Will a Scanned Paper Signature be Considered an Electronic Signature?

• By: Staff Editor
• Date: December 12, 2011

Yes – a scanned paper signature is considered an electronic signature as regulations state that an electronic record is considered signed and approved by the signatory if there’s a digital scan of the signature, symbol, digital certificate or corporate logo.

Electronic signatures can be constructed in a number of different ways.

According to the Electronic Signatures in Global and National Commerce (ESIGN) Act, an electronic signature means “an electronic sound, symbol, or process, attached to or logically associated with a contract or other record and executed or adopted by a person with the intent to sign the record.”

For 21 CFR Part 11 compliance, an electronic record is considered signed if there’s a digital scan of the provider’s signature or a digital certificate or a corporate logo – objects which the parties understand is tangible evidence of the signatory’s approval/agreement with the record. The regulation itself states that:

“Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.”

Read the FDA’s guidance to industry on 21 CFR Part 11 compliance