CAP question

Which item below covers all aspects of electronic records including signatures, integrity and authenticity, record creation, audit trails, and archiving?

A. 21 CFR Part 12
B. 12 CFR Part 14
C. 21 CFR Part 11
D. 21 CFR Part 21

CAP answer

The answer is C, “21 CFR Part 11.” Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the U.S. Food and Drug Administration regulations on electronic records and electronic signatures. It defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

References: Sands, Nicholas P. & Verhappen, Ian, A Guide to the Automation Body of Knowledge, Third Edition, ISA Press, 2019.


“Title 21 CFR Part 11”



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