Pharmaceutical testing system and method

Abstract

An embodiment of the present disclosure includes a system and method for generating an actionable batch record for a clinical trial study. The method includes displaying a user interface for having a production user input batch record information, including via a production user interface (UI), and receiving packaging instructions, a bill of materials, and lot allocations from the production user. The method further includes creating a preliminary batch record based on the information entered by the production user. The method further includes displaying a customer UI including the preliminary batch record and an interface for approving the preliminary batch record, and receiving approval of the preliminary batch record from the customer user. The method further includes creating an actionable batch record for execution by the producer after customer approval.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 295,050, filed December 30, 2021, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to systems and methods for generating executable batch records for packaging output material for clinical trial studies, and more specifically to generating standardized electronic executable batch records for packaging output material for clinical trial studies that can be used across multiple packaging sites. [Background technology]

[0003] Companies engaged in clinical trial research, especially pharmaceutical clinical trials, are required to comply with government-regulated clinical packaging and labeling standards. For example, various national agencies such as the Food and Drug Administration (FDA), Medicines and Healthcare products Regulatory Agency (MHRA), and European Medicines Agency (EMA) provide regulatory frameworks for clinical packaging. As such, each clinical packaging operation, whether it is a primary packaging operation (e.g., placing the bulk drug product into a bottle, blister, vial, or similar) or a secondary packaging operation (e.g., clinically labeling the primary bottle, placing it in a box, and labeling the box to create a patient kit), must be controlled and repeatable during the activity and must follow appropriate regulatory guidelines.

[0004] Traditionally, clinical packaging is first managed through a document known as a study batch record or study packaging record. The study batch record then becomes the execution batch record or execution packaging record. The existing study batch record and execution batch record are typically captured in the form of a paper batch record. The paper batch record may be pre-approved by one or more individuals overseeing the clinical trial study. The paper batch record may then be distributed to one or more packaging sites and manually completed by operators at the primary or secondary packaging process. However, this paper-based process relies heavily on manual input, can lead to human error, and does not create a standardized batch record across sites. Additionally, if the company conducting the clinical trial determines that additional batches should be produced, the batch record must be regenerated and undergo the approval process again. Summary of the Invention [Problem to be solved by the invention]

[0005] Therefore, there is a need to provide an electronically based record that can reduce the possibility of human error and provide harmonized records across various packaging sites that can be efficiently scaled without cumbersome approval processes. [Means for solving the problem]

[0006] Embodiments of the present disclosure include computer-based systems and methods for generating standardized actionable batch records. Such systems are designed to allow actionable batch records to be used across multiple packaging sites (including domestic and international packaging sites), generate actionable batch records that require minimal manual updates at packaging sites, and reduce duplicate approvals by companies responsible for clinical trial studies. In addition, study batch records are maintained and approved on a centralized system, so that when a company conducting a study wants to produce additional batches of output materials (e.g., to produce a second set of output materials for a further clinical trial study), the system can generate new actionable batch records based on existing study batch records and study information (e.g., without having to regenerate new study batch records). Additionally, the system can maintain an audit history that tracks the activities of individuals interacting with the system.

[0007] Embodiments of the present disclosure include systems and methods for generating an actionable batch record for a clinical trial study. For example, in one or more embodiments, the method may include displaying, at a first electronic device associated with a production facilitator, a user interface (UI) for inputting batch record information, the UI including at least packaging instructions, a bill of materials, and a lot allocation. In one or more examples, the batch record information may include a selection of inventory associated with a production site and a selection of inventory associated with a pharmaceutical customer. In one or more embodiments, the method may further include receiving, at the first electronic device, the packaging instructions, the bill of materials, and the lot allocation from a user associated with the production facilitator. In one or more embodiments, the method may further include creating a preliminary batch record based on the information entered by the user associated with the production facilitator. In one or more embodiments, the method may further include displaying, at a second electronic device associated with a pharmaceutical batch customer, a customer user interface including the preliminary batch record and an interface for approving the preliminary batch record. In one or more embodiments, the method can further include receiving, at the second electronic device, approval of the preliminary batch record from a user associated with the pharmaceutical batch customer. In one or more embodiments, the method can further include creating an executable batch record for the producer to execute in accordance with receiving approval of the preliminary batch record.

[0008] An embodiment of the present disclosure may further include an electronic system for generating an executable batch record for a clinical trial study. The electronic system may include one or more processors, a memory, and one or more programs, the one or more programs being stored in the memory and configured to be executed by the one or more processors. According to an embodiment of the present disclosure, the one or more programs may include instructions for displaying a user interface (UI) for inputting batch record information at a first electronic device associated with the production facilitator, the UI including at least packaging instructions, a bill of materials, and a lot allocation. In such an embodiment, the batch record information may include a selection of inventory associated with the production site and a selection of inventory associated with the pharmaceutical customer. In such an embodiment, the one or more programs may further include instructions for receiving, at the first electronic device, from a user associated with the production facilitator, the packaging instructions, the bill of materials, and the lot allocation. In such an embodiment, the one or more programs may further include instructions for creating a preliminary batch record based on information entered by a user associated with the production facilitator. In one or more embodiments, the one or more programs may further include instructions for displaying, at a second electronic device associated with the pharmaceutical batch customer, a customer user interface including a preliminary batch record and an interface for approving the preliminary batch record. In one or more embodiments, the one or more programs may further include instructions for receiving, at the second electronic device, approval of the preliminary batch record from a user associated with the pharmaceutical batch customer. In one or more embodiments, the one or more programs may further include instructions for creating an executable batch record for the producer to execute pursuant to receiving approval of the preliminary batch record.

[0009] An embodiment of the present disclosure may further include a non-transitory computer-readable storage medium storing one or more programs, the one or more programs including instructions that, when executed by one or more processors of one or more electronic devices having a display, cause the one or more electronic devices to perform a method. In one or more examples, the method may include displaying, at a first electronic device associated with the production facilitator, a user interface (UI) for inputting batch record information, the UI including at least packaging instructions, a bill of materials, and a lot allocation. In such examples, the batch record information may include a selection of inventory associated with the production site and a selection of inventory associated with the pharmaceutical customer. In such examples, the method may further include receiving, at the first electronic device, the packaging instructions, the bill of materials, and the lot allocation from a user associated with the production facilitator. In one or more examples, the method may further include creating a preliminary batch record based on the information entered by the user associated with the production facilitator. In one or more examples, the method may further include displaying, at a second electronic device associated with the pharmaceutical batch customer, a customer user interface including the preliminary batch record and an interface for approving the preliminary batch record. In one or more examples, the method can further include receiving, at the second electronic device, approval of the preliminary batch record from a user associated with the pharmaceutical batch customer. In one or more examples, the method can further include creating an executable batch record for the producer to execute in accordance with receiving approval of the preliminary batch record. [Brief description of the drawings]

[0010] [Figure 1A] FIG. 1 illustrates an exemplary system for generating an actionable batch record of packaging materials for a clinical trial study, according to some embodiments of the present disclosure. [Figure 1B]FIG. 1 illustrates an exemplary system for generating an actionable batch record of packaging materials for a clinical trial study, according to some embodiments of the present disclosure. [Figure 1C] FIG. 1 illustrates an exemplary process for generating an actionable batch record of packaging material for a clinical trial study, according to some embodiments of the present disclosure. [Figure 1D] FIG. 1 illustrates an exemplary process for generating an actionable batch record of packaging material for a clinical trial study, according to some embodiments of the present disclosure. [Figure 2A] 1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 2B] 1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 2C] 1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 2D] 1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 2E] 1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 2F] 1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 2G] 1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 2H] 1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 2I] 1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 3A] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 3B] FIG. 1 illustrates an exemplary process for generating research information according to some embodiments of the present disclosure. [Figure 3C]1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 3D] 1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 3E] 1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 3F] 1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 3G] 1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 3H] 1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 3I] 1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 3J] 1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 3K] 1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 3L] 1A-1C are diagrams illustrating example user interfaces according to some embodiments of the present disclosure. [Figure 4A] FIG. 1 illustrates an exemplary process for generating a study portion, according to some embodiments of the present disclosure. [Figure 4B] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 4C] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 4D] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 4E] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 4F]1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 4G] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 4H] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 4I] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 4J] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 4K] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 4L] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 4M] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 4N] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 4O] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 4P] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 4Q] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5A-1] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5A-2] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5B]FIG. 1 illustrates an exemplary process for generating a study batch record, according to some embodiments of the present disclosure. [Figure 5C] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5D] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5E] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5F] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5G] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5H] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5I] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5J] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5K] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5L] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5M] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5N] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5O] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5P]1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5Q] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5R] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5S] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5T] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5U] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5V] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5W] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5X] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 5Y] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 6A] FIG. 1 illustrates an example process for creating packaging instructions according to some embodiments of the present disclosure. [Figure 6B] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 6C] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 6D] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 6E]1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 6F] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 6G] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 6H] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 6I] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 6J] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 6K] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 6L] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 6M] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 6N] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 6O] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7A] FIG. 1 illustrates an example process for generating lot allocations according to some embodiments of the present disclosure. [Figure 7B] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7C] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7D]1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7E] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7F] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7G] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7H] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7I] FIG. 1 illustrates an example process for generating lot allocations according to some embodiments of the present disclosure. [Figure 7J] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7K] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7L] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7M] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7N] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7O] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7P] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7Q] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7R]1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7S] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7T] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7U] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 7V] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 8A] FIG. 1 illustrates an example process for generating an executable batch record, according to some embodiments of the present disclosure. [Figure 8B-1] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 8B-2] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 8B-3] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 8C-1] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 8C-2] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 8D] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 8E] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 8F] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 8G]1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 8H] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 8I] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 8J] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 8K] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 8L] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 8M] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 8N] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 9A] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 9B] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 9C] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 10A] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 10B] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 10C] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 11A] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 11B] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 11C] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 11D] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 11E] 1A-1C illustrate example user interfaces according to some embodiments of the present disclosure. [Figure 12] FIG. 1 illustrates an exemplary electronic device, according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The present disclosure includes a technique for generating an actionable batch record for packaging materials for a clinical trial study. A system including a user interface according to an embodiment of the present disclosure is designed to allow the actionable batch record to be used across multiple entities (e.g., production facilitators and customers) and accessed at multiple packaging sites (including domestic and international packaging sites). Furthermore, the system according to an embodiment of the present disclosure is designed to generate an actionable batch record that requires minimal manual updates and reduces duplicate approvals by the customer (e.g., a company responsible for a clinical trial study). In addition, because the study batch record is maintained and approved centrally, if the customer wants to produce additional batches of output materials (e.g., to produce a second set of output materials for a further clinical trial study), the system can generate a new actionable batch record based on the existing study batch record and study information (e.g., without having to regenerate a new study batch record).

[0012] The system may be used and accessed by a customer (e.g., a company managing a clinical trial study) and / or a production facilitator (e.g., a company responsible for packaging batches of output material used in a clinical trial study). For example, a production facilitator may input information into the system for generating an actionable batch record, while a customer may approve the information for generating an actionable batch record.

[0013] The following description is presented to enable those skilled in the art to make and use the various embodiments. Descriptions of specific devices, techniques, and applications are provided only as examples. Various modifications to the examples described herein will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other examples and applications without departing from the spirit and scope of the various embodiments. Thus, the various embodiments are not intended to be limited to the examples described and illustrated herein, but are to be accorded the scope consistent with the claims.

[0014] In the following description, terms such as "first" and "second" are used to describe various elements, but these elements should not be limited by the terms. These terms are only used to distinguish one element from another. For example, a first graphic representation can be referred to as a second graphic representation, and similarly, a second graphic representation can be referred to as a first graphic representation, without departing from the scope of various described embodiments. A first graphic representation and a second graphic representation are both graphic representations, but are not the same graphic representation.

[0015] The terms used in the description of the various described embodiments herein are intended to describe only the specific embodiments and are not intended to be limiting. As used in the description of the various described embodiments and the appended claims, the singular articles "a," "an," and "the" are intended to include the plural, unless the context clearly indicates otherwise. The term "and / or" as used herein will also be understood to refer to and encompass any and all possible combinations of one or more of the associated listed items. Furthermore, the terms "comprise," "comprising," "comprising," and / or "comprising," when used herein, will also be understood to refer to the presence of the stated features, integers, steps, operations, elements, and / or components (or components) and not to preclude the presence or addition of one or more other features, regions, integers, operations, elements, components (or components), and / or groups thereof.

[0016] The word "if" is interpreted to mean "when" or "after" or "in response to determining" or "in response to detecting," depending on the context, as appropriate. Similarly, the phrase "if it is determined that" or "if [the stated condition or event] is detected" is interpreted to mean "after determining" or "in response to determining" or "after detecting [the stated condition or event]" or "in response to detecting [the stated condition or event]," depending on the context, as appropriate.

[0017] FIG. 1A illustrates an exemplary system 100A for generating actionable batch records of packaging materials for clinical trial studies, according to some embodiments of the present disclosure. The system can include master data 102 and study information 104. The master data 102 can correspond to information related to a customer, for example, a company performing a clinical trial study, including a pharmaceutical clinical trial study. As shown, the master data 102 can include customer information 122, contacts 124, packaging site 126, instructions 128, instruction set 130, equipment 132, and reconciliation limits 134. Additional details regarding the master data 102 are described in more detail below. In some examples, the system can include master data 102 for multiple different customers, each master data corresponding to a different customer. In one or more examples, a single customer (e.g., a company) can be associated with multiple instances of customer information 122 (e.g., when a company can include multiple divisions overseeing different clinical trial studies).

[0018] The study information 104 may include one or more study portions 106, one or more study batch records 108, one or more lot allocations 114, and one or more batch records 116. To the extent that FIG. 1A illustrates a single study portion 106, a single study batch record 108, a single lot allocation 114, and a single batch record 116, one of ordinary skill in the art will understand that multiple instances of these study components may be included in the study information 104. For example, the study information may include multiple study portions 106. As shown, each study batch record 108 may include study instructions 110 and a bill of materials 112. In one or more embodiments, each study batch record 108 may correspond to a study portion 106.

[0019] In one or more examples, research information 104 can access data from master data 102, such as customer information 122 and packaging site 126. In one or more examples, research instructions 110 can access data from master data 102, such as packaging instructions 128, instruction sets 130, and equipment 132. In some embodiments, bill of materials 112 can access data from master data 102, such as reconciliation limits 134.

[0020] FIG. 1B illustrates an exemplary system 100B for generating an actionable batch record of packaging materials for a clinical trial study, according to some embodiments of the present disclosure. The exemplary system 100B can include a system 100A including master data 102 and study information 104 as described above, as well as a production facilitator user interface (UI) 120 and a customer UI 180. The production facilitator UI 120 can correspond to a UI used by a production facilitator (e.g., a company associated with packaging clinical trial study materials). The customer UI 180 can correspond to a UI used by a customer (e.g., a business associated with the execution of a clinical trial study). As illustrated, information from the system 100A can be accessed by and used to create the production facilitator UI 120 and the customer UI 180. Similarly, information from the production facilitator UI 120 and the customer UI 180 can be used to update information included in the system 100A.

[0021] FIG. 1C illustrates an exemplary process 150 for generating an executable batch record of packaging materials for a clinical trial study, according to some embodiments. The process 150 is performed, for example, using one or more electronic devices implementing a software platform. In some examples, the process 150 is performed using a client-server system, with the blocks of the process 150 being divided in any manner between a server and a client device. In other examples, the blocks of the process 150 are divided between a server and multiple client devices. In other examples, the process 150 is performed using only one client device or only multiple client devices. In the process 150, some blocks are optionally combined, the order of some blocks is optionally changed, and some blocks are optionally omitted. In some examples, additional steps may be performed in combination with the process 150. Thus, the operations as illustrated (and described in more detail below) are exemplary in nature and, as such, should not be considered limiting. In one or more examples, the process 150 may correspond to a process associated with a production facilitator UI.

[0022] At block 152, the system may access master data associated with the customer who plans to conduct a clinical trial study, e.g., master data 102. As used herein, system may refer to either system 100A or 100B. For example, the system may access customer data 122 associated with the customer's master data 102. In some examples, the system may also access packaging site data 126 associated with the customer's master data 102. In one or more examples, the master data regarding the customer may be entered into the system by an individual associated with a production facilitator. In this manner, information associated with the master data may be accessible to the system after receiving an indication that the customer plans to conduct a clinical trial.

[0023] At block 154, the system can create study information, such as study information 104. For example, the system can obtain study information corresponding to a clinical trial study to be conducted by a customer. For example, one or more individuals associated with a production facilitator can enter study information associated with the clinical trial study via the production facilitator UI 120. The study information 104 can include, but is not limited to, information associated with a packaging site, a destination country, a study language, output materials, dosage codes, a business unit, and a study approver. For example, the production facilitator UI can obtain input corresponding to a facilitator and can enter one or more packaging sites, destination countries, study languages, output materials, dosage codes, business units, and approvers from one or more individuals associated with the production facilitator.

[0024] The approver specified in block 154 may correspond to a customer approver, e.g., an individual associated with a customer who has the authority to approve components associated with the study information. As used herein, an individual associated with a production facilitator may be referred to as a production user or a production facilitator user, while an individual associated with a customer may be referred to as a customer user.

[0025] In one or more examples, the packaging site may correspond to one or more facilities that package output materials for a customer's clinical trial study. The destination country may correspond to a country associated with the packaging site. The study language may correspond to a language associated with the destination country. For example, the system may receive instructions from a production user indicating that a study is utilizing packaging sites in Philadelphia and Berlin, where the destination countries may correspond to the United States and Germany, and the study languages ​​may correspond to English and German.

[0026] In one or more examples, the output material may correspond to materials, such as a medication, provided to a participant in a clinical trial study. The dosage code may correspond to a particular dosage that a participant in the clinical trial study should adhere to during the study. For example, the output material may correspond to a bottle containing 60 tablets of a particular medication M. The dosage code may correspond to dosage instructions for the participant, such as instructions to take two tablets daily, one in the morning and one in the evening.

[0027] A business unit may correspond to a department associated with a customer associated with a study. An approver may correspond to a particular customer user who oversees a clinical trial study and has the authority to approve one or more stages of the process 150. The study information 104 may also include which parts of the process 150 are subject to approval from an approver. In one or more embodiments, a customer approver may be designated to approve one or more of the study instructions 110, bill of materials 112, lot allocations 114, and batch records 116.

[0028] In one or more examples, the research information 104 can retrieve the customer information 122 and packaging sites 126 accessed in block 152. For example, the research information 104 can be associated with the customer information 122 and packaging sites 126 associated with the customer. In this manner, the system can automatically import data from the master data 102 associated with the customer (e.g., the customer information 122 and packaging sites 126) to populate the data related to the research information 104. For example, if a customer is associated with packaging sites in Philadelphia, Berlin, and Seoul, information about these packaging sites can be automatically imported into the research information 104. In such an example, the production facilitator UI 120 can present the imported packaging sites to the production user. This allows the production user to select the packaging site associated with the customer without having to separately enter or search for the information.

[0029] In one or more examples, the system may obtain approval of the study information at block 154 before proceeding to the next block in process 150. In one or more examples, the approval may be provided by one or more designated production users. For example, the system may cause the completed study information to be presented on a display via the production facilitator UI 120 for review by the designated production user. The system may then receive approval by receiving the designated production user's credentials (e.g., username and password). In one or more examples, the system may cause a notification to be sent to the designated production user that the study information is ready for review and approval.

[0030] In block 156, the system can obtain study portion data, e.g., study portion 106. The study portion or study portion data can correspond to one or more output materials of a study that can share the same packaging instructions. In one or more examples, the output materials can share the same packaging instructions when the output materials can be packaged under the same conditions. For example, the study portion can correspond to a 60-count bottle filled with 60 tablets that can be packaged at controlled room temperature (CRT). In one or more examples, the study portion data can include, but is not limited to, output materials, input materials, common materials, drug classification, alternative materials, storage temperature, time out environment detail, humidity control details, lighting control details, label details, and blinding information. In one or more examples, the system can obtain the study portion data from one or more production users via the production facilitator UI 120.

[0031] As described above, output materials can correspond to products provided to participants in a clinical trial study. Input materials can correspond to items used to create an output material. For example, an output material of a 60-count bottle filled with 60 tablets can correspond to input materials including a 60-count bottle, 60 tablets, a bottle closure, a desiccant, and a label for the bottle. Common materials can include input materials and / or labels that are common to one or more output materials. For example, if multiple output materials include a 60-count bottle, the 60-count bottle can be included as a common material.

[0032] The drug classification may be used to indicate whether a drug is a controlled substance or is otherwise potentially dangerous. The alternative materials may correspond to materials that may be used to identify an output material or an input material that may be used as a substitute for a corresponding output material or input material, for example, when there is insufficient inventory of the original output material or input material. For example, a 70-count bottle may be used as an alternative material to a 60-count bottle. The storage temperature corresponds to an environmental temperature that should be maintained for storing the input and / or output material. The timeout environmental details correspond to the length of time that the input and / or output material may be exposed to a temperature outside of the storage temperature without affecting the potency of the drug in the input and / or output material. The humidity control details correspond to a level of humidity that should be maintained for the input and / or output material. The lighting control details correspond to the amount of light exposure that the input and / or output material can tolerate. The label details may correspond to a general description of a label associated with the output material, including whether the label includes a barcode.

[0033] In one or more examples, the system may obtain approval of the study portion at block 156 before proceeding to the next block in process 150. For example, the system may cause a display to present the completed study portion 106 for review by one or more designated production users via the production facilitator UI 120. The system may then receive approval by receiving the designated production user's credentials (e.g., username and password). In one or more examples, the system may cause a notification to be sent to the designated production user that the study portion is ready for review and approval.

[0034] At block 158, the system may create a study batch record, such as the study batch record 108. In one or more examples, the system may generate the study batch record 108 based on the completed study portion 106. In one or more examples, the system may automatically generate the study batch record 108 after receiving approval of the completed study portion 106 from a production user. In one or more examples, the study batch record 108 may serve as a container for the study instructions 110 and the bill of materials 112. In one or more examples, the study batch record may be configured to link and / or display the latest version of the study instructions 110 to the bill of materials 112.

[0035] In block 160, the system may retrieve study instructions associated with the study batch record, e.g., study instructions 110 associated with study batch record 108. For example, production facilitator UI 120 may provide a user interface through which a production user may enter packaging instructions and other data associated with the packaging instructions. In one or more examples, the system may create a translation of the packaging instructions based on the destination country and / or study language associated with the study information 104 specified in block 154. In one or more examples, if the system receives an update to the packaging instructions, the system may automatically update the translation of the packaging instructions accordingly. In this manner, packaging instructions may be harmonized between different packaging sites regardless of the location of the packaging sites.

[0036] For example, packaging instructions for a typical batch record are not harmonized between different packaging sites. For example, if a product is packaged in Philadelphia, Kansas City, and Berlin, each of these locations will typically receive a separate batch record that may contain different instructions. This example embodiment can provide a centralized repository for research batch records, including packaging instructions, that can be accessed from any of the packaging sites to provide harmonized packaging instructions.

[0037] In one or more examples, the system may obtain approval of the research instruction 110. In one or more examples, the approval may be provided by one or more designated production facilitator users. For example, the system may cause the completed research information to be presented on a display via the production facilitator UI 120 for review by the designated production facilitator users. In one or more embodiments, each translation of the instruction may be approved separately. The system may then receive the approval by receiving the production approver's credentials (e.g., username and password). In one or more examples, the system may cause a notification to be sent to the production approver that the research instruction 110 is ready for review and approval.

[0038] In block 162, the system can retrieve a bill of material associated with the research batch record, e.g., the bill of material 112 associated with the research batch record 108. For example, the production facilitator UI 120 can provide a user interface where a production user can enter input and output material updates with inventory numbers to create a bill of material. In one or more examples, the system can import data, e.g., input materials, output materials, label details, etc., from the research portion 106 to generate the bill of material 110. In one or more examples, the system can access inventory information associated with a customer and assign inventory numbers to the output materials and / or input materials. In some examples, the system can receive information specific to a packaging site, e.g., to verify units of measurement and avoid future problems. In one or more examples, the system can use third party software (e.g., JD Edwards Enterprise One, version 9.1) to retrieve inventory information to complete the bill of material. In one or more examples, the system can receive reconciliation limits 134 for output materials in block 162. For example, the reconciliation limits 134 may be obtained from the master data 102 or manually entered by a user.

[0039] In one or more examples, the system may obtain approval of the bill of material 112. In one or more examples, the approval may be provided by one or more designated production users. For example, the system may cause the completed bill of material 112 to be presented on a display via the production facilitator UI 120 for review by a designated production facilitator user. The system may then receive approval by receiving the production approver's credentials (e.g., username and password). In one or more examples, the system may cause a notification to be sent to the production approver that the bill of material 112 is ready for review and approval. In one or more examples, the process 150 may not proceed to block 164 without approval of the bill of material 112 and the lab instructions 110.

[0040] In block 164, the system can generate a lot assignment, e.g., lot assignment 114. For example, production facilitator UI 120 can provide a user interface through which a production user can enter and / or update information associated with the lot assignment. In one or more examples, the lot assignment can be used to associate a batch record with a particular packaging site. For example, a study batch record 108, e.g., bill of materials 112, may indicate output materials, e.g., 60-count bottles containing 60 tablets, while the lot assignment 114 may specify that 100 of these bottles should be included in a particular batch at a particular packaging site. In one or more examples, production facilitator UI 120 presents a list of approved bills of materials 112 (e.g., each bill of materials corresponding to a respective study part) to the production user. Production facilitator UI 120 can then receive instructions from the user indicating which bills of materials should be included in the lot assignment and the packaging site for which the output materials should be packaged. In this manner, the system can determine what output materials should be produced and the quantities of those materials, as well as where the output materials should be produced.

[0041] In one or more examples, the system can receive instructions to include sample output materials and / or retainer output materials. The retainer output materials can correspond to output materials to be retained for regulatory inspection. The number of sample output materials and retainer output materials can be added to the amount of output materials to be produced in the lot allocation. For example, if the number of output materials for the clinical study itself includes 100 bottles, the number of sample output materials is 5 bottles, and the number of retainer output materials is 10 bottles, the total number for the lot allocation is 115 bottles.

[0042] In one or more examples, the system can access inventory at a selected packaging site. In one or more examples, the inventory information can include corresponding supplier lot numbers, supplier lot sizes, and supplier lot expiration dates associated with various input materials and packaging sites. In one or more examples, a user can assign a particular supplier lot to an input material included in a selected bill of material. For example, the system can receive an indication of a supplier lot number assigned to an input material for a selected bill of material. In one or more examples, the system can automatically assign a supplier lot number to an input material based on a total quantity of the input material and one or more of a respective supplier lot size and / or a respective supplier lot expiration date. In this manner, the system can ensure that there is sufficient inventory at a particular site to package the output material associated with the batch record before the batch record is sent to the packaging site.

[0043] In one or more examples, the system may prioritize the supplier lot with the smallest lot size and the earliest expiration date. For example, if the quantity indicates that 100 60-count bottles containing 60 tablets are to be packaged at a packaging site, the system may access the packaging site's inventory. Continuing with this example, the packaging site may have five supplier lots corresponding to the input material of 60-count bottles. According to this example embodiment, the system may determine a respective supplier lot size and expiration date for each of the supplier lots and assign the supplier lot with the smallest lot size and the earliest expiration date to the input material of 100 60-count bottles.

[0044] In this manner, the system can reduce waste and the amount of human manual work at the packaging site. For example, typically, a packaging site worker would be responsible for reviewing a research batch order and manually checking and comparing the quantities of input materials against the inventory available at the packaging site. Not only does this process require significant time and effort, but there is no guarantee that the packaging site will have the inventory necessary to fulfill the research batch record. Thus, embodiments of the present disclosure improve upon the state of the art by ensuring that sufficient inventory is available before sending the research batch record to the packaging site, reducing waste by allocating supplier lots with earlier expiration dates to be used first, and reducing the amount of manual work associated with checking inventory.

[0045] In one or more examples, the system may obtain approval of the lot allocation 114. For example, the system may cause the completed lot allocation to be presented on a display via the production facilitator UI 120 for review by a designated production user. The system may then receive approval by receiving the production approver's credentials (e.g., username and password). In one or more examples, the system may cause a notification to be sent to the production approver that the lot allocation is ready for review and approval.

[0046] In block 166, the system may create a preliminary batch record, e.g., corresponding to the batch record 116. For example, the production facilitator UI 120 may provide a user interface through which a production user may update and review information related to the preliminary batch record. As used herein, the term preliminary batch record may refer to a batch record that has not been approved. An actionable batch record may refer to an approved preliminary batch record. In one or more examples, the preliminary batch record may be generated automatically after receiving approval of the lot allocation 114. The preliminary batch record may include the bill of material 112 selected in the lot allocation in block 164 and the corresponding packaging instructions 110 for each bill of material 112.

[0047] In one or more examples, the system can receive information regarding equipment, labels, deviations, and change management in block 166. For example, the production facilitator UI 120 can provide a user interface for receiving instructions of which equipment should be used when packaging the batch record. In one or more examples, the equipment information can be obtained in block 158. As another example, the system can receive instructions of which labels should be used. In one or more examples, a specific label can be produced for a specific packaging process. For example, sequence numbers can be generated to ensure proper randomization of output materials, such as bottles and / or kits. As another example, deviations (e.g., reasons for deviating from packaging instructions) can be included in the preliminary batch record to provide an operator at the packaging site with an explanation as to why it may be necessary to deviate from the packaging instructions. For example, a deviation can occur when a bottle seal is found to be defective. Deviations included in the batch record can provide an explanation as to why an operator should debottle the batch.

[0048] In one or more examples, the system may obtain approval of the preliminary batch record 116 by a production user. For example, the system may cause the completed preliminary batch record to be presented on a display via the production facilitator UI 120 for review by a designated production user. The system may then receive approval by receiving the production approver's credentials (e.g., username and password). In one or more examples, the system may cause a notification to be sent to the approver that the batch record 116 is ready for review and approval. In one or more examples, an actionable batch record is generated after receiving customer approval.

[0049] The embodiments of the present disclosure may also provide a customer with a system for efficiently producing additional batches of output materials for the same study using one or more components of an actionable batch record for the same study. For example, conventionally, a customer who wants to produce additional batches of output materials for a study must start the process of generating a batch record for a particular site from scratch (e.g., creating study information, defining output materials, input materials, and packaging sites, etc.). In contrast, a system according to an embodiment of the present disclosure may create a new actionable batch record by creating a new lot allocation corresponding to the bill of materials for the desired output material. Thus, the system may create a new actionable batch record by having a production user update the new quantity and inventory number. In one or more examples, if the new batch record requires updated packaging instructions, the packaging instructions may be updated accordingly. Thus, the embodiments of the present disclosure may provide a centralized and efficient way of producing output materials for a clinical trial study without creating a new study batch record for each actionable batch record.

[0050] FIG. 1D illustrates an exemplary process 160 for generating an executable batch record of packaging materials for a clinical trial study, according to some embodiments. The process 160 is performed, for example, using one or more electronic devices implementing a software platform. In some examples, the process 160 is performed using a client-server system, with the blocks of the process 160 being divided in any manner between a server and a client device. In other examples, the blocks of the process 160 are divided between a server and multiple client devices. In other examples, the process 160 is performed using only one client device or only multiple client devices. In the process 160, some blocks are optionally combined, the order of some blocks is optionally changed, and some blocks are optionally omitted. In some examples, additional steps may be performed in combination with the process 160. Thus, the operations as illustrated (and described in more detail below) are exemplary in nature, and as such should not be considered limiting.

[0051] In one or more examples, process 160 may correspond to a process associated with production facilitator UI 120 and customer UI 180. For example, process 160 may correspond to a process for generating an actionable batch record that includes receiving approval from one or more customer approvers. In one or more examples, one or more blocks of process 160 may correspond to blocks associated with process 150.

[0052] At block 152, the system may access master data, e.g., master data 102, associated with a customer planning to conduct a clinical trial study, as described above with respect to process 150. At block 154, the system may create study information, e.g., study information 104. For example, the system may obtain study information corresponding to a clinical trial study to be conducted by the customer, as described above with respect to process 150. At block 156, the system may obtain study portion data, e.g., study portion data 106, as described above with respect to process 150. At block 158, the system may create a study batch record, e.g., study batch record 108, as described above with respect to process 150.

[0053] In block 160, the system may obtain a study instruction associated with the study batch record, e.g., the study instruction 110 associated with the study batch record 108, as described above with respect to process 150. In block 182, the system may obtain customer approval for the study instruction 110. In one or more examples, the customer approval may be obtained via the customer UI 180. In one or more examples, block 182 may be optional based on the selection of which components should be submitted for customer approval made in block 154. For example, if the system did not receive an instruction to obtain customer approval for the study instruction, the system may skip block 182. In one or more examples in which block 182 is implemented, the system causes a display to present the completed study instruction for review by the customer approver. The system may then receive approval by receiving the customer approver's credentials (e.g., username and password) as well as the customer approver's signature. In one or more examples, the approval process for the customer approver may be compliant with relevant regulations. In one or more examples, the system may cause a notification to be sent to the customer approver that the research instruction is ready for review and approval. In one or more examples, the process 160 may not proceed to block 164 without customer approval of the research instruction 110.

[0054] In block 162, the system may obtain a bill of material associated with the study batch record, e.g., bill of material 112 associated with study batch record 108, as described above with respect to process 150. In block 184, the system may obtain customer approval for the bill of material. In one or more examples, customer approval may be obtained via customer UI 180. In one or more examples, block 184 may be optional based on the selection of which components should be submitted for customer approval made in block 154. For example, if the system did not receive an instruction to obtain customer approval for the bill of material, the system may skip block 184. In one or more examples in which block 184 is implemented, the system may cause a display to present the completed bill of material for review by a customer approver. The system may then receive approval by receiving the customer approver's credentials (e.g., username and password) as well as the customer approver's signature. In one or more examples, the system may cause a notification to be sent to the customer approver that the bill of material is ready for review and approval. In one or more examples, the process 160 may not proceed to block 164 without customer approval of the bill of material.

[0055] In block 164, the system may generate a lot allocation, e.g., lot allocation 114, as described above with respect to process 15. In block 186, the system may obtain customer approval for the lot allocation. In one or more examples, the customer approval may be obtained via customer UI 180. In one or more examples, block 186 may be optional based on the selection of which components should be submitted for customer approval made in block 154. For example, if the system did not receive an instruction to obtain customer approval for the lot allocation, the system may skip block 186. In one or more examples in which block 186 is implemented, the system may cause a display to present the completed lot allocation for review by a customer approver. The system may then receive approval by receiving the customer approver's credentials (e.g., username and password) as well as the customer approver's signature. In one or more examples, the system may cause a notification to be sent to the customer approver that the lot allocation is ready for review and approval. In one or more examples, the process 160 may not proceed to block 166 without customer approval of the lot allocation.

[0056] In block 166, the system may generate a batch record, e.g., batch record 116, as described above with respect to process 150. In block 188, the system may obtain customer approval for the batch record. In one or more examples, the customer approval may be obtained via the customer UI 180. In one or more examples, block 188 may be optional based on the selection of which components should be submitted for customer approval made in block 154. For example, if the system did not receive an instruction to obtain customer approval for the preliminary batch record, the system may skip block 188. In one or more examples where block 188 is implemented, the system may cause a display to present the completed preliminary batch record for review by the customer approver. The system may then receive approval by receiving the customer approver's credentials (e.g., username and password) as well as the customer approver's signature. In one or more examples, the system may cause a notification to be sent to the customer approver that the batch record is ready for review and approval. In one or more examples, the process 160 may not generate a completed, actionable batch record without customer approval of the batch record.

[0057] Master Data The master data may be used to create and maintain information associated with one or more customers. The master data, for example, master data 102, may include customer information 122, contacts 124, packaging sites 126, packaging instructions 128, instruction sets 130, equipment 132, reconciliation limits 134, and research 136. In one or more examples, the master data may be configured to interface with one or more third party software and / or servers. For example, in one or more examples, the master data may access information associated with a customer in JD Edwards EnterpriseOne.

[0058] 2A illustrates an example customer details page 220A associated with a master data user interface (UI) and presented via a production facilitator UI 120. As shown, the customer details page 220A can include a number of navigation user affordances 222, a number of operation user affordances 224, and a customer details information display area 226A. In one or more examples, the customer details information display area 226A can correspond to an area of ​​the customer details page 220A that displays information about a selected customer. As shown, the customer details information display area 226A can display information including, but not limited to, customer name, customer number, customer group, active / inactive information, system information, and the like.

[0059] In one or more examples, the master data UI navigation user affordances 222 can include multiple user affordances, with each user affordance corresponding to a tab and corresponding page associated with the master data UI. As shown, the navigation user affordances 222 can include a CUSTOMER DETAILS tab, a CONTACTS tab, and a STUDIES tab. The examples of the navigation user affordances 222 are merely illustrative, and more or less navigation user affordances may be used without departing from the scope of the present disclosure. A user can navigate between the respective pages associated with the tabs by selecting the corresponding user affordance.

[0060] In one or more examples, the system can also navigate among the pages and / or study components using the navigation bar 228. For example, the system can receive a selection of a page of any of the study components (e.g., master data, study information, study parts, study batch records, packaging instructions, bill of materials, lot allocation, batch records) from a drop-down menu in the navigation bar 228 and then present the selected page.

[0061] In one or more examples, the plurality of operation user affordances 224 may include a plurality of buttons, each corresponding to a different action that may be implemented by a user. As shown, the operation user affordances 224 may include, without limitation, a create study information user affordance and a history user affordance. In one or more examples, the create study information user affordance may be used to create study information associated with a customer. In one or more examples, the history user affordance may present an audit history associated with a customer, master data, and / or other study components.

[0062] 2B illustrates an example contact page 220B associated with the master data UI and presented via the production facilitator UI. As shown, the contact page 220B can include a number of navigation user affordances 222, a number of operation user affordances 224, and a contact information display area 226B. In one or more examples, the contact information display area 226B can correspond to an area of ​​the master data UI that displays information regarding contact information for one or more individuals associated with the customer information. For example, as shown, the contact can include, but is not limited to, a name, email, phone number, and title (e.g., a position at a company that serves customers), as well as a role associated with the contact (e.g., a role within a system and / or research).

[0063] FIG. 2C illustrates an example contact details page 220C associated with the master data UI and presented via the production facilitator UI 120. In one or more examples, the system can receive an indication that a user has selected one of the contacts listed on the contacts page 220B. For example, the user can click on a link associated with one of the listed contacts. The contact details page 220C can include information associated with the selected contact presented in a contact details display area 226C. As shown, the contact details display area 226C can include, but is not limited to, customer name, customer email, contact owner, title, system information, and related customer information, roles for each of the related customers.

[0064] 2D illustrates an exemplary study page 220D associated with the master data UI and presented via the production facilitator UI 120. As shown, the study page 220D can include a number of navigation user affordances 222, a number of operation user affordances 224, and a study information display area 226D. In one or more examples, the study information display area 226D can correspond to an area of ​​the master data UI that displays a list of studies associated with a customer. Each study in the list can include, but is not limited to, project information, customer protocol, study information description, version number, study objectives, status, and external software / server integration number.

[0065] FIG. 2E illustrates an example packaging site page 220E associated with the master data UI and presented via the production facilitator UI. In one or more examples, the packaging site page 220E may be associated with a particular customer. In one or more examples, the system may navigate to the packaging site page 220E via a navigation bar 228. As shown, the packaging site page 220E may include a number of operation user affordances 224, and a packaging site information display area 226E. In one or more examples, the packaging site information display area 226E may correspond to an area of ​​the master data UI that displays information associated with a packaging site associated with a customer. The packaging site information may include, but is not limited to, the name of the site, the location of the site (e.g., city and country), a company code, a language, one or more addresses, one or more emails, and the like.

[0066] FIG. 2F illustrates an example equipment page 220F associated with the master data UI and presented via the production facilitator UI 120. The equipment described on the equipment page may correspond to equipment used to package one or more output materials for a study. In one or more examples, the equipment may be associated with a particular customer. In one or more examples, the system may navigate to the packaging site page 220E via a navigation bar 228. As shown, the equipment page 220F may include a number of operation user affordances 224, and an equipment information display area 226F. In one or more examples, the equipment information display area 226F may correspond to an area of ​​the master data UI that displays information associated with the equipment associated with the customer. The equipment information may include, but is not limited to, one or more of equipment type, equipment group details, record type, system information, and the like.

[0067] FIG. 2G illustrates an example reconciliation limits page 220G associated with the master data UI and presented via the production facilitator UI 120. The reconciliation limits relate to acceptable deviations in output material from output material packaged according to correct packaging instructions. In one or more examples, the reconciliation limits may be customer specific. For example, a 100% reconciliation limit for a 60-count bottle of tablets must contain 60 tablets, whereas the same output material (e.g., a 60-count bottle) with a 98% reconciliation lower limit and a 103% reconciliation upper limit could contain 59-61 tablets. In one or more examples, the system may navigate to the reconciliation limits page 220G via the navigation bar 228. As shown, the reconciliation limits page 220G can include a number of operational user affordances 224 and a reconciliation limits information display area 226G. In one or more examples, the reconciliation limits information display area 226G can correspond to an area of ​​the master data UI that displays information associated with the reconciliation limits associated with the customer. The reconciliation limits include a lower reconciliation limit, an upper reconciliation limit, a reconciliation identifier, a reconciliation limits description, a version, a status, and the like. The reconciliation limits can be provided as a percentage. In one or more examples, the operational user affordances can include an APPROVAL button (e.g., for approving the reconciliation limits) and a HISTORY button (e.g., for reviewing the audit history associated with the reconciliation limits).

[0068] 2H-1 and 2H-2 illustrate an exemplary packaging instructions page 220H associated with the master data UI and presented via the production facilitator UI 120. The packaging instructions may be used by one or more packaging site operators to package output materials for a study. In one or more examples, the system may navigate to the packaging instructions page 220H via a navigation bar 228. As shown, the packaging instructions page 220H may include a number of operation user affordances 224, and a packaging instructions information display area 226H. In one or more examples, the packaging instruction information display area 226H may include, but is not limited to, a list of translations, a list of related instruction sets, and for each language, the text and execution results, an indication of whether the instruction is valid or invalid, a version number, an instruction category, an instruction type (e.g., packaging instructions, processing checklist, or important notes), an instruction identifier, an effective date, comments, an instruction group ID, instruction details, the language of the instruction, and available translations of the instruction. In one or more examples, when an instruction is marked as valid, the instruction may use an instruction set, e.g., instruction set 130. In one or more examples, valid instructions may not be directly edited. Rather, to edit an instruction marked as valid, a new version of the instruction may be created, e.g., using the "NEW VERSION" user affordance 242H.

[0069] FIG. 2I illustrates an example instruction set page 220I associated with the master data UI and presented via a production facilitator UI. An instruction set may include one or more active instructions. In one or more examples, the system can navigate to the instruction set page 220I via a navigation bar 228. As shown, the instruction set page 220I can include an instruction information display area 226I. In one or more examples, the instruction information display area 226I can include, but is not limited to, an instruction type (e.g., packaging instructions, checking process, important notes), an instruction status, a version, an instruction category, an indication of whether the instruction is active, a search bar, one or more languages, text, a version, an indication of whether the instruction set is inactive, and instruction grouping information (e.g., name, description, and language).

[0070] Research information The study information (e.g., study information 104) may correspond to information associated with a clinical trial study run by a customer company. A production user can create and enter study information associated with a study (e.g., Study X) via the production facilitator UI. For example, a customer intends to conduct a study including one or more pharmaceutical products to be provided to study participants. The production user can create the study information in a system corresponding to the customer and generate an executable batch record that can be used to package the pharmaceutical products to be provided to the study participants.

[0071] In one or more embodiments, the system can include a research information UI. The research information UI can be presented via the production facilitator UI 120 to create, review, and obtain information related to research information. Figure 3A illustrates an example research information page 320A associated with the research information UI, according to an embodiment of the present disclosure. As shown, the research information page 320A can include a number of navigation user affordances 322, a number of operation user affordances 324, and a research information display area 326A.

[0072] In one or more examples, the study information display area 326A may correspond to an area of ​​the study information UI that displays information related to the study information. As shown, the study information display area 326A may display information including, but not limited to, a customer protocol, a customer number, a CoC type, a study purpose, a study information description, a version of the study information, a status of the version, a reason or version, the creator of the current version of the study information, and an owner of the study information.

[0073] In one or more examples, the navigation user affordances 322 can include multiple user affordances, each corresponding to a tab and corresponding page associated with study information. As shown, the navigation user affordances 322 can include a STUDY INFORMATION tab, a DESTINATION COUNTRIES / LABEL... tab, an OM GROUPS tab, a DOSAGE CODES tab, a STUDY APPROVERS tab, a STUDY PARTS tab, a PROJECT MANAGERS tab, and a BUSINESS UNIT tab. The examples of the navigation user affordances 322 are merely illustrative and more or less navigation user affordances may be used without departing from the scope of the present disclosure.

[0074] In one or more examples, the production facilitator UI 120 can receive an indication that the user has selected a navigation user affordance. After receiving the indication, the production facilitator UI 120 can navigate to a page corresponding to the selected study navigation user affordance 322. For example, if the system receives an indication that the user has selected the OM Groups tab, the system can update the production facilitator UI 120 to display a page associated with the OM Groups tab. In one or more examples, the system can obtain data regarding each of the navigation user affordances 322 via a corresponding page associated with the respective navigation user affordance. For example, the system can obtain information related to the OM Groups via a page associated with the OM Groups tab.

[0075] In one or more examples, the plurality of operational user affordances 324 may include a plurality of buttons, each corresponding to a different action that may be implemented by a user. As shown, the operational user affordances 324 may include, without limitation, an approve button, a new version button, a create lot allocation button, a hold button, an inactive button, and the like.

[0076] In one or more examples, the approve button may be used to receive approval of the study information by a production user. In one or more examples, the new version button may be used to create a new version of the study information by a production user. In one or more examples, the create lot allocation button may be used to create a lot allocation. In one or more examples, the hold button may be used to change the status of the study information to "hold." In one or more examples, depending on the status of different items associated with the study information 104, one or more of the operational user affordances 324 may be inactive and / or one or more of the operational user affordances may be removed or made visible. For example, as described in more detail below, the create lot allocation button may be inactive and / or invisible when the system has not received approval of the study instruction 110 and bill of materials 112.

[0077] In one or more examples, the research information UI of the production facilitator UI may be configured to obtain information related to the research information 104 as described above with respect to block 154 in processes 150 and 160 .

[0078] 3B illustrates a process 354 for obtaining research information, according to one or more embodiments of the present disclosure. In one or more embodiments, the process 354 may correspond to block 154 described above with respect to processes 150 and 160. The process 354 may be performed, for example, using one or more electronic devices implementing a software platform. In some examples, the process 354 is performed using a client-server system, with the blocks of the process 354 being split in any manner between a server and a client device. In other examples, the blocks of the process 354 are split between a server and multiple client devices. In other examples, the process 354 is performed using only one client device or only multiple client devices. In the process 354, some blocks are optionally combined, the order of some blocks is optionally changed, and some blocks are optionally omitted. In some examples, additional steps may be performed in combination with the process 354. Thus, the operations as illustrated (and described in more detail below) are exemplary in nature, and as such should not be considered limiting.

[0079] At block 302, the system can receive an instruction to create a study. For example, the system can receive a search for a particular customer record from a production user. The customer record can correspond to customer information 122 from the master data 102. In one or more examples, the production user can navigate to a master data UI, such as the master data UI 220A of FIG. 2A, and begin the process of creating a new study associated with the customer in the system using the create study operation user affordance 222. Based on information about the customer from the master data 102 and one or more third-party software applications (e.g., JD Edwards), the system can automatically associate data related to the customer with the study information 104.

[0080] In one or more examples, the production facilitator UI can receive study information from a production user, including, but not limited to, a protocol number, a project number, a study objective, a study information description, and a CoC type. In one or more examples, the system can prompt the user to indicate which portions of the study information require approval from a customer approver. In one or more examples, the system can be configured to receive customer approval for one or more of the study instructions 110, the bill of materials 112, the lot allocation 114, and the batch record 116.

[0081] 3B, in block 304, the system can receive an instruction to add one or more packaging sites to the study information. For example, the production facilitator UI 120 can receive an instruction indicating that the production user has selected a destination country / label country group tab from the study information navigation user affordance 322. After receiving the selection of the destination country / label country group tab, the system can navigate to a destination country / label country group page 320C, as shown in FIG. 3C. The destination country / label country group page 320C can be presented via the production facilitator UI 120. As shown, the destination country / label country group page 320C can include multiple navigation user affordances 322, a new input user affordance 332C, a destination country information display area 326C, and multiple edit user affordances 334C.

[0082] In one or more examples, the system can receive an indication that the production user has selected the new input user affordance 332C. The new input user affordance 332C can be used to add a new packaging site to the research information. After receiving a selection of the new input user affordance 332C, the system can cause a destination country information input window to be displayed. An exemplary destination country information input window 330D is shown in FIG. 3D. As shown, the production user can select a destination country. Based on the selected destination country, the system can populate one or more available packaging sites located in the selected destination country. The system can receive a selection of one or more packaging sites by the production user. In one or more examples, the system can pre-populate the destination country and packaging site based on data obtained from the packaging site 126 and / or third-party software.

[0083] In one or more examples, the system may allow a user to bundle one or more packaging sites into a label group. FIG. 3E shows an example destination country group window 330E. The destination country group window 330E may be used to group one or more packaging sites. For example, the system may receive a user selection of "Label Country Groups" from a drop-down menu, a corresponding name for the label group, and one or more packaging sites to be included in the label group. In one or more examples, after a packaging site is included in a label group, it may not be included in a second label group. In one or more examples, a packaging site may be included in any number of label groups.

[0084] The destination country information display area 326C can display the destination country, packaging site, and label country group based on the selections made in the destination country group windows 330D, 330E. The user can edit and / or remove sites from the list shown in the destination country information display area 326C using the corresponding user edit affordance 334C.

[0085] In block 306, the system may receive an instruction from a production user to create one or more output material (OM) groups within the study information 104. In one or more examples, block 306 may be omitted. An OM group may include one or more output materials that may be grouped together for delivery to participants of the study. In one or more examples, the system may receive an indication that a user has selected an OM Groups tab from the study information navigation user affordances 322. After receiving the selection of the OM Groups tab, the system may navigate to an OM Groups page 320F, as shown in FIG. 3F. The OM Groups page 320F may be presented via the production facilitator UI 120. As shown, the OM Groups page 320F may include multiple navigation user affordances 322, a new input user affordance 342F, and an OM Group information display area 326F. The multiple navigation user affordances 322 may be similar to the multiple navigation user affordances 322 described above. The new OM group user affordance 342F can be selected by the user to create a new OM group. The OM group information display area 326F can display a list containing existing OM groups that have been created.

[0086] At block 308, the system may receive an instruction to add one or more dosage codes to the study information. The dosage codes may be assigned to the output materials to indicate the amount of each drug that goes into the respective output materials. In one or more examples, block 308 may be omitted. In one or more examples, the system may receive an instruction indicating that a user has selected a dosage codes tab from the study information navigation user affordances 322. After receiving the selection of the dosage codes tab, the system may navigate to a dosage codes page 320G, as shown in FIG. 3G. The dosage codes page 320G may be presented via the production facilitator UI 120. As shown, the dosage codes page 320G may include a number of navigation user affordances 322, a new input user affordance 342G, and a dosage code information display area 326F. The number of navigation user affordances 322 may be similar to the number of navigation user affordances 322 described above. The new input user affordance 342G may be selected by the user to create a new OM group. The dosage code information display area 326G may display dosage codes for various output materials associated with the study information.

[0087] At block 310, the system may receive instructions to add one or more study approvers to the study information. An approver may correspond to a customer user authorized to approve one or more study components. A customer approver may be associated with credentials used to approve one or more components of the study information. As described above, the system may receive instructions of which components of the study information should be approved when the study information 104 is configured at block 302 and / or block 154. In one or more examples, a customer approver may be configured to approve one or more of a study instruction, a bill of materials, a lot allocation, and a batch record.

[0088] In one or more examples, the production facilitator UI can receive an indication that the production user has selected a research approver tab as provided in the navigation user affordances 322. After receiving the selection of the research approver tab, the system can navigate to a research approver page 320H, as shown in FIG. 3H. The research approver page 320H can be presented via the production facilitator UI 120. As shown, the research approver page 320H can include a number of navigation user affordances 322, a new input user affordance 342H, and a research approver information display area 326H. The number of navigation user affordances 322 can be similar to the number of navigation user affordances 322 described above. The new input user affordance 342H can be selected by the production user to add a new research approver. In one or more examples, a drop-down menu 364H can be used to add a new research approver after selecting the new input user affordance 342H. The research approver information display area 326H may display a list of existing research approvers for the research information.

[0089] In one or more examples, the process 354 can include adding one or more project managers to the study. For example, the system can receive an indication from a production user to add one or more project managers to the study information. In one or more examples, the system can receive an indication indicating that the production user selected a project manager tab from a number of navigation user affordances 322 in the study information UI 320. After receiving the selection of the project manager tab, the production facilitator UI can navigate to a project manager page 320J, as shown in FIG. 3J. As shown, the project manager page 320J can include a number of navigation user affordances 322, a new input user affordance 342J, and a project manager information display area 326J. The number of navigation user affordances 322 can be similar to the number of navigation user affordances 322 described above. The new input user affordance 342J can be selected by the production user to add a new project manager. The project manager information display area 326J can display the project manager assigned to the study information.

[0090] FIG. 3K illustrates an example business unit page 320K. The business unit page 320K may be presented via the production facilitator UI 120. In one or more examples, a user may navigate to the business unit page using a study information navigation user affordance 322. In one or more examples, the business units may be based on information obtained from the master data 102 and / or from third party software integrated with the system. As shown, the business unit page 390K may include multiple navigation user affordances 322 and a business unit information display area 326K. The multiple navigation user affordances 322 may be similar to the multiple navigation user affordances 322 described above. The business unit information display area 326K may display a list of business units associated with the various packaging sites associated with the study information.

[0091] FIG. 2L illustrates an exemplary study portion page 320L. The study portion page 320L may be presented via the production facilitator UI 120. In one or more examples, a user may navigate to the study portion page 320L using a study information UI navigation user affordance 322. A study portion may include one or more output materials for a study that may share the same packaging instructions. As shown, the study portion page 320L may include multiple navigation user affordances 322, a new study portion user affordance 342L, and a study portion information display area 326L. The multiple navigation user affordances 322 may be similar to the multiple navigation user affordances 322 described above. The new input user affordance 342L may be used to add a new study portion to the study information 104. In one or more examples, the new study part use affordance 342L may only become active after receiving approval of the study information as described below (e.g., a production user may add a new study part after the study information is approved). The study part information display area 326L may display a list of study parts 106 associated with the study information 104.

[0092] In block 312, the system may receive approval of the study information from one or more production users, e.g., a production approver, as described above with respect to processes 150 and 160. In one or more examples, the system may not allow approval to be accessed without receiving completed destination country / label group, OM group, dosage code, and customer approver information. FIG. 3I illustrates an example approval page 320I presented via the production facilitator UI 120. The example approval page 320I may include one or more of an approval report 372I and an approval window 374I.

[0093] In one or more examples, the system can receive an indication that a user has selected an APPROVAL button from the operation user affordances 324. The APPROVAL button can be selected from any of the pages and / or tabs associated with the study information UI. After receiving the selection of the APPROVAL button, the system can present an approval report 372I. The approval report can include study information associated with each of the information display areas across the various study information tabs. For example, the approval report can include information included in one or more of the study information display area 326A, the destination country information display area 326C, the OM group information display area 326F, the dosage code information display area 326G, the study approver information display area 326H, the project manager information display area 326J, the business unit information display area 326K, or the study portion information display area 326L.

[0094] After a user is ready to sign the approval report 372I at any time, for example after a production user has reviewed and verified the information in the approval report 372I, the system can receive an indication that the production user has selected the sign button 376I. After receiving input corresponding to the selection of the sign button 376I, the system can cause an approval window 374I to be displayed. As shown, the sign window can be displayed overlaid on the approval report 372I. The sign window 374I can include one or more user affordances for receiving the production user's credentials. For example, the sign window 374 can include text boxes for the production user to enter a user identifier and a corresponding password.

[0095] The system may then receive an indication from the production user whether to accept or reject the approval. In one or more examples, the production user may cancel the pending approval. After receiving the acceptance or rejection of the approval, the system may verify the production user's credentials. If the credentials are valid and correspond to the designated research approver, the system may accept or reject the approval based on the indication received from the signature window 374I. If the credentials are valid and do not correspond to the designated research approver, the system does not accept or reject the approval.

[0096] After the study information 102 is approved, the system may not allow changes to be made to the approved version of the study information. If a production user desires to make changes to the study information 102, the production user may create a new version of the study information 102. The system may create a new version of the study information 102 by receiving input from the operation user affordance 324 corresponding to the selection of a new version button. Changes to the new version of the study information may be made, for example, according to the description provided above with respect to process 354. After the new version is created, the old version remains the controlled version of the study information until the new version is approved, as described above with respect to block 312.

[0097] research part After the study information 102 is approved, the system can allow the production user to add one or more study parts. A study part can correspond to one or more output materials of the study that may be prepared using the same packaging instructions. In one or more examples, the output materials can share the same packaging instructions when the output materials may be packaged under the same conditions. For example, a study part can correspond to a 60-count bottle filled with 60 tablets that may be packaged at controlled room temperature (CRT). In one or more examples, the study part data can include, but is not limited to, output materials, input materials, common materials, drug classification, alternative materials, storage temperature, timeout environment details, humidity control details, lighting control details, and label details.

[0098] FIG. 4A illustrates a process 456 for acquiring the study portion 106 according to one or more embodiments of the present disclosure. In one or more embodiments, the process 456 may correspond to block 156 described above with respect to processes 150 and 160. The process 456 may be performed, for example, using one or more electronic devices implementing a software platform. In some examples, the process 456 is performed using a client-server system, with the blocks of the process 456 being divided in any manner between a server and a client device. In other examples, the blocks of the process 456 are divided between a server and multiple client devices. In other examples, the process 456 is performed using only one client device or only multiple client devices. In the process 456, some blocks are optionally combined, the order of some blocks is optionally changed, and some blocks are optionally omitted. In some examples, additional steps may be performed in combination with the process 456. Accordingly, the operations as illustrated (and described in more detail below) are exemplary in nature and, as such, should not be considered as limiting.

[0099] At block 402, the system may receive an instruction to create a study portion 106 associated with the study information 102. For example, while the system is displaying a study information UI (e.g., any one of pages 320A, 320F, 320G, 320H, 320J, 320K), the system may receive an indication that a production user has selected a study portion tab from the navigation user affordance 322. After receiving the selection of the study portion tab, the system may navigate to the study portion page 320L, as shown in FIG. 3L. The system may then receive an indication that the production user has clicked a new input user affordance 342L. In response to receiving the selection of the new input user affordance 342L, the production facilitator UI may display a study portion details window.

[0100] FIG. 4B illustrates a STUDY PART DETAILS window 430B that includes multiple user affordances for receiving input from a production user. For example, a production user can input details about the study part. As shown, the user affordances can include text entry boxes, drop-down menus, and the like. In one or more examples, the study details can include, but are not limited to, a STUDY INFORMATION number, a PACKAGING TYPE, a SP UNIQUE IDENTIFIER, a DESCRIPTION, a LCG / DEST COUNTRY, whether the study is blinded, whether the study is fastchain, and can associate one or more STUDY BATCH RECORDs. After receiving the study part details and receiving a user instruction to save them, the system can generate the study part.

[0101] FIG. 4C illustrates an exemplary study portion details page 420C associated with a study portion UI according to one or more examples of the present disclosure. The study portion details page 420C may be presented via the production facilitator UI 120. The study portion details page 420C may be configured to present details related to the study portion. The study portion details page 420C may include a number of navigation user affordances 422, a number of operation user affordances 424, and a study portion detailed information display area 426C. In one or more examples, the study portion detailed information display area 426C may correspond to an area of ​​the study portion details page 420C that displays information about the study portion. As shown, the study portion detailed information display area 426C may display information including, but not limited to, a study information number, a packaging type, a study portion identifier, a description, one or more destination / label country groups, a study portion language, one or more packaging sites, whether the study is blinded, whether the study is fast chain, and one or more study batch records.

[0102] In one or more examples, the study part navigation user affordances 422 can include multiple user affordances, with each user affordance corresponding to a tab associated with study information. As shown, the study part navigation user affordances 422 can include a STUDY PART DETAILS tab, an OUTPUT AND INPUT MATERIALS tab, a COMMON tab, a RELATED BATCH RECORDS tab, and a STUDY PART LIST tab. The examples of navigation user affordances 322 are merely illustrative, and more or less navigation user affordances may be used without departing from the scope of the present disclosure.

[0103] In one or more examples, the production facilitator UI can receive an indication indicating that a user has selected a study portion navigation user affordance 422. After receiving the indication, the study portion UI can navigate to a page corresponding to the selected study portion navigation user affordance 422. In one or more examples, the page corresponding to the study portion navigation user affordance 422 can be configured to obtain information regarding the respective user affordance, e.g., output and input materials, common materials, etc. For example, if the system receives an indication indicating that the user has selected the output and input materials tab, the system can update the study portion UI to display a page associated with the output and input materials tab. The system can obtain information related to the output and input materials via the page associated with the output and input materials tab.

[0104] In one or more examples, the operational user affordances 424 may include a number of buttons, each corresponding to a different action that may be implemented by a user. As shown, the operational user affordances 424 may include, but are not limited to, an accept button, a new version button, a clone button, a hold button, an inactive button, a history button, and the like. In one or more examples, depending on the status of different items associated with the study portion 106, one or more of the operational user affordances 424 may be inactive and / or one or more of the operational user affordances may be removed or made visible. For example, the accept button may be inactive if the system has not received sufficient information related to the study portion 106, such as information related to output materials, input materials, common materials, drug classifications, alternative materials, storage temperatures, timeout environmental details, humidity control details, lighting control details, and label details. The buttons associated with the operational user affordances 424 may have functionality similar to that described above with respect to the operational user affordances 324. In one or more instances, the clone button may be used to create a copy of the study portion.

[0105] Returning to FIG. 4A, at block 404, the system can receive instructions to create an output material record within the study portion. For example, the system can navigate to an output and input material page, and the system can obtain information about the output and input materials from a production user. The output material record can correspond to a product provided to a participant in a clinical trial study. For example, a 60-count bottle filled with 60 tablets of a drug (or placebo) provided to a participant in the clinical trial. In one or more examples, the system can receive an indication from a navigational user affordance 422 indicating that the user has selected the output and input materials tab 420B.

[0106] FIG. 4D illustrates an exemplary output and input material page 420D corresponding to an output and input material tab associated with the study portion UI. The output and input material page 420D can be presented via the production facilitator UI 120 and configured to obtain information related to the output and input materials associated with the study portion. The output and input material page 420D can include a number of navigation user affordances 422, a number of operation user affordances 424, and an output and input material information display area 426D. In one or more examples, the output and input material information display area 426D can correspond to an area of ​​the study portion UI that displays information about the input and output materials of a selected study portion. As shown, the output and input material information display area 426D can display information including, but not limited to, one or more output materials, corresponding drug input materials, corresponding non-drug input materials, and corresponding labels. The output and input material information display area 426D can further include a number of user affordances 428D, 434D.

[0107] As shown, the output and input material page 420D has been approved by the production user (e.g., in an approved status). However, while the output and input material page is in a draft status, the production facilitator UI may display a new output material user affordance. FIG. 4E illustrates an example portion of the output and input material page 420E in a draft status. The output and input material page in a draft status may include a new output material user affordance 432E. In response to receiving an indication that the user has selected the new output material user affordance 432E, the system may display an output material details window.

[0108] 4F illustrates an exemplary output material details window 430F. As shown, the output material details window 430F can include a number of user affordances for receiving input from a production user regarding output material details for creating an output material record. As shown, the user affordances can include text entry boxes, drop-down menus, and the like. In one or more examples, the output material details can include, but are not limited to, one or more of a general material description, an output material type, a UOM, an output material group, a dosage code, sample information, a destination country / label country group, a label, a bar code, a storage temperature range, timeout environmental information, humidity information, lighting information, and a customer material identifier.

[0109] In one or more examples, the system may not allow an output material record to be completed without receiving information associated with each of the fields included in the output material details window 430F. For example, the system may continue to present the output material details window 430F until the production user has entered the corresponding details. In one or more examples, multiple output materials may be created for one study part. After creating an output material record, the user may navigate to the Output and Input Materials page to create a new output material record. In one or more examples, once a study part is approved, the user may not be allowed to create additional output material records associated with the study part. To add a new output material record, the user may have to create a new version of the study part or clone the study part (e.g., using the corresponding operation user affordance 424).

[0110] 4D, the user may be allowed to edit, delete, clone, preview, and view relationships of the output material using corresponding output material user affordances 428D. For example, proceeding from left to right, each user affordance 428D corresponds to a respective icon associated with an edit action, a delete action, a clone action, a preview action, and a view relationships action. In one or more examples, if the study portion is approved, the system may deactivate the edit, delete, and clone user affordances.

[0111] After receiving an indication that the user selected the edit icon, the system may allow the user to modify information associated with the output material record. After receiving an indication that the user selected the delete icon, the system may delete the corresponding output material record. If there are input material records associated with the deleted output material record, those input material records may be deleted from the study portion. After receiving an indication that the user selected the clone icon, the system may duplicate the output material record by creating a new output material record and updating the general material description field to distinguish the cloned output material record from the parent output material record. After receiving an indication that the user selected the preview icon, the system may present the output material record in a read-only mode without updating it. This may be useful when the study portion is approved and the user wants to view the output material record. After receiving an indication that the user selected the view relationships icon, the system may present each of the output materials used within the same output material group.

[0112] At block 406, the system may receive an instruction to create one or more input material records for one or more input materials corresponding to the output material. In one or more examples, three types of input materials may be associated with an output material. For example, referring to output and input material page 420D, each of the output materials may be associated with a drug input material, a non-drug input material, and a label input material.

[0113] In block 408, the system can obtain data corresponding to the drug input material. FIG. 4G illustrates an example portion of the output and input material page 420G including a new input (drug) material user affordance 432G. The input (drug) material can correspond to a drug and / or a placebo. The new input (drug) material user affordance can be associated with the output material created in block 404. The new input (drug) material user affordance 432G can be used to create one or more input (drug) material records for the input (drug) material associated with the output material. In response to receiving an indication that the production user has selected the new input (drug) material user affordance 432G, the system can display a drug input material details window.

[0114] 4H illustrates an exemplary input (drug) material details window 430H. As shown, the input (drug) material details window 430H can include a number of input user affordances for a user to input details to create an input (drug) material record. As shown, the user affordances can include text entry boxes, drop-down menus, and the like. In one or more examples, the output material details can include, but are not limited to, one or more of a general material description, label information, UOM, customer material identifier, drug classification information, alternative material information, storage temperature range, timeout environmental information, humidity information, lighting information, and the like.

[0115] In one or more examples, the system will not allow an input (drug) material record to be completed without receiving information associated with each of the fields included in the input (drug) material details window 430H. In one or more examples, a single output material record may be associated with multiple input (drug) materials. In one or more examples, after a study portion is approved, the user may not be allowed to create additional input drug material records. In such examples, the user may create a new version of the study portion or clone the study portion (e.g., using the corresponding operation user affordances 424) to add new input (drug) material records. As described above with respect to output materials, the user may be allowed to edit, delete, clone, and preview drug input material records using the corresponding input material user affordances 434D.

[0116] In block 410, the system can obtain data corresponding to a non-drug input material. FIG. 4I illustrates an example portion of an output and input material page including a new input (non-drug) material user affordance 432I. The new input (non-drug) material user affordance 432I can be associated with the output material created in block 404. The new input (non-drug) material user affordance 432I can be used to create one or more input (non-drug) materials associated with the output material. The input (non-drug) material can include one or more input materials that do not include a drug, such as a bottle, a desiccant, a closure, etc. In response to receiving an indication indicating that the production user has selected the new input (non-drug) material user affordance 432I, the production facilitator UI can display an input (non-drug) material details window.

[0117] 4H illustrates an example input (non-drug) material details window 430J. As shown, the input (non-drug) material details window 430J can include a number of input user affordances for a user to input details regarding the input (non-drug) material record. As shown, the user affordances can include text entry boxes, drop-down menus, and the like. In one or more examples, the output material details can include, but are not limited to, one or more of a general material description, output material group information, UOM, customer material identifier, alternative material information, destination country / label country group, and the like.

[0118] In one or more examples, the system will not allow an input (non-drug) material record to be completed unless it receives information associated with each of the fields included in the non-drug input material details window 430J. In one or more examples, multiple input (non-drug) materials may be associated with a single output material record. After creating an input (non-drug) material record, the production user may navigate to an output and input material page, e.g., 420I, to create a new input (non-drug) material record, as described above. In one or more examples, after a study part is approved, the user may not be allowed to create additional input (non-drug) material records. In such examples, the user may create a new version of the study part or clone the study part (e.g., using the corresponding operation user affordance 424) to add a new input (non-drug) material record. As described above with respect to output materials, the user may be allowed to edit, delete, clone, and preview the non-drug input material records using the corresponding input material user affordance 434D.

[0119] In block 412, the system can obtain data corresponding to the input (label) material. FIG. 4K illustrates an example portion of the output and input material page 420K including a new input (label) material user affordance 432K. The new input (label) material user affordance 432K can be associated with the output material created in block 404. In one or more examples, the label is available for production for secondary packaging, for example, bottles, cardboard boxes, plastic boxes, paper boxes, and the like. The new input (label) material user affordance 432K can be used to create one or more label input material records associated with the output material. In response to receiving an indication indicating that the production user has selected the new input (label) material user affordance 432K, the system can display an input (label) material details window.

[0120] 4L illustrates an exemplary input (label) material details window 430L. As shown, the input (label) material details window 430L can include a number of input user affordances for a user to input details regarding the input (label) material record. As shown, the user affordances can include text entry boxes, drop-down menus, and the like. In one or more examples, the output material details obtained via the input (label) material details window 430L can include, but are not limited to, one or more general material descriptions, UOMs, barcode information, and the like.

[0121] In one or more examples, the system may not allow a label input material record to be completed without receiving information associated with each of the fields included in the label input material details window 430L. In one or more examples, multiple input (label) material records may be associated with a single output material record. After creating an input (label) material record, the user may navigate to the Output and Input Materials page to create a new input (label) material record, as described above. In one or more examples, after a study portion is approved, the user may not be allowed to create additional input (label) material records. In such examples, the user may create a new version of the study portion or clone the study portion (e.g., using the corresponding operation user affordances 424) to add new input (label) material records. As described above, the user may be allowed to edit, delete, clone, and preview non-drug input material records, using the corresponding input material user affordances 434D.

[0122] At block 414, the system may receive instructions to add common materials to the study portion. In one or more examples, the same common material record may be associated with multiple output material records. For example, one study portion includes two output materials, each output material including a respective 60-count bottle. In such an example, rather than creating the same input material record multiple times under different output material records, the user may create one input material record in the common section. In one or more examples, the common material record may be created as described above with respect to the input material records (e.g., blocks 406-412). Mapping the common material record to the corresponding output material may occur when the batch record is created. An embodiment according to the present disclosure may include three types of common material records created for the study portion: common (drug) materials, common (non-drug) materials, and common (label) input materials. The common (label) input materials may be associated with secondary packaging.

[0123] The system can receive an indication to add a common material to the study portion. For example, the system can receive an indication from a navigation user affordance 422 indicating that a production user has selected a common material tab. FIG. 4M illustrates an exemplary common material page 420M corresponding to a common material tab associated with a study portion UI. The common material page 420M can be presented via the production facilitator UI 120 and configured to obtain information related to a common material associated with the study portion. The common material can correspond to a material used in a plurality of output materials. The common material page 420M can include a plurality of study portion navigation user affordances 422, a plurality of operation user affordances 424, and a common material information display area 426M. In one or more examples, the common material information display area 426M can correspond to an area of ​​the study portion UI that displays information related to the common material. In one or more examples, the common material page 420M may include information similar to the input material information (e.g., input (drug) materials, input (non-drug) materials, and input (label) materials) displayed by the input and output material page 420D (e.g., information corresponding to common (drug) materials, common (non-drug) materials, and common (label) materials).

[0124] One difference between the common materials page 420M and the input / output materials page 420D is that the common materials include one or more user affordances for linking the common materials to corresponding output materials. As shown, the common materials page 420M has been approved by a production user (e.g., approved status). However, while the common materials page 420M is in draft status, the common materials page can be used to link common input (drug) materials to dosage codes, common input (non-drug) materials to output material groups or destination / label country groups, and / or common input (label) materials to destination / label country groups.

[0125] For example, while the common material page is in a draft status, the system may display a common material mapping user affordance. FIG. 4N illustrates an example portion of a common material page 420N corresponding to a common (drug) material from a common material page in a draft status. As shown, the common material page may include a common (drug) material user affordance 434N, as well as an input material user affordance 434D. However, one difference is that the common (drug) material user affordance 434N includes a mapping user affordance 436N. The mapping user affordance 436N may be used to map each common material (e.g., a common drug input material) to one or more output materials.

[0126] 4O illustrates an exemplary drug common mapping window 430O. The system can receive user input via the drug-common mapping window 430O to map common (drug) materials to one or more dosage codes associated with the study portion.

[0127] For common (non-drug) materials, the common material page (e.g., while in draft status) may be configured to receive an indication of an output material group or a destination country / label country group. For example, a production user may enter an output material group or a destination country / label country group for the common (non-drug) material via one or more user affordances. For common (label) materials, the common material page (e.g., while in draft status) may be configured to receive an indication of a destination country / label country group. For example, a production user may enter a destination country / label country group for the common (label) material via one or more user affordances. Although a specific UI for mapping common (non-drug) materials and common (label) materials is not shown, one skilled in the art would understand that the UI may be similar to that described with respect to Figures 4N and 4O.

[0128] At block 416, the system may receive approval of the study portion from one or more study approvers. In one or more examples, the system will not allow approval to be accessed without receiving completed output and input material information. The approval process may be similar to that described above with respect to block 312 of process 354. For example, the system may receive an indication indicating that the user selected an approval button from the operation user affordance 424. The approval button may be selected from any of the pages and / or tabs associated with the study portion UI. After receiving the selection of the approval button, the system may present an approval report. The approval report may include study portion information associated with each of the information display areas across the various study portion tabs. For example, the approval report may include information included in one or more of the study portion detailed information display area 426C, the output and input material information display area 426D, the common material information display area 426M, the study portion list information display area 426P, and the related batch record information display area 426Q.

[0129] After the study information 102 is approved, the system may not allow changes to be made to the approved version of the study information. If a production user desires to make changes to the study portion 104, the production user may create a new version of the study portion or may clone the study portion. For example, the system may create a new version of the study portion by receiving a user selection of a new version button from an operation user affordance 424 associated with the study portion UI. Similarly, the system may clone an existing study portion by receiving a user selection of a clone button from an operation user affordance 424 associated with the study portion UI. Changes to the new version of the study information may be made according to the description provided above, for example, with respect to process 456. After the new version is created, the old version remains the controlled version of the study information until the new version is approved, as described above with respect to block 416.

[0130] In one or more examples, the system can present a study part list to a production user. FIG. 4P illustrates an exemplary study part list page 420P according to an embodiment of the present disclosure. The study part list page 420P includes the approved study parts. The study part list page 420P can be presented via the production facilitator UI 120 and configured to display the created study parts. As shown, the study part list page 420P can include a number of navigation user affordances 422, operation user affordances 424, and a study part list information display area 426P. The navigation user affordances 422 and operation user affordances 424 can be similar to those described above. The study part list information display area 426P can display study parts associated with the same study information. For example, the study part list information can include, but is not limited to, a description, packaging type, blinding status, fast chain status, approval status, and version for each study part.

[0131] In one or more examples, the system can present related batch records to a user. FIG. 4Q illustrates an example related batch records page 420Q, according to an embodiment of the present disclosure. The related batch records page 420Q can be presented via the production facilitator UI 120 and configured to display batch records associated with the study portion. As shown, the related batch records page 420Q can include a number of navigation user affordances 422, an operation user affordance 424, and a related batch record information display area 426Q. The navigation user affordances 422 and the operation user affordances 424 can be similar to those described above. The related batch records information display area 426Q can display batch records associated with the study portion. In one or more examples, the system can navigate to the batch records via the related batch records page 420Q (e.g., by receiving a user selection of a link associated with a listed batch record).

[0132] Research Batch Record The study batch record 108 may include one or more study instructions 110 and a bill of materials 112. In one or more examples, each study portion 106 may be associated with a respective study batch record 108. In one or more examples, the system may generate the study batch record 108 based on the completed study portion 106. In one or more examples, the system may automatically generate the study batch record 108 after receiving approval of the completed study portion 106, for example, from a customer approver. In one or more examples, the study batch record 108 may act as a container for the study instructions 110 and the bill of materials 112. In one or more examples, the study batch record may be configured to link and / or display the latest version of the study instructions 110 to the bill of materials 112.

[0133] 5A-1 and 5A-2 illustrate an example batch record details page 520A of a study batch record UI, according to one or more embodiments of the present disclosure. The batch record details page 520A can be presented via the production facilitator UI 120 and configured to display batch record information related to approved study portions. As shown, the batch record details page 520A can include a number of navigation user affordances 522, a number of operation user affordances 524, and a batch record detailed information display area 526A.

[0134] In one or more examples, the information display area 526A can correspond to an area of ​​a batch record detail page that displays information related to the study batch record. As shown, the study batch record information display area 526A can display information including, but not limited to, instructions, room process temperature, room process humidity, room process lighting conditions, batch record name, blinding status, study batch record identifier, project number, corresponding study part, and customer.

[0135] In one or more examples, the navigation user affordances 522 can include multiple user affordances, each corresponding to a tab and a respective page associated with study information. As shown, the navigation user affordances 522 can include a STUDY BATCH RECORDS tab, INSTRUCTIONS & EQUIPMENT GROUP tab, BILL OF MATERIALS tab, RELATED STUDY PARTS tab, and RELATED BATCH RECORDS tab. The examples of the navigation user affordances 522 are merely illustrative, and more or less navigation user affordances may be used without departing from the scope of the present disclosure. Tabs may be used to navigate between the respective pages of the STUDY BATCH UI.

[0136] In one or more examples, the operational user affordances 524 can include a number of buttons, each corresponding to a different action that can be implemented by a production user. As shown, the operational user affordances 524 can include, but are not limited to, an APPROVAL button, a NEW VERSION button, a CREATE LOT ALLOCATION button, a HOLD button, an INACTIVE button, a HISTORY button, and the like. In one or more examples, depending on the status of different items associated with the research batch record 108, one or more of the operational user affordances 524 can be inactive and / or one or more of the operational user affordances can be removed or made visible. The operational user affordances 524 can correspond to the functionality of the operational user affordances described above.

[0137] In one or more embodiments, the process of generating a study batch record may correspond to block 158 described above with respect to process 150 and process 160. In one or more examples, the system may obtain information associated with the study batch record via a study batch record UI.

[0138] FIG. 5B illustrates a process 558 for generating a study batch record, according to one or more embodiments of the present disclosure. In one or more embodiments, the process 558 may correspond to block 158 described above with respect to process 150. The process 558 may be performed, for example, using one or more electronic devices implementing a software platform. In some examples, the process 558 is performed using a client-server system, with the blocks of the process 558 being split in any manner between a server and a client device. In other examples, the blocks of the process 558 are split between a server and multiple client devices. In other examples, the process 558 is performed using only one client device or only multiple client devices. In the process 558, some blocks are optionally combined, the order of some blocks is optionally changed, and some blocks are optionally omitted. In some examples, additional steps may be performed in combination with the process 558. Thus, the operations as illustrated (and described in more detail below) are exemplary in nature, and as such should not be considered limiting.

[0139] At block 502, the system may receive instructions to create a study batch record according to one or more embodiments of the present disclosure. In one or more examples, the study batch record 108 may be created from the approved study portion 106. In one or more examples, the system may create a version of the study instructions 110 and bill of materials 112 when the study batch record 108 is created. In one or more examples, after receiving approval of the study portion 106, a new user affordance may appear among the study portion operation user affordances. FIG. 5C illustrates an example operation user affordance 424 of the study portion UI as it may appear after approval of the study portion. As shown, the "Create SBR" user affordance 470 is visible. In one or more examples, when the corresponding study portion is versioned, subsequent versions may be associated with the same study batch record. After receiving a selection of the Create SBR user affordance 470, the system may generate a study batch record. In one or more examples, information associated with the corresponding study portion may be imported into one or more fields associated with the study batch record 108.

[0140] At block 504, the system may receive an indication to add one or more instruction sets to the study batch record. For example, the system may receive an indication from a navigation user affordance 522 indicating that the user has selected the Instructions and Equipment Groups tab. After receiving the selection of the Instructions and Equipment Groups tab, the system may navigate to the Instructions and Equipment Groups (Study Instructions) page 520D, as shown in FIG. The Instructions and Equipment Groups (Study Instructions) page 520D corresponds to a draft study batch record UI (e.g., not an approved study batch record).

[0141] As shown, the Instructions and Equipment Group (Study Instructions) page 520D can include a plurality of navigational user affordances 522, an instruction type navigational user affordance 542D, a search user affordance 544D, and one or more language selection user affordances 546D. The second plurality of navigational affordances 542D can each correspond to one of four categories of study instructions: packaging instructions, processing checklist, important notes, and image capture.

[0142] In one or more examples, the system can receive packaging instructions associated with the study batch record. For example, the packaging instructions can be added by receiving a search for instructions via a search user affordance 544D or adding the instructions directly via an add instructions user affordance 550D. After the instructions are added, the instructions can be displayed under a language selection user affordance 546D. In one or more examples, the packaging instructions can be generated in English before creating translations in other languages. In one or more examples, the packaging instructions can be imported from an instruction repository, for example, packaging instructions 128 and / or instruction sets 130 associated with the master data 102. In one or more examples, the system can obtain the packaging instructions directly from a production user. In one or more examples, the processing checklist information can be completed based on the selected packaging instructions. In one or more examples, the important notes may be imported from the selected packaging instructions, packaging instructions 128, and / or instruction set 130 associated with the master data 102. In one or more examples, the important notes may be specific to a particular customer. In one or more examples, the image capture information may be completed based on the selected packaging instructions.

[0143] 5E illustrates an example Instructions and Equipment (Study Instructions-Packaging Instructions) page 520E from a Study Batch Record UI. The Instructions and Equipment (Study Instructions-Packaging Instructions) page 520E may correspond to approved study instructions and equipment. As shown, the Instructions and Equipment (Study Instructions-Packaging Instructions) page 520E may include multiple navigational user affordances 522, an instruction type navigational user affordance 542E, and Instructions and Equipment (Study Instructions-Packaging Instructions) display information 526E. As shown, the Instructions and Equipment (Study Instructions-Packaging Instructions) display information 526E may include, but is not limited to, sequence, text, images, names, descriptions, and versions for each step of the packaging instructions.

[0144] In one or more examples, the packaging instructions may be provided in multiple languages. In some examples, the translation may depend on the packaging site associated with the study batch record 108 and / or the study portion 106. In such examples, the text associated with the study instructions may be translated into a selected language based on the English packaging instructions. For example, a German translation may be created based on the English packaging instructions.

[0145] 5F illustrates an example Instructions and Equipment (Study Instructions-Check in Process) page 520F from a Study Batch Record UI. The Instructions and Equipment (Study Instructions-Check in Process) page 520F may correspond to approved study instructions and equipment. As shown, the Instructions and Equipment (Study Instructions-Check in Process) page 520F may include a number of navigational user affordances 522, an instruction type navigational user affordance 542F, and Instructions and Equipment (Study Instructions-Check in Process) display information 526F. As shown, the Instructions and Equipment (Study Instructions-Check in Process) display information 526F may include, but is not limited to, sequence, text, response type, job type, instruction set name, instruction set description, and version.

[0146] In one or more examples, the in-process check may be provided in multiple languages. In some examples, the translation may depend on the packaging site associated with the study batch record 108 and / or the study portion 106. In such examples, the text associated with the in-process check may be translated into a selected language based on the English in-process check. For example, a German translation may be created based on the English in-process check.

[0147] FIG. 5G illustrates an example Instructions and Equipment (Study Instructions-Important Notes) page 520G from a Study Batch Record UI. The important notes may correspond to notes that an operator should observe while the product is being packaged. The Instructions and Equipment (Study Instructions-Important Notes) page 520G may correspond to approved study instructions and equipment. As shown, the Instructions and Equipment (Study Instructions-Important Notes) page 520G may include a number of navigational user affordances 522, an instruction type navigational user affordance 542G, and Instructions and Equipment (Study Instructions-Important Notes) display information 526G. As shown, the Instructions and Equipment (Study Instructions-Important Notes) display information 526G may include, but is not limited to, text of the important notes.

[0148] In one or more examples, the important notice may be provided in multiple languages. In some examples, the translation may depend on the packaging site associated with the study batch record 108 and / or study portion 106. In such examples, the text associated with the important notice may be translated into a selected language based on the English important notice. For example, a German translation may be created based on the English important notice.

[0149] In one or more examples, the system may enable a user to edit research instructions. FIG. 5H illustrates an example Instructions and Equipment (Research Instructions-Packaging Instructions) page 520H according to an embodiment of the present disclosure. The Instructions and Equipment (Research Instructions-Packaging Instructions) page 520H can correspond to draft instructions and equipment (e.g., not approved). In one or more examples, a user can navigate to the Instructions and Equipment (Research Instructions-Packaging Instructions) page 520H using the plurality of navigational user affordances 522 and / or the second plurality of navigational affordances 542. The system can receive a selection of an Edit Instructions user affordance 554H from the user.

[0150] After receiving a selection of the edit instructions user affordance 554H, the system may display an edit packaging instructions window 530I. As shown, the edit packaging instructions window 530I may include a number of user affordances for editing details associated with the packaging instructions. For example, the user affordances may include text entry boxes, drop-down menus, and the like. In one or more examples, via the edit packaging instructions window 530I, the instruction name, text, description, and one or more images may be edited. In one or more examples, after the packaging instructions and / or equipment group are approved, the system may not allow the packaging instructions to be edited.

[0151] In this manner, a central repository for packaging instructions, in-process checks, and important notes may be created and maintained by the system. In one or more examples, the instructions may be accessed and maintained across various locations. For example, the instructions may be accessed by the company conducting the clinical trial study (e.g., the customer), the production facilitator, and at the packaging site. In contrast, packaging instructions for clinical trial studies typically vary by packaging location. This can cause issues when changes are made to the instructions at one packaging site and not at another, affecting the consistency and uniformity of the output material across packaging sites.

[0152] At block 506, the system can receive instructions to add an equipment group to the study batch record. The equipment group can correspond to one or more types of equipment that may be used at a packaging site to package the output material. For example, if the output material corresponds to a bottle of tablets, a bottle sealer may be used to package and seal the bottle.

[0153] In one or more examples, the system can receive an indication from the navigation user affordance 522 that the user selected the Instructions and Equipment Groups tab. After receiving the selection of the Equipment Groups tab, the system can navigate to the Instructions and Equipment Groups (Equipment Groups) page 520J, as shown in FIG. 5J. The Instructions and Equipment Groups (Equipment Groups) page 520J corresponds to a draft study batch record UI (e.g., not an approved study batch record). The system can receive a selection of a New Equipment Group user affordance 556J, which can result in a New Equipment Group window. In one or more examples, the equipment group can be edited using the Edit Equipment Group user affordance 558J, as shown in FIG. 5J.

[0154] 5K illustrates an example new equipment group window 530K according to an embodiment of the present disclosure. As shown, the new equipment group window 530K can include a number of input user affordances for a user to input details about the equipment group. As shown, the user affordances can include text entry boxes, drop-down menus, and the like. In one or more examples, the system can obtain the equipment group and equipment details.

[0155] 5L illustrates an example approved instruction and equipment group (equipment group) page 520L. As shown, the instruction and equipment group (equipment group) page 520L can include a number of navigational affordances 522 and an instruction and equipment group (equipment group) information display area 526L. As shown, the instruction and equipment group (equipment group) information display area 526L can include a list of equipment groups and corresponding equipment details associated with the study batch record.

[0156] At block 508, the system may receive approval of one or more instruction sets and equipment groups from one or more approvers. In one or more examples, the system will not allow approval of instructions and equipment groups to be accessed without receiving completed destination instructions and equipment group information. In one or more examples, the process associated with block 508 may be similar to block 312 of process 354.

[0157] In one or more examples, the system can receive an indication that the user selected an approve button from the study batch record operation user affordance 524. After receiving the selection of the approve button, the system can present an approval report 572M. The approval report can include packaging instructions and equipment group information associated with each of the information display areas. For example, the approval report 572M can include information included in one or more of the study batch record information display area 526A, instructions and equipment (study instructions-packaging instructions) display information 526E, instructions and equipment (study instructions-processing checks) display information 526F, instructions and equipment (study instructions-important notes) display information 526G, instructions and equipment group (equipment group) information display area 526L.

[0158] After the user is ready to sign the approval report 572M at any time, for example after the user has reviewed and verified the information in the approval report 572M, the system can receive an indication that the production user has selected the sign button 576M. After receiving the sign button, the system can cause the sign window 574N to be displayed. In one or more examples, the sign window can be displayed over the approval report 572M. The sign window 574N can include one or more user affordances for receiving the production user's credentials. For example, the sign window 574N can include text boxes for the production user to enter a userID and corresponding password. The system can then receive an indication of whether the user accepts or rejects the approval.

[0159] In one or more examples, after the packaging instructions and equipment group are approved, the system may not allow changes to be made to the approved version of the packaging instructions and equipment group (e.g., packaging instructions 110). If a user desires to make changes to the packaging instructions 110, a production user may create a new version of the packaging instructions 110. The system may create a new version of the packaging instructions 110 by receiving a user selection of a new version button from the operation user affordance 524. Changes to the new version of the packaging instructions 110 may be made, for example, according to the description provided above with respect to process 558. After the new version is created, the old version remains the controlled version of the study information until the new version is approved, as described above with respect to block 508.

[0160] In one or more examples, packaging instructions may be approved separately for each language and / or translation. For example, if the packaging instructions for a research batch record are in English (ENGLISH), German (GERMAN), and Chinese (CHINESE), a separate approval should be performed for each language. For example, briefly referring to the research batch record detail page 520, a separate plurality of operation user affordances 538 are provided for the German instructions. In this manner, translations for the instructions can be reviewed and approved separately. In one or more examples, the English instructions should be approved before approving the packaging instructions for the other languages.

[0161] In one or more examples, a situation may arise where version 1 of a study part includes English as a site language. Thus, the generated study instructions may have an English header. Thus, the English instructions may be created and / or imported. In such an example, version 2 of the study part may be created and approved. In this example, version 2 may include both English and German as site languages. In such an example, when a user versions the study instructions, the system may search for the most recently approved study part. The system may determine that English and German should correspond to site languages. Thus, the system may create a header for the new study instructions version in both English and German. However, there are no German instructions (e.g., because German was not previously included in the site languages). In such an example, the system may clone the English instructions to create the German instructions. In such an example, the user may have to translate the German instructions before submitting for approval.

[0162] In one or more examples, a production user can copy study instructions from previous drafts and / or other approved study instructions belonging to the same customer-linked study. In such an example, if there are missing languages ​​(e.g., as described above with respect to versioning), the system can copy the English instructions and create corresponding translations for the various other field instruction languages. In one or more examples, extra languages ​​in the selected study instructions that are not present in the original can be ignored.

[0163] At block 510, the system may obtain information corresponding to the bill of materials. In one or more examples, information obtained from the output and input materials pages, e.g., output and input materials page 420D, created in the study portion 108 (e.g., blocks 404-412 of FIG. 4A) may be carried over to the bill of materials. For example, the system may receive at least an item ID 582O and a quantity 584O for each of the materials from the study portion 108. In one or more examples, reconciliation limits may be configured for each of the input materials (e.g., drug, non-drug, and label). For example, a production user may select the reconciliation limits from a drop-down list of reconciliation units.

[0164] 5P illustrates an example bill of materials (output materials-input materials) page 520P (output materials-input materials) from a study batch record UI. In one or more examples, the bill of materials (output materials-input materials) page 520P can include multiple navigation user affordances 522, multiple operation user affordances 524, and a bill of materials (output materials-input materials) information display area 526P. The bill of materials (output materials-input materials) information display area 526P may include information related to approval status, version number, bill of materials identifier, hold reason, versioning reason, URL, output material information (e.g., item identifier, one or more material descriptions, stock number, label, substitute material, and quantity), drug input material information (e.g., item identifier, one or more material descriptions, stock number, label, substitute material, and quantity), non-drug input material information (e.g., item identifier, one or more material descriptions, stock number, label, substitute material, and quantity), and label input material information (e.g., item identifier, one or more material descriptions, stock number, label, substitute material, and quantity).

[0165] 5Q illustrates an example bill of materials (common materials) page 520Q from a study batch record UI. In one or more examples, the bill of materials (common materials) page 520Q can include a number of navigation user affordances 522, a number of operation user affordances 524, and a bill of materials (common materials) information display area 526Q. The bill of materials (common materials) information display area 526Q can include information related to approval status, version number, bill of materials identifier, hold reason, versioning reason, URL, common drug material information (e.g., item identifier, one or more material descriptions, stock number, label country group, output material group, dosage code), common non-drug input material information (e.g., item identifier, one or more material descriptions, stock number, label, substitute material, and quantity), and common label input material information (e.g., item identifier, one or more material descriptions, stock number, label, substitute material, and quantity).

[0166] In one or more examples, the system can obtain information related to the bill of materials from the third party software. For example, the system can be integrated with third party software that can provide item identifiers associated with inventory maintained by the third party software (e.g., JD Edwards). In one or more examples, the production user can select one or more item identifiers based on the integration with the third party software. FIG. 5R illustrates an example portion of a research batch record page 520R according to an embodiment of the present disclosure. As shown, the system includes a number of operation user affordances, including an item ID acquisition user affordance 584R. After receiving a selection of the user affordance 584R, the system can present a pop-up window to the user. FIG. 5S illustrates an example pop-up window according to an embodiment of the present disclosure. The pop-up window 530S can include an inventory associated with and / or maintained by the third party software, including a list of item identifiers (and corresponding descriptions) that can be assigned to input and / or output materials in the research batch record. In one or more examples, the user can select one or more of the list items and update the research batch record accordingly.

[0167] In one or more examples, the example pack may be included in a bill of material. FIG. 5T illustrates an example example pack window 530T. The example pack window 520T may be configured to obtain information about the example pack from a production user. The information may include general information about the example pack (e.g., material description, bill of material quantity, UoM information, bill of material information, customer material identifier), and customer inventory information (e.g., item identifier, one or more item descriptions, and third party software information). In one or more examples, the bill of material quantity may be automatically set to 1.

[0168] At block 512, the system may receive approval of the bill of material from one or more production approvers. In one or more examples, the system may not allow approval of the bill of material to be accessed without receiving the completed bill of material. In one or more examples, the process associated with block 512 may be similar to block 508.

[0169] For example, the system can receive an indication that the user has navigated to a bill of materials page, e.g., 520P associated with a study batch UI. FIG. 5U illustrates an example portion of the bill of materials page 520P including an approval user affordance 578U. In one or more examples, the system can receive an indication that the user has selected an approval user affordance 578U from the operation user affordances 524. After receiving a selection of the approval user affordance 578U, the system can present an approval report 572V. The approval report can include information associated with the bill of materials information display area, e.g., output materials-input materials display area 526P, common materials information display area 526Q.

[0170] After the production user is ready to sign the approval report 572V, for example after the user has reviewed and verified the information in the approval report 572V, the system can receive an indication that the user has selected the sign button 576V. After receiving input corresponding to the selection of the sign button, the system can cause the sign window 574W to be displayed. In one or more examples, the sign window can be displayed over the approval report 572V. The sign window 574W can include one or more user affordances for receiving the user's credentials. For example, the sign window 574W can include text boxes for the production user to enter a userID and a corresponding password. The system can then receive an indication of whether the user accepts or rejects the approval.

[0171] In one or more examples, after a bill of material is approved, the system may not allow changes to be made to the approved version of the bill of material (e.g., bill of material 112). If a production user wants to make changes to the bill of material 112, the user may create a new version of the bill of material 112. The system may create the new version of the bill of material 112 by receiving a selection by the production user of a new version button from operation user affordance 524. Changes to the new version of the bill of material 112 may be made according to the description provided above, for example, with respect to process 558.

[0172] In one or more examples, the system can present a related study part page. FIG. 5X shows an example related study part page 520X from a study batch record UI configured to show a list of study parts associated with the same study information. In one or more examples, the related study part page 520X can include multiple navigation user affordances 522, multiple operation user affordances 524, and a related study part information display area 526X. The related study part information display area 526X can include a list and / or links to study parts associated with the same study information, e.g., study information 104.

[0173] In one or more examples, the system can present a related study component page. FIG. 5Y shows an example related study component page 520Y from a study batch record UI, configured to show related study components (e.g., study instructions, bill of materials, and study batch records) associated with the same study information. In one or more examples, the related study component page 520Y can include multiple navigation user affordances 522, multiple operation user affordances 524, and a related study component information display area 526Y. The related study component information display area 526Y can include a list of related study components, e.g., study instructions, bill of materials, and related batch records.

[0174] Creating Instructions FIG. 6A illustrates a process 600A for creating packaging instructions according to one or more embodiments of the present disclosure. At block 602, the system can receive instructions to create a set of instructions corresponding to output materials. The instructions can correspond to packaging instructions for the output materials. For example, the system can receive instructions to navigate to an instruction page 220H corresponding to a packaging instruction 128 from the master data 102. For example, a user can select an "Instructions" label from a navigation menu 662. FIG. 6B illustrates an example portion of a packaging instructions page 620B according to an embodiment of the present disclosure. As shown, the system includes a number of operation user affordances 624, including a NEW INSTRUCTION user affordance 664B. After receiving a selection of the NEW INSTRUCTION user affordance 664B, the system can present a NEW INSTRUCTION window to the user. FIG. 6C illustrates an example NEW INSTRUCTION window 630C according to an embodiment of the present disclosure. The new instructions window 630C can include text entry boxes, drop-down menus, and the like. In one or more embodiments, the instructions window 630C can be configured to capture packaging instruction text, language, validity status, version number, execution result, instruction type, and instruction category.

[0175] At block 604, the system may receive an instruction to translate the instructions. For example, the system may navigate to a language tab that corresponds to an available language for the instructions. In one or more examples, the available languages ​​may be based on one or more packaging sites associated with the customer. FIG. 6D illustrates an example portion of an instruction page 620D. As shown, after receiving a selection of a desired language tab from a production user, the system may present a new translation user affordance 662D. After receiving a selection of the new translation user affordance 662D, the system may present a new translation window 630E. The new translation window 630E may include multiple user affordances for generating a translation, including text formatting affordances, execution result affordances, active instruction user affordances, inactive instruction user affordances, and instruction details (e.g., language, instruction type, and instruction category). After the fields are completed, the system may generate a translation of the instructions.

[0176] In one or more examples, when an instruction is marked as valid, the instruction may be used in an instruction set and a research instruction. No changes may be made to a valid instruction. To make changes to a valid instruction, a new version of the instruction must be created. In one or more examples, the new version may be based on the valid instruction. Thus, to update the valid instruction, the system may receive an indication that a new version of the instruction should be created, as shown in FIG. 6F.

[0177] As shown in Figure 6G, the system can then receive an indication of whether the meaning of the instructions has changed. As shown in Figure 6H, the system can then receive an indication of whether the instructions are valid. As shown in Figure 6I, in one or more examples, a user can manually update the translation based on the English instructions when a new version of the English instructions is created.

[0178] In one or more examples, the system may also update the valid translation of the packaging instructions. In such an example, as shown in FIG. 6J, the system may receive an indication that a new version of the translation of the packaging instructions should be created. As shown in FIG. 6K, the system may receive an indication of whether the meaning of the instructions has changed. As shown in FIG. 6L, the system may then receive an indication that the translation should be edited. As shown in FIG. 6M, the system may receive an indication of whether the instructions are valid.

[0179] English instructions may also be made inactive, which may restrict a user from adding instructions 110 to a study batch record 108. When a user changes an active instruction back to an active state, the system may update all associated translations to an active state. Instructions that are not used within an instruction set 130 or study instructions 110 may be deleted.

[0180] In one or more examples, the instruction created in block 602 may be edited. FIG. 6N illustrates an example portion of a study instruction (packaging instruction) page 620N showing an edit instruction user affordance 646N. After receiving a selection of the edit instruction user affordance 646N, the system may present an edit instruction window. FIG. 6O illustrates an example EDIT STUDY INSTRUCTION window 630O. The edit instruction window 630O may be similar to the new instruction window 630C and may be updated as described above with respect to the new instruction window 630C.

[0181] Lot Allocation In one or more examples, the lot allocation can be used to associate a batch record with a particular packaging site and quantity of output material. For example, a study batch record 108, e.g., a bill of materials 112, may indicate output materials, e.g., 60-count bottles containing 60 tablets, while a lot allocation would specify that 100 of these bottles should be included in a particular batch at a particular packaging site. In one or more examples, the production facilitator UI can present a list of approved bills of materials (e.g., each bill of materials corresponding to a respective study part) to a production user. The production facilitator UI can then receive instructions from the production user that one or more of the bills of materials should be included in the lot allocation and the site where the output materials should be packaged. In this manner, the system can determine the output materials to be produced and the quantities of these materials, as well as where the output materials should be produced.

[0182] 7A illustrates a process 764 for obtaining lot allocation 114 according to one or more embodiments of the present disclosure. In one or more embodiments, process 764 may correspond to block 164 described above with respect to processes 150 and 160. Process 764 may be performed, for example, using one or more electronic devices implementing a software platform. In some examples, process 764 is performed using a client-server system, with the blocks of process 764 being divided in any manner between a server and client devices. In other examples, the blocks of process 764 are divided between a server and multiple client devices. In other examples, process 764 is performed using only one client device or only multiple client devices. In process 764, some blocks are optionally combined, the order of some blocks is optionally changed, and some blocks are optionally omitted. In some examples, additional steps may be performed in combination with process 764. Accordingly, the operations as illustrated (and described in more detail below) are exemplary in nature and, as such, should not be considered as limiting.

[0183] At block 702, the system may receive instructions to create a lot allocation 114 associated with the study information 102. For example, a production facilitator UI may receive instructions to create a lot allocation record from the study information UI. FIG. 7B illustrates a portion of a study information page 720B that includes multiple operation affordances 724, including a "Create Lot Allocation" user affordance 742B. In one or more examples, the "Create Lot Allocation" user affordance 742B may become visible after approval of the bill of materials and packaging instructions.

[0184] After receiving a selection of the create lot allocation user affordance 742B, the system may display create lot allocation windows 730C, 730D, 730E, as shown in FIGS. 7C-7E. The create lot allocation windows 730C-730E may include a number of user affordances for obtaining details regarding the lot allocation from the production user. As shown, the user affordances may include text entry boxes, drop-down menus, checkboxes, and the like. In one or more examples, the lot allocation window 730C may include user affordances for obtaining information regarding the lot allocation name, lot allocation notes, study part type (e.g., primary, secondary), and packaging site location. In one or more examples, the lot allocation window 730D may include a user affordance for selecting a previously approved bill of material (e.g., corresponding to one or more bills of material approved via process 658). In one or more examples, the lot allocation window 730E may include a user affordance for output materials associated with the packaging site selected in the lot allocation window 730C.

[0185] At block 704, the system can create a lot allocation record corresponding to the study information. FIG. 7F illustrates an example lot allocation details page 720F corresponding to a lot allocation UI created based on completion of lot allocation creation windows 730C-730E. The lot allocation details page can be presented via a production facilitator UI and configured to display information associated with the lot allocation record. As shown, the lot allocation details page 720F can include a number of navigation user affordances 722, a number of operation user affordances 724, and a lot allocation detailed information display area 726F. In one or more examples, the lot allocation detailed information display area 726F can correspond to an area of ​​the lot allocation UI that displays information about the lot allocation. As shown, the lot allocation detailed information display area 726F can display information including, but not limited to, lot allocation name, lot allocation notes, packaging type, lot allocation site location, protocol number, related study information number, lot allocation description, approval status, active / inactive status, and version number.

[0186] In one or more examples, the study portion navigation user affordances 722 can include multiple user affordances, with each user affordance corresponding to a tab associated with study information. As shown, the study portion navigation user affordances 722 can include a lot allocation details tab, an output and input materials tab, a common materials tab, and a relationship batch records tab. The examples of navigation user affordances 722 are merely illustrative, and more or less navigation user affordances may be used without departing from the scope of the present disclosure.

[0187] In one or more examples, the plurality of operational user affordances 724 may include a plurality of buttons, each corresponding to a different action that may be implemented by the user. As shown, the operational user affordances 724 may include, but are not limited to, an approve button, a new version button, an edit button, a hold button, a history button, and the like. In one or more examples, depending on the status of different items associated with the study portion 106, one or more of the operational user affordances 724 may be inactive and / or one or more of the operational user affordances may be removed or made visible. The operational user affordances may have functionality similar to that described above.

[0188] In one or more examples, after the lot allocation 114 is created, the system can receive confirmation of the develop to order (ETO) number and ETO description. FIG. 7G illustrates an example lot allocation details page 720G, according to an embodiment of the present disclosure. The lot allocation details page 720G may correspond to a draft lot allocation. In one or more examples, the system can receive an indication that a user has selected the edit ETO number user affordance 742G. After receiving a selection of the edit ETO number user affordance 742G, the system can receive an input of an ETO number from the user. The system can then access information regarding the ETO and apply the ETO information to the lot allocation.

[0189] Once the lot allocation record is created and in draft status, the production user can update the common materials, output materials, and input materials. In one or more examples, the common materials, output materials, and input materials can be auto-populated based on information associated with the bill of material 112 approved in process 558 and / or block 158. Referring again to FIG. 7A, in block 706, the system can present the common materials, input materials, and / or output materials for review. For example, the user can navigate to a common materials page or an output and input materials page using corresponding navigation user affordances 722.

[0190] 7H illustrates an exemplary output and input material page 720H, in accordance with an embodiment of the present disclosure. In one or more examples, the output and input material page 720H ​​can include multiple output materials. The output and input material page 720H ​​can correspond to an approved output and input material page 720H. As shown, the output and input material page 720H ​​can include a navigation user affordance 722, an operation user affordance 724, and an output and input material information display area 726H. In one or more examples, the output and input material information display area 726H can include, but is not limited to, a number of user affordances, information about an output material (e.g., item identifier, one or more item descriptions, UoM, label country group, OM group, label lot number, and expiration date), drug input material (e.g., item identifier, one or more item descriptions, UoM, label status, alternate material, bill of material quantity, lot quantity, supplier lot number, expiration date, and batch record status), non-drug input material (e.g., item identifier, one or more item descriptions, UoM, label status, alternate material, bill of material quantity, lot quantity, supplier lot number, expiration date, and batch record status), label input material (e.g., item identifier, one or more item descriptions, UoM, label status, barcode type, bill of material quantity, lot quantity, supplier lot number, expiration date, and batch record status), and example pack material (e.g., item identifier, one or more item descriptions, UoM, label status, alternate material, bill of material quantity, lot quantity, supplier lot number, expiration date, and batch record status). In one or more examples, information regarding output and input materials may be auto-populated based on corresponding study batch records.

[0191] 7I illustrates an example process 708I for obtaining additional output material information according to an embodiment of the present disclosure. In one or more examples, process 708I may correspond to block 708 of process 764. Although process 708I is described with respect to output materials, a similar process may be applied to obtaining additional information regarding input materials (drug, non-drug, label), example pack materials, and common materials.

[0192] At block 782, a user may receive a selection of output materials for a packaging site. In one or more examples, the system may receive a selection by a user to edit the output materials shown on the output and input materials page. FIG. 7J illustrates an example output and input materials page 720J, according to an embodiment of the present disclosure. The output and input materials page 720J may be associated with a draft lot allocation, but may otherwise be substantially similar to the output and input materials page 720H. As shown in the figure, a user may select one or more user affordances 724 to update the output materials. For example, the user affordances 724 may be used to edit (user affordance 742J), preview (user affordance 744J), and consider relationships (user affordance 746J) for the output materials. In one or more examples, the system may receive a selection by a user to edit the output materials via the user affordances 742J. The edit user affordance 742J may be used to edit information associated with an output material, and the preview user affordance 744J may be used to view the lot allocation record of an output material without being able to update the record. The relationship user affordance 746J may be used to display output materials associated with an output material group and common materials linked to that output material.

[0193] After receiving a selection of user affordance 742J, the system may display an EDIT OUTPUT MATERIAL window 730K, as shown in FIG. 7K. The EDIT OUTPUT MATERIAL window 730K may include multiple input user affordances for the production user to input details regarding the lot allocation record for the output material. As shown, the user affordances may include text entry boxes, drop down menus, and the like. In one or more examples, the system may obtain additional information related to the quantity produced, supplier lot number, labeled lot number, expiration date, labeled expiration date, customer lot number, and sample status. In one or more examples, the system may not allow the production user to edit information imported from the research batch record.

[0194] In one or more examples, additional information (e.g., quantity to be produced, supplier lot number, labeled lot number, expiration date, labeled expiration date, customer lot number, and sample status) may be auto-populated based on inventory records associated with the packaging site corresponding to the lot allocation record. At block 784, the system may access the inventory of each packaging site. For example, the system may access the inventory of each packaging site via integration with third party software and / or servers that maintain the inventory of each packaging site. In one or more examples, the inventory information may include information regarding output materials, input materials (drug and non-drug) associated with the packaging site, and corresponding supplier lot numbers, supplier lot sizes, and supplier lot expiration dates. In one or more examples, a production user may view and enter one or more of the quantity to be produced, supplier lot number, labeled lot number, expiration date, labeled expiration date, customer lot number, and sample status based in part on the inventory of the packaging site.

[0195] In one or more examples, at block 786, the system can automatically assign at least a supplier lot number, a labeled lot number, an expiration date, a labeled expiration date, and a customer lot number based on the accessed inventory at the packaging site. For example, the system can automatically assign a supplier lot number to the input material based on the total quantity of the input material and one or more of the corresponding supplier lot size and / or supplier lot expiration date. In this manner, the system can ensure that there is sufficient inventory at a particular site to package the output material associated with the batch record before the batch record is sent to the packaging site.

[0196] In one or more examples, the system may prioritize the supplier lot having the smallest lot size with the earliest expiration date. For example, if the output quantity indicates that 100 60-count bottles containing 60 tablets are to be packaged at a packaging site, the system may access the packaging site's inventory. Continuing with this example, the packaging site may have five supplier lots corresponding to this output material. According to this example embodiment, the system may determine the respective supplier lot size and expiration date for each of the supplier lots and assign the supplier lot with the smallest lot size and earliest expiration date in the most efficient manner to fulfill the output material of 100 60-count bottles.

[0197] In this manner, the system can reduce waste and the amount of manual human effort at the packaging site. For example, typically, a packaging site worker would be responsible for reviewing a research batch order and manually checking and comparing the quantities of input materials against the inventory available at the packaging site. Not only does this require significant time and effort, but there is no guarantee that the packaging site will have the inventory necessary to fulfill the conditions of the research batch record. Thus, embodiments of the present disclosure improve upon the state of the art by ensuring that sufficient inventory is available before sending a research batch record to the packaging site, reducing waste by allocating supplier lots with earlier expiration dates to be used first, and reducing the amount of manual effort associated with checking inventory.

[0198] Although process 708I is described with respect to output materials, a similar process may be applied to input materials (drug, non-drug, labels, exemplary packs), and common materials.

[0199] For example, referring to the output and input materials page 720J, the system may receive an indication that a production user has selected an edit user affordance 752J corresponding to an input (drug) material. After receiving a selection of the user affordance 752J, the system may display an edit input (drug) material window 730L, as shown in FIG. 7L. The edit input (drug) material window 730L may include a number of input user affordances for a user to enter details regarding the lot allocation record for the input (drug) material. As shown, the user affordances may include text entry boxes, drop-down menus, and the like. In one or more examples, the system may obtain additional information related to a supplier lot number, lot quantity, expiration date, and customer lot number. In one or more examples, the system may not allow a user to edit information imported from a study batch record. In one or more examples, the lot quantity may be automatically calculated based on the amount entered for the corresponding output material.

[0200] Referring to the output and input materials page 720J, the system can receive inventory information related to the input (drug) materials. For example, a production user can select a supplier lot user affordance 756J to access inventory records associated with a packaging site. For example, the system can access the inventory of each packaging site through integration with third party software and / or servers that maintain inventory for each packaging site. In one or more examples, the inventory information can include information regarding a supplier lot number, supplier lot size, supplier lot status (hold, conditionally released, WIP, quarantined, expired, released), and supplier lot expiration date associated with the packaging site. As discussed above, in one or more examples, the system can automatically assign supplier lot numbers based on the inventory information.

[0201] In one or more examples, the system can receive an indication of whether to use a listed input (drug) material or to use an alternate material. For example, the system can receive an indication that a user selected a material selection user affordance 758J to determine whether the corresponding input (drug) material should be included or whether an alternate material (e.g., one of the alternate materials specified in the study batch record) should be used in the batch record. For example, if a single input (drug) material record exists under an output material, the lot allocation record indicates that the input material drug is used in the batch record. However, if there are two input (drug) materials, e.g., a primary material and an alternate material, the system can receive a selection from a production user determining which of the two materials should be used in the batch record. In one or more examples, if the primary material is selected, the alternate material is automatically deselected, as shown in FIG. 7M.

[0202] FIG. 7N illustrates an example of an INPUT MATERIAL (NON-DRUG) EDIT window 730N. In one or more examples, after receiving a selection of a user affordance 762J from the OUTPUT AND INPUT MATERIALS page 730J, the system may display the INPUT MATERIAL EDIT window 730N as shown in FIG. 7N. The INPUT MATERIAL EDIT window 730N may include a number of input user affordances for a production user to input details regarding the lot allocation record for the INPUT (NON-DRUG) material. The process for updating and editing information associated with the INPUT (NON-DRUG) material may be substantially similar to that described above with respect to the INPUT (DRUG) material.

[0203] FIG. 7O illustrates an example INPUT MATERIAL (LABEL) window 730O. In one or more examples, the lot quantity field for the label in the lot allocation record is automatically calculated based on the quantity produced from the output material multiplied by the bill of material quantity from the input material label. In one or more examples, there may be multiple label records for the same output material record in the lot allocation record, e.g., primary and alternate materials. In one or more examples, the user may select which label is applied to the batch record in the manner described above with respect to FIG. 7M. In one or more examples, information from the study batch record related to the input (label) material record may not be updated.

[0204] 7P illustrates an EXAMPLE PACK material edit window 730P. In one or more examples, the process for updating and editing information associated with an EXAMPLE PACK record may be substantially similar to that described above with respect to the input (drug material). For example, the system may receive additional information associated with lot quantity, supplier lot, supplier lot number, expiration date, and customer lot number. In one or more examples, the system may access inventory associated with the packaging site to determine the additional information.

[0205] 7Q illustrates an example common materials page 720Q, in accordance with an embodiment of the present disclosure. In one or more examples, the common materials page 720Q can include multiple common materials. As shown, the common materials page 720Q can include a navigation user affordance 722, an operation user affordance 724, as well as a common materials information display area 726Q. In one or more examples, the common material information display area 726Q can include, but is not limited to, multiple user affordances, information regarding drug input materials (e.g., item identifier, one or more item descriptions, UoM, label status, alternate materials, bill of material quantity, lot quantity, supplier lot number, expiration date, and batch record status), non-drug input materials (e.g., item identifier, one or more item descriptions, UoM, label status, alternate materials, bill of material quantity, lot quantity, supplier lot number, expiration date, and batch record status), label input materials (e.g., item identifier, one or more item descriptions, UoM, label status, barcode type, bill of material quantity, lot quantity, supplier lot number, expiration date, and batch record status), and example pack materials (e.g., item identifier, one or more item descriptions, UoM, label status, alternate materials, bill of material quantity, lot quantity, supplier lot number, expiration date, and batch record status).

[0206] In block 710 of Figure 7A, the system may obtain additional information related to the common material for the lot allocation. In one or more examples, the additional information associated with the common material may be updated as described above with respect to block 708, process 708I, and / or Figures 7I-7P.

[0207] At block 712, the system may receive approval of the study information from one or more production approvers. In one or more examples, the system may not allow the lot allocation record approval to be accessed without receiving completed information regarding quantity and supplier lot information (e.g., lot quantity, supplier lot number, supplier lot, expiration date, customer lot number). In one or more examples, the process associated with block 712 may be similar to the approval process described above.

[0208] 7R illustrates an example portion of a lot allocation UI 720R including an approval user affordance 778R. In one or more examples, the system can receive an indication that a production user has selected the approval user affordance 778R from the operations user affordances. After receiving a selection of the approval user affordance 778R, the system can present an approval report 772S. The approval report can include information associated with one or more of the lot allocation UI information display areas, such as the output and input material display area 726Q, the common material information display area 726Q, the relationship batch record information display area 726U, and the bill of material information display area 726V.

[0209] After the user is ready to sign the approval report 772S at any time, for example after the user has reviewed and verified the information in the approval report 772S, the system can receive an indication that the user has selected the sign button 776S. After receiving input corresponding to the selection of the sign button 776S, the system can cause the sign window 774T to be displayed. In one or more examples, the sign window 774T can be displayed overlaid on the approval report 772S. The sign window 774T can include one or more user affordances for receiving the production user's credentials. For example, the sign window 774T can include text boxes for the production user to enter a userID and a corresponding password. The system can then receive an indication of whether the production user accepts or rejects the approval.

[0210] In one or more examples, after a lot allocation record is approved, the system may not allow changes to be made to the approved version of the lot allocation record. If a production user wants to make changes to the lot allocation, the production user may create a new version of the lot allocation. The system may create the new version of the lot allocation by receiving a user selection of a new version button from operation user affordance 724. Changes to the new version of the lot allocation may be made according to the description provided above, for example, with respect to process 764.

[0211] The lot allocation UI can further present a list of related batch records. FIG. 7U illustrates an example related batch record (XBR) page 720U associated with the lot allocation UI. In one or more examples, the related XBR page 720U can include a number of navigation user affordances 724, a number of operation user affordances 724, and a related batch record information display area 726U. The related batch record information display area 726U can include a list of existing batch records that are automatically created for each bill of material after receiving approval for the lot allocation.

[0212] The lot allocation UI can further present a list of related bills of materials. FIG. 7V illustrates an example bill of materials page 720V associated with the lot allocation UI. In one or more examples, the bill of materials page 720V can include a number of navigation user affordances 722, a number of operation user affordances 724, and a bill of materials information display area 726V. The bill of materials information display area 726V can include a list of bills of materials associated with the study batch record on which the lot allocation is based.

[0213] Batch Recording In one or more examples, the ready batch record may correspond to the packaging and control information obtained in blocks 152-164. In one or more examples, the ready batch record may refer to a batch record that has been approved by a customer approver. In one or more examples, the batch record may be associated with a corresponding study batch record. In one or more examples, study instructions and equipment groups specific to the packaging site associated with the batch record may be imported from the study batch record. In one or more examples, the imported information may not be editable at the batch record stage, e.g., via the batch record UI. In one or more examples, a user may be able to add and / or edit new equipment groups, drug list identification, sample details, and sequence ranges. In one or more examples, the approved ready batch record may be accessed by an operator at the packaging site to package a batch of output material based on the packaging instructions, bill of materials, and lot allocations, as described above.

[0214] 8A illustrates a process 866 for approving batch records, according to one or more embodiments of the present disclosure. In one or more embodiments, the process 866 may correspond to block 166 described above with respect to processes 150 and 160. The process 866 may be performed, for example, using one or more electronic devices implementing a software platform. In some examples, the process 866 is performed using a client-server system, with the blocks of the process 866 being divided in any manner between a server and a client device. In other examples, the blocks of the process 866 are divided between a server and multiple client devices. In other examples, the process 866 is performed using only one client device or only multiple client devices. In the process 866, some blocks are optionally combined, the order of some blocks is optionally changed, and some blocks are optionally omitted. In some examples, additional steps may be performed in combination with the process 866. Thus, the operations as illustrated (and described in more detail below) are exemplary in nature, and as such should not be considered limiting.

[0215] In block 802, the system may create a batch record upon receiving approval of the lot allocation. For example, as described above, the system may automatically create a batch record after receiving approval of the lot allocation (e.g., as described with respect to block 712).

[0216] 8B-1, 8B-2, and 8B-3 illustrate an example batch record detail page 820B associated with a batch record UI, according to an embodiment of the present disclosure. As shown, the batch record detail page 820B can include a number of navigation user affordances 822, a number of operation user affordances 824, and a batch record detailed information display area 826B. In one or more examples, the batch record detailed information display area 826B can correspond to an area of ​​the batch record UI that displays information about the batch record. As shown, the batch record detailed information display area 826B can display information including, but not limited to, a batch record name, a customer number, a project number, a customer protocol, whether the material includes blinding information, a status, a hold reason, one or more batch record notes, an associated lot allocation header, a lot allocation identifier, a name of the lot allocation site, a room processing temperature, a room processing humidity, a room processing lighting condition, a drug identifier list, created from a PS / PADI instruction, created from a packaging request instruction, range values, and / or system information. In one or more examples, a user may be able to update one or more fields associated with the batch record detailed information display area 826B. For example, a user may be able to update the medication identifier list, the created from PS / PADI display, the created from packaging request instruction, and the range values.

[0217] In one or more examples, the batch record UI navigation user affordances 822 can include multiple user affordances, with each user affordance corresponding to a tab and corresponding page associated with the batch record UI. As shown, the batch record navigation user affordances 822 can include a batch record details tab, an equipment groups and instructions tab, a bill of materials tab, a deviations and controls tab, and a work order tab. The examples of navigation user affordances 822 are merely illustrative, and more or less navigation user affordances may be used without departing from the scope of the present disclosure. A user can navigate between the respective pages associated with the tabs by selecting the corresponding user affordance.

[0218] In one or more examples, the operational user affordances 824 may include a number of buttons, each corresponding to a different action that may be implemented by a user. As shown, the operational user affordances 824 may include, but are not limited to, an approve button, an open drawing button, a hold button, a batch record cancel button, a history button, and the like. In one or more examples, depending on the status of different items associated with the batch record 116, one or more of the operational user affordances 824 may be inactive and / or one or more of the operational user affordances may be removed or made visible. The functionality associated with the operational user affordances may be similar to those described above. In one or more examples, a batch record cancel button may be used to void an approved batch record. In one or more examples, an open drawing button may be used to open one or more drawings associated with the batch record.

[0219] 8A, at block 804, the system can receive instructions to add one or more equipment groups to the batch record. Adding an equipment group to the batch record can associate the equipment group with the batch record such that when an approved, actionable batch record is accessed by an operator at a packaging site, the operator can see what equipment will be needed to package the batch of output material. In one or more examples, the system can receive the one or more equipment groups via an equipment groups and packaging instructions page.

[0220] 8C-1 and 8C-2 illustrate an exemplary equipment group and packaging instructions page 820C associated with a batch record UI. The equipment group and packaging instructions page 820C may include multiple navigation user affordances 822, multiple operation user affordances 824, and an equipment group and packaging instructions information display area 826C. In one or more examples, the equipment group and packaging instructions information display area 826C may correspond to an area of ​​the batch record UI that displays information about equipment groups and packaging instructions. As shown, the output and input material information display area 826C may be similar to the respective information display areas associated with the Instructions and Equipment (Lab Instructions-Packaging Instructions) page 520E and the Instructions and Equipment (Equipment Group) page 520L. In one or more examples, the user may navigate to a page within the Equipment Group and Packaging Instructions page, which may be substantially similar to the Instructions and Equipment (Study Instructions - Processing Checks) page 520F and the Instructions and Equipment (Study Instructions - Important Notes) page 520G, as described above.

[0221] Figure 8D illustrates how a user can add equipment groups to a batch record. Figure 8D illustrates a portion of an equipment group and packaging instructions page 820D that can receive instructions for additional equipment groups to be added to the batch record. As shown, the system can receive new equipment groups via drop down menus and / or text entry for equipment details.

[0222] At block 806, the system can receive instructions to add a deviation or change control. The deviation and / or change control can include the reason for deviating from the packaging instructions and what steps should be taken. This can provide an operator at the packaging site with an explanation as to why it is necessary to deviate from the packaging instructions and how to do so. For example, a deviation can occur when a bottle seal is discovered to be defective. The deviation included in the batch record can provide an explanation as to why the operator should debottle the batch.

[0223] 8E illustrates an example deviation and change management page 820E associated with a batch record UI. The deviation and change management page 820E can include a number of navigation user affordances 822, a number of operation user affordances 824, and a deviation and change management information display area 826E. In one or more examples, the deviation and change management information display area 826E can include a list of deviations and change management for the batch record.

[0224] FIG. 8F illustrates a portion of an example deviation and change management page 820F associated with a batch record UI. When a user selects a new deviation user affordance 842F, the system can receive an instruction to add a deviation or change management. After receiving a selection of the new deviation user affordance 842F, the system can navigate to a new deviation and change management window 830G, as shown in FIG. 8G. The new deviation and change management window 830G can include a number of input user affordances for a user to input details regarding the deviation and / or change management. As shown, the user affordances can include text entry boxes, drop-down menus, and the like. In one or more examples, the deviation and / or change management details can include, but are not limited to, a record number, a short description, a related batch record, and a type.

[0225] In block 808, the system may present the bill of materials to the user. For example, the system may navigate to a bill of materials page associated with the batch record UI. In one or more examples, the user may review the bill of materials before approving the batch record.

[0226] 8H illustrates an example bill of materials page 820H. The bill of materials page 820H can include a number of navigation user affordances 822, a number of operation user affordances 824, and a bill of materials information display area 826H. In one or more examples, the deviation and bill of materials information display area 826H can include output materials and corresponding input materials associated with the batch record.

[0227] In block 810, the system may receive approval of the batch record from one or more production users, such as a production approver. In one or more examples, the process associated with block 810 may be similar to the approval process described above for approval by a production user.

[0228] 8I illustrates an example portion of a batch record UI 820I including an approval user affordance 878I. In one or more examples, the system can receive an indication that a user has selected the approval user affordance 878I from the operations user affordances. After receiving a selection of the approval user affordance 878I, the system can present an approval report 872J. The approval report can include information associated with one or more of the batch record UI information display areas, e.g., bill of materials information display area 826H, equipment group and instruction information display area 826C, deviation and change management information display area 826E.

[0229] After the production user is ready to sign the approval report 872J, for example after the production user has reviewed and verified the information in the approval report 872J, the system can receive an indication that the production user has selected the sign button 876J. After receiving an input corresponding to the sign button, the system can cause a sign window 874K to be displayed, as shown in FIG. 8K. In one or more examples, the sign window can be displayed overlaid on the approval report 872J. The sign window 874K can include one or more user affordances for receiving the production user's credentials. For example, the sign window 874K can include text boxes for the production user to enter a userID and a corresponding password. The system can then receive an indication of whether the production user accepts or rejects the approval.

[0230] At block 812, the system may receive an instruction to create a new work order. In one or more examples, after the batch record is approved, a new navigation user affordance 822, (e.g., a "Work Order" navigation user affordance) may become visible in the batch record UI. In one or more examples, if the work order has a status of "Work Order Created," a production user can manually mark the work order's status as completed.

[0231] FIG. 8L illustrates an example work order page 820L associated with a batch record UI. The work order page 820L may include multiple navigation user affordances 822, multiple operation user affordances 824, and a work order information display area 826L. In one or more examples, the work order information display area 826L may correspond to an area of ​​the batch record UI that displays information about the work order, including, but not limited to, an item identifier, a work order number, a work order status, a supplier lot number, one or more expiration dates, a quantity to be manufactured, a sample quantity, a quantity to produce, a UoM, a work order status, and information associated with the input (drug) materials (e.g., customer lot, supplier lot, customer lot status, one or more expiration dates, a UoM, and a customer committed quantity), as well as information associated with the input (non-drug) materials (e.g., customer lot, supplier lot, customer lot status, one or more expiration dates, a UoM, and a customer committed quantity). In one or more examples, a user can manually update the status of the work order using the WO status field 842L.

[0232] In one or more examples, after all work orders associated with the lot allocation are completed and / or approved by a customer approver, the status of the batch record may change to "ready to produce." Once the ready batch record is associated with a "ready to produce" status, the ready batch record, e.g., the ready batch record report, may be accessed and displayed by clicking on the "XBR Report" user affordance 842M, as shown in FIG. 8M. In one or more examples, the ready batch record report may be printed and used by a packaging site operator to package the output material described in the ready batch record. FIG. 8N illustrates an example page of a ready batch record report according to an embodiment of the present disclosure.

[0233] Customer User Interface A customer user interface, e.g., customer UI 180, provides a portal or user interface through which a customer and / or individuals associated with a customer can review study components (e.g., bills of materials, study instructions, lot allocations, and batch records) associated with one or more studies. FIG. 9A illustrates an exemplary customer UI home page 980A. The customer UI home page 980A may be specific to a particular customer user. For example, the customer UI home page 980A may be presented to customer user A after logging into the system. The pending approvals displayed for customer user A may be based on the information entered in block 154 of the designated customer study approver. Thus, customer user B may have a different customer UI home page corresponding to the pending approvals for customer user B.

[0234] As shown, the customer UI home page 980A may include a navigation bar 922 and a list of pending approvals 926A. If there are no pending approvals associated with the customer user, the list of pending approvals 926A may be hidden and / or empty. As shown, the navigation bar 922 may include multiple user affordances for the customer user to navigate between different pages. As shown, the navigation bar includes a home tab, a bill of materials tab, a study instructions tab, a lot allocations tab, and a batch records tab. The system may navigate to a page corresponding to the tab selected by the customer user. Each of the corresponding pages may include a list of items associated with the respective study component. For example, the bill of materials page may include a list of bills of materials associated with the customer user that are pending or have been approved. The study instructions page may include a list of study instructions associated with the customer user that are pending or have been approved. The lot allocations page may include a list of lot allocations associated with the customer user that are pending or have been approved. The batch records page may include a list of batch records associated with the customer user that are pending or have been approved.

[0235] 9B illustrates an example lot allocation page 980B. The lot allocation page 980B includes a list 926B of lot allocations associated with the customer user that are pending or have been approved. In one or more examples, each list item (e.g., each lot allocation in the list) may include a link that, when selected, causes the system to present a summary of the corresponding item (e.g., display the lot allocations).

[0236] 9C illustrates an example lot allocation summary page 980C according to an embodiment of the present disclosure. In one or more examples, the lot allocation summary page 980C can include information associated with the lot allocation including, but not limited to, the version, packaging type, customer protocol, status, lot allocation name, lot allocation identifier, ETO number, and associated files including the lot allocation approval report.

[0237] The lot allocation summary page 980C may further include an approval user affordance 982C. After receiving a selection of the approval user affordance 982C, the system may present an approval window as described above with respect to approval for a production user. In one or more examples, the customer approval window may include a user affordance for the customer user to provide credentials and / or their signature as a signature. Upon receiving the customer approval, the system may update the corresponding information (e.g., lot allocation 114). This approval process may correspond to block 186 described above.

[0238] One skilled in the art will appreciate that the bill of material page, lab instruction page, and batch record page may be similar to the lot allocation page 980B and the lot allocation detail page 980C. Thus, approvals for the bill of material page, lab instruction page, and batch record page may be similar to the approval process for lot allocation.

[0239] audit In a clinical trial study, audits may be performed to evaluate clinical trial conduct and compliance with various regulatory requirements. Thus, the system is configured to generate an audit history for actions performed within the system, from the creation of study information to the approval of actionable batch records. In one or more examples, all actions completed within the system for each of the study components, e.g., master data 102, study information 104, study parts 106, study batch records 108, study instructions 110, bill of materials 112, lot allocation 114, and actionable batch records 116, as well as various approvals, may be included in the audit history. In one or more examples, the audit history may include a list of actions for each of the study components and the corresponding users who completed the actions.

[0240] In one or more examples, if a study is being audited, a production user can log onto the system and retrieve the audit history associated with the study. In one or more examples, the production user can print the audit history to send to the agency performing the audit. In one or more examples, the audit process shown and described with respect to the system may comply with current government regulations.

[0241] 10A illustrates an example lot allocation details page 1020A, according to an embodiment of the present disclosure. As shown, the lot allocation details page 1020A can include a “history” user affordance 1042A. In one or more examples, when the system receives an indication that a production user has selected the history user affordance 1042A, the system can present a corresponding audit history window 1030A that includes a list of lot allocations. Although the figure illustrates a single item, one of ordinary skill in the art will understand that one or more items can be included in the audit history window 1030A depending on the selected field 1044A.

[0242] A production user may select a link corresponding to an item in the list. For example, based on the audit history window 1030A, the system may receive an indication that a user selected the "Test LCG" lot allocation 1052A. After receiving a selection of an item in the list, for example, the "Test LCG" lot allocation 1052A, the system may present an audit history for the selected item. For example, FIG. 10B illustrates an example audit history 1020B for the "Test LCG" lot allocation. As shown, the audit history includes, but is not limited to, the action, the corresponding user, the date of the action, and information associated with the particular study component (e.g., for lot allocation, this information can include one or more of general material description, output substance type, UOM, quantity produced, bill of materials quantity, lot quantity, dosage code action, dosage code quantity action, dosage code quality, output material group, and output material dosage code, and the like. One of ordinary skill in the art will appreciate that the information associated with a particular study component (e.g., study information, study part, study batch record, study instructions, bill of materials, lot allocation, batch record) may vary based on which study component is being audited.

[0243] 10C illustrates another exemplary window that may be accessed for audit purposes. As shown, the approval flow window 1030C can include a history of the records that were included in the study component as part of the approval flow of the record (i.e., from the time the record was submitted for approval until the record received approval or rejection).

[0244] In one or more examples, the system can generate a user-specific audit report by selecting a particular user (e.g., a customer user or a production user). For example, referring to the audit history window 1030A, a particular user can be selected from the "User" user affordance 1046A. After selecting the "User" user affordance 1046A, the system can display changes to relevant study components specific to the selected user.

[0245] Blinded study The system may be configured to retain blinding information when presenting completed study components to customer users for approval. As described above, the production facilitator may indicate whether the study is blinded. In such an instance, information associated with the study may be redacted and / or unavailable to customer users that are indicated as blinded in the system. In this manner, the system may implement a blinding protocol that redacts unblinding information to ensure it is not shared with customers.

[0246] In contrast, other processes for blinding studies can rely on manual labor and be prone to error. For example, when preparing a batch record for a customer, a production facilitator may manually edit the batch record before sending it to the customer. In one or more examples, an individual associated with the production facilitator may have to replace a page of the batch record with an edited page in order to edit information associated with the kit number and sequence number listed in the batch record. Not only is this process manual, it is also not particularly secure; for example, the production facilitator may fail to send unblinding information, which would then unblind the study.

[0247] However, embodiments according to the present disclosure provide a secure process for blinding studies without relying on extensive manual effort. For example, as described above, the production user entering the study information can indicate whether the study is blinded and can specify which customer users, including customer approvers, are blinded. After the study and customer users are indicated as blinded, the system automatically redacts and / or withholds unblinding information from blinded customer users. In this manner, embodiments according to the present disclosure provide a secure method of maintaining blinded studies throughout the process of generating executable batch records.

[0248] In one or more examples, unblinding data associated with a batch record may be edited for a blinded customer user. FIG. 11A illustrates a view of a batch record report 1100A for a blinded study presented to an unblinded customer user. As shown, the batch record report 1100A displays unblinding information 1110A, including, but not limited to, kit number ranges and sequence number ranges. FIG. 11B illustrates a view of a batch record report 1100B for a blinded study presented to a blinded customer user. As shown, the batch record report 1100B has the unblinding information in area 1110B edited (e.g., not displayed). In this manner, the system can automatically edit the unblinding information for customer users who are designated as blinded.

[0249] Additionally, to the extent files uploaded to the study instructions 110, bill of materials 112, lot allocations 114, and batch records 116 contain unblinding information, these files may be unavailable for viewing by blinded customer users. Figure 11C illustrates an example file upload window 1130C according to an embodiment of the present disclosure. As shown, the file upload window 1130C can include a user affordance 1032C for indicating whether a file contains unblinding information.

[0250] After receiving an indication that the file contains unblinded information, the system can mark the file as containing unblinded information. For example, FIG. 1180D illustrates an example customer lot allocation detail page 1180D presented via customer UI 180 that includes a file that has been marked as containing unblinded information. In one or more examples, the system can deactivate the file link 1112D. In one or more examples, the file link 1112D can be active for the unblinded customer. After receiving a selection of the file link 1112D from the unblinded customer user, the system can display a warning window 1114E informing the unblinded customer user that they are about to view a document that contains unblinded information. The system can receive a selection from the unblinded customer user to open and present the file or to return to the details page without opening the file.

[0251] The operations described above with reference to the figures described above are optionally implemented by the components depicted in Figure 12. It will be apparent to one skilled in the art how other processes may be implemented based on the components depicted in Figure 12.

[0252] FIG. 12 illustrates an example of a computing device according to one embodiment. The device 1200 may be a host computer connected to a network. The device 1200 may be a client computer or a server. As shown in FIG. 12, the device 1200 may be any suitable type of microprocessor-based device, such as a personal computer, a workstation, a server, or a handheld computing device (portable electronic device) such as a phone or tablet. The device may include, for example, one or more of a processor 1210, an input device 1220, an output device 1230, a storage 1240, and a communication device 1260. The input device 1220 and the output device 1230 may generally correspond to those described above and may be connectable to or integrated with the computer.

[0253] The input device(s) 1220 may be any suitable device that provides input, such as a touch screen, a keyboard or keypad, a mouse, or a voice recognition device. The output device(s) 1230 may be any suitable device that provides output, such as a touch screen, a tactile device, or a speaker.

[0254] Storage 1240 may be any suitable device that provides storage, such as electrical, magnetic, or optical memory, including RAM, cache, a hard drive, or a removable storage disk. Communications device 1260 may include any suitable device that can transmit and receive signals over a network, such as a network interface chip or device. The components of a computer may be connected in any suitable manner, such as via a physical bus or in a wireless manner.

[0255] Software 1250, which may be stored in storage 1240 and executed by processor 1210, may include, for example, programming that embodies functionality of the present disclosure (e.g., as embodied in a device as described above).

[0256] The software 1250 may also be stored and / or transported in any non-transitory computer-readable storage medium for use by or in connection with an instruction execution system, apparatus, or device, such as those described above, that can fetch instructions associated with the software from the instruction execution system, apparatus, or device and execute those instructions. In the context of the present disclosure, a computer-readable storage medium may be any medium, such as storage 1240, that can contain or store programming for use by or in connection with an instruction execution system, apparatus, or device.

[0257] The software 1250 may also be propagated in any transport medium for use by or in connection with an instruction execution system, apparatus, or device, as described above, that can fetch instructions associated with the software from the instruction execution system, apparatus, or device and execute those instructions. In the context of this disclosure, a transport medium may be any medium that can communicatively convey, propagate, or transport programming for use by or in connection with an instruction execution system, apparatus, or device. Transport-readable media may include, but are not limited to, electronic, magnetic, optical, electromagnetic, or infrared, wired, or wireless propagation media.

[0258] The device 1200 may be connected to a network, which may be any suitable type of interconnected communication system. The network may implement any suitable communication protocol and may be secured by any suitable security protocol. The network may include any suitable arrangement of network links capable of implementing the transmission and reception of network signals, such as wireless network connections, T1 or T3 lines, cable networks, DSL, or telephone lines.

[0259] Device 1200 may implement any operating system suitable for operating on a network. Software 1250 may be written in any suitable programming language, such as C, C++, Java, or Python. In various embodiments, application software embodying functionality of the present disclosure may be deployed in various configurations, such as, for example, in a client / server arrangement or via a web browser as a web-based application or web service.

[0260] Embodiments of the present disclosure include systems and methods for generating an actionable batch record for a clinical trial study. For example, in one or more embodiments, the method may include displaying, at a first electronic device associated with a production facilitator, a user interface (UI) for inputting batch record information, the UI including at least packaging instructions, a bill of materials, and a lot allocation. In one or more examples, the batch record information may include a selection of inventory associated with a production site and a selection of inventory associated with a pharmaceutical customer. In one or more embodiments, the method may further include receiving, at the first electronic device, the packaging instructions, the bill of materials, and the lot allocation from a user associated with the production facilitator. In one or more embodiments, the method may further include creating a preliminary batch record based on the information entered by the user associated with the production facilitator. In one or more embodiments, the method may further include displaying, at a second electronic device associated with the pharmaceutical batch customer, a customer user interface including the preliminary batch record and an interface for approving the preliminary batch record. In one or more embodiments, the method may further include receiving, at the second electronic device, an approval of the preliminary batch record from a user associated with the pharmaceutical batch customer. In one or more embodiments, the method can further include creating an actionable batch record for the producer to execute pursuant to receiving approval of the preliminary batch record.

[0261] In one or more examples, according to the methods of the present disclosure, a user associated with the pharmaceutical batch customer may be configured to approve the preliminary batch record without editing the preliminary batch record. In one or more examples, according to the methods of the present disclosure, receiving the packaging instructions may include receiving the packaging instructions in a first language, determining whether the first language is used at the production site, and generating a translation of the packaging instructions corresponding to a second language used at the production site according to a determination that the first language is not used at the production site.

[0262] In one or more examples, according to the method of the present disclosure, receiving the lot allocation can include receiving a quantity of output materials to be produced, each output material corresponding to one or more input materials, accessing an inventory at the production site, and assigning, for each output material, a first supplier lot number based on at least one of a first supplier lot size or a first supplier lot expiration date determined from the inventory, and assigning, for each input material, a second supplier lot number based on at least one of a second supplier lot size or a second supplier lot expiration date determined from the inventory. In one or more examples, the method can further include generating a second actionable batch record for the clinical trial study, including receiving, at the first electronic device, the second lot allocation associated with the production site. In one or more examples, receiving the second lot allocation can include receiving a second quantity of output materials to be produced, each output material corresponding to one or more input materials, accessing an inventory at the production site, and assigning, for each output material, a third supplier lot number based on at least one of a third supplier lot size or a third supplier lot expiration date determined from the inventory at the production site, and assigning, for each input material, a fourth supplier lot number based on at least one of a fourth supplier lot size or a fourth supplier lot expiration date determined from the inventory at the production site. In one or more examples, the method can further include creating a second preliminary batch record based on information entered by a user associated with the production facilitator, receiving approval of the second preliminary batch record from the second electronic device, and creating a second executable batch record for execution by the producer in response to receiving approval of the second preliminary batch record.

[0263] In one or more examples, a method according to the present disclosure may include receiving, at a first electronic device, customer data associated with a pharmaceutical batch customer, study information for a clinical trial study, the clinical trial study associated with the customer data, and output material information, where the output material information corresponds to one or more output materials associated with the clinical trial study. In one or more examples, receiving the bill of materials may further include importing at least a portion of the output material information into the bill of materials, receiving quantities associated with each of the one or more output materials and corresponding input materials from the output material information, and assigning a customer identifier based on customer inventory. In one or more examples, the study information may include a packaging site, a study language, a destination country, an output material, a dosage code, a business unit, an approver, or a combination thereof. In one or more examples, the output material information may include an output material, an input material, a drug classification, an alternative material, a storage temperature, a timeout environment details, a humidity control details, a lighting control details, a label details, or a combination thereof.

[0264] In one or more examples according to the present disclosure, this may include the executable batch record may be accessed by a user associated with the production facilitator before being accessed by the producer. In one or more examples, a method according to the present disclosure may include causing the first electronic device to present an audit history, the audit history corresponding to a list of actions associated with entering the batch record information and receiving approval of the preliminary batch record.

[0265] In one or more examples, a method according to the present disclosure can include receiving, at a first electronic device, study information for a clinical trial study, the study information including one or more customer approvers, the one or more customer approvers including a user associated with the pharmaceutical batch customer. The methods can further include determining whether the batch record information includes blinding information, and, in accordance with a determination that the batch record information includes blinding information, causing, at a second electronic device, a user associated with the pharmaceutical batch customer to be presented with a limited view of the preliminary batch record that omits the blinding information. In such examples, the user associated with the pharmaceutical batch customer can be configured to be blinded. In such examples, the blinding information can include a drug list, an identification number, a kit number, a starting sequence number, an ending sequence number, or a combination thereof. In such examples, the one or more customer approvers can further include a second user associated with the pharmaceutical batch customer, the second user associated with the pharmaceutical batch customer being configured to not be blinded. In such examples, the method according to the present disclosure may further include, in accordance with a determination that the batch record information includes blinding information, causing a second user associated with the pharmaceutical batch customer to be presented with an unrestricted view of the actionable batch record including the blinding information.

[0266] An embodiment of the present disclosure may further include an electronic system for generating an executable batch record for a clinical trial study. The electronic system may include one or more processors, a memory, and one or more programs, the one or more programs being stored in the memory and configured to be executed by the one or more processors. According to an embodiment of the present disclosure, the one or more programs may include instructions for displaying a user interface (UI) for inputting batch record information at a first electronic device associated with a production facilitator, the UI including at least packaging instructions, a bill of materials, and a lot allocation. In such an embodiment, the batch record information may include a selection of inventory associated with a production site and a selection of inventory associated with a pharmaceutical customer. In such an embodiment, the one or more programs may further include instructions for receiving, at the first electronic device, the packaging instructions, the bill of materials, and the lot allocation from a user associated with the production facilitator. In such an embodiment, the one or more programs may further include instructions for creating a preliminary batch record based on information input by a user associated with the production facilitator. In one or more embodiments, the one or more programs may further include instructions for displaying, at a second electronic device associated with the pharmaceutical batch customer, a customer user interface including a preliminary batch record and an interface for approving the preliminary batch record. In one or more embodiments, the one or more programs may further include instructions for receiving approval of the preliminary batch record from a user associated with the pharmaceutical batch customer at the second electronic device. In one or more embodiments, the one or more programs may further include instructions for creating an executable batch record for the producer to execute pursuant to receiving approval of the preliminary batch record.

[0267] In one or more examples, according to the system of the present disclosure, a user associated with the pharmaceutical batch customer may be configured to approve the preliminary batch record without editing the preliminary batch record. In one or more examples, according to the system of the present disclosure, receiving the packaging instructions may include receiving the packaging instructions in a first language, determining whether the first language is used at the production site, and generating a translation of the packaging instructions corresponding to a second language used at the production site according to a determination that the first language is not used at the production site.

[0268] In one or more examples, according to the system of the present disclosure, receiving the lot allocation can include receiving a quantity of output materials to be produced, each output material corresponding to one or more input materials, accessing an inventory at the production site, and assigning, for each output material, a first supplier lot number based on at least one of a first supplier lot size or a first supplier lot expiration date determined from the inventory, and assigning, for each input material, a second supplier lot number based on at least one of a second supplier lot size or a second supplier lot expiration date determined from the inventory. In such examples, the one or more programs can further include instructions for generating a second executable batch record for the clinical trial study, including receiving, at the first electronic device, the second lot allocation associated with the production site. In such examples, receiving the second lot allocation can include receiving a second quantity of output materials to be produced, each output material corresponding to one or more input materials, accessing an inventory at the production site, and assigning, for each output material, a third supplier lot number based on at least one of a third supplier lot size or a third supplier lot expiration date determined from the inventory at the production site, and assigning, for each input material, a fourth supplier lot number based on at least one of a fourth supplier lot size or a fourth supplier lot expiration date determined from the inventory at the production site. In such examples, the one or more programs can further include instructions for creating a second preliminary batch record based on information entered by a user associated with the production facilitator, receiving approval of the second preliminary batch record from the second electronic device, and creating a second executable batch record for execution by the producer in response to receiving approval of the second preliminary batch record.

[0269] In one or more examples, the one or more programs may further include instructions for receiving, at the first electronic device, customer data associated with the pharmaceutical batch customer, study information for the clinical trial study, the clinical trial study associated with the customer data, and output material information, where the output material information corresponds to one or more output materials associated with the clinical trial study. In one or more examples, the instructions for receiving the bill of materials may further include importing at least a portion of the output material information into the bill of materials, receiving quantities associated with each of the one or more output materials and corresponding input materials from the output material information, and assigning a customer identifier based on customer inventory. In one or more examples, the study information may include a packaging site, a study language, a destination country, an output material, a dosage code, a business unit, an approver, or a combination thereof. In one or more examples, the output material information may include an output material, an input material, a drug classification, an alternative material, a storage temperature, a timeout environment details, a humidity control details, a lighting control details, a label details, or a combination thereof.

[0270] In one or more examples according to the present disclosure, the executable batch record may be accessed by a user associated with the production facilitator before being accessed by the producer. In one or more examples, a system according to the present disclosure may include instructions for causing the first electronic device to present an audit history, the audit history corresponding to a list of actions associated with entering the batch record information and receiving approval of the preliminary batch record.

[0271] In one or more examples, a system according to the present disclosure may include instructions for receiving, at a first electronic device, study information for a clinical trial study, the study information including one or more customer approvers, the one or more customer approvers including a user associated with the pharmaceutical batch customer. The system may further include instructions for determining whether the batch record information includes blinding information, and, pursuant to a determination that the batch record information includes blinding information, causing, at a second electronic device, a user associated with the pharmaceutical batch customer to be presented with a limited view of the preliminary batch record that omits the blinding information. In such examples, the user associated with the pharmaceutical batch customer may be configured to be blinded. In such examples, the blinding information may include a drug list, an identification number, a kit number, a starting sequence number, an ending sequence number, or a combination thereof. In such examples, the one or more customer approvers may further include a second user associated with the pharmaceutical batch customer, the second user associated with the pharmaceutical batch customer configured to not be blinded. In such an example, a system according to the present disclosure may further include instructions for causing, pursuant to a determination that the batch record information includes blinding information, to present an unrestricted view of the actionable batch record including the blinding information to a second user associated with the pharmaceutical batch customer.

[0272] An embodiment of the present disclosure may further include a non-transitory computer-readable storage medium storing one or more programs, the one or more programs including instructions that, when executed by one or more processors of one or more electronic devices having a display, cause the one or more electronic devices to execute the method. In one or more examples, the method may include displaying, at a first electronic device associated with the production facilitator, a user interface (UI) for inputting batch record information, the UI including at least packaging instructions, a bill of materials, and a lot allocation. In such examples, the batch record information may include a selection of inventory associated with the production site and a selection of inventory associated with the pharmaceutical customer. In such examples, the method may further include receiving, at the first electronic device, the packaging instructions, the bill of materials, and the lot allocation from a user associated with the production facilitator. In one or more examples, the method may further include creating a preliminary batch record based on the information entered by the user associated with the production facilitator. In one or more examples, the method may further include displaying, at a second electronic device associated with the pharmaceutical batch customer, a customer user interface including the preliminary batch record and an interface for approving the preliminary batch record. In one or more examples, the method can further include receiving, at the second electronic device, approval of the preliminary batch record from a user associated with the pharmaceutical batch customer. In one or more examples, the method can further include creating an executable batch record for the producer to execute in accordance with receiving approval of the preliminary batch record.

[0273] In one or more examples, in accordance with the present disclosure, receiving the lot assignments can include receiving a quantity of output materials to be produced, each output material corresponding to one or more input materials, accessing an inventory at the production site, and assigning, for each output material, a first supplier lot number based on at least one of a first supplier lot size or a first supplier lot expiration date determined from the inventory, and assigning, for each input material, a second supplier lot number based on at least one of a second supplier lot size or a second supplier lot expiration date determined from the inventory. In such examples, the one or more programs can further include instructions that cause the one or more electronic devices to generate a second executable batch record for the clinical trial study, including receiving, at the first electronic device, the second lot assignment associated with the production site. In such examples, receiving the second lot allocation can include receiving a second quantity of output materials to be produced, each output material corresponding to one or more input materials, accessing an inventory at the production site, and assigning, for each output material, a third supplier lot number based on at least one of a third supplier lot size or a third supplier lot expiration date determined from the inventory at the production site, and assigning, for each input material, a fourth supplier lot number based on at least one of a fourth supplier lot size or a fourth supplier lot expiration date determined from the inventory at the production site. In such examples, the one or more programs can further include instructions that cause the one or more electronic devices to create a second preliminary batch record based on information entered by a user associated with the production facilitator, receive approval of the second preliminary batch record from the second electronic device, and create a second executable batch record for execution by the producer in response to receiving approval of the second preliminary batch record.

[0274] In one or more examples, the one or more programs may further include instructions that cause the one or more electronic devices to receive, at the first electronic device, customer data associated with the pharmaceutical batch customer, study information for the clinical trial study, the clinical trial study associated with the customer data, and output material information, the output material information corresponding to the one or more output materials associated with the clinical trial study. In one or more examples, the instructions for receiving the bill of materials may further include importing at least a portion of the output material information into the bill of materials, receiving quantities associated with each of the one or more output materials and corresponding input materials from the output material information, and assigning a customer identifier based on customer inventory. In one or more examples, the study information may include a packaging site, a study language, a destination country, an output material, a dosage code, a business unit, an approver, or a combination thereof. In one or more examples, the output material information may include an output material, an input material, a drug classification, an alternative material, a storage temperature, a timeout environment details, a humidity control details, a lighting control details, a label details, or a combination thereof.

[0275] In one or more examples according to the present disclosure, the executable batch record may be accessed by a user associated with the production facilitator before being accessed by the producer. In one or more examples, a non-transitory computer-readable storage medium according to the present disclosure may include instructions for causing a first electronic device to present an audit history, the audit history corresponding to a list of actions associated with entering batch record information and receiving approval of the preliminary batch record.

[0276] In one or more examples according to the present disclosure, the instructions may further cause the one or more electronic devices to receive, at the first electronic device, study information for the clinical trial study, the study information including one or more customer approvers, the one or more customer approvers including a user associated with the pharmaceutical batch customer. In such examples, the instructions may further cause the one or more electronic devices to determine whether the batch record information includes blinding information, and, pursuant to a determination that the batch record information includes blinding information, to present, at the second electronic device, a limited view of the preliminary batch record that omits the blinding information to a user associated with the pharmaceutical batch customer. In such examples, the user associated with the pharmaceutical batch customer may be blinded. In such examples, the blinding information may include a drug list, an identification number, a kit number, a starting sequence number, an ending sequence number, or a combination thereof. In such examples, the one or more customer approvers may further include a second user associated with the pharmaceutical batch customer, the second user associated with the pharmaceutical batch customer being configured to be unblinded. In such an example, the instructions may further cause the one or more electronic devices to, pursuant to a determination that the batch record information includes blinding information, present an unrestricted view of the actionable batch record including the blinding information to a second user associated with the pharmaceutical batch customer.

[0277] Although the present disclosure and examples have been fully described with reference to the accompanying drawings, it should be noted that various changes and modifications will become apparent to those skilled in the art, and such changes and modifications should be understood to be included within the scope of the disclosure and examples as defined by the claims.

[0278] The foregoing description has been described with reference to specific embodiments for purposes of illustration. However, the above illustrative description is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Numerous modifications and variations are possible in light of the above teachings. These embodiments were chosen and described in order to best explain the principles of the technology and its practical application. This will enable those skilled in the art to best utilize the technology and various embodiments with various modifications as appropriate for the particular use contemplated. [Explanation of symbols]

[0279] 100A System 100B System 102 Master Data 104 Research information 106 Research part 108 Research Batch Record 110 Research Instructions 112 Parts List 114 Lot Allocation 116 Batch Records 120 Production Facilitator User Interface (UI) 122 Customer information 124 Contacts 126 Packaging site 128 Instructions 130 Instruction Set 132 Equipment 134 Reconciliation Limit 136 Research 150 Processes 160 Processes 180 Customer UI 220A Customer Details Page 220B Contact Page 220C Contact Details Page 220D Research Page 220E Packaging site page 220F Equipment Page 220G Reconciliation Limits Page 220H Packaging Instruction Page 220I Instruction Set Page 222 Navigation User Affordances 224 Operation User Affordance 226A Customer detailed information display area 226D Research information display area 226E Packaging site information display area 226F Device information display area 226G Reconciliation limit information display area 228 Navigation Bar 320A Research Information Page 320C Destination Country / Label Country Group Page 320F OM Group Page 320G Dosage Code Page 320H Research Approval Page 320I Acknowledgement Page 320J Project Manager Page 320K Business Unit Pages 320L Research section page 322 Navigation User Affordances 324 Operation User Affordance 326A Research information display area 326C Destination country information display area 326F OM group information display area 326G Dosage code information display area 326H Research approver information display area 326J Project Manager Information Display Area 326K Business unit information display area 326L Research partial information display area 326M Common material information display area 330D Destination Country Information Entry Window 330E Destination Group Window 332C New Input User Affordance 334C Edit User Affordances 342F New Input User Affordance 342G New Input User Affordance 342H New Input User Affordance 342J New Input User Affordance 342L New Research Part User Affordance 354 Process 372I Approval Report 374 Signature Window 374I Approval window, signature window 390K Business Unit Pages 420C Research section details page 420D Output and Input Materials Page 420E Output and Input Materials Page 420G Output and Input Materials Page 420M Common Materials Page 420N Common Materials Page 420P Research Part List Page 420Q Related batch record page 422 Navigation User Affordances 424 Operation User Affordance 426C Research part detailed information display area 426D Output and input material information display area 426M Common material information display area 426P Research part list information display area 426Q Related batch record information display area 428D, 434D User Affordance 430B Research section details window 430F Output material details window 430H Input (Drug) Material Details Window 430L Input (Label) Material Details Window 432E New Output Material User Affordance 432G New Input (Drug) Material User Affordance 432I New Input (Non-Drug) Material User Affordance 432K New input (label) material user affordance 434D Input Material User Affordance 430J Input (Non-Drug) Material Details Window 430L Input (Label) Material Details Window 430O Drug Common Mapping Window 434N Common (Drug) Material User Affordance 436N Mapping User Affordance 456 Process 470 "SBR Creation" User Affordance 520A Batch Record Detail Page 520D Instructions and Equipment Group (Research Instructions) Page 520E Instructions and Equipment (Research Instructions - Packaging Instructions) Page 520F Instructions and Equipment (Research Instructions - Check in Progress) Page 520G Instructions and Equipment (Research Instructions - Important Notes) Page 520H Instructions and Equipment (Research Instructions - Packaging Instructions) Page 520J Instructions and Equipment Groups (Equipment Groups) Page 520L Approved Instructions and Equipment Groups (Equipment Groups) Page 520P Parts List (Output Materials - Input Materials) Page 520Q Parts List (Common Materials) Page 520R Research Batch Record Page 520X Related Research Part Page 520Y Relationship Research Components Page 522 Navigation User Affordances 524 Operation User Affordance 526A Batch record detailed information display area 526E Instructions and Equipment (Laboratory Instructions - Packaging Instructions) Labeling Information 526F Instructions and Equipment (Research Instructions - Check in Progress) Display Information 526G Instructions and Equipment (Research Instructions - Important Notices) Display Information 526L Instruction and Equipment Group (Equipment Group) Information Display Area 526P Parts list (output material - input material) information display area 526Q Parts list (common materials) information display area 526X Related research information display area 526Y Related Research Component Information Display Area 530I Packaging Instructions Edit Window 530K New Device Group Window 530T Example Pack Window 538 Operation User Affordance 542D Instruction Type Navigation User Affordance 542E Instruction Type Navigation User Affordance 542F Instruction Type Navigation User Affordance 542G Instruction Type Navigation User Affordance 544D Search User Affordance 546D Language Selection User Affordance 550D Instructions Add User Affordance 554H Instruction Edit User Affordance 556J New Device Group User Affordance 558 Process 558J Equipment Edit Group User Affordance 572M Approval Report 572V Approval Report 574N Signature Window 574W Signature window 576M Signature Button 576V Signature Button 578U Acceptance User Affordance 582O Item ID 584O quantity 584R Item ID Acquisition User Affordance 600A Process 620N Research Instructions (Packaging Instructions) Page 624 Operation User Affordance 630C New Instructions Window 630E New Translation Window 630O Instruction Editing Window 646N Instruction Editing User Affordance 662D New Translation User Affordance 664B New Instruction User Affordance 708I Process 720F Lot Allocation Details Page 720G Lot Allocation Details Page 720H Output and Input Materials Page 720J Output and Input Materials Page 720Q Common Materials Page 720R Lot Allocation UI 720U Related Batch Record (XBR) Page 720V Bill of Materials Page 722 Navigation User Affordances 724 Operation User Affordance 726F Lot allocation detailed information display area 726H Output and input material information display area 726Q Common material information display area 726U Related batch record information display area 726V Parts list information display area 730C, 730D, 730E Lot Allocation Creation Window 730K Output Material Edit Window 730L Input (Drug) Material Edit Window 730N Input (Non-drug) Material Edit Window 730O Input (Label) Material Window 730P Example Pack Material Edit Window 742B Lot Allocation Creation User Affordance 742G ETO Number Editing User Affordance 742J User Affordance 744J User Affordance 746J User Affordance 752J Edit User Affordance 756J Supplier Lot User Affordance 764 processes 772S Approval Report 774T Signature Window 776S Signature Button 778R Acceptance User Affordance 820B Batch Record Detail Page 820C Equipment Group and Packaging Instructions Page 820D Equipment Group and Packaging Instructions Page 820E Deviation and Change Management Page 820F Deviation and Change Control Page 820H Parts List Page 820I Batch Recording UI 820L Work Order Page 822 Navigation User Affordances 824 Operation User Affordance 826B Batch record detailed information display area 826C Equipment Group and Packaging Instructions Information Display Area 826E Deviation and Change Management Information Display Area 826H Parts table information display area 826L Work order information display area 830G New Deviation and Change Control Windows 842F New deviation user affordances 842L WO Status Field 842M "XBR Report" User Affordance 866 Process 872J Approval Report 874K Signature Window 876J Signature Button 878I Accept User Affordance 922 Navigation Bar 926A Pending Approval List 926B Lot Allocation List 980A Customer UI Homepage 980B Lot Allocation Page 980C Lot Allocation Summary Page 982C Authorization User Affordance 1020A Lot Allocation Details Page 1020B Audit History 1030A Audit History Window 1030C Approval Flow Window 1032C User Affordance 1042A "History" User Affordance 1044A Selected Fields 1046A "User" User Affordance 1100A Batch Record Report 1100B Batch Record Report 1110A Unblinding Information 1112D File Link 1114E Warning Window 1130C File Upload Window 1180D Customer Lot Allocation Details Page 1200 devices 1220 Input Devices 1230 Output Device 1240 Storage 1250 Software 1260 Communication Devices

Claims

1. 1. A method for generating an actionable batch record for a clinical trial study, comprising: a first electronic device associated with the production facilitator; displaying a user interface for inputting batch record information including packaging instructions, bill of materials, and lot allocations, the user interface including a selection of inventory associated with a production site and a selection of inventory associated with a pharmaceutical batch customer; receiving the packaging instructions, the bill of materials, and the lot allocation from a user associated with the production facilitator; creating a preliminary batch record based on the batch record information entered by the user associated with the production facilitator; on a second electronic device associated with the pharmaceutical batch customer; displaying a customer user interface including the preliminary batch record and an interface for approving the preliminary batch record; receiving approval of the preliminary batch record from a user associated with the pharmaceutical batch customer; creating an actionable batch record for execution by a producer pursuant to receiving said approval of said preliminary batch record; A method comprising:

2. The method of claim 1 , wherein the user associated with the pharmaceutical batch customer is configured to approve the preliminary batch record without editing the preliminary batch record.

3. The step of receiving packaging instructions includes: receiving packaging instructions in a first language; determining whether the first language is used at the production site; generating a translation of the packaging instructions corresponding to a second language used at the production site in accordance with a determination that the first language is not used at the production site; The method of claim 1 further comprising:

4. The step of receiving a lot allocation includes: receiving a quantity of output materials to be produced, each output material corresponding to one or more input materials; accessing inventory on the production floor; assigning, for each output material, a first supplier lot number based on at least one of a first supplier lot size or a first supplier lot expiration date determined from the inventory; assigning, for each input material, a second supplier lot number based on at least one of a second supplier lot size or a second supplier lot expiration date determined from the inventory; The method of claim 1 further comprising:

5. generating a second executable batch record for the clinical trial study, said generating step comprising: receiving, at the first electronic device, a second lot allocation associated with the production site; receiving a second quantity of output materials to be produced, each output material corresponding to one or more input materials; accessing the inventory at the production site; assigning, for each output material, a third supplier lot number based on at least one of a third supplier lot size or a third supplier lot expiration date determined from the inventory at the production site; assigning, for each input material, a fourth supplier lot number based on at least one of a fourth supplier lot size or a fourth supplier lot expiration date determined from the inventory at the production site; receiving a second lot allocation associated with the production site, the second lot allocation including: creating a second preliminary batch record based on the batch record information entered by the user associated with the production facilitator; receiving an acknowledgement of the second preliminary batch record from the second electronic device; creating a second executable batch record for execution by the producer pursuant to receiving the approval of the second preliminary batch record; 5. The method of claim 4, comprising:

6. In the first electronic device, receiving customer data associated with the pharmaceutical batch customer; receiving research information relating to said clinical trial study, said clinical trial study being associated with said customer data; receiving output material information, the output material information corresponding to one or more output materials associated with the clinical trial study; The method of claim 1 further comprising:

7. The step of receiving the bill of materials comprises: importing at least a portion of the output material information into the bill of materials; receiving a quantity associated with each of the one or more output materials and corresponding input materials from the output material information; assigning customer identifiers based on customer inventory; 7. The method of claim 6, further comprising:

8. 7. The method of claim 6, wherein the study information includes a packaging site, a study language, a destination country, an output material, a dosage code, a business unit, an approver, or a combination thereof.

9. 7. The method of claim 6, wherein the output material information includes output materials, input materials, drug classifications, alternative materials, storage temperatures, timeout environmental details, humidity control details, lighting control details, label details, or combinations thereof.

10. The method of claim 1 , wherein the executable batch record is accessed by the user associated with the production facilitator before being accessed by the producer.

11. 10. The method of claim 1, further comprising causing an audit history to be presented, the audit history corresponding to a list of actions associated with entering the batch record information and receiving approval of the preliminary batch record.

12. receiving, at the first electronic device, study information for the clinical trial study, the study information including one or more customer approvers, the one or more customer approvers including the user associated with the pharmaceutical batch customer; determining whether the batch record information includes blinding information; In response to a determination that the batch record information includes blinding information, causing, at the second electronic device, to present to the user associated with the pharmaceutical batch customer a limited view of the preliminary batch record omitting the blinding information; further comprising The user associated with the pharmaceutical batch customer is configured to be blinded. The method of claim 1.

13. 13. The method of claim 12, wherein the blinding information comprises a medication list, an identification number, a kit number, a starting sequence number, an ending sequence number, or a combination thereof.

14. 13. The method of claim 12, wherein the one or more customer approvers further include a second user associated with the pharmaceutical batch customer, and the second user associated with the pharmaceutical batch customer is configured to be unblinded.

15. 15. The method of claim 14, further comprising, in accordance with a determination that the batch record information includes blinding information, causing the second user associated with the pharmaceutical batch customer to be presented with an unrestricted view of the executable batch record including the blinding information.

16. 1. An electronic system comprising: one or more processors; Memory and and one or more programs stored in the memory and configured to be executed by the one or more processors, the one or more programs comprising: a first electronic device associated with the production facilitator; displaying a user interface for inputting batch record information including at least packaging instructions, a bill of materials, and lot allocations, the user interface including a selection of inventory associated with a production site and a selection of inventory associated with a pharmaceutical batch customer; receiving the packaging instructions, the bill of materials, and the lot allocation from a user associated with the production facilitator; creating a preliminary batch record based on the batch record information entered by the user associated with the production facilitator; on a second electronic device associated with the pharmaceutical batch customer; displaying a customer user interface including the preliminary batch record and an interface for approving the preliminary batch record; receiving approval of the preliminary batch record from a user associated with the pharmaceutical batch customer; creating an actionable batch record for execution by the producer pursuant to receiving said approval of said preliminary batch record; An electronic system containing instructions for performing

17. 1. A non-transitory computer-readable storage medium storing one or more programs that, when executed by one or more processors of one or more electronic devices having a display, cause the one or more electronic devices to: a first electronic device associated with the batch record facilitator; displaying a user interface for inputting batch record information including at least packaging instructions, a bill of materials, and lot allocations, the user interface including a selection of inventory associated with a production site and a selection of inventory associated with a pharmaceutical batch customer; receiving the packaging instructions, the bill of materials, and the lot allocation from a user associated with the batch record facilitator; creating a preliminary batch record based on the batch record information entered by the user associated with the batch record facilitator; on a second electronic device associated with the pharmaceutical batch customer; displaying a customer user interface including the preliminary batch record and an interface for approving the preliminary batch record; receiving approval of the preliminary batch record from a user associated with the pharmaceutical batch customer; preparing an actionable batch record for execution by the producer pursuant to receiving said approval of said preliminary batch record; A non-transitory computer-readable storage medium containing instructions to cause

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