FDA Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. Practically speaking, Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries, with some specific exceptions, to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are:
(a) required to be maintained by the FDA predicate rules or;
(b) used to demonstrate compliance to a predicate rule.
Smarsh, Inc. assumes no liability for the accuracy or completeness of this information. Please consult with an attorney for specific information on specific rules and regulations and how they apply to your business.