Syncade EBR manages production batch protocols and provides traceability to batch histories and audit trails. EBR manages the execution of standard operating procedures and production batch protocols while providing complete traceability, batch history, audit trails, and consistent reporting. It provides for any combination of sequential, parallel and branch instruction processing. It handles deviations, equipment and suite usage, as well as operator activities, such as cleaning, calibration, maintenance, repair, validation and use.
- Allows for release of batch by exception.
- Provides a centralized, controlled repository for all executed batch records.
- Guides the operator through each step with electronic work instructions.
- Produces an unalterable batch record.
- Provides a full audit trail history of production data collected.
- Enables one comprehensive batch report with easy, secure data access.
- Enables process optimization with playback functionality
A processing map of the production process is displayed. where rules-based workflow control allows instructions for events and activities to be defined and followed. It provides support for bar code scanning, wireless hand-held devices, and biometric electronic signature authentication. Batch playback allows executed recipes to be reviewed for optimization, training, and deviation resolution efforts.
The system complies with cGMP regulations, but it is not clear if it is 21 CFR Part 11 compliant. It would be most useful for large operations (greater than 100 people) that need GMP compliance.
We invite you to leave a comment or a review of this system especially if you are a current user of the system. We appreciate your feedback and we expect it will help other potential users to make a good choice when they decide to use electronic batch records in their manufacturing operation.