21 CFR Part 11 in the US: practical guide

Core Part 11 requirements for FDA-regulated trials in the US.

Part 11 as federal regulation

21 CFR Part 11 is the FDA regulation establishing criteria under which electronic records and signatures are acceptable as paper equivalents in FDA-regulated contexts.

Since the 2003 Scope and Application Guidance, FDA applies a risk-based approach: Part 11 applies where predicate rules (21 CFR 312, 812, 803, etc.) require records. Clinical = yes, marketing = no.

Critical subsections for your EDC

•§11.10 Closed system controls — base rule
•§11.30 Open system controls — cross-org transmission
•§11.50 Signature manifestations — what each signature must contain
•§11.70 Signature/record linking
•§11.100-300 Electronic signature requirements

Documented Trialinx controls

✓Append-only audit trail with UTC timestamps
✓Readable CSV/JSON copies for inspection
✓Indefinite retention with verifiable integrity
✓Granular RBAC + 2FA
✓Dual-component electronic signature available
✓Documented system validation on Institutional

FAQ

Will my sponsor ask for a Part 11 certificate?

Probably not a certificate (no such authority exists). They'll ask for your system validation package documenting how you meet each subsection.

Can I use Part 11 without a US sponsor?

You can voluntarily comply with Part 11. Often a good idea if your study might be used in future FDA submissions.

Need specific documentation?

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