Part 11

Commonly referred to as Part 11, 21 CFR Part 11 are a set of regulations by the Food and Drug Administration (FDA) 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 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in FDA regulations. FDA: 21 CFR 11, Electronic Records; Electronic Signatures