21 CFR Part 11 is the FDA's rule for when electronic records and electronic signatures are trustworthy enough to stand in for paper. If your quality and batch records are electronic — and they should be — Part 11 is the bar they need to clear.
What Part 11 requires, in plain terms
- ✓Records are attributable — you know who did what, and when
- ✓Electronic signatures are uniquely tied to an individual and can't be reused or transferred
- ✓Audit trails are secure, computer-generated, and time-stamped — and can't be altered
- ✓The system controls access by role and authority
- ✓Records can be retrieved and reproduced for the agency throughout their retention period
The common failure mode
Pharmacies often go "digital" by moving paper forms into PDFs and shared drives — which satisfies almost none of Part 11. The audit trail is the crux: it must be automatic, tamper-evident, and complete. If a record can be edited without a trace, it isn't Part 11-ready.
Meeting it without the paperwork spiral
A purpose-built system applies signatures and immutable audit trails to the actions that matter — batch release, QA sign-off, deviations, change control — automatically, as part of the work. No parallel paperwork, no after-the-fact reconstruction.
In Pharmacy Flow, controlled quality actions carry an actor, timestamp, and e-signature, and the audit log is append-only — see how compliance is built in.
Frequently asked questions
Does Part 11 apply to compounding pharmacies?+
It applies to electronic records and signatures used to meet FDA requirements — which is squarely relevant to 503B facilities and to any pharmacy keeping electronic quality/batch records.
Is a PDF of a signed form Part 11 compliant?+
Generally no. Part 11 requires attributable records, unique e-signatures, and secure, tamper-evident audit trails — which static PDFs on a shared drive don't provide.