FDA 21 CFR Part 11 compliance
January 13, 2023 ⚊ 1 Min read ⚊ Views 100 ⚊ BUSINESS
21 CFR Part 11 is the FDA guideline that defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to that of the paper records. Part 11, as it is commonly known, was introduced in 1997 and applies to FDA-governed industries that choose to store their primary, authoritative records electronically. It stipulates the guidelines and rules for storage, copying, access & permissions, audit logs & tracking.
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