TraceR2CFramework library / 21 CFR Part 11
Pharma & Life Sciences · regulatory framework
21 CFR Part 11 — Electronic Records & Signatures.
The FDA rule that makes electronic compliance records trustworthy: audit trails, access control, signature integrity.
What it is
21 CFR Part 11 defines when the FDA will accept electronic records and electronic signatures in place of paper. It requires validated systems, secure and computer-generated audit trails, record retention and copying for inspection, access controls, and signature manifestations that bind a person to what they signed.
Who it applies to
Any regulated life-sciences company keeping required records electronically — which today is everyone moving off paper and spreadsheets.
The evidence auditors expect
- Computer-generated, time-stamped audit trails on regulated records
- Role-based access controls and unique user accountability
- Records exportable in human-readable form for inspection
- Signature records linking who, what and when for approvals
How ComplianceFlow keeps you ready
- Every action in ComplianceFlow — upload, verification, approval, exception — is captured in a time-stamped audit trail
- Reviews and approvals carry the reviewer’s identity and timestamp, giving decisions a defensible signature trail
- Evidence and its full history export in human-readable, inspection-ready form
Related frameworks
See 21 CFR Part 11 evidence assemble itself.
ComplianceFlow keeps a living copy of 21 CFR Part 11 mapped to your suppliers, products and evidence — so what you must prove is always current, and always exportable.
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