Title 21 Part 11

21 CFR Part 11Dossiers électroniques; Signatures électroniques

21 CFR FDA Part 11 - Electronic Records; Electronic Signatures

Data is current as of October 1, 2018

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.