Systems and methods for producing batch records for pharmaceutical trials

Abstract

Embodiments of the present disclosure include systems and methods for generating electronic batch records.

Description

(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202480042897.6 (22) Application Date 2024.04.30 (30) Priority Data 63 / 463183 2023.05.01 US (85) PCT International Application Entering National Phase Date 2025.12.25 (86) PCT International Application Application Data PCT / US2024 / 026973 2024.04.30 (87) PCT International Application Publication Data WO2024 / 228990 EN 2024.11.07 (71) Applicant R.P. Scheller Technologies LLC Address Nevada, USA (72) Inventors C. Stahlhofen S.J. Jones P. Zemmler A. Latold (74) Patent Agency China Patent Agent (Hong Kong) Limited 72001 Patent Attorney Liu Shuhang Liu Chunyuan (51) Int.Cl. G16H 10 / 20 (2006.01) G16H 40 / 20 (2006.01) (54) Invention Title System and Method for Generating Batch Records for Drug Testing (57) Abstract Embodiments of this disclosure include systems and methods for generating electronic batch records. Claims 3 pages, Description 26 pages, Drawings 66 pages, CN 121605482 A 2026.03.03 CN 1 21 60 54 82 A 1. A computer-implemented method for generating executed batch records for clinical trial studies, the method comprising: receiving an instruction that a batch record is assigned to a packaging room located at a packaging site, the packaging room being configured to execute the batch record; receiving an instruction that a first user at the packaging site has completed a packaging briefing associated with a packaging operation for executing the batch record; displaying a packaging instruction for producing a certain quantity of packaging materials for the packaging operation based on a determination that the first user has completed the packaging briefing; determining whether the quantity of packaging materials is within a check target, and updating the batch record to include a determination that the quantity of packaging materials is within the check limit; receiving a first approval of the batch record from the first user, the first approval including receiving credentials from the first user upon logging into an account associated with the first user; Receiving a second approval from a second user for the batch records, the second approval including receiving credentials from the second user while remaining logged into the account associated with the first user; and generating the executed batch records for the clinical trial study based on the approved batch records. 2. The method of claim 1, wherein the packaging instructions comprise multiple steps, and the method further...The steps include: for each of the plurality of steps, receiving an image including a visual indication that the step has been completed via an image capture device located in the packaging room; and updating the batch record to save the image and associate the image with the step among the plurality of steps. 3. The method of claim 2, further comprising: for each of the plurality of steps, receiving an instruction step approval from a first user associated with the step, the instruction step approval including receiving credentials from the first user. 4. The method of any one of claims 1 to 3, further comprising: acquiring input material data including one or more fields via an external resource, the material data being associated with input materials temporarily stored in the packaging room; approving the temporarily stored input materials based on a determination that one or more fields in the input material data match one or more corresponding fields in an executable batch record; displaying user availability to a first user for accepting or rejecting the input materials based on a determination that a field in the input material data does not match a corresponding field in the executable batch record; and adding the input materials to the executing batch record based on a determination that the input materials have been approved or accepted. 5. The method of claim 4, wherein the one or more fields in the input material data include one or more of a material identification number, a supplier batch number, an external resource batch number, and a customer batch number. 6. The method of claim 4 or claim 5, comprising: displaying an input material approval interface based on an indication that a first user has accepted the input material; receiving credentials from the first user via the input material approval interface; and accepting or rejecting the input material. 7. The method of any one of claims 1 to 6, further comprising receiving a comment associated with the batch record being executed via a comment user interface. 8. The method of claim 7, further comprising receiving a comment approval from a second user on the comment, the comment approval including receiving credentials from the second user while remaining logged into the account associated with the first user. Claims 1 / 3 Page 2 CN 121605482 A 9. The method of any one of claims 7 or 8, further comprising receiving an indication that the comment is associated with blinded data. 10. The method of any one of claims 9, wherein generating the executed batch record includes generating a blinded executed batch record such that the blinded data is revised. 11. The method according to any one of claims 1 to 10, further comprising configuring the packaging room to perform the batch recording, wherein configuring the packaging room comprises: assigning a packaging room at the packaging site to the packaging operation; receiving from a user at the packaging room that the packaging room meets one or more of a room cleaning checklist.The method includes: receiving instructions from the user that the packaging room meets one or more items in a room setup checklist associated with the executable batch record and the packaging room; receiving instructions from the user that the packaging room meets one or more items in a room setup checklist associated with the executable batch record and the packaging room; and receiving instructions from the user that a first piece of equipment located in the packaging room meets one or more items in an equipment setup checklist associated with the first piece of equipment and the executable batch record. 12. The method of any one of claims 1 to 11, further comprising: receiving user input for pausing the packaging operation; displaying a job pause approval interface based on the user input for pausing the packaging operation; receiving credentials of a first user via the job pause approval interface; receiving credentials of a second user via the job pause approval interface while logged into an account associated with the first user; and updating the packaging operation status to paused. 13. The method of any one of claims 1 to 12, further comprising displaying a color-coded progress bar indicating the completion of one or more tasks associated with the packaging operation. 14. The method of claim 13, further comprising automatically updating the progress bar when one or more tasks associated with the packaging operation have been approved. 15. A method for generating an executed batch record for a clinical trial study, the method comprising: at a first computer system including one or more processors and one or more memories: acquiring an executable batch record of a packaging job configured to be performed at a packaging site; assigning a packaging room at the packaging site to the packaging job; receiving an indication that the packaging room meets one or more items in a room cleaning checklist associated with the executable batch record and the packaging room; receiving an indication that the packaging room meets one or more items in a room setup checklist associated with the executable batch record and the packaging room; receiving an indication that a first piece of equipment located in the packaging room meets one or more items in an equipment setup checklist associated with the first piece of equipment and the executable batch record; receiving an indication that a first user has completed a packaging briefing associated with the packaging job; receiving an indication that one or more materials in the packaging room match one or more materials in a bill of materials; receiving an indication to start the packaging job; Claims 2 / 3 Page 3 CN 121605482 A Based on the confirmation that the first user has completed the packaging briefing, and upon logging into the account associated with the first user, packaging instructions associated with the packaging operation are displayed, the packaging instructions comprising multiple steps;For each of the multiple steps, an image including a visual indication that the step has been completed is received via an image capture device located in the packaging room; an input quantity indicating the quantity of packaging materials is received; the quantity of packaging materials is verified to be within a predetermined check target; an indication that the packaging operation is completed is received; a first user's first approval of the batch record is received, the first approval including receiving credentials from the first user while logging into an account associated with the first user; a second user's second approval of the batch record is received, the second approval including receiving credentials from the second user while remaining logged into an account associated with the first user; and based on the approved batch record, the executed batch record for the clinical trial study is generated. Claims 3 / 3 Page 4 CN 121605482 A System and method for generating batch records for drug trials

[0001] Cross-reference to related applications This application claims the benefit of U.S. Provisional Application No. 63 / 463,183, filed May 1, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure generally relates to systems and methods for generating batch records for clinical trial studies, and more specifically, to systems and methods for generating electronic batch records for output materials of clinical trial studies. Background Art

[0003] Companies participating in clinical trials (particularly drug clinical trials) must comply with government-regulated clinical packaging and labeling standards. Various national agencies, such as the U.S. Food and Drug Administration (FDA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), and the European Medicines Agency (EMA), provide regulatory frameworks for clinical packaging. Therefore, every clinical packaging operation, whether primary packaging (e.g., filling bulk medicines into bottles, blister packs, vials, or the like) or secondary packaging (e.g., clinically labeling primary bottles and placing them in boxes, and labeling the boxes to create patient kits), must be a controlled and repeatable action and follow appropriate regulatory guidelines. Furthermore, packaging should be implemented in a manner that does not reveal which patient's kit is associated with which type of treatment (e.g., clinical trials should not be made unblinded by allowing subjects or another individual involved in the clinical trial to discover whether the kit is an active treatment or a placebo).

[0004] Traditionally, batch records for clinical trials are prepared in the form of paper batch records. Upon receiving pre-approval from one or more individuals monitoring the clinical trial, paper batch records can then be distributed to one or more packaging sites and manually completed by operators during primary or secondary packaging runs. Additional paperwork that may be generated during the packaging process can be added to the batch record to produce an executed batch record. However, this paper-based process...The process heavily relies on manual input, which is prone to human error and makes it impossible to generate standardized batch records across sites. Furthermore, since all fields in paper batch records are visible to anyone viewing them during packaging, this can reveal which patient kits are associated with which treatment regimens, thus hindering the unblinding of clinical trials. Additionally, adjustments and approvals may be made to the packaging floor during the packaging process. These adjustments and approvals at various stages of the packaging process are documented via paper processes, which can be referenced during subsequent packaging runs or verification. However, paper documentation typically generates a large volume of paper documents that are difficult to organize and access.

[0005] Therefore, there is a need to efficiently generate electronic batch records corresponding to the packaged kits for clinical trials, which can provide a unified and centralized record across various packaging sites while preserving the blindness of clinical trials and without disrupting the flow of the packaging process. Summary of the Invention

[0006] Embodiments of this disclosure can provide computational systems and methods for efficiently and accurately generating electronic batch records. For example, embodiments of this disclosure may provide systems and methods that enable users (e.g., operators, team leaders, quality assurance personnel) to efficiently and accurately package output materials for packaging runs in one or more clinical trial studies. Embodiments of this disclosure also provide a centralized system for generating and retaining data throughout the packaging process—from room allocation and ensuring packaging occurs in the correct room with the correct equipment, to packaging instructions and documenting the various steps of the packaging process, to reconciliation and ensuring that the packaged output materials meet predetermined reconciliation limits. Embodiments of this disclosure also provide a pipeline system that accurately tracks which users update and approve data for entries to the executed batch record during the packaging process. For example, each comment and / or approval entered by a user is attributed to the appropriate user based on user credentials, rather than based on which user logged into the system to associate the comment and / or approval. This eliminates the need for multiple users to log into the system and / or log in and out of user accounts to grant approvals during the packaging process. In this manner, embodiments of this disclosure also provide a system that enhances accountability throughout the packaging process because each step of the packaging process is associated with a corresponding user.

[0007] Embodiments of this disclosure provide a computer-implemented method for generating executed batch records for clinical trial studies. In one or more embodiments, such a method may include: receiving an indication that a batch record has been assigned to a packaging room at a packaging site, the packaging room being configured to execute the batch record; receiving an indication that a first user at the packaging site has completed [something related to a previous context, possibly related to a previous context, but the context is unclear].Instructions for a packaging briefing associated with the packaging operation to perform the batch record; displaying a packaging instruction for generating a certain quantity of packaging materials for the packaging operation based on a determination that the first user has completed the packaging briefing; determining whether the quantity of packaging materials is within the check target and updating the batch record to include a determination that the quantity of packaging materials is within the check limit; receiving a first user's first approval of the batch record, the first approval including receiving credentials from the first user when logging into an account associated with the first user; receiving a second user's second approval of the batch record, the second approval including receiving credentials from the second user while remaining logged into an account associated with the first user; and generating an executed batch record for a clinical trial study based on the approved batch record.

[0008] In some embodiments, the packaging instruction includes multiple steps, and the method further includes: for a step of the multiple steps, receiving an image including a visual indication that the step has been completed via an image capture device located in a packaging room; and updating the batch record to save the image and associate the image with the step of the multiple steps. In some embodiments, the method further includes: for a step of the multiple steps, receiving an instruction step approval from the first user associated with the step, the instruction step approval including receiving credentials from the first user.

[0009] In some embodiments, the method further includes: acquiring input material data including one or more fields via an external resource, the material data being associated with input materials temporarily stored in a packaging room; approving the temporarily stored input materials based on a determination that one or more fields of the input material data match one or more corresponding fields of an executable batch record; displaying user affordance for accepting or rejecting the input materials to a first user based on a determination that a field of the input material data does not match a corresponding field of the executable batch record; and adding the input materials to the executing batch record based on a determination that the input materials have been approved or accepted. In some embodiments, one or more fields of the input material data include one or more of a material identification number, a supplier batch number, an external resource batch number, and a customer batch number. In some embodiments, the method further includes: displaying an input material approval interface based on receiving an indication that the first user has accepted the input materials; receiving the first user's credentials via the input material approval interface; and accepting or rejecting the input materials.

[0010] In some embodiments, the method further includes: receiving a comment associated with the executing batch record via a comment user interface. In some embodiments, the method further includes: receiving a comment approval from a second user on the comment, the comment approval including receiving credentials from the second user while remaining logged into an account associated with the first user. In some embodiments, the method further includes receiving an indication that the comment is associated with blinded data. In some embodiments, generating an executed batch record includes generating an executed batch record of the blinded process, such that the blinded data is revised.

[0011] In some embodiments, the method further includes configuring a packaging room to perform batch recording, wherein configuring the packaging room includes: assigning a packaging room at a packaging site to a packaging operation; receiving an instruction from a user located at the packaging room that the packaging room meets one or more items in a room cleaning checklist, the room cleaning checklist being associated with the executable batch record and the packaging room; receiving an instruction from the user that the packaging room meets one or more items in a room setup checklist, the room setup checklist being associated with the executable batch record and the packaging room; and receiving an instruction from the user that a first piece of equipment located in the packaging room meets one or more items in an equipment setup checklist, wherein the equipment setup checklist is associated with the first piece of equipment and the executable batch record.

[0012] In some embodiments, the method further includes: receiving user input for pausing a packaging operation; displaying an operation pause approval interface based on the received user input for pausing a packaging operation; receiving credentials of a first user via the operation pause approval interface; receiving credentials of a second user via the operation pause approval interface while remaining logged into an account associated with the first user; and updating the packaging operation status to paused.

[0013] In some embodiments, the method further includes: displaying a color-coded progress bar indicating the completion of one or more tasks associated with the packaging operation. In some embodiments, the method further includes: automatically updating the progress bar when one or more tasks associated with the packaging operation have been approved.

[0014] In some embodiments, a method is provided for generating an executed batch record for a clinical trial study. At a first computer system including one or more processors and one or more memories, the method includes: acquiring an executable batch record of a packaging operation configured to be performed at a packaging site; assigning a packaging room at the packaging site to the packaging operation; receiving an indication that the packaging room meets one or more items in a room cleaning checklist associated with the executable batch record and the packaging room; receiving an indication that the packaging room meets one or more items in a room setup checklist associated with the executable batch record and the packaging room; receiving an indication that first equipment located in the packaging room meets one or more items in an equipment setup checklist associated with the equipment and the executable batch record; receiving an indication that a first user has completed a packaging briefing associated with the packaging operation; receiving an indication to verify that one or more materials in the packaging room match one or more materials in a bill of materials; receiving an indication to start the packaging operation; and, upon login to an account associated with the first user, displaying the packaging operation associated with the packaging operation based on the determination that the first user has completed the packaging briefing.The instructions, packaging instructions include multiple steps; for each of the multiple steps, receiving an image including a visual indication that the step has been completed via an image capture device located in the packaging room; receiving an input quantity indicating the quantity of packaged materials; verifying that the quantity of packaged materials is within a predetermined check target; receiving an indication that the packaging operation has been completed; receiving a first user's first approval of the batch record, the first approval including receiving credentials from the first user while logged into an account associated with the first user; receiving a second user's second approval of the batch record, the second approval including receiving credentials from the second user while remaining logged into an account associated with the first user; and generating an executed batch record for a clinical trial study based on the approved batch record. Brief Description of the Drawings

[0015] Figures 1A and 1B illustrate exemplary processes for generating electronic batch records according to some embodiments of the present disclosure.

[0016] Figure 1C illustrates a progress bar of an exemplary batch record in execution associated with an exemplary process for generating electronic batch records according to some embodiments of the present disclosure.

[0017] Figures 2A-2E illustrate exemplary user interfaces associated with obtaining executable batch records of packaging operations according to some embodiments of the present disclosure.

[0018] Figures 3A-3M illustrate exemplary user interfaces associated with allocating packaging rooms to packaging operations according to some embodiments of the present disclosure.

[0019] Figures 4A and 4B illustrate exemplary user interfaces associated with completing a room cleaning checklist according to some embodiments of the present disclosure.

[0020] Figures 5A-5D illustrate exemplary user interfaces associated with completing a room setup checklist according to some embodiments of the present disclosure.

[0021] Figures 6A-6J illustrate exemplary user interfaces associated with completing equipment setup for packaging operations according to some embodiments of the present disclosure.

[0022] Figures 7A-7G illustrate exemplary user interfaces associated with briefing the user on packaging operations according to some embodiments of the present disclosure.

[0023] Figure 8 illustrates an exemplary user interface associated with verifying that materials in the packaging room match materials in the material list according to some embodiments of the present disclosure.

[0024] Figures 9A-9H illustrate exemplary user interfaces associated with starting packaging operations and displaying packaging instructions according to some embodiments of the present disclosure.

[0025] Figures 10A and 10B illustrate exemplary user interfaces for verifying that materials are within check limits according to some embodiments of the present disclosure.

[0026] Figures 11A and 11B illustrate exemplary user interfaces for generating electronic executed batch records for review according to some embodiments of the present disclosure.

[0027] Figure 12 illustrates an excerpt from an exemplary electronic executed batch record according to some embodiments of the present disclosure.

[0028] Figures 13A-13I illustrate an exemplary user interface for completing an ongoing checklist according to some embodiments of the present disclosure.

[0029] Figures 14A and 14B illustrate an exemplary user interface for adding sample data to an executed batch record according to some embodiments of the present disclosure.

[0030] Figure 15 illustrates an exemplary user interface for adding comments to an executed batch record according to some embodiments of the present disclosure.

[0031] Figures 16A-16D illustrate an exemplary user interface for editing an executed batch record according to some embodiments of the present disclosure.

[0032] Figure 17 illustrates an exemplary electronic device according to some embodiments of the present disclosure. Detailed Description

[0033] Embodiments of the present disclosure can provide computing systems and methods for efficiently generating electronic batch records. For example, embodiments of the present disclosure provide systems and methods that enable users (e.g., operators, team leaders, quality assurance personnel) to efficiently and accurately package output materials for package runs of one or more clinical trial studies. Embodiments of this disclosure also provide a centralized system for generating and retaining data throughout the packaging process—from room allocation and ensuring that the equipment used is packaged in the correct room, to packaging instructions and recording various steps of the packaging process, to checking and ensuring that the packaged output material meets predetermined check limits. Embodiments of this disclosure also provide a pipeline system that can accurately track which users update and approve data for entries to the executed batch record during the packaging process. For example, each comment and / or approval entered by a user is attributed to the appropriate user based on user credentials, rather than based on which user logged into the system to associate the comment and / or approval. This eliminates the need for multiple users to log into the system and / or log in and out of user accounts to grant approvals during the packaging process. In this manner, the embodiment description of this disclosure, page 4 / 26, 8 CN 121605482 A, also provides a system that enhances accountability throughout the packaging process because each step of the packaging process is associated with a corresponding user.

[0034] The following description is presented to enable those skilled in the art to make and use various embodiments. The descriptions of specific devices, technologies, and applications are provided by way of example only. Various modifications to the examples described herein will be readily apparent to those skilled in the art, and the general principles defined herein can be applied to other examples and applications without departing from the spirit and scope of the various embodiments. Therefore, the various embodiments are not intended to be limited to the examples described and shown herein, but should be accorded the scope consistent with the claims.

[0035] Although the following description uses the terms “first,” “second,” etc., to describe various elements, these elements should not be limited by these terms. These terms are used only to distinguish one element from another. For example, a first graphical representation may be referred to as a second graphical representation, and similarly, a second graphical representation may be referred to as a first graphical representation, without departing from the scope of the various described embodiments. Both the first graphical representation and the second graphical representation are graphical representations, but they are not identical graphical representations.

[0036] The terminology used in the description of the various described embodiments herein is for the purpose of describing particular embodiments only and is not intended to limit its scope. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” as used in the description of the various described embodiments and their appended claims are also intended to include the plural forms. It will also be understood that the term “and / or,” as used herein, refers to and covers any and all possible combinations of one or more associated listed items. Furthermore, it will be understood that when the terms “comprising,” “including,” “containing,” and / or “comprising” are used in this specification, they indicate the presence of the stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or combinations thereof.

[0037] Depending on the context, the term “if” may optionally be interpreted as meaning “when…” or “in…” or “in response to determining…” or “in response to detecting…”. Similarly, depending on the context, the phrase “if determined” or “if [status or event] is detected” may optionally be interpreted as meaning “when determined” or “in response to determining…”, “in response to detecting [status or event]”, or “in response to detecting [status or event]”.

[0038] Embodiments of this disclosure provide a system and method for facilitating the completion of packaging operations corresponding to batch records in progress. Figures 1A and 1B illustrate exemplary processes 100A and 100B for generating electronic batch records. Processes 100A and 100B can be implemented, for example, using one or more electronic devices implementing the software platform. In some examples, processes 100A and 100B are implemented using a client-server system, and blocks of processes 100A and 100B can be divided in any way between the server and client devices. In other examples, blocks of processes 100A and 100B can be divided between the server and multiple client devices. In other examples, processes 100A and 100B are implemented using only one client device or only multiple client devices. In processes 100A and 100B, some blocks can be optionally combined, the order of some blocks can be optionally changed, and some blocks can be optionally omitted. In some examples, processes 100A and 100B can be combined to implement additional...Add steps. Therefore, the illustrated operations (and described in more detail below) are exemplary in nature and should therefore not be considered limiting.

[0039] At block 102 of FIG1A, the system may acquire an executable batch record containing various information fields associated with a supply order. The acquired batch record may be executed as part of a packaging operation. At block 104 of FIG1A, the system may present a room assignment tab, which includes a user interface for the user to assign rooms for the packaging operation. At block 106 of FIG1A, the system may present a room cleaning tab, which includes a user interface for the user to complete a room cleaning checklist. At block 108 of FIG1A, the system may present a room setup tab, which includes a user interface for the user to complete a room setup checklist. At block 110 of FIG1A, the system may present an equipment setup tab, which includes a user interface for the user to complete the equipment setup procedure. At block 112 of Figure 1A, the system may present a packaging briefing tab including a user interface that includes information for a first user (e.g., an operator) to view and / or for a second user (e.g., a team leader) to brief. In one or more embodiments, the packaging briefing tab may be available for user completion upon confirmation that blocks 102 through 110 have been completed. At block 114 of Figure 1A, the system may present a temporary lot verification tab, which includes a user interface for users to verify whether the materials temporarily stored in the packaging room match the bill of materials (BOM) associated with the executing batch record (BRX). At block 116 of Figure 1A, the system may begin the packaging operation and display packaging instructions. One or more users may complete the packaging operation according to the packaging instructions. For example, one or more users may produce one or more output materials according to the packaging instructions included in the executing batch record. In some embodiments, users may capture one or more images of various steps in the packaging process and upload the images to the system. At block 118 of Figure 1A, the system may verify that the produced output materials are within check limits. At block 120 of Figure 1B, the system may end the packaging operation. At block 122 of Figure 1B, the system can generate an Electronic Executed Batch Record (EBR) for review. At block 124 of Figure 1B, the system can publish the Executed Batch Record (EBR) after review is completed. Each of these steps will be described in more detail below.

[0040] Embodiments of this disclosure provide a system and method for facilitating the completion of a packaging operation corresponding to an executing batch record. Embodiments of this disclosure may display a user interface including one or more tabs or pages for facilitating the completion of the packaging operation. According to embodiments of this disclosure, the user interface displayed to the user may include a progress bar,The progress bar includes a summary of one or more steps in the processing of the job and indicates the status of each of the one or more steps. Figure 1C illustrates an exemplary progress bar. As shown, the progress bar includes one or more segments, each segment corresponding to one or more steps in the packaging job, including: room cleaning, room setup, equipment setup, BRX (Batch Record in Progress) progress, packaging briefing, staging batch, verification, and packaging instructions. The progress bar may include more or fewer steps without departing from the scope of this disclosure.

[0041] In one or more examples, one or more segments may be color-coded to indicate the status of the corresponding step. For example, a green shaded segment may indicate that the step has been completed, a blue shaded segment may indicate that the step is in progress, and a white segment may indicate that the step has not yet started. If a step has received approval from one or more users as required by the system, the system can determine that the corresponding step has been completed. If a step has received user input about the step (e.g., the user has entered data or updated one or more fields of the user interface associated with the step), but the step has not yet received the necessary approval, the system can determine that the corresponding step is in progress. If the system has not yet received user input regarding a step (e.g., the user has not entered data or updated one or more fields of the user interface associated with the step), the system can determine that the step has not yet started.

[0042] In one or more examples, multiple segments of the progress bar may be in progress. For example, as shown, the BRX progress segment, packaging briefing segment, and temporary batch segment are in progress (e.g., shaded in blue), the room cleaning segment, room setup segment, and equipment setup segment are completed (e.g., shaded in green), and the check segment and packaging instruction segment have not yet started (e.g., shaded in white).

[0043] Referring to block 102 of FIG1A, the system can obtain an executable batch record (XBR) containing various information fields associated with a supply order. For example, the system can receive input from the user selecting the executable batch record to be performed for the packaging operation. Methods and systems for generating executable batch records are described in more detail in application number PCT / US2022 / 082479, filed December 28, 2022, which is incorporated herein by reference in its entirety.

[0044] Figure 2A illustrates an exemplary user interface showing an executable batch record obtained at block 102. It is noteworthy that the executable batch record may contain information associated with the preparation and packaging of output materials, such as reagent kits for clinical trials. That is, the system according to embodiments of this disclosure can be used to execute executable batch records to package output materials. For example, the executable batch record includes information such as packaging instructions, equipment sets, room allocation, and whether the study is ongoing.Blinding, etc. As shown in Figure 2A, the summary tab of the executable batch record can display various information fields, including but not limited to batch record name, customer name, project number, packaging site, medication type, reagent kit details, document version, associated executable batch record, unique identifier, packaging room name, additional remarks, status, study section, packaging type, blinding status, and pause status. The information types shown in Figure 2A are exemplary, and more or less information may be associated with the executable batch record without departing from the scope of this disclosure.

[0045] The executable batch record that can be displayed to the user is determined based on the user's permissions for a given site. As used herein, the user can correspond to an individual who assists in packaging output materials. The user can be associated with one or more roles, including but not limited to: operator, team leader, quality assurance personnel, etc. The user can also be associated with other roles without departing from the scope of this disclosure. The user's access permissions in the system can be determined in part based on their role. Access permissions can refer to one or more actions that the user is permitted to take in the system, such as, but not limited to, entering information and providing approval. In one or more examples, the user can be associated with a specific packaging site. For example, if a user is associated with a packaging site in Philadelphia, they may have access to executable batch records at the Philadelphia site, but not to batch records at another site (e.g., Kansas City). Therefore, the list of available executable batch records for the user to view would include executable batch records assigned to the Philadelphia site for packaging.

[0046] To view the desired executable batch records, the system may receive a selection from the user's "Home" dropdown menu on the user interface, and also a selection of the "Batch Records" option, as shown in Figure 2B. This opens the Batch Records tab. On this tab, the system may receive a user selection of the dropdown menu below "Batch Records," and a user selection of the "BRX-All" option, as shown in Figure 2C. Making this selection will display the approved executable batch records and their corresponding status (e.g., whether the batch record is available for execution and / or is in execution). In some embodiments, the system may allow the user to perform a search for a specific batch record. For example, the system may present a "Search" box, as shown in Figure 2D, where the user can enter an identifier associated with a batch record. The system can display search results via a user interface and receive user selections of batch records (e.g., a user can select and / or open a batch record for execution by clicking the name of the desired batch record), as shown in Figure 2E.

[0047] The selected batch record for execution can be changed from "Executable Batch Record" (XBR) to "Batch Record in Execution" (BRX). A batch record in execution refers to a batch record that is being executed during a packaging operation (e.g., a packaging job).Batch Records. Referring back to block 104 of Figure 1A, the system may present a room allocation tab, which includes a user interface for users to allocate rooms to packaging jobs. A packaging site may include multiple rooms for packaging output materials to complete an executable batch record. A packaging site may complete multiple packaging jobs spanning multiple days, and each packaging room is dedicated to a single corresponding packaging job at a time. Assigning a room to a specific packaging job avoids room conflicts and ensures that a new room allocation does not interrupt an ongoing packaging job. In addition to ensuring that a room is available for a packaging job (e.g., not assigned to another packaging job) or assigning a room to a packaging job in block 4, it may also include ensuring that the room includes the appropriate equipment to complete a specific executable batch record. Thus, room allocation ensures that the room assigned to an ongoing batch record is available for packaging and includes the necessary equipment to complete the executable batch record.

[0048] At a packaging site, each of the packaging rooms may be labeled with a room number and a barcode. The system may access data about the room via the system's master data. The master data may include information about the room setup, such as room handling conditions (including but not limited to temperature, humidity, and light conditions). The system's master data may also include information about the equipment available in the room. As used herein, the term "master data" can refer to data used to create and maintain information associated with one or more clients (e.g., companies running clinical trials). Master data may include, but is not limited to, client information, packaging site information (e.g., room setup), instruction sets, packaging instructions, equipment information, check limits, and studies.

[0049] In one or more examples, room assignment may be performed by one or more users. In some examples, room assignment may be performed by a user associated with a specific access right (e.g., a team leader). In one or more examples, the user performing the room assignment may select the Room Assignment tab within the selected batch record in execution at block 102, as shown in Figure 3A. Referring to Figure 3B, the Room Assignment tab may allow the user to check the availability of the room to be assigned to the batch record in execution. For example, the system may receive a barcode value associated with the room to check the availability. In some examples, the user may physically scan a barcode located outside the packaging room at the packaging site. In some examples, the user may manually enter the barcode associated with the packaging room. If the packaging room is currently assigned to another batch of records in progress, an error message will be displayed, as shown in Figure 3C. If the packaging room is available, the "Room Details" field will be displayed below the "Enter Barcode Value" text input box, as shown in Figure 3D. For each packaging room, one or more of the following fields can be displayed.The “Room Details” field includes: “Room Name”, “Room Barcode Value”, “Room Condition”, “Site”, “Status”, “Allowed Light Control”, and “Allowed Humidity Control”. Additional fields may be included without departing from the scope of this disclosure.

[0050] Referring to FIG3D, the system may receive user input indicating that the user has selected the “Check Batch” button. The system may then perform a room location lookup and display all materials currently in the packing room. Additionally, in some examples, the system may display a pop-up window showing all Bill of Materials (BOM) details for each output material associated with the packing room and its corresponding input(s) materials(s), as shown in FIG3E. The user can review the materials currently in the packing room and compare the materials in the packing room with the BOM details. If any(s) of the materials(s) displayed in the packing room should not be present in the room during the packing of the batch record being executed, the user can select the “Cancel” button to exit the room assignment. The user can then clear any materials in the packing room that are not needed for the packing operation or select a different room for the packing operation. In some embodiments, the user can add equipment to the room, for example, by physically introducing equipment into the room and updating the information in the system. If all materials displayed in the packing room can remain in the room during packing, the user can select the "Click Continue" button. Upon receiving the user's selection of the "Click Continue" button, the system can display an electronic signature page for the user to complete, as shown in Figure 3F. The user can confirm the room assignment and make an electronic signature to complete the room assignment process. For example, the system can attribute the electronic signature to the user by receiving user credentials and indicate that the room assignment has been approved. Figure 3G illustrates an exemplary room assignment tab after the system receives an electronic signature from the user who has completed the room assignment.

[0051] In one or more embodiments, the batch record in progress may already be associated with a packing room on the site before the room assignment is completed on the system. In such embodiments, the user can still complete the room assignment to ensure that the room is not associated with another packing job and / or that the room includes the appropriate equipment to complete the packing job for the batch record in progress.

[0052] In some embodiments, packing rooms may not be configured in the system. If no packing room exists in the system, the system allows the user to add a new packing room to the master data. To add a packing room, the system can receive a user selection of the "Home" drop-down menu on the user interface and also receive a selection of the "Room" option, as shown in Figure 3H. Referring to Figures 3I and 3J, the system can present a room tab, which includes a "New" button for adding new rooms. Upon receiving a user's selection of the "New" button, the system presents a "New Room" window with corresponding "Room Editable" and "Room Read-Only" buttons.The user availability is shown in Figure 3K. The system can then present a "New Room: Room Editable" window or a "New Room: Room Read-Only" window, which has various user availability fields, including but not limited to room name, site, room description, room barcode value, room condition, humidity control, and light control. If the user selects the "Room Read-Only" button, the system may allow the user to edit these user availability fields, as shown in Figure 3L. If the user selects the "Room Read-Only" button, the system may prevent the user from editing one or more fields associated with the packaged room. When the user selects the "Save" button on the window, the system can display an electronic signature page for the user to complete, as shown in Figure 3M. The user can then make an electronic signature (e.g., enter their user credentials) to add the new room to the master data. The system can then allow the user to assign the packaged job to the new room as described above.

[0053] Returning to block 106 of Figure 1A, the system can present a room cleaning tab, which includes a user interface for the user to complete the room cleaning. In one or more embodiments, room cleaning is performed upon completion of room assignment. Figure 4A illustrates an exemplary user interface for electronically completing the room cleaning process. As shown in Figure 4A, the room cleaning tab includes a first section and a second section, the first section including a text input box allowing the user to enter a work order number, and the second section providing a checklist. The checklist may correspond to instructions that the user should complete in order to clean the room and ensure that the room is clean for packing operations.

[0054] In one or more embodiments, the system may receive input from the user selecting the room cleaning tab for an ongoing batch record. The system may then receive entries from the user in a text input box corresponding to a work order number for an ongoing batch record. The system may then present the user with one or more steps associated with the checklist for the user to complete in order to clean the room (e.g., prepare the room for packing). As shown in Figure 4A, depending on the packing site where the user is located, the instructions may be presented in different languages. The system may complete the "room cleaning checklist" by receiving and saving the user's selection of "pass," "fail," or "N / A" responses for each step. If the response to one or more steps in the checklist is "failure," the system can display an error message, as shown in Figure 4B. The user can then resolve the error(s) by following standard operating procedures. To complete the room cleaning process, each step should have a "pass" or "N / A" response.

[0055] Once each step meets these criteria (e.g., "pass" or "N / A"), the system can receive approval from a first approver. In one or more embodiments, the first approver (e.g., an operator or team leader) may have a specific...Credentials associated with access permissions. The system may receive an electronic signature from a first approver to indicate that a checklist has been approved and completed. As used herein, receiving an electronic signature from a user may correspond to receiving user credentials (e.g., a user login identifier and a unique signature identifier associated with the user). In some embodiments, the system is configured to receive additional approval from a second user before room cleaning is completed. The second approval is performed by a second approver with specific access permissions (e.g., a team leader or operations quality assurance personnel) who independently performs a second verification of the room cleaning according to the steps of the checklist. For example, once the second approver has confirmed that all steps of the room cleaning tab meet the room cleaning criteria, the system may receive an option for “secondary approval” user availability. The system may then receive the second user’s credentials to approve and complete the room cleaning process.

[0056] In one or more embodiments, one or more devices at the packaging site are available to the first and second users to perform a batch recording process. In some embodiments, the devices may be available to multiple users to perform a batch recording process. In such embodiments, although the system may be logged into the first user’s account on the device, the electronic signature and / or approval may be entered by the second user. This is because the system attributes electronic signatures to users based on credentials received during the electronic signature process, rather than automatically attributing them to the user currently checking into the system. This feature allows packaging teams to work smoothly and collaboratively when using embodiments of this disclosure. For example, multiple users can attach their electronic signatures to steps in the approval batch record execution process without checking out of their current accounts. Allowing multiple users to enter their approvals without switching accounts saves time and simplifies the packaging process when multiple users share a device to perform batch records. For example, having a first user electronically sign, check out of the system, and then have a second user check in to approve steps is cumbersome and time-consuming. Therefore, by attributing electronic signatures to users based on credentials entered during the electronic signature process (rather than to the account used to complete the packaging operation), embodiments of this disclosure provide verifiable approval trails (e.g., regulatory compliance approvals), saving time in the packaging workshop and potentially contributing to more efficient packaging operations.

[0057] Referring back to block 108 of FIG1A, the system may present a room settings tab, which includes a user interface for the user to complete room settings. In one or more embodiments, room settings are performed when room assignment and room cleaning are completed. In one or more embodiments, the room settings process is completed once the room assignment and room cleaning processes have been completed. To initiate the room settings process, the system may receive a record of room settings selected by the user within an ongoing batch.The tab instructions are shown in Figure 5A. The system can display "Room Setup Checklist" and "Actual Packaging Status" on the Room Setup tab. The "Room Setup Checklist" provides the user with a checklist to confirm that the room has been correctly set up for batch recording during packaging. The "Actual Packaging Status" provides the user with an interface for entering information associated with the actual status of the room.

[0058] Regarding the "Room Setup Checklist," the system can present the user with one or more steps, and corresponding options for the user to select the response associated with the step. As shown in Figure 5A, the Room Setup tab can provide user availability corresponding to a "Pass" or "N / A" button for each step associated with the "Room Setup Checklist." The steps listed in the “Room Setup Checklist” may include one or more of the following check steps: “The color of the room status indicator outside the door has changed,” “The room is set up according to the temperature, humidity, and / or light conditions recorded for each batch,” “The appropriate pressure differential between the room and the external environment,” “The tables and chairs are set up for proper packaging operations,” “The room is set up for single-piece flow,” “The room is in a corrected state (e.g., cleaned for production),” “Special instructions have been implemented (e.g., wearing PPE),” and “Batch-specific log entries have been completed.” In some embodiments, the “Room Setup Checklist” may include more or fewer steps. As shown, in one or more embodiments, the “Room Setup Checklist” may be provided in one or more languages ​​depending on the location of the packaging operation. In one or more embodiments, the system may receive comments from a user regarding one or more steps in the “Room Setup Checklist.”

[0059] In one or more embodiments, as part of the room setup process, the system may receive information entered by the user regarding “Actual Packaging Condition,” as shown in FIG5B. For example, “Actual Packaging Condition” may include one or more user availability options for selecting a temperature range and / or temperature conditions. In some embodiments, one or more user availability options may relate to humidity and / or light conditions. In one or more embodiments, the user interface may provide a text input box for the user to indicate the actual packaging condition.

[0060] Referring to FIG5C, the system may receive comments entered by the user regarding the room setup process. For example, in one or more embodiments, the system may receive the selection of the "Enter Comment" user availability shown in FIG5A. This may result in a "Comment" pop-up, as shown in FIG5C. As shown in FIG5C, the comment pop-up may include a text input box (where the user can enter comments associated with the room setup process) and / or user availability (where the user can indicate whether the setup is blind or non-blinded).

[0061] In one or more embodiments, each comment may be saved to the execution process once the comment is electronically signed off.In the batch record. That is, a user who enters a comment can (e.g., by entering their user credentials) attach their electronic signature to the comment so that the comment is saved to the batch record in progress. For example, referring to FIG5C, the system receives the user's input of "actual packaging condition", blind status and / or comment, and the system may receive an indication that the user has selected "electronic signature" user availability. The system may then present the user with one or more text input boxes to enter the user login ID, personal signature identifier and / or any additional comments, as shown in FIG5D. The system may receive user credentials and / or comments as part of approving the comment. In one or more examples, the electronic signature pop-up illustrated in FIG5D is exemplary and may be similar to other electronic signature pop-ups described herein. Specification 10 / 26 pages 14 CN 121605482 A

[0062] In one or more embodiments, even if the system may be logged into the first user's account, the comment may still be entered and checked out by a second user. This is because the system will attribute the comment to a user based on the credentials received during the electronic signature process, rather than automatically attributing the comment to the user currently checking into the system. This feature allows packaging teams to work smoothly and collaboratively when using embodiments of this disclosure. For example, multiple users can attach their electronic signatures to comments and / or approvals on steps of the execution process for a batch record without checking out of their current accounts. That is, in some examples, certain steps of the packaging process may solicit check-outs from multiple users (e.g., operators and team leaders). Having a first user electronically sign off, check out of the system, and then have a second user check in to approve the steps is both cumbersome and time-consuming. Therefore, by attributing electronic signatures to users (rather than accounts used to complete packaging runs) based on credentials entered during the electronic signature process, embodiments of this disclosure provide a verifiable approval trail that saves time in the packaging workshop and can contribute to more efficient packaging runs.

[0063] Referring back to block 110 of FIG1A, the system may present an equipment settings tab, which includes a user interface for users to complete equipment settings. In one or more embodiments, equipment settings are performed when room allocation, room cleaning, and room setup are completed. Equipment settings may be used to add equipment to an executing batch record. The system may include equipment in master data, which may be associated with a packaging run of an executing batch record. As shown in Figure 6A, the fields associated with the equipment may include, but are not limited to: brand and model, equipment name, asset number, site using the equipment, approval status, and equipment barcode.

[0064] Referring to Figure 6B, in order to add equipment to the batch record in execution, the system can receive a user selection on the equipment settings tab of the user interface. Then, the system can add the equipment via a text input box corresponding to the "Add Equipment" user availability.The system receives user input, as shown in Figure 6C. In some embodiments, the system may receive barcode values ​​by scanning and / or capturing an image of the equipment barcode of the desired equipment to be added (e.g., equipment located in an assigned packing room). For example, if the device used by the user includes a camera, the device may capture an image of the barcode deployed on the equipment to identify the equipment in the system. In some embodiments, an error message may occur if the scanned equipment is not properly registered on the platform and / or is not associated with an ongoing batch record. In one or more embodiments, if the scanned equipment is not associated with an ongoing batch record, the system may allow the user to manually add the equipment to the ongoing batch record. In one or more embodiments, the user may also remove equipment associated with an ongoing batch record (e.g., if the equipment is unavailable and / or unused during packing operations).

[0065] As shown in Figure 6D, if the scanned equipment is registered, the system may display a “Scan Equipment Details” pop-up window. The system may then receive an indication that the user has selected the “Add” button to confirm adding the equipment to the ongoing batch record. The system may also receive an electronic signature from the user as described above. In some embodiments, the addition of equipment can be approved by a second user (e.g., a team leader) with a predetermined access status. In one or more examples, the second user can select the "Approval Required" user availability, which will cause the system to display a "Supervisor Approval" pop-up window as shown in FIG6E. The system can display an electronic signature pop-up window as shown in FIG6F and receive the second user's credentials to complete the equipment setup process. As discussed above, in one or more embodiments, the second user can use the same electronic device as the first user to make an electronic signature without logging out of the first user's account.

[0066] In one or more embodiments, each piece of equipment to be used in a packaged run for an ongoing batch record can be added as described above. When the equipment setup is complete, the corresponding equipment setup document can be added to the list of approved equipment associated with the ongoing batch record. An exemplary list of equipment added to the batch record is shown in FIG6G.

[0067] In one or more examples, the system can allow the user to attach one or more documents to a piece of equipment during equipment setup. In such examples, the system can receive the user's selection of the attachment icon under the "Equipment Setup" column. In response to this selection, the system can open a pop-up window for file attachments, as shown in Figure 6H. As shown in Figure 6I, the system can receive the user's selection of the appropriate file type, receive the uploaded file, receive a "yes" or "no" selection regarding whether the file "contains non-blind information," and receive an electronic signature from the user. In one or more embodiments, the file can be stored locally on the electronic device.Access can be made via the cloud. The system can then save the equipment setup document to the corresponding equipment on the executing batch record.

[0068] In one or more embodiments, each piece of equipment can be assigned to an "equipment group". An equipment group can refer to a type of equipment, such as an "induction sealing machine". An "equipment group" can be added during the creation of an executable batch record and can be displayed on the equipment setup tab in the user interface of the executing batch record. If an "equipment group" added during the creation of an executable batch record is determined to be non-essential for completing the executing batch record, it can be removed upon receiving electronic signatures from two approvers with appropriate access rights (e.g., as described above, receiving approvals from the operator and supervisor). If an "equipment group" is not added during the creation of an executable batch record, but it is determined that a specific equipment group should be used to complete the packaging operation for the executing batch record, the specific equipment group can be added during the execution of the batch record upon receiving electronic signatures from two approvers with appropriate access rights. Figure 6J illustrates an exemplary pop-up window for adding an "equipment group" to an executing batch record.

[0069] Referring to block 112 of FIG1A, the system may present a packaging briefing tab including a user interface that includes information about the packaging process for review by a first user (e.g., an operator) and / or for presentation by a second user (e.g., a supervisor or team leader). In some examples, one or more operators may be presented with the packaging briefing tab and complete the briefing process. In such examples, a user with specified access rights (e.g., a team leader) may check out or otherwise approve that one or more operators have completed the packaging briefing. Referring to FIGS. 7A and 7B, the packaging briefing tab may include an instruction page and a summary page. The instruction page may include multiple packaging instructions associated with the batch record being executed. The summary page may include a summary that includes a list of users (e.g., operators) who received the briefing and the date and / or time of the briefing.

[0070] To complete a packaging briefing, the system may receive an indication that a user has selected the packaging briefing tab for the batch record being executed, as shown in FIG7C. Referring to FIG7D, the packaging briefing tab may allow the user to select user availability (e.g., “Start Briefing”) to initiate the packaging briefing process for the batch record being executed. In one or more examples, the system may display various fields that a second user (e.g., a team leader) and the user receiving the briefing (e.g., an operator) can review together as part of the packaging briefing process. Figure 7E illustrates some exemplary fields. These fields may include, but are not limited to: sequences, packaging instructions, packaging status requirements, work order and / or BOM details, important notes, and other attachments. Additional fields may be included without departing from the scope of this disclosure. When a second user (e.g., a team leader) sends a briefing to one or more...After a first user (e.g., an operator) completes a presentation, each of the first users can electronically sign to indicate that they have completed the presentation.

[0071] Once one or more first users (e.g., operators) have completed the review and electronic signature of the presentation for the batch record in progress, a second user (e.g., a team leader) can electronically sign by selecting the “Team Leader Electronic Signature” button on the summary section, as shown in FIG7F. This approval by the supervising team leader is used to confirm that one or more operators have completed the packaging presentation. Referring to FIG7G, upon receiving electronic signatures from the team leader indicating that one or more operators have completed the packaging presentation, the system can display a list of users who have completed the packaging presentation in the summary section of the Packaging Presentation tab.

[0072] Returning to block 114 of FIG1A, the system can present a Temporary Batch Verification tab, which includes a user interface for users to verify whether the materials temporarily stored in the packaging room match the Bill of Materials (BOM) associated with the batch record in progress. In one or more examples, the system may receive a staging batch verification tab within the executing batch record selected by a user (e.g., an operator) at block 102, as shown in Figure 8. Once the input materials are staging in the packaging room, the user can select “Refresh” user availability, highlighted in Figure 8. Selecting the “Refresh” button allows the system to retrieve information from external resources (such as, but not limited to, JD Edwards). In some embodiments, external resources may include information concerning the bill of materials and available and / or allocated supply batches for the packaging run. If the staging input materials match the BOM, no action is required, and the staging input materials may appear in the executing batch record in an “Approved” status. If the staging input materials do not match the BOM, the system displays the option to “Accept” the mismatched(one or more) input materials (i.e., add(one or more) input materials to the executing batch record) or “Reject” the mismatched(one or more) input materials. For example, if the item number, supplier batch, and / or customer batch number do not match those listed in the BOM, the system may mark the material as mismatched. For each input material, selecting "accept" or "reject" may require an electronic signature from a user with specific access permissions (e.g., a team leader).

[0073] Once the user who has completed the temporary batch verification has added each input material to the batch record in progress, the system can receive approval from the first approver. In one or more embodiments, the first approver (e.g., a team leader) may have credentials associated with specific access permissions. The system can receive the first approver's electronic signature to confirm each...The status of each input material (e.g., “approved,” “accepted,” or “rejected”). In some embodiments, the system is configured to receive additional approval from a second user before completing the temporary batch verification. The second approval may be performed by a second approver with specific access permissions (e.g., a quality assurance operator), who can independently confirm the status of each input material. The system may receive the second approver’s electronic signature to complete the temporary batch verification process.

[0074] Referring back to block 116 of FIG1A, the system may begin a packaging job and display packaging instructions. For example, the system may present a job actions tab, which includes a user interface for users to perform actions related to the packaging job (e.g., start a packaging job). In some examples, a user with specified access permissions (e.g., a team leader) may begin a packaging job. FIG9A illustrates an exemplary user interface for starting a packaging process. In one or more examples, a user starting a packaging job may select a “Start Packaging” button located on the job actions tab. The system may prompt the user to make an electronic signature to confirm that the packaging job has started. In some embodiments, the system may not approve the start of a packaging job if the access permissions of the user entering the electronic signature do not match the specified access permissions.

[0075] At any point in time after the start of the packaging operation and before the end of the packaging operation, if there is a suspected or known quality event that could affect the safety, quality, identification, potency, and / or purity (SQuIPP) of the material, the batch record in operation can be placed on execution pause. If an in-process batch record is placed on execution pause, it will become read-only until the execution pause is lifted. In some examples, a user with first designated access rights (e.g., a team leader or quality assurance operations manager) can set the execution pause. In one or more examples, the user setting the execution pause can select the "Execution Pause" button on the job action tab, as shown in Figure 9A. The system can receive an electronic signature from the user as confirmation that the in-process batch record should be placed on execution pause. The system can then change the status of the packaging operation from "In Progress" to "Execution Pause". In some examples, a user with second designated access rights (e.g., a quality assurance operator) can lift the execution pause. In one or more examples, to lift the execution pause, the system can receive a user selection of the "Release Execution Pause" button on the job action tab. The system can then receive an electronic signature from the user to confirm the in-process batch record that should be removed from the execution pause. The system can change the job status of a packaging operation from "Execution Paused" to "Executing". In some embodiments, if the access permissions of the user entering the electronic signature do not match the specified access permissions, the system may not approve the execution pause and / or lift the execution pause of the packaging operation. (Instruction manual, 13 / 26 pages, 17 CN 121605482 A)

[0076] At any point in time after the start of a packaging operation and before its end (e.g., between shifts, at the end of the day, or during a break / lunch break), if no packaging activity is currently taking place, the ongoing batch record can be placed on an operation pause. In some examples, a user with specified access permissions (e.g., a team leader) can set and unpause the operation. In one or more examples, the system can receive a user selection of the "Pause Operation" button on the Job Actions tab shown in Figure 9A to pause the packaging operation. In one or more embodiments, this operation pause can be based on a timer (e.g., not shown) displayed on the Job Actions tab. The system can prompt the user for an electronic signature to confirm that the ongoing batch record should be placed on an operation pause. The job status of the packaging operation can be changed from "In Progress" to "Operation Paused". In one or more examples, the system can receive a user selection of the "Unpause Operation" button on the Job Actions tab to unpause the operation. Then, the user can electronically sign to confirm that the ongoing batch record should be removed from the operation pause. The job status of the packaging operation can be changed from "Operation Paused" to "In Progress". In some embodiments, if the access permissions of the user entering the electronic signature do not match the specified access permissions, the system may not approve the operation suspension and / or release the operation suspension of the packaging job.

[0077] Upon receiving an indication that the packaging job has started, the system may be configured to display packaging instructions to the user. For example, the system may present a packaging instructions tab, which includes a user interface for displaying and executing packaging instructions to the user. In some examples, the packaging instructions may be optionally displayed to users with specified access permissions (e.g., operators or team leaders). In one or more examples, a user who has completed a packaging briefing (e.g., an operator) will be able to view the packaging instructions. If the user has not yet completed a packaging briefing, the user is prompted to complete the packaging briefing before the system displays the packaging instructions.

[0078] In one or more examples, the system may receive a user selection of a packaging instructions tab for an ongoing batch record, as shown in FIG9B. In some cases, as shown in FIG9C, the system may display the packaging instructions as a slideshow on the screen, with each instruction and its corresponding image (if applicable) shown one by one. The packaging instructions can be forwarded, backwarded, paused, and stopped by selecting the applicable icon, as shown in FIG9D. In some embodiments, the system may display each instruction for a set amount of time (e.g., five seconds). However, the system can increase or decrease this display time by receiving user input to adjust the time bar, as shown in Figure 9E. In such embodiments, when a step of the packaging instruction is displayed, the user can perform that step according to the instruction. The system can then receive the user's electronic signature to confirm the completion of the step. The electronic signature may contain...Fields, including but not limited to the user's name and a timestamp of the electronic signature. In one or more embodiments, the instructions may be displayed in list form, as shown in FIG9F. In such embodiments, the system may allow the user to scroll through each step and receive an electronic signature from the user when the user completes the corresponding step.

[0079] In one or more embodiments, as part of executing packaging instructions, the system may prompt one or more users performing the packaging job to capture images of one or more steps of the packaging job during execution in the packaging room. For example, one or more steps in the packaging instructions may include a prompt requesting the user to capture images to document that the corresponding step has been completed. In such embodiments, the system may capture or receive images of the packaging job after the packaging job has started (e.g., as part of block 116 of FIG1A).

[0080] As shown in FIG9G, the system may present an image capture tab, which includes a user interface for the user to capture images. As shown, packaging instructions may be displayed sequentially on the image capture tab. The system may provide the user with options to capture and attach images associated with each packaging instruction. In some examples, image capture may be performed by a user with specified access rights (e.g., an operator, team leader, or quality assurance operator). The system can capture images on a local device (e.g., an electronic device used by a user performing a packaging task) or a camera associated with the system. In an example, the system may present a "camera" button to the user and receive images captured by the user from a local device or camera. For example, the user can view packaging instructions on a tablet or mobile device. Images can also be captured using the same tablet or mobile device. In one or more embodiments, the system can receive images uploaded from an external device or camera. In an example, the system may present a "file upload" button to the user and receive uploaded images captured on an external device or camera.

[0081] FIG9H illustrates an exemplary user interface that allows a user to select a specific image to attach to a particular packaging instruction. If relevant images associated with each relevant packaging instruction have been added, the user can review all images for each instruction and select the "electronic signature" button. Upon receiving the user's selection of the "electronic signature" button, the system may display an electronic signature page for the user to complete. The user can then confirm the image capture and provide their credentials to the system to complete the electronic signature. In the example, after receiving an electronic signature from a first user, the system can display another electronic signature page for a second user to complete. The second user can then independently review the captured image for each instruction, confirm the image capture, and provide their credentials to the system to complete the electronic signature. In one or more embodiments, the system can obtain signatures from users with different instructions.At least two signatures from users with access permissions are required to save the image to the packaging instructions.

[0082] Referring back to block 118 of FIG1A, the system may present an input check tab, which includes a user interface for users to verify whether the quantity of input materials is within its respective check limits. FIG10A illustrates an exemplary input check tab and associated user interface for completing the input check process electronically. As shown, when materials are approved at step 114, materials that have been temporarily stored during the temporary batch verification can be displayed in the input check tab. Input materials are grouped by their respective output materials. In one or more examples, one or more of the following input material fields may be displayed for each input material, as shown in Table 2: Table 2.

[0083] In one or more examples, one or more values ​​associated with the bill of materials may be automatically populated on the input check tab based on information stored at an external resource (e.g., JD Edwards). For example, these values ​​may include, but are not limited to, BOM quantity, quantity issued, and quantity consumed. In such examples, if a user determines that one of these values ​​associated with the bill of materials is not corrected, the user can update these values ​​by accessing an external resource. For example, the system can navigate to and / or open a pop-up window corresponding to the external resource for the user to update these values.

[0084] In one or more examples, after a user produces a certain quantity of output materials based on packaging instructions (e.g., packaging one or more kits based on packaging instructions), the user can use the system's input check tab to verify that the quantity of packaging materials is within a predetermined check target. For example, the system can receive input from the user that the input check tab has been selected. The system can display a user interface corresponding to the input check tab as shown in Figure 10A. At the input check user interface, the system can receive an indication of an edit icon for the output materials selected by the user. The system can receive and save the data entry for "Production Quantity" from the user. The system can receive and save the data entries for each of "Input Rejection Quantity," "Sample Quantity," and "Return Quantity." In one or more examples, the system can automatically calculate the "Check Percentage" (e.g., corresponding to the calculated check value) and display the value in the appropriate field.

[0085] If the calculated check value is within a predetermined check limit, the calculated check value is displayed in green. For example, referring to Figure 10A, the input material has a BOM quantity of 4, an issue quantity of 10, and a consumption quantity of 4. As shown, the system has received a return quantity of 6 from the user. This provides a calculated check value of 100 (e.g., check percentage). Since this value is between the predetermined check limit (99.7–100.3), the calculated check value appears in green text. In one orIn several examples, the check limit (e.g., check target) may correspond to a check target determined as part of the executable batch record.

[0086] If the calculated check value exceeds the check limit, the calculated check value is displayed in red. For example, referring to Figure 10B, the BOM quantity of the input materials is 4, the quantity issued is 10, and the quantity consumed is 4. As shown, the system has received a return quantity of 5 from the user. This provides a calculated check value of 90% (e.g., check percentage). Since the calculated check value exceeds the check limit of 99.7–100.3, the calculated check value may be displayed in red, and / or the system may display a warning pop-up banner indicating "Check percentage is not within the limit".

[0087] The system may receive data entries (e.g., based on the bill of materials) for each of the input materials displayed on the Input Check tab. In one or more examples, a check is performed for each temporary batch. For example, if the same input material is used in three different staging batches, the user interface will present a separate input material check entry for each of the staging batches. This allows the check to be performed on a basis consistent with a batch-organized inventory record stored by an external resource. The system allows multiple input material checks to be completed. Each check is captured in the check history.

[0088] Once the system has calculated the input check, the system can receive a first approval from a first approver (e.g., an operator or quality assurance operator) with first access rights. For example, the first approver can review the check, and the system can receive a user selection corresponding to the "Approve" button. In response to the user selection of the "Approve" button, the system can present an electronic signature pop-up window for the first user to review and sign. When the first approval is completed, the system can display a "Pending Second Approval" message. In some embodiments, the corresponding input material may not be edited before the second approval is performed. The second approval may be performed by a second approver with an operator or quality assurance operator role. The second approver can review the check, and the system can receive a second user selection of the "Approve" button. In response to a second user selection of the "Approve" button, the system may present an electronic signature pop-up for the second user to review and sign. In one or more examples, if the calculated verification value exceeds a predetermined verification limit, the system may request additional approval from a user with second access rights (e.g., a team leader).

[0089] An electronic signature process for having multiple user approvals and / or signatures can be substantially similar to the electronic signature process described above. For example, in response to receiving a selection of the "Approve" button from a user, the system may present the user with one or more text input boxes (page 16 / 26 of specification 20 CN 121605482 A) to enter the user login ID, personal signature identifier, and / or any additional comments. In one or more embodimentsIn this case, even if the system is logged into the first user's account, the approval and / or electronic signature may still be attributed to the second user. This is because the system attributes comments to users based on credentials received during the electronic signature process, rather than automatically attributing comments to the user currently checked into the system. This feature allows packaging teams to work smoothly and collaboratively when using embodiments of this disclosure. For example, multiple users can quickly and sequentially attach their electronic signatures to the steps of the approval batch record execution process without checking out of their current accounts. For example, as with approvals to verify limits, the system can request approvals from multiple users. Having the first user electronically sign, check out of the system, and then have the second user log in for approval verification is both cumbersome and time-consuming. Therefore, by attributing electronic signatures to users (rather than the account used to complete the packaging operation) based on credentials entered during the electronic signature process, embodiments of this disclosure provide verifiable approval trails, which save time in the packaging workshop and can contribute to more efficient packaging operations.

[0090] Referring back to block 120 of FIG1B, the system can receive instructions from users to end the packaging operation. For example, the system can receive user input corresponding to a selection of a job action tab. Referring back to FIG9A, at the job action tab, the system can present a user interface for the user to perform actions involving a packaging job (e.g., ending a packaging job). In some examples, the packaging job can be ended by a user with specified access rights (e.g., a team leader). In one or more examples, the user ending the packaging job can select a "End Packaging" button located on the user interface corresponding to the job action tab. In some embodiments, the system can prompt one or more users to electronically sign to approve the end of the packaging job.

[0091] Referring back to block 122 of FIG1B, the system can generate an electronic executed batch record (EBR) for review. In one or more examples, after checking and / or ending the packaging job, the system can convert the executing batch record (BRX) into an electronic executed batch record (EBR). The executed batch record can reflect one or more comments, notes, updates, and / or actions taken regarding the batch record during execution (e.g., the packaging process).

[0092] The executed batch record may be subject to both technical and quality reviews by various users. Executed batch records can be accessed for review by navigating to the Job Actions tab (e.g., the Job Actions tab shown in Figure 9A) and selecting the "Operation Pause and Remove History" button. The system can present a drop-down menu that includes the "Detailed Executed Batch Records" user option, as shown in Figure 11A. Upon receiving this user option selection, the system can present a pop-up window, as shown in Figure 11B, allowing the user to choose whether to view the blinded or unblinded version of the detailed executed batch records. Selecting the blinded version allows the user to review the executed batch records.The blinded version of the execution batch record will include one or more revision fields associated with the blinding information. Figure 12 shows an exemplary excerpt of an executed batch record from blinding according to one or more embodiments of this disclosure.

[0093] In some embodiments, a user with first designated access rights (e.g., a production reviewer) can select an electronic executed batch record for technical review. The technical review may cover the completeness and organization of the batch record as recorded on the batch record content page, and does not need to be an independent review (i.e., a user involved in the packaging operation can also participate in the technical review). Corrections can be made at any point during the review process. In some embodiments, errors or omissions may be corrected by one or more users responsible for the initial entry of the error or omission data. In some embodiments, a second user (e.g., a user not responsible for the error data) may also make corrections. In one or more examples, for completeness and accuracy, the user performing the review can read through the contents of the electronic executed batch record, including any previous user approvals.

[0094] In some embodiments, the system may display an “Electronic Executed Batch Record Checklist” to support user review. The steps listed in the “Electronic Performed Batch Record Checklist” may include one or more of the following check categories: “Batch Record Overview,” “Approval,” “Summary,” “Content,” “Production Line Cleanup,” “Start and End of Production,” “Bill of Materials,” “Materials Temporary Storage,” “Equipment,” “Briefing,” “Labeled Samples,” “Packaging Instructions,” “In-Process Control Checklist,” “Verification,” “Batch Record Comments,” “Corrections,” “Blinded Inspection,” “Batch Record Materials,” “Packaging Certificates,” “Deviations and Comments,” and “Other Items.” In some embodiments, the “Electronic Performed Batch Record Checklist” may include additional categories. In some embodiments, the “Electronic Performed Batch Record Checklist” may include one or more user availability options for completing a technical review and one or more user availability options for completing a quality review. When completing one or more user availability options for the technical review of the “Electronic Performed Batch Record Checklist,” the user may enter an electronic signature to confirm that the electronic performed batch record has been fully reviewed. The user may select the “Submit Review” button on the job action tab to end the technical review and submit the electronic performed batch record to the quality review process.

[0095] In some examples, a user with a second designated access right (e.g., a quality assurance personnel) can select electronically executed batch records for quality review. The quality review can cover the completeness, accuracy, and regulatory compliance of the batch records, and can be an independent review (i.e., the user or operator involved in the packaging operation cannot participate in the quality review).The system can provide users performing quality reviews with an “electronically executed batch record checklist,” which, if completed during a technical review, may include one or more user availability options to complete the quality review. If a user performing a quality review identifies a problem, the user can request corrections from one or more users with relevant access rights (e.g., team leaders and / or operators). Once the system receives all identified corrections, it can receive a user selection of the “Submit Review History” button on the job action tab. The system can display an electronic signature user interface to allow one or more users to electronically sign to complete the quality review.

[0096] The electronic signature process can be substantially similar to the electronic signature process described above. For example, in response to receiving a selection of the “Approve” button from a user, the system can present the user with one or more text input boxes to enter a user login ID, personal signature identifier, and / or comment. In one or more embodiments, even if the system is logged into a first user's account, the approval and / or electronic signature may still be attributed to a second user. This is because the system attributes approvals to users based on credentials received during the electronic signature process, rather than automatically attributing comments to the user currently logged into the system. This feature allows packaging teams to work seamlessly and collaboratively when using embodiments of this disclosure. For example, multiple users can attach their electronic signatures to approve executed batch records without having to sign out of their current accounts. For example, the system can request approvals from multiple users. Having a first user electronically sign, sign out of the system, and then have a second user sign in to approve the executed batch record can be cumbersome and time-consuming. Therefore, by attributing electronic signatures to users (rather than the accounts used to complete packaging operations) based on credentials entered during the electronic signature process, embodiments of this disclosure provide a verifiable approval trail, which improves efficiency.

[0097] Referring back to block 124 of FIG1B, the system can publish the executed batch record (EBR) upon completion of technical and quality reviews. Where applicable, the system can permit users to perform additional actions at this step, including but not limited to changing the product's expiration date, requesting a qualified person (QP) to perform additional reviews of the electronic executed batch record, obtaining customer corrections and / or approvals, and completing compliance certifications. The published executed batch record can summarize information received by the system from various user interface tabs. In some embodiments, the published executed batch record may correspond to the executed batch record reviewed at block 122. In one or more embodiments, while both blind and unblinded versions of the executed batch record may be generated, the blind executed batch record may be published and shared with the client, while the unblinded executed batch record may not be published or shared with the client.

[0098] Referring back to the exemplary processes 100A and 100B in Figures 1A and 1B, the system can perform additional operations in conjunction with processes 100A and 100B. These operations may include, but are not limited to: completing the in-process checklist (IPC) for a packaging operation, receiving target values ​​for steps in the IPC, recording sample data from the packaging operation, entering comments about the packaging operation, editing batch records, canceling the execution of batch records, and adding attachments to batch records. Specification 18 / 26 pages 22 CN 121605482 A

[0099] In one or more embodiments, after room cleaning is completed and before the start of the packaging operation (i.e., between blocks 106 and 116 in Figure 1A), the system may allow the user to perform actions associated with one or more in-process checklists (IPCs). In-process checklists may typically involve checking input materials during the packaging operation. For example, IPCs may be used to verify blister integrity (e.g., the integrity of blister packaging), sensor seals on bottles, material counts as specified in the batch record, etc. General IPCs may be configured as part of the master data on the system. The IPC tab allows users to select, add, and / or update checklists during the process and associate IPCs with batch records in progress. In one or more examples, the checklist can be configured to be performed by one or more users at the beginning, during, or near the end of the packaging process.

[0100] FIG13A illustrates an exemplary IPC tab according to an embodiment of the present disclosure. The system can present an IPC tab and display a corresponding IPC user interface for users to configure one or more IPCs. In an example, the system can associate instructions with batch records in progress by receiving a user selection of an existing set of instructions associated with a batch record in progress or by a user selection of a “Select Instruction Set” option. The “Select Instruction Set” option will allow the user to add one or more instruction sets from master data.

[0101] In one or more examples, an IPC can be associated with one or more target values. For example, a step in the checklist can be associated with a specific value or range of values, such as verifying that the count of each bottle of Chinese medicine tablets is as specified in the batch record in progress. As shown in FIG13A, the system can present a “Target Value” text input box for receiving IPC target values ​​entered by the user. For example, a user can enter the number of tablets to be included in each bottle as specified in the batch record. The system can receive user input corresponding to the user selecting the "Target Value Approval" button to indicate that a target value has been entered. The system can then display an electronic signature page to receive the user's electronic signature, thereby approving the user-entered target value. The system can repeat any of the above steps to receive IPC target values ​​for any additional (one or more) IPCs from the "Select IPC" drop-down menu. In one or...In several embodiments, the IPC target value may typically be associated with a checklist and in updating and saving master data. In one or more examples, the IPC target value may be associated with a specific batch record in execution and may not be saved to master data.

[0102] The system may receive a user's selection of a specific IPC and display the IPC to be completed. In some embodiments, the user may additionally enter a work order number in a "Work Order" text input box. As shown in FIG13A, the system may display various input fields, including but not limited to "Number of Samples Received", "Container ID", "Reagent Kit Details", "Label", "Actual Value", and "Result" (e.g., "Pass", "Fail", or "N / A"). The fields shown in FIG13A are exemplary, and more or fewer fields may be displayed and / or associated with IPCs without departing from the scope of this disclosure. The system may receive input values ​​from the user corresponding to one or more of these fields. For example, under the "Actual Value" column, for a specific step in the checklist, the user may enter the observed actual value and / or indicate the result, such as whether the step passed, failed, or N / A, in the corresponding text box. For each step of the IPC, the system may request approval. Once the system receives input for each of the input fields, it can activate the "IPC Approval" button to receive the user's approval and electronic signature. The system can display the approved IPCs in the IPC Summary tab, as shown in Figure 13B.

[0103] If the actual value entered in the IPC exceeds the target value set by the user, the system can prevent the user from completing another IPC. In the example, on the IPC tab, the system can display the "Fault Check Approval" button and the corresponding error message (as shown in Figure 13C) until a user with specific access rights (e.g., a quality assurance operator) provides input confirming that the fault has been resolved. Upon receiving the user's selection of the "Fault Check Approval" button, the system can receive the user's approval and electronic signature. The system can then allow the user (or other user) to complete another IPC.

[0104] In some embodiments, an IPC checklist can be added to the batch record in progress. In some embodiments, as described on pages 19 / 26 of CN 121605482 A, the IPC checklist can be added to the batch record in progress before or after packaging has begun (e.g., block 116). For example, if an operator in the packaging workshop determines that a new checklist should be generated, an IPC can be associated with an ongoing batch record to be completed as part of a packaging run. To add an IPC to an ongoing batch record, the system can present a "select instruction" to a user with specific access permissions (e.g., a team leader or operations quality assurance personnel).The system includes a "Collection" text input box that allows users to search for IPCs to add; an "Add" button that allows users to select IPCs to add; and an "Add Second Approval" button, as shown in Figure 13D. The system can then display an electronic signature page to receive the user's electronic signature. Upon receiving the user's electronic signature, the system can display a "Second Approval Required" notification, as shown in Figure 13E. If the user selects the "Add Second Approval" button, the system can display a pop-up window with fields, including but not limited to the IPC name and approval status, as shown in Figure 13F. Upon receiving the user's selection of the IPC to be approved, the system can display an electronic signature page to receive the user's electronic signature. The electronic signature process can be similar to the electronic signature process described above. In some examples, the second approval can be associated with specific access permissions (e.g., a quality assurance operator or team leader).

[0105] In the example, the system can present the user with options to mark an IPC as "unnecessary" for an ongoing batch record. For example, in the IPC tab, the system can display an "Unnecessary" button near the "Select IPC" drop-down menu, as shown in Figure 13G. After receiving the user's selection of an IPC to be marked as "unnecessary," the system can display a "Marked as Unnecessary" notification associated with the selected IPC, as shown in Figure 13H. Figure 13I illustrates the IPC summary user interface, which displays a list of each of the IPCs associated with an ongoing batch record.

[0106] In one or more embodiments, the executable batch record may specify one or more samples to be obtained from the packaging run. For example, the executable batch record may specify four samples to be obtained from the output material, two of which should be reserved for the customer and two of which should be retained at the packaging site as a quality assurance measure or for future packaging run reference. The system may receive input from the user indicating that the user has obtained one or more samples according to the executable batch record. For example, as shown in Figure 14A, the system may present a Samples tab, which includes a user interface for the user to enter sample data from the packaging operation. If the sample is specified as output material, the system may present "Sampling" below the applicable output material. The system accepts a "Sampling" button to receive sample data entered by the user. If the user selects the "Sampling" button, the system can then present the user with various input fields for the sample data, including but not limited to "Sampling Quantity," "Sample Batch #," and "Additional Remarks," as shown in Figure 14B. The fields shown in Figure 14B are exemplary and may be associated with more or less information about the sample data without departing from the scope of this disclosure. As shown, the sampling user can enter an electronic signature to input sample table data into the system. The system can then record the sample data and display the user's initials and the timestamp of the entry on the sample tab. The system can repeat any of the above steps to record sample data for any applicable output material.

[0107] In one or more embodiments, the system may record user comments during batch recording execution. The system may record user comments on various tabs of an exemplary user interface, including but not limited to Room Assignment, Room Cleaning, Room Setup, Equipment Setup, Temporary Batch Validation, Packaging Briefing, Input Checklist, Sample, IPC, Packaging Instructions, and Image Capture. These tabs are exemplary, and more or fewer tabs may be associated with user comments without departing from the scope of this disclosure. On each tab, the system may present an "Enter Comment" button for the user to select. Upon receiving a selection, the system may display a "Field Checkbox" near an available field where a comment can be entered. The system receives the user selection of the "Field Checkbox" and presents an "Add Comment" window to the user. Figure 15 illustrates an exemplary "Add Comment" window. The "Add Comment" window may include, but is not limited to, the following pre-populated fields associated with the selected "Field Checkbox": "Record Name", "Record Field", and "Field Value". Additionally, on the "Add Comment" display, the system may receive comments entered by the user, who can mark the comments as "blinded" or "unblinded". The system can display any comments marked "unblinded" in the electronic execution batch report. The system can revise any comments marked "blinded" in the blinded version of the electronic execution batch report. In response to a user selection to receive an electronic signature button, the system can display an electronic signature page to receive the user's credentials. The system can repeat any of the above steps to enter user comments on any applicable tab.

[0108] The system can display user comments under their respective "Entered Comments List" section for each tab. Additionally, the system can display comments entered across all tabs in a Comments Summary tab. In one or more embodiments, comments can be entered based on user credentials in response to a user's selection of the electronic signature button. That is, even if a first user has checked into the system, the comment will not be automatically attributed to that checked-in user account. Instead, the comment will be attributed to the user credentials entered using an electronic signature. This feature facilitates the formation of an accurate and verifiable history of which users have entered which comments. For example, since one or more users can enter comments throughout the execution of a batch record without logging out of the system, comments are associated with user credentials entered during approval / electronic signature, ensuring that comments are correctly attributed to the user rather than automatically attributed to the user logged into the system.

[0109] In one or more embodiments, the system may present the user with options to edit the executing batch record (BRX) after room allocation is completed (i.e., after block 104 of FIG1A). In one or more examples, editing of the batch record may...This can be implemented when the batch record is in "execution pause" (refer to block 116 of FIG1A). When a first user with a specific access status (e.g., pre-production) completes editing and a second user with a specific access status (e.g., quality) approves the editing, the system can lift the "execution pause" and continue executing the batch record. The system can present a "BRX Edit" button for editing the batch record to the user on various tabs of the exemplary user interface, including but not limited to Summary, Temporary Batch Validation, Packaging Briefing, Sample, and Image Capture. These tabs are exemplary, and more or fewer tabs may display options for editing the batch record without departing from the scope of this disclosure.

[0110] FIG16A provides an exemplary "BRX Edit" user interface associated with the Summary tab. In one or more examples, the user interface shown in FIG16A may include a pop-up window with one or more editable fields. The "BRX Edit" window may include, but is not limited to, the following fields associated with the Summary tab: General Notes, Kit Number Range, Serial Number Range, Temperature Range, Humidity Range, and Light Condition Range. The system may receive new values ​​for one or more fields. The system can then display an electronic signature page to receive the user's electronic signature to complete the editing. In some embodiments, the system may also prompt a second user to provide an electronic signature to approve the editing. This electronic signature process can be similar to the electronic signature process described above.

[0111] Figures 16B and 16C illustrate exemplary “BRX Exit” user interfaces for output and input materials (pharmaceuticals) associated with the Temporary Batch Validation tab, respectively. As shown, the “BRX Edit” user interface may include pop-up windows with one or more editable fields. These windows may include, but are not limited to, the following fields associated with the input and output materials of the Temporary Batch Validation tab: Item ID, Item Description, Batch Number, Expiry Date, Quantity to be Manufactured, BOM Quantity, Check Limit, and Temporary Total. Upon receiving an edit from a first user on the desired field, the system can display an electronic signature page to receive the first user's electronic signature to complete the editing. In some embodiments, the system may also prompt a second user to provide an electronic signature to approve the editing. This electronic signature process can be similar to the electronic signature process described above.

[0112] The Packaging Briefing tab may also include “BRX Edit” user availability. In response to a user selection that receives the "BRX Edit" user availability, the system may present a "BRX Edit" pop-up window with one or more editable fields. The "BRX Edit" window may include, but is not limited to, the following editing features associated with packaging instructions in the Packaging Briefing tab: adding and deleting packaging instructions, adding and deleting images associated with packaging instructions, adding and deleting images associated with packaging instructions, and so on.Important notes, categorizing packaging instructions or important notes, and / or adding or updating label placement and / or assembly drawings. Upon receiving user edits, the system may then display an electronic signature page to receive the first user's electronic signature for completion and approval. In some embodiments, the system may also prompt a second user to provide an electronic signature to review the edits. This electronic signature process may be similar to the electronic signature process described above.

[0113] Figure 16D illustrates an exemplary “BRX Edit” pop-up window associated with the Sample tab. Upon receiving user input that selects the “BRX Edit” user availability, the system may present an “OM Sample” (e.g., Output Material Sample) pop-up window with one or more editable fields. The “OM Sample” window may include, but is not limited to, the following fields associated with the Sample tab: Item ID, Include Sample (Yes / No), Partial Sample, Sample Quantity, Sample Type, and Sample Notes. Upon receiving user edits, the system may receive user input to save the user edits to the system (e.g., the user may select “Save” user availability). The system can then display an electronic signature page to receive the user's electronic signature for approval of the edit. In some embodiments, the system may also prompt a second user to provide an electronic signature for approval of the edit. This electronic signature process may be similar to the electronic signature process described above.

[0114] The image capture tab may also include a "BRX Edit" user availability and present a "BRX Edit" pop-up window with one or more editable fields. The "BRX Edit" window may include, but is not limited to, the following editing features associated with image capture instructions on the image capture tab: adding / editing / deleting image capture instructions, and categorizing image capture instructions in a desired order. When receiving user edits, the system may receive user input to save the user edits to the system (e.g., the user may select the "Save" user availability). The system can then display an electronic signature page to receive the user's electronic signature for approval of the edit. In some embodiments, the system may also prompt a second user to provide an electronic signature for approval of the edit. This electronic signature process may be similar to the electronic signature process described above.

[0115] In one or more embodiments, the system may receive user input to cancel the execution of batch records after the verification of the input materials has been completed (i.e., after block 118 in FIG1A). For example, the system may present a job action tab, which includes a user interface for users to perform actions related to the packaging job (such as canceling the execution of a packaging job). In one or more examples, execution cancellation can be performed before the packaging run begins (e.g., step 116). In such examples, execution cancellation can cancel the batch record in execution without further processing of the batch record. In some examples, execution cancellation can...The cancellation can be approved by two users with two different access permissions (e.g., a pre-production operator and a team leader). In one or more examples, the pre-production operator can select the “Execute Cancellation History” button located on the job action tab (e.g., the job action tab shown in Figure 9A). The system can prompt one or more users to electronically sign to approve the execution cancellation. Upon receiving the electronic signature of the first user, the system can prompt another user with different access permissions (e.g., a team leader) to electronically sign to complete another approval for the execution cancellation. If the executing batch record (BRX) is successfully cancelled, the record will become read-only, and the system will no longer be able to execute the batch record.

[0116] The system can allow the user to attach a file to the executing batch record (BRX) at one or more points in time during the exemplary processes 100A and 100B from Figures 1A and 1B. For example, in the “Files” section of the Summary tab, the system can present an “Upload File” button. Upon receiving the user selection of the “Upload File” button, the system can present a pop-up window allowing the user to drag and drop and / or select a file. The system can also present user availability corresponding to the "Contains non-blind information" drop-down menu and receive a "yes" or "no" selection to indicate whether the file "contains non-blind information". The system can then attach the file to the executing batch record. The system can prompt the user to provide an electronic signature (e.g., enter user credentials) to approve the file attachment. In some examples, the file attached to the executing batch record may not appear in the electronic executed batch record. In one or more embodiments, one or more users can access the file attached to the batch record when reviewing the executed batch record.

[0117] Those skilled in the art will understand that these user interfaces are exemplary and may include more or less information without departing from the scope of this disclosure. Additionally, different display configurations may be used without departing from the scope of this disclosure. Specification 22 / 26 pages 26 CN 121605482 A

[0118] The above operations described with reference to the accompanying drawings may be implemented alternatively by the components illustrated in FIG17. Those skilled in the art will understand how other processes are implemented based on the components illustrated in FIG17.

[0119] FIG17 illustrates an example of a computing device according to one embodiment. Device 1700 may be a host connected to a network. Device 1700 may be a client computer or a server. As shown in FIG17, device 1700 may be any suitable type of device based on a microprocessor, such as a personal computer, workstation, server, or handheld computing device (portable electronic device such as a mobile phone or tablet computer). The device may include, for example, a processor 1710, an input device 1720, an output device 1730, and storage.One or more of storage device 1740 and communication device 1760. Input device 1720 and output device 1730 may generally correspond to the above-described devices and may be connected to or integrated with a computer.

[0120] Input device 1720 may be any suitable device that provides input, such as a touch screen, keyboard or keypad, mouse or voice recognition device. Output device 1730 may be any suitable device that provides output, such as a touch screen, haptic device or speaker.

[0121] Storage device 1740 may be any suitable device that provides storage, such as electrical memory, magnetic memory or optical memory (including RAM, cache, hard disk or removable storage disk). Communication device 1760 may include any suitable device (such as a network interface chip or device) capable of transmitting and receiving signals over a network. Components of the computer may be connected in any suitable manner (such as via a physical bus or wirelessly).

[0122] Software 1750 may be stored in storage device 1740 and executed by processor 1710, and may include, for example, programming that embodies the functionality of this disclosure (e.g., as embodied in the devices described above).

[0123] The software 1750 may also be stored and / or transmitted in any non-transitory computer-readable storage medium for use or in connection with an instruction execution system, apparatus, or device (such as the system, apparatus, or device described above), which is capable of retrieving and executing instructions associated with the software from the instruction execution system, apparatus, or device. In the context of this disclosure, the computer-readable storage medium may be any medium (such as storage device 1740) capable of containing or storing programming for use or in connection with the instruction execution system, apparatus, or device.

[0124] The software 1750 may also be propagated within any transmission medium for use or in connection with an instruction execution system, apparatus, or device (such as the system, apparatus, or device described above), which is capable of retrieving and executing instructions associated with the software from the instruction execution system, apparatus, or device. In the context of this disclosure, the transmission medium may be any medium capable of transmitting, propagating, or transmitting programming for use or in connection with the instruction execution system, apparatus, or device. A readable transmission medium may include, but is not limited to, electronic, magnetic, optical, electromagnetic, or infrared wired or wireless propagation media.

[0125] Device 1700 can be connected to a network, which can be any suitable type of interconnected communication system. The network can implement any suitable communication protocol and can be protected by any suitable security protocol. The network can include any suitable network link arrangement that enables the transmission and reception of network signals (such as wireless network connections, T1 or T3 lines, wired networks, DSL, or telephone lines).

[0126] Device 1700 can implement any operating system suitable for operation on the network. Software 1750 can be used...It can be written in any suitable programming language (such as C, C++, Java, or Python). In various embodiments, application software embodying the functionality of this disclosure can be deployed in different configurations (such as in a client / server setup, or, for example, via a web browser as a web-based application or web service).

[0127] In one or more examples according to this disclosure, the instructions may also cause the system to receive research information from a clinical trial study, the research information including one or more client approvers, the one or more client approvers including a user associated with a drug batch customer. In such examples, the instructions may also cause the system to determine whether batch record information includes blinding information, and, based on the determination that the batch record information includes blinding information, cause the system to present a limited view of a preliminary batch record, omitting blinding information, to the user associated with the drug batch customer. In such examples, the user associated with the drug batch customer may be blinded. In such examples, blinding information may include a drug list, identification number, reagent kit number, start serial number, end serial number, or a combination thereof. In such examples, a second user associated with the drug batch customer may be unblinded. In such examples, the instructions may also cause the system to present an unrestricted view of the executable batch record, including blinding information, to a second user associated with the drug batch customer, based on the determination that the batch record information includes blinding information.

[0128] 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. Such changes and modifications should be understood to be included within the scope of the present disclosure and examples as defined by the claims.

[0129] Exemplary Embodiments Exemplary embodiments of the methods and systems described herein include: 1. A computer-implemented method for generating executed batch records for clinical trial studies, the method comprising: receiving an indication that a batch record has been assigned to a packaging room located at a packaging site, the packaging room being configured to execute the batch record; receiving an indication that a first user at the packaging site has completed a packaging briefing associated with a packaging operation for executing the batch record; displaying a packaging instruction for producing a quantity of packaging materials for the packaging operation based on a determination that the first user has completed the packaging briefing; determining whether the quantity of packaging materials is within a check target and updating the batch record to include a determination that the quantity of packaging materials is within a check limit; receiving a first approval of the batch record from the first user, the first approval including receiving credentials from the first user when logging into an account associated with the first user; receiving a second approval of the batch record from a second user, the second approval including receiving credentials from the second user while remaining logged into an account associated with the first user; andBased on the approved batch records, generate executed batch records for clinical trial studies.

[0130] 2. The method according to Clause 1, wherein the packaging instruction comprises multiple steps, and the method further comprises: for a step among the multiple steps, receiving an image including a visual indication that the step has been completed via an image capture device located in a packaging room; and updating the batch record to save the image and associate the image with the step among the multiple steps.

[0131] 3. The method according to Clause 2, comprising: for the step among the multiple steps, receiving an instruction step approval from a first user associated with the step, the instruction step approval comprising receiving credentials from the first user.

[0132] 4. The method according to any one of Clauses 1-3, comprising: acquiring input material data including one or more fields via an external resource, the material data being associated with input materials temporarily stored in a packaging room; approving the temporarily stored input materials based on a determination that one or more fields in the input material data match one or more corresponding fields in an executable batch record; displaying user availability to a first user for accepting or rejecting the input materials based on a determination that fields in the input material data do not match corresponding fields in the executable batch record; adding the input materials to an executing batch record based on a determination that the input materials have been approved or accepted.

[0133] 5. The method according to Clause 4, wherein one or more fields in the input material data include one or more of the following: material label identification number, supplier batch number, external resource batch number, and customer batch number.

[0134] 6. The method according to Clause 4 or Clause 5, comprising: displaying an input material approval interface based on an instruction from a first user that the input materials have been accepted; receiving the first user's credentials via the input material approval interface; and accepting or rejecting the input materials.

[0135] 7. The method according to any one of Clauses 1-6, further comprising receiving a comment associated with the batch record being executed via a comment user interface.

[0136] 8. The method according to Clause 7, further comprising receiving a comment approval from a second user, the comment approval including receiving credentials from the second user while maintaining login to an account associated with the first user.

[0137] 9. The method according to any one of Clauses 7 or 8, further comprising receiving an indication that the comment is associated with blinding data.

[0138] 10. The method according to any one of Clauses 9, wherein generating the executed batch record includes generating the blinded executed batch record such that the blinding data is revised.

[0139] 11. The method according to any one of Clauses 1-10, further comprising configuring a packaging room to execute the batch record, wherein configuring the packaging room includes: assigning a packaging room at a packaging site to a packaging operation;The method receives an instruction from a user at the packaging room that the packaging room meets one or more items in a room cleaning checklist, the room cleaning checklist being associated with an executable batch record and the packaging room; receives an instruction from a user that the packaging room meets one or more items in a room setup checklist, the room setup checklist being associated with an executable batch record and the packaging room; receives an instruction from a user that a first piece of equipment located in the packaging room meets one or more items in an equipment setup checklist, wherein the equipment setup checklist is associated with the first piece of equipment and an executable batch record.

[0140] 12. The method according to any one of claims 1-11 further comprises: receiving user input for pausing the packaging operation; displaying an operation pause approval interface based on receiving user input for pausing the packaging operation; receiving credentials of a first user via the operation pause approval interface; receiving credentials of a second user via the operation pause approval interface while still logged into an account associated with the first user; updating the packaging operation status to paused.

[0141] 13. The method according to any one of claims 1-12 further comprises displaying a color-coded progress bar indicating the completion of one or more tasks associated with the packaging operation.

[0142] 14. The method according to Clause 13 further includes automatically updating the progress bar when one or more tasks associated with the packaging operation have been approved.

[0143] 15. A method for generating an executed batch record for a clinical trial study, the method comprising: at a first computer system including one or more processors and one or more memories: acquiring an executable batch record of a packaging job configured to be performed at a packaging site; assigning a packaging room at the packaging site to the packaging job; receiving an instruction that the packaging room meets one or more items in a room cleaning checklist, the room cleaning checklist being associated with the executable batch record and the packaging room; receiving an instruction that the packaging room meets one or more items in a room setup checklist, the room setup checklist being associated with the executable batch record and the packaging room; receiving an instruction that a first piece of equipment located in the packaging room meets one or more items in an equipment setup checklist, wherein the equipment setup checklist is associated with the first piece of equipment and the executable batch record; receiving an instruction that a first user has completed a packaging briefing associated with the packaging job; receiving an instruction to verify that one or more materials in the packaging room match one or more materials in a bill of materials; receiving an instruction to start the packaging job; Based on the confirmation that the first user has completed the packaging briefing, and upon logging into the account associated with the first user, packaging instructions related to the packaging operation are displayed. These instructions include multiple steps. For each step, an image capture device located in the packaging room receives information including the steps already completed.The image of the completed visual indication; receiving an input quantity indicating the quantity of packaging materials; verifying that the quantity of packaging materials is within a predetermined check target; receiving an indication that the packaging operation is completed; receiving a first user's first approval of the batch record, the first approval including receiving credentials from the first user when logging into the account associated with the first user; receiving a second user's second approval of the batch record, the second approval including receiving credentials from the second user while remaining logged into the account associated with the first user; and generating an executed batch record for the clinical trial study based on the approved batch record.

[0144] For purposes of explanation, the foregoing description has been described with reference to specific embodiments. However, the above illustrative discussion is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in accordance with the above teachings. These embodiments were chosen and described in order to best explain the principles of the technology and its practical application. Thus, those skilled in the art will be able to best utilize the technology and various embodiments and various modifications suitable for the particular purpose contemplated. Instruction Manual Page 26 / 26, 30 CN 121605482 A, Figure 1A; Instruction Manual Figure 1 / 66, 31 CN 121605482 A, Figure 1B, Figure 1C; Instruction Manual Figure 2 / 66, 32 CN 121605482 A, Figure 2A; Instruction Manual Figure 3 / 66, 33 CN 121605482 A, Figure 2B; Instruction Manual Figure 4 / 66, 34 CN 121605482 A, Figure 2C; Instruction Manual Figure 5 / 66, 35 CN 121605482 A, Figure 2D; Instruction Manual Figure 6 / 66, 36 CN 121605482 A, Figure 2E; Instruction Manual Figure 7 / 66, 37 CN 121605482 A, Figure 3A, Figure 3B, Figure 3C; Instruction Manual Figure 8 / 66, 38 CN 121605482 A, Figure 3D; Instruction Manual Figure 9 / 66, 39 CN 121605482 A Figure 3E Instruction Manual Drawings, Page 10 / 66, 40 CN 121605482 A Figure 3F Instruction Manual Drawings, Page 11 / 66, 41 CN 121605482 A Figure 3G Instruction Manual Drawings, Page 12 / 66, 42 CN 121605482 A Figure 3H Figure 3I Figure 3J Instruction Manual Drawings, Page 13 / 66, 43 CN 121605482 A Figure 3K Figure 3L Instruction Manual Drawings, Page 14 / 66, 44 CN 121605482 A Figure 3M DescriptionFigure 4A on page 15 / 66 of the instruction manual (CN 121605482 A); Figure 4B on page 16 / 66 of the instruction manual (CN 121605482 A); Figure 5A on page 17 / 66 of the instruction manual (CN 121605482 A); Figure 5B on page 18 / 66 of the instruction manual (CN 121605482 A); Figure 5C on page 19 / 66 of the instruction manual (CN 121605482 A); Figure 5D on page 21 / 66 of the instruction manual (CN 121605482 A); Figure 6A on page 22 / 66 of the instruction manual (CN 121605482 A); Figure 6B on page 23 / 66 of the instruction manual (CN 121605482 A); Figure 6C on page 24 / 66 of the instruction manual (CN 121605482 A). Figure 6D of the instruction manual, page 25 / 66, CN 121605482 A; Figure 6E of the instruction manual, page 26 / 66, CN 121605482 A; Figure 6F of the instruction manual, page 27 / 66, CN 121605482 A; Figure 6G of the instruction manual, page 28 / 66, CN 121605482 A; Figure 6H of the instruction manual, CN 121605482 A; Figure 6I of the instruction manual, page 29 / 66, CN 121605482 A; Figure 6J of the instruction manual, page 30 / 66, CN 121605482 A; Figure 7A of the instruction manual, page 31 / 66, CN 121605482 A; Figure 7B of the instruction manual, page 32 / 66, CN 121605482 A; Figure 7C of the instruction manual, page 33 / 66, CN 121605482 A. Figure 7D of the instruction manual, page 34 / 66, CN 121605482 A; Figure 7E of the instruction manual, page 35 / 66, CN 121605482 A; Figure 7F of the instruction manual, page 36 / 66, CN 121605482 A; Figure 7G of the instruction manual, page 37 / 66, CN 121605482 A; Figure 8 of the instruction manual, page 38 / 66, CN 121605482 A; Figure 9A of the instruction manual, page 39 / 66.Page 69 CN 121605482 A Figure 9B Instruction Manual Drawings 40 / 66 Page 70 CN 121605482 A Figure 9C Instruction Manual Drawings 41 / 66 Page 71 CN 121605482 A Figure 9D Figure 9E Instruction Manual Drawings 42 / 66 Page 72 CN 121605482 A Figure 9F Instruction Manual Drawings 43 / 66 Page 73 CN 121605482 A Figure 9G Instruction Manual Drawings 44 / 66 Page 74 CN 121605482 A Figure 9H Instruction Manual Drawings 45 / 66 Page 75 CN 121605482 A Figure 10A Instruction Manual Drawings 46 / 66 Page 76 CN 121605482 A Figure 10B Instruction Manual Drawings 47 / 66 Page 77 CN 121605482 A Figure 11A Figure 11B Instruction Manual Drawings 48 / 66 Page 78 CN 121605482 A Figure 12 Instruction Manual Drawings 49 / 66 Page 79 CN 121605482 A Figure 12 Continued Instruction Manual Drawings 50 / 66 Page 80 CN 121605482 A Figure 13A Instruction Manual Drawings 51 / 66 Page 81 CN 121605482 A Figure 13B Instruction Manual Drawings 52 / 66 Page 82 CN 121605482 A Figure 13C Instruction Manual Drawings 53 / 66 Page 83 CN 121605482 A Figure 13D Instruction Manual Drawings 54 / 66 Page 84 CN 121605482 A Figure 13E Instruction Manual Drawings 55 / 66 Page 85 CN 121605482 A Figure 13F Instruction Manual Drawings 56 / 66 Page 86 CN 121605482 A Figure 13G Instruction Manual Drawings 57 / 66 Page 87 CN 121605482 A Figure 13H Instruction Manual Drawings, Page 58 / 66, 88 CN 121605482 A Figure 13I Instruction Manual Drawings, Page 59 / 66, 89 CN 121605482 A Figure 14A Instruction Manual Drawings, Page 60 / 66, 90 CN 121605482 A Figure 14B Instruction Manual Drawings, Page 61 / 66, 91 CN 121605482 A Figure 15 Instruction Manual Drawings, Page 62 / 66, 92 CN 121605482 A Figure 16A Instruction ManualFigure 63 / 66, page 93, CN 121605482 A; Figure 16B, Figure 16C; Figure 64 / 66, page 94, CN 121605482 A; Figure 16D; Figure 65 / 66, page 95, CN 121605482 A; Figure 17; Figure 66 / 66, page 96, CN 121605482 A

Claims

1. A computer-implemented method for generating executed batch records of clinical trial studies, the method comprising: An instruction is received that a batch record is assigned to a packaging room located at a packaging site, the packaging room being configured to execute the batch record; Receive an instruction from the first user at the packaging site that a packaging briefing associated with the packaging operation used to execute the batch record has been completed; Based on the confirmation that the first user has completed the packaging briefing, a packaging instruction for producing a certain quantity of packaging materials for the packaging operation is displayed; Determine whether the quantity of packaging materials is within the verification target, and update the batch record to include the determination that the quantity of packaging materials is within the verification limit; Receive a first user’s first approval of the batch records, the first approval including receiving credentials from the first user when logging into the account associated with the first user; Receive a second approval from a second user for the batch records, the second approval including receiving credentials from the second user while maintaining login to the account associated with the first user; as well as Based on the approved batch records, the executed batch records for the clinical trial study are generated.

2. The method according to claim 1, wherein, The packaging instructions include multiple steps, and the method further includes: for each of the multiple steps, receiving an image including a visual indication that the step has been completed via an image capture device located in the packaging room; and updating the batch record to save the image and associate the image with the step of the multiple steps.

3. The method according to claim 2, comprising: For one of the plurality of steps, receiving an instruction step approval associated with the step from a first user, the instruction step approval including receiving credentials from the first user.

4. The method according to any one of claims 1 to 3, comprising: Input material data, including one or more fields, is obtained via external resources and is associated with input materials temporarily stored in the packaging room; Based on the determination that one or more fields in the input material data match one or more corresponding fields in the executable batch record, the temporarily stored input materials are approved; Based on the determination that the fields in the input material data do not match the corresponding fields in the executable batch record, user availability is displayed to the first user to accept or reject the input material; Based on the confirmation that the input materials have been approved or accepted, the input materials are added to the batch record in the process.

5. The method according to claim 4, wherein, The one or more fields in the input material data include one or more of the following: material identification number, supplier batch number, external resource batch number, and customer batch number.

6. The method according to claim 4 or claim 5, comprising: Upon receiving the instruction that the first user has accepted the input materials, the input materials approval interface is displayed; The first user's credentials are received via the input material approval interface; as well as Accept or reject the input material.

7. The method according to any one of claims 1 to 6, further comprising receiving comments associated with the batch records being executed via a comment user interface.

8. The method of claim 7, further comprising receiving comment approval from a second user for the comment, the comment approval including receiving credentials from the second user while remaining logged into an account associated with the first user.

9. The method according to any one of claims 7 or 8, further comprising receiving an indication that the comment is associated with blinded data.

10. The method according to any one of claims 9, wherein, Generating the executed batch record includes generating the executed batch record of the blind method, such that the blind method data is revised.

11. The method according to any one of claims 1 to 10, further comprising configuring the packaging room to perform the batch recording, wherein, The packaging room configuration includes: Assign the packaging room at the packaging station to the packaging operation; Receive an instruction from a user at the packaging room that the packaging room meets one or more items in a room cleaning checklist, the room cleaning checklist being associated with the executable batch record and the packaging room; Receive an instruction from the user that the packaged room meets one or more items in a room setup checklist, the room setup checklist being associated with the executable batch record and the packaged room; and The system receives an instruction from the user that a first piece of equipment located in the packaging room meets one or more items in an equipment setup checklist, wherein the equipment setup checklist is associated with the first piece of equipment and the executable batch record.

12. The method according to any one of claims 1 to 11, further comprising: Receive user input to pause the packaging operation; Based on the user input used to receive the pause of the packaging operation, the operation pause approval interface is displayed; The first user's credentials are received via the job pause approval interface. While remaining logged into the account associated with the first user, the second user's credentials are received via the job pause approval interface; The packaging operation status has been updated to paused.

13. The method according to any one of claims 1 to 12, further comprising displaying a color-coded progress bar indicating the completion of one or more tasks associated with the packaging operation.

14. The method of claim 13, further comprising automatically updating the progress bar when one or more tasks associated with the packaging operation have been approved.

15. A method for generating executed batch records of a clinical trial study, the method comprising: At a first computer system comprising one or more processors and one or more memories: Obtain executable batch records for packaging operations configured to be performed at packaging sites; Assign the packaging room at the packaging station to the packaging operation; Receive an instruction that the packaging room meets one or more items in a room cleaning checklist, the room cleaning checklist being associated with the executable batch record and the packaging room; Receive an indication that the packaging room meets one or more items in a room setup checklist, the room setup checklist being associated with the executable batch record and the packaging room; Receive an indication that a first piece of equipment located in the packaging room meets one or more items in an equipment setup checklist, wherein the equipment setup checklist is associated with the first piece of equipment and the executable batch record; Receive an indication from the first user that a packaging briefing associated with the packaging operation has been completed; Receive an instruction to verify that one or more materials in the packaging room match one or more materials in the material list; Receive instructions to begin the packaging operation; Based on the confirmation that the first user has completed the packaging briefing, and upon logging into the account associated with the first user, packaging instructions associated with the packaging operation are displayed, the packaging instructions comprising multiple steps; For each of the plurality of steps, an image including a visual indication that the step has been completed is received via an image capture device located in the packaging room; Receive the input quantity indicating the amount of packaging materials; Verify that the quantity of packaging materials is within the predetermined verification target; Receive an indication that the packaging operation is complete; Receive a first user’s first approval of the batch records, the first approval including receiving credentials from the first user when logging into the account associated with the first user; Receive a second user's second approval for the batch records, the second approval including receiving credentials from the second user while maintaining login to the account associated with the first user; and Based on the approved batch records, the executed batch records for the clinical trial study are generated.

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