What is 21 CFR Part 11?

21 CFR Part 11 is the FDA guideline 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, as it is commonly known, was introduced in 1997 and applies to FDA-governed industries that choose to store their primary, authoritative records electronically. It stipulates the guidelines and rules for storage, copying, access & permissions, audit logs & tracking. It also identifies version control of the electronic records and the application of electronic signatures to them.

Title 21 CFR Part 11 enacted the FDA’s requirement that they are able to recognize electronic records and electronic signatures as trustworthy, reliable, and legal equivalents to paper records and handwritten signatures. This also allows companies to adopt a ’paperless’ system of record keeping.

Electronic Signature

To remain compliant with 21 CFR Part 11, Adobe Acrobat Sign Part 11 automatically secures the authenticated user’s electronic signature while ensuring the user has signed onto the system and showcased their signature via the authentication process.

Audit Trail

Audit Trail is one of the most useful features from Adobe Acrobat Sign Part 11. The Audit Trail includes various information, including the field’s values and details related to the change.