What’s FDA 21 CFR Part 11?
FDA 21 CFR Part 11 is the FDA guideline that defines the criteria under which electronic records and electronic autographs are considered to be secure, dependable and original to that of the paper records. FDA 21 CFR Part 11 Part 11, as it’s generally known, was introduced in 1997 and applies to FDA- governed diligence […]
How To Navigate Compliance With FDA’s 21 CFR Part 11
Compliance With FDA’s 21 CFR Part 11 Compliance With FDA’s 21 CFR Part 11 21 CFR Part 11, the regulation on electronic records and electronic autographs, causes insomniac nights for numerous quality control experts and directors of nonsupervisory compliance whose companies are subject to examinations by the FDA. These companies include Contract Research Organizations (CROs) […]