21 CFR Part 11
PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
- PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter A—General
- 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.
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