Understanding both Electronic and Handwritten Signatures within the Context of Part 11

Written by Robert Finamore - Director, Validation Services, QPharma

21 CFR Part 11; Electronic Records, Electronic Signatures defines the FDA’s requirements for using records and signatures in electronic form to meet the record-keeping requirements of Agency regulations.  In more than ten years dealing with Part 11 compliance, I have often seen confusion over exactly what constitutes an “Electronic Signature.”  The title of the regulation itself uses the term “Electronic Signature,” which is somewhat of a misnomer since the regulation deals with several different types of signatures that are used in electronic form.  The different types of signatures include standard electronic signatures, digital signatures, and handwritten signatures captured electronically.

Electronic Signatures (“e-sigs”) are the types of signatures most people think of when considering Part 11.  Electronic Signatures are defined as “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.”  This indicates that some information must be entered electronically and associated to a record for that record to be considered signed.  There are two standard types of e-sigs: Biometric and Non-Biometric signatures.

Biometric Electronic Signatures involve “a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.”  This unique measurement must be captured every time a record is signed and such measurement would need to be securely linked to the signed record.  Examples of biometric signatures included fingerprint scans or iris scans.  This type of signature requires some type of measurement hardware attached to the computerized systems for the signature to be executed so it has not currently seen widespread use in the life science industries.  Biometric Signatures must comply with both the General Signature Requirements and Electronic Signature Requirements as defined in §11.50, §11.70, §11.100, and §11.200(b) of the regulation.

The other type of standard e-sig is the Non-Biometric Signature.  This type of signature requires entry of two or more distinct signature components into the computerized system as the e-sig execution action.  The traditional e-sig requires entry of a User ID and. . .