the LC-MS system; 5. The analyst verifies that the equipment is being used; 6. The analyst selects the appropriate test; 7. The analyst prepares the LC-MS system for use; 8. The analyst performs a system suitability test and obtains a pass; 9. The analyst imports the work list from the sample preparation device and verifies the sample position; 10. The analyst loads the LC-MS sample into the LCMS system; 11. The analyst performs analysis of the LC-MS sample by starting an injection sequence; 12. The analyst processes the data from the LC-MS injection sequence; 13. The super analyst reviews the data and makes adjustments to the integration as needed; 14. The super analyst approves / rejects the results and issues a report; 15. The analyst exports the data to the LIS system. Acceptance Criteria: Successful completion of aggregate usability testing and achievement of target completion and error rates for the above workflow.

[0083] Use Case III :

[0084] Description: The laboratory provides high volume testing services using LC-MS (flow injection, MRM) to identify and quantify (without separation) organic compounds contained in a human biological fluid sample matrix (such as blood or urine) from dried blood filter paper using automated sample preparation, electronic import of sample information, and export of results to the LIS. Trigger: The laboratory supervisor implements routine high volume targeted screening services in the laboratory using LC-MS. Prerequisites: LC-MS protocols and sample preparation methods have been developed according to laboratory SOPs. Data transfer between sample preparation equipment and LIS has been established. Steps: 1. Analyst collects and assembles patient samples, e.g., for a worklist generated by the LIS; 2. Analyst prepares automated sample preparation equipment for use and initiates sample preparation; 3. Analyst verifies equipment is being used; 4. Analyst selects appropriate tests; 5. Analyst prepares LC-MS system for use; 6. Analyst performs system suitability testing and passes; 7. Analyst provides LC-MS sample information to the equipment by completing a worklist [imported from the LIS or sample preparation equipment] incorporating QC and blank plates; 8. Analyst places LC-MS samples on the LC-MS system; 9. Analyst performs analysis of samples by starting an injection sequence using flow injection with MRM; 10. Analyst processes data from the LC-MS injection sequence using peak area ratios; 11. Supervisor reviews data and approves / rejects results based on QC results and absolute strength from the IS and issues a report; 12. Analyst exports results to the LIS. Acceptance criteria: Successful completion of summary usability testing and achievement of target completion and error rates for the workflow above.

[0085] Fig.10 An embodiment of an exemplary computing architecture 1000 suitable for implementing various embodiments as described above is shown. In various embodiments, the computing architecture 1000 may include or be implemented as part of an electronic device. In some embodiments, the computing architecture 1000 may represent, for example, computing devices 110 and / or 410. The embodiments are not limited in this context.

[0086] As used in this application, the terms "system" and "component" and "module" are intended to refer to computer-related entities, which may be hardware, a combination of hardware and software, software, or software in execution, examples of which are provided by the exemplary computing architecture 1000. For example, a component can be, but is not limited to, a process running on a processor, a processor, a hard drive, multiple storage drives (optical and / or magnetic storage media), an object, an executable file, an execution thread, a program, and / or a computer. For example, both an application running on a server and a server can be components. One or more components can reside in a process and / or an execution thread, and a component can be located on a computer and / or distributed between two or more computers. In addition, components can be communicatively coupled to each other through various types of communication media to coordinate operations. Coordination can involve unidirectional or bidirectional information exchange. For example, a component can communicate information in the form of a signal conveyed through a communication medium. The information can be implemented as a signal assigned to various signal lines. In such an assignment, each message is a signal. However, another embodiment can alternatively adopt a data message. Such data messages can be sent through various connections. Exemplary connections include parallel interfaces, serial interfaces, and bus interfaces.

[0087] The computing architecture 1000 includes various general computing elements, such as one or more processors, multi-core processors, co-processors, memory units, chipsets, controllers, peripherals, interfaces, oscillators, timing devices, video cards, audio cards, multimedia input / output (I / O) components, power supplies, etc. However, the embodiments are not limited to the implementation of the computing architecture 1000.

[0088] like Fig.10 As shown, computing architecture 1000 includes a processing unit 1004, a system memory 1006, and a system bus 10010. Processing unit 1004 can be any of a variety of commercially available processors, including but not limited to: and processor; Application, embedded and security processors; and and Processors; IBM and Cell processor; Core(2) and Dual microprocessors, multi-core processors, and other multi-processor architectures may also be used as the processing unit 1004 .

[0089] The system bus 10010 provides an interface for system components, including but not limited to an interface connecting the system memory 1006 to the processing unit 1004. The system bus 10010 can be any of several types of bus structures, which can be further interconnected to a memory bus (with or without a memory controller), a peripheral bus, and a local bus using any of a variety of commercially available bus architectures. Interface adapters can be connected to the system bus 10010 via a slot architecture. Exemplary slot architectures can include but are not limited to accelerated graphics port (AGP), card bus, (extended) industry standard architecture ((E)ISA), micro channel architecture (MCA), NuBus, peripheral component interconnect (extended) (PCI (X)), PCI Express, personal computer memory card international association (PCMCIA), etc.

[0090] The system memory 1006 may include various types of computer-readable storage media in the form of one or more higher-speed memory cells, such as read-only memory (ROM), random access memory (RAM), dynamic RAM (DRAM), double data rate DRAM (DDRAM), synchronous DRAM (SDRAM), static RAM (SRAM), programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), flash memory, polymer memory (such as ferroelectric polymer memory, bidirectional memory, phase change or ferroelectric memory), silicon-oxide-nitride-oxide-silicon (SONOS) memory, magnetic or optical cards, device arrays (such as redundant array of independent disks (RAID) drives), solid-state memory devices (e.g., USB memory, solid-state drives (SSDs), and any other type of storage medium suitable for storing information. Fig.10 In the illustrated embodiment, system memory 1006 may include non-volatile memory 1010 and / or volatile memory 1012. A basic input / output system (BIOS) may be stored in non-volatile memory 1010.

[0091] The computer 1002 may include various types of computer-readable storage media in the form of one or more slower memory units, including an internal (or external) hard disk drive (HDD) 1014, a magnetic floppy disk drive (FDD) 1016 for reading or writing to a removable magnetic disk 10110, and an optical drive 1020 (e.g., a CD-ROM or DVD) for reading or writing to a removable optical disk 1022. The HDD 1014, FDD 1016, and optical drive 1020 may be connected to the system bus 10010 via a HDD interface 1024, a FDD interface 1026, and an optical drive interface 10210, respectively. The HDD interface 1024 for external drive implementations may include at least one or both of a universal serial bus (USB) and IEEE 13104 interface technologies.

[0092] The drives and associated computer-readable media provide volatile and / or nonvolatile storage of data, data structures, computer-executable instructions, etc. For example, a number of program modules may be stored in drive 1010 and memory unit 1012, including operating system 1030, one or more application programs 1032, other program modules 1034, and program data 1036. In one embodiment, one or more application programs 1032, other program modules 1034, and program data 1036 may include various applications and / or components of computing devices 110 and / or 410, for example.

[0093] A user may enter commands and information into the computer 1002 through one or more wired / wireless input devices, such as a keyboard 10310 and a pointing device such as a mouse 1040. Other input devices may include a microphone, an infrared (IR) remote control, a radio frequency (RF) remote control, a game controller, a stylus, a card reader, a dongle, a fingerprint reader, a glove, a graphics tablet, a joystick, a keyboard, a retina reader, a touch screen (e.g., capacitive, resistive, etc.), a trackball, a trackpad, a sensor, a stylus, etc. These and other input devices are typically connected to the processing unit 1004 through an input device interface 1042 coupled to the system bus 10010, but may be connected through other interfaces such as a parallel port, an IEEE 1394 serial port, a game port, a USB port, an IR port, etc.

[0094] A monitor 1044 or other type of display device is also connected to the system bus 10010 via an interface, such as a video adapter 1046. The monitor 1044 may be internal or external to the computer 802. In addition to the monitor 1044, computers typically include other peripheral output devices, such as speakers, printers, and the like.

[0095] The computer 1002 can operate in a networking environment using logical connections via wired and / or wireless communications to one or more remote computers, such as remote computer 10410. The remote computer 10410 can be a workstation, server computer, router, personal computer, portable computer, microprocessor-based entertainment device, peer device, or other public network node, and typically includes many or all of the elements described relative to the computer 1002, but only a memory / storage device 1050 is shown for simplicity. The depicted logical connections include wired / wireless connections to a local area network (LAN) 1052 and / or a larger network, such as a wide area network (WAN) 1054. Such LAN and WAN networking environments are common in offices and companies, and facilitate enterprise-wide computer networks, such as intranets, all of which can be connected to a global communications network, such as the Internet.

[0096] When used in a LAN networking environment, the computer 1002 is connected to the LAN 1052 through a wired and / or wireless communication network interface or adapter 1056. The adapter 1056 can facilitate wired and / or wireless communication to the LAN 1052, which may also include a wireless access point disposed thereon for communicating with the wireless functionality of the adapter 1056.

[0097] When used in a WAN networking environment, the computer 1002 may include a modem 10510, or be connected to a communications server on the WAN 1054, or have other means for establishing communications over the WAN 1054, such as over the Internet. The modem 10510 may be internal or external and a wired and / or wireless device connected to the system bus 10010 via the input device interface 1042. In a networking environment, program modules or portions thereof described relative to the computer 1002 may be stored in the remote memory / storage device 1050. It should be appreciated that the network connections shown are exemplary and other means of establishing a communications link between the computers may be used.

[0098] The computer 1002 is operable to communicate with wired and wireless devices or entities using the IEEE 802 family of standards, such as wireless devices operatively arranged in wireless communications (e.g., IEEE 802.16 over-the-air modulation techniques). This includes at least Wi-Fi (or Wireless Fidelity), WiMax, and Bluetooth. TMWi-Fi networks use radio technologies called IEEE 802.11x (a, b, g, n, etc.) to provide secure, reliable, and fast wireless connectivity. Wi-Fi networks can be used to connect computers to each other, to the Internet, and to wired networks (using IEEE 802.3 related media and functions).

[0099] Many specific details have been set forth herein to provide a thorough understanding of the embodiments. However, those skilled in the art will appreciate that the embodiments may be practiced without these specific details. In other cases, well-known operations, components, and circuits are not described in detail to avoid obscuring the embodiments. It is understood that the specific structural and functional details disclosed herein may be representative and do not necessarily limit the scope of the embodiments.

[0100] The expressions "coupled" and "connected," as well as their derivatives, may be used to describe some embodiments. These terms are not intended to be synonymous with each other. For example, the terms "connected" and / or "coupled" may be used to describe some embodiments to indicate that two or more elements are in direct physical or electrical contact with each other. However, the term "coupled" may also mean that two or more elements are not in direct contact with each other, but still cooperate or interact with each other.

[0101] Unless expressly stated otherwise, it is understood that terms such as "processing", "computing", "calculating", "determining", etc. refer to the operation and / or process of a computer or computing system or similar electronic computing device, which processes and / or transforms data represented as physical quantities (e.g., electronic) within the registers and / or memories of the computing system into physical quantities similarly represented as memories, registers or other such information storage devices, transmission or display devices of the computing system. The embodiments are not limited to this context.

[0102] It should be noted that the methods described herein do not have to be performed in the order described or in any particular order. In addition, the various activities described with respect to the methods identified herein can be performed in series or in parallel.

[0103] Although specific embodiments have been depicted and described herein, it should be understood that any arrangement that is expected to achieve the same purpose can replace the specific embodiments shown. The present disclosure is intended to cover any and all adaptations or changes of various embodiments. It should be understood that the above description is carried out in an illustrative manner, rather than restrictive. After reading the above description, the combination of the above-mentioned embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art. Therefore, the scope of the various embodiments includes any other application in which the above-mentioned compositions, structures and methods are used.

[0104] Although the subject matter has been described in language specific to structural features and / or methodological acts, it should be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts are disclosed as example forms of implementing the claims.

Claims

1. A device for analyzing services, the device comprising: at least one memory; and logic, the logic coupled to the at least one memory, the logic being configured to cause the apparatus to: executing an analysis service on a primary analysis device, wherein the analysis service includes an analysis method for sample analysis and processing information associated with executing the analysis method on the primary analysis device, In response to determining that the analysis service is operating correctly on the primary analysis device, accepting the analysis service, and An analysis service package is generated for the analysis service, the analysis service package being configured to facilitate execution of the analysis service on a client analysis device having a similar hardware and / or software configuration and having a reduced number of options or configurations as compared to the primary analysis device.

2. The apparatus of claim 1, wherein at least a portion of the analysis service package is immutable.

3. The apparatus of claim 1, wherein the primary analytical device comprises a liquid chromatography (LC) device.

4. The apparatus of claim 1, wherein the primary analysis device comprises a mass spectrometer (MS) device. The apparatus of claim 1 , wherein the analysis service package comprises a status of the analysis service.

6. The apparatus of claim 1, the analysis service package comprising a security level for an operator permitted to run the analysis service.

7. The apparatus of claim 1, wherein the logic is configured to: access to the analytical services package, and The analysis service package is provided to the client analysis device for performing the analysis service on the client device.

8. The apparatus of claim 1, said logic to set an acceptance variable of the analytics service package to an acceptance value in response to acceptance of the analytics service package.

9. The apparatus of claim 1, said logic to associate the analytical services package with a regulatory certificate.

10. A method for analyzing a service, the method comprising: executing an analysis service on a primary analysis device, wherein the analysis service includes an analysis method for sample analysis and processing information associated with executing the analysis method on the primary analysis device; in response to determining that the analytical service is operating properly on the primary analytical device, accepting the analytical service; as well as An analysis service package is generated for the analysis service, the analysis service package being configured to facilitate execution of the analysis service on a client analysis device having a similar hardware and / or software configuration and having a reduced number of options or configurations as compared to the primary analysis device. The method of claim 10 , wherein at least a portion of the analytical service package is immutable.

12. The method of claim 10, wherein the primary analytical equipment comprises a liquid chromatography (LC) equipment.

13. The method of claim 10, wherein the primary analysis device comprises a mass spectrometer (MS) device. The method of claim 10 , the analytical service package comprising a status of the analytical service.

15. The method of claim 10, the analysis service package comprising a security level for operators permitted to run the analysis service.

16. The method according to claim 10, comprising: access to the analytical services package, and The analysis service package is provided to the client analysis device for performing the analysis service on the client device.

17. The method according to claim 10, comprising: An acceptance variable of the analytical service package is set to an acceptance value in response to acceptance of the analytical service package.

18. The method according to claim 10, comprising: The analytical services package is associated with a regulatory certificate.

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