How does it help me?
Batch Production Record
What is Batch Production Record?
Electronic Batch Record (EBR), also known as Batch Production Record (BPR), or Batch Manufacturing Record (BMR), is the methodology applied to manage and document manufacturing processes in highly regulated industries.
The purpose of implementing EBR is to ensure thorough verification and demonstration that each specific batch created is done in accordance to the Master Batch Record (MBR). The Electronic Batch Record also explains and breaks down deviations, helping identify if these deviations occurred during production stages of any given batch.
Why do we need it?
Organizations subject to government regulations, such as FDA 21 CFR Part 11, are required to record each batch manufactured. The batch production record must include complete information relating to the production and control of each batch, accurately following the appropriate master manufacturing record.
Using Dot Compliance Suite empowers organizations with efficient and easy maintenance of compliance, while also driving quality manufacturing processes in a simple and user-friendly cloud interface. Dot Compliance Suite ensures each batch record is completed according to the Master Batch Record, while also reinforcing that acceptance tests are performed accurately.
Management of associated product and Bill of Material (BOM).
List of applicable documents.
Related equipment tracking.
Electronic worksheets and protocols.
Required samples and tests.
Tracking of quality events, deviations and malfunctions associated with the batch.
QA/QP release process.