21 CFR Part 11: Electronic Records; Electronic Signatures

Law · 21 CFR Part 11 · eCFR as of 25 Sep 2026 · checked 30 Sep 2026 · Official source: ecfr.gov

Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.

Source: 62 FR 13464, Mar. 20, 1997, unless otherwise noted.

Subpart A—General Provisions

Subpart B—Electronic Records

§ 11.10 Controls for closed systems.BatchGlow
§ 11.30 Controls for open systems.
§ 11.50 Signature manifestations.BatchGlow
§ 11.70 Signature/record linking.BatchGlow

Subpart C—Electronic Signatures

§ 11.100 General requirements.BatchGlow
§ 11.200 Electronic signature components and controls.BatchGlow
§ 11.300 Controls for identification codes/passwords.BatchGlow