ComplianceQuest (CQ) supports 21 CFR Part 11 FDA compliance requirements for life sciences organizations in health-care, pharmaceutical, life-science, biotechnology, medical- manufacturing, medical devices, and other FDA-regulated industries.
What is FDA 21 CFR Part 11 Compliance?
21 CFR Part 11 compliance 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.
