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What is it?
Title
21 CFR Part 11 of the Code
of Federal Regulations deals with the FDA
guidelines on electronic records and electronic
signatures in the United
States. Part 11, as it is commonly called, defines the criteria under
which electronic records and electronic signatures are considered to be
trustworthy, reliable and equivalent to paper records.
Part 11 Table of Content
- Subpart A – General Provisions
- Scope
- Implementation
- Definitions
- Subpart B – Electronic Records
- Controls for closed systems
- Controls for open systems
- Signature manifestations
- Signature/record linking
- Subpart C – Electronic Signatures
- General requirements
- Electronic signatures and controls
- Controls for identification codes/passwords
U.S FDA: Title 21
Code of Federal Regulations, Electronic Records and Electronic Signatures
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