According to Good Manufacturing Practices (GMP), every pharmaceutical process must be properly documented to give evidence that the process operates within pre-established parameters and prove that the manufactured product meets its specifications and quality attributes.
A Batch Manufacturing Record (BMR) is a written document that contains the complete “history” of the batch produced during the pharmaceutical manufacturing process, including actual production data, components’ properties, and operations.
Life Sciences Supply Chain Management allows for the generation of an Electronic Batch Record (EBR) for a batch order/production order (Production control > All production orders > View tab > Electronic batch record).
The Electronic Batch Record functionality is built on top of the Standard D365 Electronic reporting feature. This tool allows business users to manage reports in a configurable and flexible way.
Life Sciences Supply Chain Management adds the possibility to configure an EBR template to generate an electronic Batch manufacturing record (BMR). The EBR template is configured as a format based on data model configuration (Organization administration > Workspaces > Electronic reporting > Reporting configurations) associated with the BPHBatchRecord tag. For details on how to configure electronic reporting from scratch, please refer to Microsoft material.
Once the EBR template is completed and its status is changed to Completed, it is possible to approve the format by using the Approve button (the approver is recorded in the Approved by field).
Approved formats cannot be directly modified, but it is possible to create a new version and apply changes to it. Life Sciences Supply Chain Management enables the definition of the activation period of each EBR template version by populating the Effective from and Effective to fields. A version can be activated/deactivated by using the Activation button (the user who activates the version is recorded in the Activated by field). Two versions of the same EBR template cannot be active during overlapping periods.
The EBR template activation and approval can be secured via electronic signature by enabling the Activate ER configuration and Approve ER configuration electronic signature requirements (Organization administration > Setup > Electronic signature > Electronic signature requirements).
Approved EBR templates can be linked to a Formula/BOM version by selecting them in the EBR template field (Product information management > Products > Released products > Engineer tab > Formula version/BOM version). This allows to define different EBR template formats based on the BOM/Formula version.
It is not possible to select a not approved or not active EBR template. Additionally, the system verifies that the EBR template activation period is consistent with the formula activation period and displays a warning message if the EBR template validity period does not fully cover the BOM/Formula version validity period.
When a production order or batch order is processed using a BOM/Formula version with an EBR template associated, it is possible to print the EBR using the Electronic batch record button (Production control > Production orders > All production orders > View tab > Print section). If no EBR templates are selected for the BOM/Formula version used in the order, the system displays an error.
If the EBR template is not approved, the EBR is not generated. If the EBR template is not active on the current date, a validation message is displayed, requiring the user’s confirmation before printing the document. These checks are only run when printing the EBR for the first time for the selected order (that is, original print). Once the first report is generated, users are always allowed to reprint it regardless of the approval and activation of the template.
The EBR can be generated in multiple formats (for example, Excel, Word, PDF), stored in SharePoint, or sent via email, according to the destination selected for the EBR template in the Electronic reporting destination form (Organization administration > Electronic reporting > Electronic reporting destination).
The printed reports are archived in the Electronic reporting archived jobs form (Organization administration > Electronic reporting > Electronic reporting archived jobs). The archive specifies if the generated report is an Original or a Reprint. For reprints, the number of copies generated is recorded. It is always possible to reprint an EBR, the system does not verify the approval/activation status of the EBR template.