Compliance to FDA 21 CFR Part 11 Requirements

21 CFR Part 11 is the FDA guideline that defines the criteria under which electronic records and electronic signatures are considered to be dependable, reliable and equivalent to that of the paper records. Part 11, as it is commonly known, was introduced in 1997 and applies to the 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. It also identifies version control of the electronic records and the application of electronic signatures to them. Part 11 applies to all records that are defined in the underlying Acts and Regulations which govern activities in the life science industries. Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries to implement controls, including: audits, system validations, audit trails, electronic signatures, & documentation for software and systems involved in processing electronic data that are either required to be maintained by the FDA predicate rules or used to demonstrate compliance to a predicate rule.
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