System and method for creating batch records for pharmaceutical testing

Abstract

Embodiments of this disclosure include systems and methods for creating electronic batch records.

Claims

1. A computer implementation method for generating completed batch records for clinical trial research, The steps include receiving instructions that a batch record is assigned to a packaging room located in a packaging facility, the packaging room being configured to execute the batch record, The steps include: receiving instructions at the packaging facility that the first user has completed the packaging briefing associated with the packaging job for executing the batch record; The steps include, in accordance with the decision that the first user has completed the packaging briefing, displaying packaging instructions for producing the quantity of packaged material for the packaging job, The steps include determining whether the amount of the packaged material is within the adjustment target range and updating the batch record to include determining whether the amount of the packaged material is within the adjustment limit range, A step of receiving a first approval of the batch record by the first user, wherein the first approval comprises a step of receiving credentials from the first user while logged into the account associated with the first user, A step of receiving a second approval of the batch record by a second user, wherein the second approval comprises receiving credentials from the second user while remaining logged into the account associated with the first user, A step of generating the completed batch record for the clinical trial study based on the approved batch record; A computer implementation method comprising the following features.

2. The method according to claim 1, wherein the packaging instruction comprises a plurality of steps, and the method further comprises the steps of receiving an image via an image capture device located in the packaging chamber that provides a visual indication that one of the plurality of steps has been completed, and updating the batch record, saving the image and associating the image with one of the plurality of steps.

3. The method according to claim 2, comprising the step of receiving instruction step approval from a first user for one of the plurality of steps, wherein the instruction step approval comprises the step of receiving the credentials from the first user.

4. A step of obtaining input material data comprising one or more fields via an external resource, wherein the material data is associated with input materials staged in the packaging chamber. The step of approving the staged input materials in accordance with the determination that one or more fields of the input material data match one or more corresponding fields of the executable batch record, The steps include: displaying user affordances for the first user to pass or fail the input material, based on the determination that a field in the input material data does not match a corresponding field in the executable batch record; The steps include adding the input material to the running batch record in accordance with the decision that the input material has been approved or passed, and The method according to any one of claims 1 to 3, comprising:

5. The method according to claim 4, wherein the one or more fields of the input material data include one or more of a material identification number, a supplier lot number, an external resource lot number, and a customer lot number.

6. The first user receives an instruction that the input material has been approved, and the step of displaying the input material approval interface, The steps include receiving the credentials of the first user via the input material approval interface, The steps of determining whether the input material is acceptable or unacceptable. The method according to claim 4 or 5, comprising:

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

8. The method according to claim 7, further comprising the step of receiving comment approval of the comment by the second user, wherein the comment approval includes receiving the credentials from the second user while logged into the account associated with the first user.

9. The method according to claim 7 or 8, further comprising the step of receiving an instruction that the comment is associated with blinded data.

10. The method according to claim 9, wherein the step of generating the executed batch record comprises the step of generating the executed batch record, which has been blinded so that the blinded data is edited.

11. The step of configuring the packaging room to perform the batch recording further comprises, The steps include assigning a packaging room in the packaging facility to the packaging job, A step of receiving instructions from a user located in the packaging room that the packaging room meets one or more items on a room clearance checklist, wherein the room clearance checklist is associated with the executable batch record and the packaging room. The step of receiving instruction from the user that the packaging room satisfies one or more items of a room setup checklist, wherein the room setup checklist is associated with the executable batch record and the packaging room. The steps include receiving instructions from the user that a first device located in the packaging chamber satisfies one or more items on a device setup checklist, wherein the device setup checklist is associated with the first device and the executable batch record, and The method according to any one of claims 1 to 10, comprising:

12. The steps include receiving user input to put the aforementioned packaging job on hold, The steps include: displaying a job hold approval interface upon receiving the user input to hold the packaging job; The steps include receiving the credentials of the first user via the job hold approval interface, The steps include receiving the credentials of the second user via the job hold approval interface while remaining logged into the account associated with the first user, Steps to update the packaging job status to pending and The method according to any one of claims 1 to 11, further comprising:

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

14. The method according to claim 13, further comprising the step of automatically updating the progress bar when one or more tasks associated with the packaging job are approved.

15. A method for generating completed batch records for clinical trial research, In a first computer system comprising one or more processors and one or more memories, A step of obtaining an executable batch record for a packaging job, wherein the packaging job is configured to be executed at a packaging facility, The steps include assigning a packaging room in the packaging facility to the packaging job, A step of receiving an instruction that the packaging room meets one or more items of a room clearance checklist, wherein the room clearance checklist is associated with the executable batch record and the packaging room. A step of receiving an instruction that the packaging room satisfies one or more items of a room setup checklist, wherein the room setup checklist is associated with the executable batch record and the packaging room. A step of receiving an instruction that a first device located in the packaging chamber satisfies one or more items of a device setup checklist, wherein the device setup checklist is associated with the first device and the executable batch record, The first user receives an instruction that the package briefing associated with the packaging job has been completed, The steps include receiving instructions to verify that one or more materials in the packaging chamber match one or more materials in the bill of materials, The steps include receiving instructions to start the aforementioned packaging job, A step in which, in accordance with the decision that the first user has completed the package briefing, the first user is logged into the account associated with the first user and the packaging instructions associated with the packaging work are displayed, wherein the packaging instructions comprise a plurality of steps, For one of the aforementioned steps, the step of receiving an image via an image capture device located in the packaging chamber that includes a visual indication that the step has been completed, A step of receiving an input amount indicating the amount of packaged material, A step of verifying that the amount of the packaged material is within a predetermined adjustment target range, The steps include receiving an instruction that the aforementioned packaging job has been completed, A step of receiving a first approval of the batch record by the first user, wherein the first approval comprises the step of receiving credentials from the first user while logged into the account associated with the first user, A step of receiving a second approval of the batch record by a second user, wherein the second approval comprises receiving credentials from the second user while remaining logged into the account associated with the first user, A step of generating the completed batch record for the clinical trial study based on the approved batch record; A method that includes [a certain feature].

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