Get Electronic Signature Compliance

Your choice of e-signature tool should help you meet title 21 CFR part 11 requirements. Discover what more you can do with Acrobat Sign to keep signatures safe and secure. About Title 21 CFR Part 11 FDA compliant signatures.

Accepted signature methods by FDA are: Scanned signatures. Digital signatures. Flattened digital signatures. A flattened digital signature must include (see example): the printed name of the signer. the date and time when the signature was executed. the reason for signature.

Accepted signature methods by FDA are: Scanned signatures. Digital signatures. Flattened digital signatures. A flattened digital signature must include (see example): the printed name of the signer. the date and time when the signature was executed. the reason for signature.

21 CFR Part 11 refers to the automated collection, processing and analysis of research information which results in the creation of an electronic record. This regulation applies to all electronic records*, electronic signatures, and handwritten signatures converted to electronic format.

Title 21 CFR Part 11 brings FDA regulations into the digital age by allowing electronic documents and signatures on official government business. This affects industries regulated by the FDA, including: Drug manufacturers.

The method used must be connected to an electronic communication. It must also be either as reliable as appropriate in the circumstances, or proven to be accurate. Identity could be shown by a typed name, a personal mark, a personal email, or use of an online ID verification method.

SignNow Electronic Signature Service | University of Michigan Medical School Research. The University's E-signature Service, SignNow, has a version that is compliant with FDA regulations at 21 CFR Part 11.