Revised Schedule M for MSMEs: What Inspectors Look For in Batch Records
Revised Schedule M now applies to MSMEs. Here is what inspectors tend to look for in batch records, why eBMR is not mandatory but makes records easier to show, and how to try it in a 14-day pilot.
Paper vs electronic batch records: what changes for QA and production
What really changes for production and QA when a plant moves from paper to electronic batch records: enforced steps, section review, exceptions in one list, and what Part 11 support does and does not cover.