The FDA requires that batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch.
Batch records could be created manually or automatically by integrating to other production systems.
PART 211. Batch Manufacturing Record and Batch Production Record
Batch Manufacturing Record and Batch Production Record workflow
We invite you to run a free trial using your company’s specific use cases to see how Simploud works for you. In our experience, the proof is in the pudding, as nearly 90% of companies who try the Simploud platform become customers. We believe you’ll enjoy the pudding too.
Solutions
© Copyright Simploud 2023
Follow our story on
