Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

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.

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

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


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1. Subpart A - General Provisions