Part 11 of Title 21 of the Federal Code of Regulations outlines expectations for creating, managing and maintaining electronic records as well as electronic signature capture and intent. Its purpose is to outline when electronic records and electronic signatures are to be considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. Part 11 applies to FDA regulated entities and activities with a few exceptions and may apply to certain medical device and pharmacological development, such as clinical trials and other research at the university. The university uses AdobeSign as our preferred vendor to verify and track electronic signatures.

Part 11 requires that electronic signature information be unique to each individual, verify the signer’s identity, be included and linked to respective signed records, in order to consider an electronic signature trustworthy and equivalent to handwritten signatures executed on paper. The University uses AdobeSign, which complies with this regulation. Contact the Office of Software Licensing to eCFR :: 21 CFR Part 11 — Electronic Records; Electronic Signatures