FDA Title 21 CFR Part 11: What Is It?
FDA Title 21 CFR Part 11 is a set of regulations established by the United States Food and Drug Administration (FDA) that outlines the requirements for electronic records and electronic signatures. Labs in industries regulated by the FDA – such as pharmaceutical, medical device, and biotechnology companies – are required to follow the standards defined in 21 CFR Part 11 to demonstrate to the FDA that their electronic records and signatures are “trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.”
