Title 21 CFR Part 11

Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

Electronic signature

An electronic signature, or e-signature, is data that is logically associated with other data and which is used by the signatory to sign the associated data. This type of signature has the same legal standing as a handwritten signature as long as it adheres to the requirements of the specific regulation under which it was created.

Electronic signatures are a legal concept distinct from digital signatures, a cryptographic mechanism often used to implement electronic signatures. While an electronic signature can be as simple as a name entered in an electronic document, digital signatures are increasingly used in e-commerce and in regulatory filings to implement electronic signatures in a cryptographically protected way.

Part 11

Practically speaking, Part 11 applies to FDA-regulated industries. For example this applies to submissions made to the FDA in electronic format. It requires that they implement controls, including audits, system validations, audit trails. Most food manufacturers are not explicitly required to keep detailed records.

Authoritative document

If a regulated firm keeps “hard copies” of all required records, those paper documents can be considered the authoritative document for regulatory purposes. Firms should be careful to make a claim that the “hard copy” of required records is the authoritative document. For the “hard copy” produced from electronic source to be the authoritative document, it must be a complete and accurate copy of the electronic source. The manufacturer must use the hard copy (rather than electronic versions stored in the system) of the records for regulated activities.