System and method for generating batch records for pharmaceutical assays

Abstract

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

Description

[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 Technology

[0003] Companies involved in clinical trials (especially drug clinical trials) must comply with government-regulated clinical packaging and labeling standards. For example, 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 drugs 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 process, following appropriate regulatory guidelines. Furthermore, packaging should be carried out in a manner that does not reveal which patient 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, these 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 records to produce executed batch records. However, this paper-based process relies heavily on manual input, which is prone to human error and fails to produce standardized batch records across sites. Furthermore, because all fields in the paper batch records are visible to anyone viewing them during packaging, this can reveal which patient kits are associated with which treatment regimens, thus compromising the non-blinding 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, where such documentation can be referenced during subsequent packaging runs or verification periods. 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 packaging kits used in clinical trials, which can provide a unified and centralized record across various packaging sites while preserving the blindness of clinical trials, without interrupting the flow of the packaging process. Summary of the Invention

[0006] Embodiments of this disclosure can provide computing systems and methods for efficiently and accurately generating electronic batch records. For example, embodiments of this disclosure can 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 using the correct equipment, to packaging instructions and documenting various steps of the packaging process, to reconciliation and ensuring that packaged output materials meet predetermined reconciliation 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 is 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, as 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 instruction 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 instruction at the packaging site that a first user has completed a packaging briefing associated with a packaging operation for executing the batch record; displaying packaging instructions 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 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 from the first user for 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 approval from a second user for 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 executed batch records for clinical trial studies based on the approved batch records.

[0008] In some embodiments, the packaging instruction includes multiple steps, and the method further includes: for one 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 a batch record to save the image and associate the image with the step among the multiple steps. In some embodiments, the method further includes: for one of the multiple steps, receiving instruction step approval from a 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 an executed batch record via a comment user interface. In some embodiments, the method further includes: receiving a comment approval from a second user, 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 blinding data. In some embodiments, generating an executed batch record includes generating an executed batch record of blinding, such that the blinding 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 an executable batch record and the packaging room; receiving 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; and receiving 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 being associated with a first piece of equipment and an executable batch record.

[0012] In some embodiments, the method further includes: receiving user input for pausing the packaging operation; displaying an operation pause approval interface based on the received user input for pausing the packaging operation; receiving a first user's credentials via the operation pause approval interface; receiving a second user's credentials via the operation pause approval interface while still logged into the 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 executed batch records for a clinical trial study, at a first computer system including one or more processors and one or more memories, the method comprising: 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 a 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; and receiving a validation package. The process includes: receiving an instruction that one or more materials in the room match one or more materials in a materials list; receiving an instruction to begin a packaging operation; displaying packaging instructions associated with the packaging operation, which include multiple steps, upon login to the account associated with the first user, based on a determination that a packaging briefing has been completed by the first user; receiving, via an image capture device located in the packaging room, an image indicating that the step has been completed for each step; 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 instruction that the packaging operation has been completed; receiving a first approval from the first user for the batch record, the first approval including receiving credentials from the first user upon login to the account associated with the first user; receiving a second approval from the second user for 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 a clinical trial study based on the approved batch record. Attached Figure Description

[0015] Figure 1A and Figure 1B An exemplary process for generating electronic batch records according to some embodiments of the present disclosure is illustrated.

[0016] Figure 1C The illustration shows a progress bar for 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 An exemplary user interface associated with obtaining executable batch records of a packaging operation is illustrated according to some embodiments of the present disclosure.

[0018] Figures 3A-3MAn exemplary user interface associated with assigning a packaging room to a packaging operation is illustrated according to some embodiments of the present disclosure.

[0019] Figure 4A and Figure 4B An exemplary user interface associated with a completed room cleaning checklist is illustrated according to some embodiments of this disclosure.

[0020] Figures 5A-5D An exemplary user interface associated with a complete room setup checklist is illustrated according to some embodiments of this disclosure.

[0021] Figures 6A-6J The illustration shows an exemplary user interface associated with equipment setup for completing packaging operations, according to some embodiments of the present disclosure.

[0022] Figures 7A-7G The illustration shows an exemplary user interface associated with briefing a user on a packaging operation, according to some embodiments of the present disclosure.

[0023] Figure 8 An exemplary user interface associated with verifying the matching of materials in the packaging room with materials in the bill of materials, according to some embodiments of the present disclosure, is illustrated.

[0024] Figures 9A-9H The illustration shows an exemplary user interface associated with starting a packaging operation and displaying packaging instructions according to some embodiments of the present disclosure.

[0025] Figure 10A and Figure 10B An exemplary user interface for verifying that materials are within verification limits is illustrated according to some embodiments of the present disclosure.

[0026] Figure 11A and Figure 11B An exemplary user interface for generating electronic executed batch records for review, according to some embodiments of the present disclosure, is illustrated.

[0027] Figure 12 The illustration shows an excerpt from an exemplary electronically executed batch record according to some embodiments of the present disclosure.

[0028] Figures 13A-13I An exemplary user interface for completing an in-progress checklist is illustrated according to some embodiments of the present disclosure.

[0029] Figure 14A and Figure 14B An exemplary user interface for adding sample data to a batch record in execution, according to some embodiments of the present disclosure, is illustrated.

[0030] Figure 15An exemplary user interface for adding comments to a batch record in execution, according to some embodiments of the present disclosure, is illustrated.

[0031] Figures 16A-16D An exemplary user interface for editing batch records in execution is illustrated according to some embodiments of the present disclosure.

[0032] Figure 17 Exemplary electronic devices according to some embodiments of the present disclosure are illustrated. Detailed Implementation

[0033] Embodiments of this disclosure can provide computing systems and methods for efficiently generating electronic batch records. For example, embodiments of this disclosure 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 that packaging occurs in the correct room, to packaging instructions and documenting various steps of the packaging process, to checking and ensuring that packaged output materials meet 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 is logged into the system. 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, as 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 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 only used to distinguish one element from another. For example, a first graphic representation may be called a second graphic representation, and similarly, a second graphic representation may be called a first graphic representation, without departing from the scope of the various described embodiments. Both the first graphic representation and the second graphic representation are graphic representations, but they are not the same graphic representation.

[0036] The terminology used in the description of the various embodiments herein is for the purpose of describing particular embodiments only and is not intended to limit the scope thereof. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” as used in the description of the various embodiments and their appended claims are intended to include the plural forms as well. 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 exclude 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 "when," "at," "in response to determining," or "in response to detecting." Similarly, depending on the context, the phrases "if determining" or "if [the stated situation or event] is detected" may optionally be interpreted as "when determining," "in response to determining," "when [the stated situation or event] is detected," or "in response to detecting [the stated situation 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. Figure 1A and Figure 1BExemplary processes 100A and 100B for generating electronic batch records are illustrated. Processes 100A and 100B can be implemented, for example, using one or more electronic devices implementing a 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 may be optionally combined, the order of some blocks may be optionally changed, and some blocks may be optionally omitted. In some examples, additional steps may be performed in combination with processes 100A and 100B. Therefore, the illustrated operations (and described in more detail below) are exemplary in nature and should not be considered limiting.

[0039] exist Figure 1A At block 102, the system can retrieve an executable batch record, which contains various information fields associated with the supply order. The retrieved batch record can be executed as part of a packaging operation. Figure 1A At block 104, the system can display a room assignment tab, which includes a user interface for users to assign rooms for packaging jobs. Figure 1A At block 106, the system can display a room cleaning tab, which includes a user interface for the user to complete a room cleaning checklist. Figure 1A At block 108, the system can display a room settings tab, which includes a user interface for the user to complete a room settings checklist. Figure 1A At block 110, the system can display the equipment settings tab, which includes a user interface for users to complete the equipment setup process. Figure 1A At block 112, 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 present. 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. Figure 1A At block 114, the system can 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 batch record (BRX) in progress. Figure 1AAt block 116, the system can begin the packaging operation and display packaging instructions. One or more users can complete the packaging operation according to the packaging instructions. For example, one or more users can produce one or more output materials according to the packaging instructions included in the batch record being executed. In some embodiments, users can capture one or more images of various steps in the packaging process and upload the images to the system. Figure 1A At block 118, the system can verify that the produced output material is within the verification limits. Figure 1B At block 120, the system can end the packaging operation. Figure 1B At block 122, the system can generate an Electronic Executed Batch Record (EBR) for review. Figure 1B At block 124, the system can publish the Executed Batch Record (EBR) after review is complete. 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 packaging operations corresponding to batch records in progress. 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 that includes an overview of one or more steps in processing the operation and indicates the status of each of the one or more steps. Figure 1C An exemplary progress bar is illustrated. As shown, the progress bar includes one or more segments, each segment corresponding to one or more steps of the packaging operation, 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 sections may use color coding to indicate the status of the corresponding step. For example, a green shaded section may indicate that the step is completed, a blue shaded section may indicate that the step is in progress, and a white section 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 is 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 received user input about the 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 in the figure, the BRX progress segment, packaging briefing segment, and staging 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] refer to Figure 1A In block 102, 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 a user selecting the executable batch record to be executed for a 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 An exemplary user interface is illustrated, 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 the executable batch record 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 blinded. Figure 2A As shown, 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, related executable batch record, unique identifier, packaging room name, additional remarks, status, study section, packaging type, blinding status, and paused status. Figure 2A The types of information shown 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 records that can be displayed to a user are determined based on the user's permissions for a given site. As used herein, a user can correspond to an individual assisting in packaging output materials. A user can be associated with one or more roles, including but not limited to: operator, team leader, quality assurance personnel, etc. A user can also be associated with other roles without departing from the scope of this disclosure. A 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 a user is permitted to take in the system, such as, but not limited to, entering information and providing approvals. In one or more examples, a user can be associated with a specific packaging site. For example, if a user is associated with a packaging site in Philadelphia, they can access executable batch records for the Philadelphia site but not batch records for another site (e.g., Kansas City). Therefore, the list of available executable batch records for the user to view will include executable batch records assigned to the Philadelphia site for packaging.

[0046] To view the desired executable batch records, the system can receive selections from the user's "Home" dropdown menu on the user interface, and also receive selections for the "Batch Records" option, such as... Figure 2B As shown. This opens the Batch Records tab. On this tab, the system can receive user selections from the drop-down menu below "Batch Records," as well as user selections for the "BRX-All" option, as shown. Figure 2C As shown. Making this selection will display the approved executable batch records and their corresponding statuses (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, such as... Figure 2D As shown, users can enter identifiers associated with batch records. The system can display search results via a user interface and receive user selections of batch records (e.g., users can select and / or open the batch record to be executed by clicking the name of the desired batch record), such as... Figure 2E As shown.

[0047] The batch record selected for execution can be changed from "Executable Batch Record" (XBR) to "Executing Batch Record" (BRX). An executing batch record refers to a batch record that is currently being executed during a packaging operation (e.g., a packaging job). Return to Reference Figure 1AIn block 104, the system may present a room allocation tab, which includes a user interface for users to allocate rooms to packaging jobs. A packaging station may include multiple rooms for packaging output materials to complete an executable batch record. A packaging station may complete multiple packaging jobs spanning multiple days, and each packaging room is dedicated to a single corresponding packaging job at a time. Assigning rooms to specific packaging jobs avoids room conflicts and ensures that new room allocations do not interrupt ongoing packaging jobs. Furthermore, 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. Therefore, room allocation ensures that the room allocated to an executing batch record is available for packaging and includes the necessary equipment to complete the executable batch record.

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

[0049] In one or more examples, room assignment can be performed by one or more users. In some examples, room assignment can be performed by a user associated with specific access permissions (e.g., a team leader). In one or more examples, the user performing the room assignment can select the Room Assignment tab within the batch record selected in the execution at block 102, as shown. Figure 3A As shown. Reference Figure 3B The room assignment tab allows users to check the availability of rooms to be assigned to in-process batch records. For example, the system can receive the barcode value associated with the room to check its availability. In some examples, users can physically scan the barcode located outside the packaging room at the packaging site. In other examples, users can manually enter the barcode associated with the packaging room. If the packaging room is currently assigned to another in-process batch record, an error message will be displayed, such as... Figure 3C As shown. If the packaged room is available, the "Room Details" field will appear below the "Enter Barcode Value" text input box, as shown. Figure 3DAs shown. For each packaged room, one or more of the following "Room Details" fields may be displayed: "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] refer to Figure 3D The system can receive user input indicating that the user has selected the "Check Batch" button. The system can then perform a room location lookup and display all materials currently in the packing room. Additionally, in some examples, the system can display a pop-up window showing all Bill of Materials (BOM) details for each output material associated with that packing room and its corresponding input(s) materials(s), such as... Figure 3E As shown. Users can review the materials currently in the packaging room and compare them with the BOM details. If any one or more materials displayed in the packaging room should not be present in the room during the packaging period of the batch being executed, the user can select the "Cancel" button to exit the room assignment. The user can then remove any materials from the packaging room that are not needed for the packaging operation, or select a different room for the packaging 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 packaging room can remain in the room during packaging, the user can select the "Click Continue" button. Upon receiving the user's "Click Continue" selection, the system can display an electronic signature page for the user to complete, such as... Figure 3F As shown, users can confirm room assignments and electronically sign to complete the room assignment process. For example, the system can attribute an electronic signature to a user by receiving their credentials and indicate that the room assignment has been approved. Figure 3G The illustration shows 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, an ongoing batch record may already be associated with a packing room at the site before 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 ongoing batch record.

[0052] In some embodiments, packaging rooms may not be configured in the system. If no packaging room exists in the system, the system allows the user to add a new packaging room to the master data. To add a packaging room, the system can receive user selections from the "Home" dropdown menu on the user interface, and also receive selections from "Room" options, such as... Figure 3H As shown. Reference Figure 3I and Figure 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 user availability corresponding to the "Room Editable" and "Room Read-Only" buttons, such as... Figure 3K As shown. The system can then present a "New Room: Editable Room" window or a "New Room: Read-Only Room" window, which has various user availability fields, including but not limited to room name, location, room description, room barcode value, room condition, humidity control, and lighting control. If the user selects the "Read-Only Room" button, the system may allow the user to edit these availability fields, such as... Figure 3L As shown. If the user selects the "Room Read-Only" button, the system may not allow the user to edit 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. Figure 3M As shown. Users can then electronically sign (e.g., enter their user credentials) to add the new room to the master data. The system can then allow users to assign packaging jobs to the new room as described above.

[0053] Return to reference Figure 1A In block 106, the system may present a room cleaning tab, which includes a user interface for the user to complete room cleaning. In one or more embodiments, room cleaning is performed upon completion of room allocation. Figure 4A The illustration shows an exemplary user interface for completing the room cleaning process electronically. Figure 4A As shown, the Room Cleaning tab includes a first section and a second section. The first section includes a text input box that allows the user to enter a work order number, and the second section provides a checklist. The checklist corresponds to the instructions that the user should complete in order to clean the room and ensure that the room is clean for the packing operation.

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

[0055] Once each step meets these criteria (e.g., "pass" or "N / A"), the system can receive approval from the first approver. In one or more embodiments, the first approver (e.g., an operator or team leader) may have credentials associated with specific access permissions. The system can receive the first approver's electronic signature to indicate that the 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 completing room cleaning. 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 on the room cleaning tab meet the room cleaning criteria, the system can receive a "secondary approval" user availability option. The system can 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 a packaging site are available to a first user and a second user to perform a batch recording process. In some embodiments, the device may be used by multiple users to perform the 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 the electronic signature to a user based on credentials received during the electronic signature process, rather than automatically attributing the electronic signature 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 approve steps in the batch recording execution process without checking out of their current accounts. Allowing multiple users to enter their approvals without switching accounts when multiple users share a device to perform batch recording saves time and simplifies the packaging process. For example, having a first user electronically sign, check out of the system, and then have a second user check in to approve the steps is cumbersome and time-consuming. Therefore, by attributing electronic signatures to users (rather than accounts used to complete packaging operations) based on credentials entered during the electronic signature process, embodiments of this disclosure provide verifiable approval trails (e.g., approvals compliant with applicable regulations), which saves time in the packaging workshop and can contribute to more efficient packaging operations.

[0057] Return to reference Figure 1A In block 108, the system can 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 upon completion of room assignment and room cleaning. 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 can receive an indication that the user has selected the room settings tab within an ongoing batch record, such as... Figure 5A As shown, the system can display the "Room Setup Checklist" and "Actual Packaging Status" on the Room Setup tab. The "Room Setup Checklist" provides users with a checklist to confirm that the room has been correctly set up for batch recording during packaging. The "Actual Packaging Status" provides users with an interface for entering information associated with the actual condition of the room.

[0058] Regarding the "Room Setup Checklist," the system can present the user with one or more steps, along with corresponding options for the user to select the response associated with each step. For example... Figure 5A As shown, 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 checks: "The room status indicator outside the door has changed color," "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," "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 the 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 the "actual packaging condition," such as... Figure 5B As shown. For example, "Actual Packaging Condition" may include one or more user-available options for selecting a temperature range and / or temperature conditions. In some embodiments, one or more user-available 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 specify the actual packaging condition.

[0060] refer to Figure 5CThe system can receive user-entered comments about the room setup process. For example, in one or more embodiments, the system can receive... Figure 5A The "Enter Comment" user option is shown. This may cause a "Comment" pop-up to appear, such as... Figure 5C As shown. Figure 5C As shown, the comment pop-up may include a text input box (where users can enter comments related to the room setup process) and / or user availability (where users can indicate whether the setup is blind or unblinded).

[0061] In one or more embodiments, once a comment receives an electronic signature, each comment can be saved to the batch record in progress. That is, the user entering the comment (e.g., by entering their user credentials) can attach their electronic signature to the comment to save it to the batch record in progress. For example, see reference... Figure 5C The system receives user input regarding the "actual packaging condition," blinding status, and / or comments. The system may also receive indication that the user has selected "electronic signature" user availability. The system can then present the user with one or more text input fields to enter their login ID, personal signature identifier, and / or any additional comments, such as... Figure 5D As shown. The system can receive user credentials and / or comments as part of the approval process. In one or more examples, Figure 5D The electronic signature pop-up illustrated herein is exemplary and may be similar to other electronic signature pop-ups described herein.

[0062] In one or more embodiments, comments can be entered and checked out by a second user even if the system may be logged into a first user's account. This is because the system attributes comments to users based on credentials received during the electronic signature process, rather than automatically attributing them to the user currently checked 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 comments and / or approvals for steps in a batch record execution process without checking out of their current accounts. That is, in some examples, certain steps in the packaging process may solicit check-outs from multiple users (e.g., operators and team leaders). Having a first user electronically sign, check out of the system, and then have a second user check in to approve the steps is 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 operations.

[0063] Return to reference Figure 1ABlock 110 of the system can 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 during room assignment, room cleaning, and room setup completion. Equipment settings can be used to add equipment to an ongoing batch record. The system can include equipment in master data, which can be associated with a package run of an ongoing batch record. Figure 6A As shown, the fields associated with 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] refer to Figure 6B To add equipment to an ongoing batch record, the system can receive user selections from the equipment settings tab in the user interface. The system can then receive user input via text input boxes corresponding to the "Add Equipment" user availability settings, such as... Figure 6C As shown. In some embodiments, the system can 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 packaging room). For example, if the device used by the user includes a camera, the device can 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 packaging operations).

[0065] like Figure 6D As shown, if the scanned equipment is already registered, the system can display a "Scanned Equipment Details" pop-up window. The system can then receive an indication that the user has selected the "Add" button to confirm adding the equipment to the batch record in progress. The system can 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 with a predetermined access status (e.g., a team leader). In one or more examples, the second user can select the "Approval Required" user availability, which will cause the system to display as shown... Figure 6E The "Supervisor Approval" pop-up window shown is displayed. The system can display, for example,... Figure 6F The system displays an electronic signature pop-up window and receives 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 perform electronic signatures 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. Once equipment setup is complete, the corresponding equipment setup document can be added to the list of approved equipment associated with the ongoing batch record. Figure 6G The document shows an exemplary list of equipment added to the batch record.

[0067] In one or more examples, the system may allow a user to attach one or more files to an item during equipment setup. In such examples, the system may receive a user selection of the attachment icon under the "Equipment Setup" column. In response to this selection, the system may open a pop-up window for the file attachment, such as... Figure 6H As shown. Figure 6I As shown, the system can receive user selection of appropriate file types, receive uploaded files, 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 an electronic device or accessed 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 "inductive sealing machine." An "equipment group" can be added during the creation of an executable batch record and can be displayed on the equipment settings 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., approval from the operator and supervisor, as described above). 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, that specific equipment group can be added during batch record execution upon receiving electronic signatures from two approvers with appropriate access rights. Figure 6J The illustration shows an exemplary pop-up window for adding an "equipment group" to an executing batch record.

[0069] refer to Figure 1AIn block 112, the system may present a packaging briefing tab, including a user interface, that includes information about the packaging process for a first user (e.g., an operator) to review and / or for a second user (e.g., a supervisor or team leader) to present. 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 permissions (e.g., a team leader) may check out or otherwise approve that one or more operators have completed a packaging briefing. Reference Figure 7A and Figure 7B The Packaging Briefing tab can include an Instructions page and a Summary page. The Instructions page can include multiple packaging instructions associated with the batch record being executed. The Summary page can include a summary, which includes a list of users receiving the briefing (e.g., operators) and the date and / or time of the briefing.

[0070] To complete a packaging briefing, the system can receive an instruction from the user that they have selected the packaging briefing tab for the batch record in progress, such as... Figure 7C As shown. Reference Figure 7D The Packaging Briefing tab allows users to select user availability (e.g., "Start Briefing") to initiate a packaging briefing process for a batch of records in progress. 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 The illustration shows some exemplary fields. These fields may include, but are not limited to: sequence, packaging instructions, packaging condition 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. After a second user (e.g., a team leader) presents a briefing to one or more first users (e.g., operators), each of the first users may electronically sign to indicate that they have completed the briefing.

[0071] Once one or more first users (e.g., operators) have reviewed and electronically signed the summary of the batch records in progress, second users (e.g., team leaders) can electronically sign by selecting the "Team Leader Electronic Signature" button in the summary section, as follows: Figure 7F As shown. This approval from the team leader confirms that one or more operators have completed the packaging briefing. (Reference) Figure 7G When the system receives an electronic signature from one or more operators who have completed a packaging briefing from the team leader, it can display a list of users who have completed the packaging briefing in the summary section of the Packaging Briefing tab.

[0072] Return to reference Figure 1AIn block 114, the system may present a temporary batch verification tab, which includes a user interface for users to verify whether the materials temporarily stored in the packing room match the bill of materials (BOM) associated with the batch record in execution. In one or more examples, the system may receive the temporary batch verification tab within the batch record in execution selected by a user (e.g., an operator) at block 102, such as... Figure 8 As shown. Once the input materials are temporarily stored in the packaging room, the user can select... Figure 8 The "Refresh" user availability is highlighted in the middle. 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 material matches the BOM, no action is required, and the staging input material can be displayed in the batch record in execution with an "Approved" status. If the staging input material does not match the BOM, the system displays the option to "Accept" (i.e., add the input material to the batch record in execution) or "Reject" (i.e., reject the input material). For example, if the project number, supplier batch, and / or customer batch number do not match those listed in the BOM, the system can 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, such as 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 may receive the first approver's electronic signature to confirm 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] Return to reference Figure 1A In block 116, the system can begin a packaging job and display packaging instructions. For example, the system can present a job actions tab, which includes a user interface for users to perform actions related to the packaging job (such as starting a packaging job). In some examples, users with specified access permissions (e.g., a team leader) can begin a packaging job. Figure 9AThe illustration depicts an exemplary user interface for initiating a packaging process. In one or more examples, a user initiating a packaging job can select a "Start Packaging" button located on the Job Actions tab. The system may prompt the user to provide an electronic signature to confirm that the packaging job has begun. In some embodiments, the system may not approve the start of the packaging job if the user providing the electronic signature does not have the specified access permissions.

[0075] At any point between the start and end of a packaging operation, if a suspected or known quality event exists that could affect the safety, quality, identification, potency, and / or purity (SQuIPP) of the material, the batch record in execution can be placed on execution pause. If an in-process batch record is placed on execution pause, it becomes 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, such as... Figure 9A As shown. The system can receive an electronic signature from a user as confirmation that the batch record in execution should be placed on execution pause. The system can then change the status of the packaging job from "In Execution" to "Execution Paused". In some examples, a user with a second specified access right (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 batch record in execution that should be removed from the execution pause. The system can then change the job status of the packaging job from "Execution Paused" to "In Execution". In some embodiments, if the access right of the user entering the electronic signature does not match the specified access right, the system may not approve the execution pause and / or lift the execution pause of the packaging job.

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

[0077] Upon receiving an indication that a packaging job has begun, the system can 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. In some examples, the packaging instructions may be optionally displayed to users with specified access permissions, such as operators or team leaders. In one or more examples, users who have completed a packaging briefing (e.g., operators) will be able to view the packaging instructions. If a user has not yet completed a packaging briefing, they will be prompted to do so before the system displays the packaging instructions.

[0078] In one or more examples, the system may receive a user's selection of a packaging instruction tab for a batch of records in progress, such as... Figure 9B As shown. In some cases, such as Figure 9C As shown, the system can display packaging instructions as a slideshow on the screen, with each instruction and its corresponding image (if applicable) shown one by one. Packaging instructions can be forwarded, backwarded, paused, and stopped by selecting the appropriate icon, such as... Figure 9D As shown. In some embodiments, the system may display a set amount of time (e.g., five seconds) for each instruction. However, the system can increase or decrease this display time by receiving user input to adjust the time bar, such as... Figure 9E As shown. In such embodiments, when the packaging instructions are displayed, the user can perform the steps according to the instructions. The system can then receive the user's electronic signature to confirm the completion of the step. The electronic signature may include 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, such as... Figure 9F As shown. In this type of embodiment, the system can 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 operation to capture images of one or more steps of the packaging operation during its 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 the completion of the corresponding step. In such embodiments, the system may capture or receive images of the packaging operation after it has begun (e.g., as part of...). Figure 1A (Part of block 116).

[0080] like Figure 9G As shown, the system can present an image capture tab, which includes a user interface for users to capture images. As illustrated, the image capture tab can display packaging instructions sequentially. The system can provide users with options to capture and attach images associated with each packaging instruction. In some examples, image capture can be performed by a user with specified access permissions (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 the user performing the packaging task) or a camera associated with the system. In the example, the system can 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 the packaging instructions on a tablet or mobile device. The same tablet or mobile device can also be used to capture images. In one or more embodiments, the system can receive images uploaded from an external device or camera. In the example, the system can present a "File Upload" button to the user and receive uploaded images captured on an external device or camera.

[0081] Figure 9H An exemplary user interface is illustrated, allowing a user to select a specific image to be attached 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 can 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 at least two signatures from users with different specified access permissions to save the image to the packaging instruction.

[0082] Return to reference Figure 1AIn block 118, the system can present an input check tab, which includes a user interface for users to verify whether the quantity of input materials is within its corresponding check limits. Figure 10A The illustration shows an exemplary input verification tab and associated user interface for completing the input verification process electronically. As shown, when approving materials at step 114, materials temporarily stored during the temporary batch verification can be displayed in the input verification tab. Input materials are grouped according to their corresponding output materials. In one or more examples, one or more of the following input material fields can 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 (BOM) may be automatically populated into the input check tab based on information stored at an external resource, such as JD Edwards. These values ​​may include, for example, BOM quantities, issued quantities, and consumed quantities. In such examples, if the user determines that one of these values ​​associated with the BOM is not corrected, the user can update these values ​​by accessing the external resource. For example, the system may 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 material 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 material is within a predetermined check target. For example, the system can receive input from a user indicating that the input check tab has been selected. The system can display, as shown... Figure 10A The user interface shown corresponds to the Input Check tab. At the Input Check user interface, the system can receive an indication from the user's selected output material using an edit icon. The system can receive and save the data entry for "Production Quantity" from the user. The system can also receive and save 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 that value in the appropriate field.

[0085] If the calculated check value is within the predetermined check limit, the calculated check value is displayed in green. For example, refer to... Figure 10AThe input material has a BOM quantity of 4, an issue quantity of 10, and a consumption quantity of 4. As shown in the figure, the system has received a return quantity of 6 from the user. This provides a calculated check value (e.g., check percentage) of 100. Because this value is between predetermined check limits (99.7-100.3), the calculated check value appears in green text. In one or more 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 will be displayed in red. For example, see reference. Figure 10B The input material BOM quantity is 4, the issued quantity is 10, and the consumed quantity is 4. As shown in the figure, the system has received a return quantity of 5 from the user. This provides a calculated check value (e.g., check percentage) of 90%. Because 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 can receive data entries for each of the input materials displayed on the Input Check tab (e.g., based on a bill of materials). In one or more examples, a check is performed for each staging batch. For instance, 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 staging batch. This allows the check to be performed on a basis consistent with batch-organized inventory records stored by external resources. The system allows multiple input material checks to be performed. Each check is captured in the check history.

[0088] Once the system has calculated the input check, it can receive initial approval from a first approver with first access rights (e.g., an operator or quality assurance operator). 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 for the first user to review and sign. Upon completion of the first approval, 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 can be performed by a second approver with the role of operator or quality assurance operator. The second approver can review the check, and the system can receive a second user selection of the "Approve" button. In response to the second user selection of the "Approve" button, the system can present an electronic signature pop-up for the second user to review and sign. In one or more examples, if the calculated check value exceeds a predetermined check limit, the system can request additional approval from a user with second access rights (e.g., a team leader).

[0089] An electronic signature process for multiple user approvals and / or signatures can be substantially similar to the electronic signature process described above. For example, in response to receiving a "Approve" button selection from a user, the system can present the user with one or more text input fields to enter the user's login ID, personal signature identifier, and / or any additional comments. In one or more embodiments, approval and / or electronic signatures may be attributed to a second user even if the system is logged into a first user's account. 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 approval batch record execution process steps without checking out of their current accounts. For example, as with approvals for verifying limits, the system can request approvals from multiple users. Having a first user electronically sign, check out of the system, and then have a second user log in for approval verification is both cumbersome and time-consuming. Therefore, by attributing electronic signatures to users (rather than accounts used to complete packaging operations) 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 operations.

[0090] Return to reference Figure 1B In block 120, the system can receive instructions from the user to end the packaging operation. For example, the system can receive user input corresponding to a selection in the job action tab. (Return to Reference) Figure 9AAt the "Job Actions" tab, the system may present a user interface for users to perform actions related to a packaging job (e.g., ending a packaging job). In some examples, the packaging job may be ended by a user with specified access permissions (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 Actions" tab. In some embodiments, the system may prompt one or more users to provide an electronic signature to approve the end of the packaging job.

[0091] Return to reference Figure 1B In block 122, the system can generate electronic executed batch records (EBRs) for review. In one or more examples, after verification and / or completion of a packaging operation, the system can convert an executing batch record (BRX) into an electronic executed batch record (EBR). An executed batch record may reflect one or more comments, notes, updates, and / or actions taken regarding that batch record during execution (e.g., the packaging process).

[0092] Executed batch records may undergo both technical and quality reviews by various users. This can be done by navigating to the job actions tab (e.g., Figure 9A Access the executed batch records for review by selecting the "Pause and Remove History" button (as shown in the job action tab). The system can display a drop-down menu that includes user-available "Detailed Executed Batch Records" options, such as... Figure 11A As shown. After receiving this user's choice of availability, the system may display a pop-up window, such as... Figure 11B As shown, it allows users to choose to view either a blinded or non-blinded version of the detailed executed batch records. Selecting the blinded version of the executed batch records will include one or more revision fields associated with the blinded information. Figure 12 An exemplary excerpt of an executed batch record from a blind method according to one or more embodiments of the present disclosure is shown.

[0093] In some embodiments, a user with first designated access rights (e.g., a production reviewer) can select an electronically executed batch record for technical review. The technical review can cover the completeness and organization of the batch record, as recorded on the batch record content page, and does not need to be a standalone review (i.e., users 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 can be corrected by one or more users responsible for the initial entry of the erroneous or missing data. In some embodiments, a second user (e.g., a user not responsible for the erroneous data) can also make corrections. In one or more examples, for completeness and accuracy, the user performing the review can read through the contents of the electronically executed batch record, including any prior user approvals.

[0094] In some embodiments, the system may display an "Electronic Performed 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 Storage," "Equipment," "Briefing," "Labeled Samples," "Packaging Instructions," "In-Process Control Checklist," "Verification," "Batch Record Comments," "Corrections," "Blinded Inspection," "Batch Record Materials," "Packaging Certificates," "Discretions 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 can enter an electronic signature to confirm that the electronic performed batch record has been fully reviewed. The user can 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 permission (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 the user performing the quality review with an "electronically executed batch record checklist," if completed during a technical review, which may include one or more user availability options to complete the quality review. If the user performing the quality review identifies an issue, the user can request corrections from one or more users with relevant access permissions (e.g., team leaders and / or operators). Once the system receives all identified corrections, it can receive user selections via 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 one described above. For example, in response to receiving a "Approve" button selection from a user, the system can present the user with one or more text input fields to enter the user's login ID, personal signature identifier, and / or comments. 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 approval 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 attach their electronic signatures to approve executed batch records without checking out of their current accounts. For example, the system can request approvals from multiple users. Having a first user electronically sign, check out of the system, and then have a second user check in to approve executed batch records can be 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 a verifiable approval trail, which improves efficiency.

[0097] Return to reference Figure 1B At block 124, the system may publish the Executed Batch Record (EBR) upon completion of technical and quality reviews. Where applicable, the system may allow users to perform additional actions at this step, including but not limited to changing the product's expiration date, requesting a qualified personnel (QP) to conduct an additional review of the electronic Executed Batch Record, obtaining customer corrections and / or approvals, and completing compliance certification. The published Executed Batch Record may 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 blinded and unblinded versions of the Executed Batch Record may be generated, the blinded Executed Batch Record may be published and shared with the customer, while the unblinded Executed Batch Record may not be published or shared with the customer.

[0098] Return to reference Figure 1A and Figure 1B The system can combine processes 100A and 100B to perform additional operations. These operations may include, but are not limited to: completing the in-process checklist (IPC) for the packaging operation, receiving the target values ​​for the 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.

[0099] In one or more embodiments, after room cleaning is completed and before packing operations begin (i.e. Figure 1ABetween blocks 106 and 116 (in the code), the system allows users to perform actions associated with one or more In-Process Checklists (IPCs). In-Process Checklists typically involve checking input materials during a packaging run. For example, an IPC might be used to verify blister integrity (e.g., the integrity of blister packs), sensor seals on bottles, material counts as specified in a batch record, etc. Generic IPCs can be configured as part of the master data on the system. An IPC tab allows users to select, add, and / or update in-process checklists and associate IPCs with batch records in progress. In one or more examples, the checklists can be configured to be performed by one or more users at the start, during, or near the end of the packaging process.

[0100] Figure 13A An exemplary IPC tab according to an embodiment of this disclosure is illustrated. The system can present an IPC tab and display a corresponding IPC user interface for a user to configure one or more IPCs. In the example, the system can associate instructions with an executing batch record by receiving a user selection of an existing instruction set associated with the executing batch record or a user selection of a "Select Instruction Set" option. The "Select Instruction Set" option allows the user to add one or more instruction sets from master data.

[0101] In one or more examples, IPC can be associated with one or more target values. For instance, a step in a checklist can be associated with a specific value or a range of values, such as verifying that the number of tablets per bottle matches the count specified in the batch record being executed. Figure 13A As shown, the system can present a "Target Value" text input box to receive user-entered IPC target values. For example, a user can enter the number of pills 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 more embodiments, IPC target values ​​may typically be associated with a checklist and are included in updating and saving master data. In one or more examples, IPC target values ​​may be associated with a specific batch record in execution and may not be saved to master data.

[0102] The system can receive a user's selection of a specific IPC and display the IPCs to be completed. In some embodiments, the user can additionally enter a work order number in the "Work Order" text input box. Figure 13AAs shown, the system can display various input fields, including but not limited to "Number of samples obtained", "Container ID", "Reagent kit details", "Notes", "Actual value" and "Result" (e.g., "Pass", "Fail" or "N / A"). Figure 13A The fields shown 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 can 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 can enter the observed actual value and / or indicate the result in the corresponding text box, such as whether the step passed, failed, or N / A. The system can request approval for each step of the IPC. 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 approved IPCs in the IPC Summary tab, such as... Figure 13B As shown.

[0103] If the actual value entered in the IPC exceeds the user-defined target value, the system can prevent the user from completing another IPC. In the example, on the IPC tab, the system can display a "Fault Check Approval" button and a corresponding error message (such as...). Figure 13C As shown), until a user with specific access permissions (e.g., a quality assurance operator) provides input confirming that the fault has been resolved. Upon receiving a 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 users) to complete another IPC.

[0104] In some embodiments, an IPC checklist can be added to the batch record in execution. In some embodiments, the IPC checklist can be added to the batch record in execution before or after packaging has begun (e.g., block 116). For example, if an operator determines in the packaging workshop that a new checklist should be generated, the IPC can be associated with the batch record in execution to be completed as part of a packaging run. To add an IPC to the batch record in execution, the system can present a “Select Instruction Set” text input box that allows the user to search for the IPC to add; an “Add” button that allows the user to select the IPC to add; and an “Add Second Approval” button, such as… Figure 13D As shown. 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 "Secondary Approval Required" notification, such as... Figure 13EAs shown. 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, such as... Figure 13F As shown. When receiving a user's selection of an 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 one 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 IPCs as "not needed" for batch records in progress. For instance, in the IPC tab, the system can display a "not needed" button near the "Select IPC" dropdown menu, such as... Figure 13G As shown. After receiving a user's selection of IPCs to be marked as "unnecessary", the system can display a "marked as unnecessary" notification associated with the selected IPC, such as... Figure 13H As shown. Figure 13I The diagram illustrates the IPC overview user interface, which displays a list of each of the IPCs associated with the batch record being executed.

[0106] In one or more embodiments, an executable batch record may specify one or more samples to be obtained from a packaging run. For example, an executable batch record may specify four samples to be obtained from 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 a user indicating that the user has obtained one or more samples according to the executable batch record. For example, as... Figure 14A As shown, the system can present a sample tab, which includes a user interface for users to enter sample data from the packaging operation. If the sample is specified as the output material, the system can present a "Sampling" button below the applicable output material to receive the 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 "Sample Quantity," "Sample Batch #," and "Additional Remarks," such as... Figure 14B As shown. Figure 14B The fields shown 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, a 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 can record user comments during batch recording execution. The system can 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, Samples, 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 can present an "Enter Comment" button for the user to select. Upon receiving a selection, the system can display a "Field Checkbox" near the available fields where comments can be entered. The system receives the user's selection of the "Field Checkbox" and presents an "Add Comment" window to the user. Figure 15 The illustration depicts 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 can 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 of the receive 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 in each tab. Additionally, the system can display comments entered across all tabs in a Comment 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 batch record execution without checking out of the system, associating comments based on user credentials entered during approval / electronic signature ensures that comments are correctly attributed to users rather than automatically attributed to users logged into the system.

[0109] In one or more embodiments, the system can complete room allocation (i.e. Figure 1A Following block 104, the user is presented with options to edit the executing batch record (BRX). In one or more examples, editing of the batch record can be performed while the batch record is in "execution paused" (see reference). Figure 1A(Block 116). 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 the user with "BRX Edit" buttons for editing batch records on various tabs of the exemplary user interface, including but not limited to Summary, Staging Batch Validation, Packaging Briefing, Sample, and Image Capture. These tabs are exemplary, and more or fewer tabs may display options for editing batch records without departing from the scope of this disclosure.

[0110] Figure 16A An exemplary "BRX Edit" user interface associated with the Summary tab is provided. In one or more examples, Figure 16A The user interface shown 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 may then display an electronic signature page to receive the user's electronic signature to complete 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.

[0111] Figure 16B and Figure 16C The diagrams illustrate exemplary “BRX Exit” user interfaces for output and input materials (pharmaceuticals) associated with the Temporary Batch Validation tab. 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 Limits, and Temporary Total. Upon receiving edits to desired fields from a first user, the system may display an electronic signature page to receive the first user's electronic signature to complete 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.

[0112] The Packaging Briefing tab may also include a "BRX Edit" user availability. In response to a user selection to receive 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 important notes associated with packaging instructions, categorizing packaging instructions or important notes, and / or adding or updating label placement and / or assembly diagrams. Upon receiving a user's edit, the system may then display an electronic signature page to receive the electronic signature of a first user for completion and approval. 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.

[0113] Figure 16D The illustration depicts an exemplary "BRX Edit" pop-up window associated with the Sample tab. Upon receiving user input that selects the "BRX Edit" user availability option, 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 the "Save" user availability option). The system may then display an electronic signature page to receive the user's electronic signature for approval of the edits. In some embodiments, the system may also prompt a second user to provide an electronic signature for approval of the edits. 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. Upon receiving a user's edit, the system may receive user input to save the user's edit to the system (e.g., the user may choose to "Save" user availability). The system may 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 can complete the verification of the input materials (i.e. Figure 1A (After block 118) the system receives user input to cancel the execution of a batch record. For example, the system may present a job actions tab, which includes a user interface for users to perform actions related to a packaging job (e.g., cancel 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 a batch record in execution without further processing of the batch record. In some examples, execution 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 from the job actions tab (e.g., ... Figure 9A The "Execution Cancellation History" button is located on the "Job Actions" tab. The system can prompt one or more users to provide electronic signatures to approve execution cancellation. Upon receiving the first user's electronic signature, the system can prompt another user with different access permissions (e.g., a team leader) to provide an electronic signature to complete another approval for the execution cancellation. If an executing batch record (BRX) is successfully cancelled, the record becomes read-only, and the system can no longer execute that batch record.

[0116] The system allows users to access data from... Figure 1A and Figure 1B During exemplary processes 100A and 100B, a file is attached to an executing batch record (BRX) at one or more points in time. For example, in the "Files" section of the Summary tab, the system may present an "Upload File" button. Upon receiving a user selection of the "Upload File" button, the system may present a pop-up window allowing the user to drag and drop and / or select a file. The system may also present user availability corresponding to a "Contain Non-Blind Information" drop-down menu and receive a "Yes" or "No" selection, indicating whether the file "contains non-blind information." The system may then attach the file to the executing batch record. The system may 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.

[0118] The above operations described with reference to the accompanying drawings can optionally be performed by... Figure 17 The components shown are used to implement this. Those skilled in the art will understand that, based on... Figure 17 The components shown are illustrated, and other processes are implemented accordingly.

[0119] Figure 17 An example of a computing device according to one embodiment is illustrated. Device 1700 may be a host connected to a network. Device 1700 may be a client computer or a server. Figure 17 As shown, device 1700 can be any suitable type of microprocessor-based device, 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 one or more of, for example, processor 1710, input device 1720, output device 1730, storage device 1740, and communication device 1760. Input device 1720 and output device 1730 can generally correspond to the aforementioned devices and can be connected to or integrated with a computer.

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

[0121] Storage device 1740 can be any suitable device providing storage, such as electrical memory, magnetic memory, or optical memory (including RAM, cache, hard disk, or removable storage disk). Communication device 1760 can include any suitable device (such as a network interface chip or device) capable of transmitting and receiving signals over a network. Computer components can 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 device described above).

[0123] Software 1750 may also be stored and / or transferred in any non-transitory computer-readable storage medium for use by 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 and executing the instructions. In the context of this disclosure, a computer-readable storage medium may be any medium (such as storage device 1740) capable of containing or storing programming for use by or in connection with an instruction execution system, apparatus, or device.

[0124] The software 1750 can also be propagated within any transmission medium for use by or in connection with an instruction execution system, apparatus, or device (such as those described above), capable of retrieving and executing instructions associated with the software from and executing those instructions. In the context of this disclosure, the transmission medium can be any medium capable of transmitting, propagating, or transmitting programming for use by or in connection with an instruction execution system, apparatus, or device. Readable transmission media can include, but are 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 appropriately arranged network links capable of transmitting and receiving 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 over a network. Software 1750 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, including one or more client approvers, 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 with blinding information omitted 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 sequence number, end sequence 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 an executable batch record including blinding information to the second user associated with the drug batch customer based on the determination that the batch record information includes blinding information.

[0128] Although this 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 this disclosure and examples as defined by the claims.

[0129] Exemplary embodiments Exemplary implementations of the methods and systems described herein include: 1. A computer-based method for generating executed batch records of clinical trial studies, the method comprising: The system receives an instruction that a batch record has been assigned to a packaging room located at the packaging site, which is configured to execute the batch record. The first user at the receiving packaging site has completed the instructions for the packaging briefing associated with the packaging operation used to execute the batch record; Based on the confirmation that the first user has completed the packaging briefing, a packaging instruction is displayed to produce a certain quantity of packaging materials for the packaging operation; Determine whether the quantity of packaging materials is within the verification target and update the batch record to include confirmation that the quantity of packaging materials is within the verification limit; Receive the 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, 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 capturing device located in a packaging room; and updating a 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 of a plurality of steps, receiving an instruction step approval by a first user associated with the step, the instruction step approval including receiving credentials from the first user.

[0132] 4. The method according to any one of Clauses 1-3, comprising: Input material data, including one or more fields, is obtained from external resources and is associated with input materials temporarily stored in the packaging room; Approval is granted 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; 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 materials; Based on the confirmation that the input materials have been approved or accepted, add the input materials to the batch record in the execution.

[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 identification number, supplier batch number, external resource batch number, and customer batch number.

[0134] 6. The method described under Clause 4 or Clause 5 includes: Upon receiving the instruction that the first user has accepted the input materials, the input material approval interface is displayed; The system receives the first user's credentials via the material input approval interface; and Accept or reject input materials.

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

[0136] 8. The method described in Clause 7 further includes receiving comment approval from a second user, wherein comment approval includes receiving credentials from the second user while remaining logged into the account associated with the first user.

[0137] 9. The method according to any one of Clauses 7 or 8 further includes an instruction to receive the comment in connection with the blinded 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 blinded data is revised.

[0139] 11. The method according to any one of clauses 1-10 further includes configuring a packaging room to perform batch recording, wherein configuring the packaging room includes: Assign packaging rooms at the packaging site to packaging operations; The system receives instructions from the user at the packaging room that the packaging room meets one or more items in the room cleaning checklist, which is associated with the executable batch record and the packaging room. Receive instructions from the user that the packaging room meets one or more items in the room setup checklist, which is associated with the executable batch record and the packaging room; Receive an instruction from the user that the first equipment located in the packaging room meets one or more items in the equipment setup checklist, wherein the equipment setup checklist is associated with the first equipment and the executable batch record.

[0140] 12. The method according to any one of clauses 1-11 further comprises: Receive user input to pause the packaging operation; Based on the user input used to suspend the packaging operation, the operation suspension approval interface is displayed; Receive the first user's credentials 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.

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

[0142] 14. The method described in 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 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 the executable batch record for the packaging operation, which is configured to be performed at the packaging site; Assign packaging rooms at the packaging site to packaging operations; Receive instructions that the packaging room meets one or more items in the room cleaning checklist, which is associated with the executable batch record and the packaging room; Receive an instruction that the packaging room meets one or more items in the room setup checklist, which is associated with the executable batch record and the packaging room; Receive an instruction that the first equipment located in the packaging room meets one or more items in the equipment setup checklist, wherein the equipment setup checklist is associated with the first equipment and the executable batch record; Receive an instruction from the first user that the packaging briefing associated with the packaging operation has been completed; Receive instructions to verify that one or more materials in the packaging room match one or more materials in the material list; Receive instructions to begin packaging operations; Based on the confirmation that the first user has completed the packaging briefing, and upon logging into the account associated with the first user, the packaging instructions associated with the packaging operation are displayed, which include 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; Receive the input quantity indicating the amount of packaging materials; Verify that the quantity of packaging materials is within the predetermined verification target; Receive instructions that the packaging operation is complete; Receive the 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, generate executed batch records for clinical trial studies.

[0144] For purposes of explanation, the foregoing description has been given with reference to specific embodiments. However, the illustrative discussion above 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 foregoing 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 can best utilize the technology and various embodiments and modifications suitable for the particular intended use.

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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