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21 CFR Part 11 is a regulatory framework designed by the FDA to guide drugmakers on how to create, manage, and maintain electronic records and electronic signatures. It also says under what conditions drug makers become eligible for compliance with this regulation.
The term comes from Title 21 of the Code of Federal Regulations (CFR). In effect since January 2007, 21 CFR Part 11 governs electronic records and signatures in regulated industries like pharmaceuticals, biotech, medical devices, etc.
Totally, the CFR has 50 titles. Out of them, Title 21 deals with food and drugs. Again, Title 21 has 3 chapters.
Chapter I – Food and Drug Administration
Chapter II – Drug Enforcement Administration
Chapter III – Office of National Drug Control Policy
Chapter I includes 3 Subchapters named A, B, C, and so on.
SUBPART A – GENERAL PROVISIONS
■ Sec. 11.1 Scope
■ Sec. 11.2 Implementation
■ Sec. 11.3 Definitions
SUBPART B – ELECTRONIC RECORDS
■ Sec. 11.10 Controls for closed systems
■ Sec. 11.30 Controls for open systems
■ Sec. 11.50 Signature Manifestations
■ Sec. 11.70 Signature record/linking
SUBPART C – ELECTRONIC SIGNATURES
■ Sec. 11.100 General Requirements
■ Sec. 11.200 Electronic signature components and controls
■ Sec. 11.300 Controls for identification codes/passwords
