What is 21 CFR Part 11? Comply with FDA 21 CFR Part 11 Compliance

Compliancequest14 Apr, 2022Technology

21 CFR part 11 is Part 11 of Title 21 of the Code of Federal Regulations by FDA as compliance guidelines for trustworthiness of electronic records and electronic signatures.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. It also identifies version control of the electronic records and the application of electronic signatures to them.