CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL

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.