Title 21 Part 11

21 CFR FDA Part 11 - Electronic Records; Electronic Signatures

FEBRUARY 2017 EDITION

Contents:

Subpart A - GENERAL PROVISIONS

§11.1 Scope.
§11.2 Implementation.
§11.3 Definitions.

Subpart B - ELECTRONIC RECORDS

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

Subpart C - ELECTRONIC SIGNATURES

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