What is 21 CFR Part 11?

21 CFR Part 11 is a document from the US Food and Drugs Administration (FDA) that sets forth the requirements that have to be met in order that electronic records and electronic signatures are considered to be as trustworthy as paper records with handwritten signatures.

Definition of electronic records and signatures

• An electronic record is - any combination of text, graphics, data, audio, pictorial or other information represented in a digital form that is created, modified, maintained, archived and retrieved or distributed by a computer system.
• An electronic signature is - a computer data compilation of any symbol or series of symbols executed, adopted or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.