FDA 21 CFR Part 11 Part11.50_70: Signature manifestations + signature / record linking (21 CFR §§11.50 + 11.70)

Section 11.50 (Signature Manifestations): (a) signed electronic records must contain information associated with the signing that clearly indicates all of the following: (1) the printed name of the signer; (2) the date and time when the signature was executed; (3) the meaning (such as review + approval + responsibility + or authorship) associated with the signature. (b) the items identified in §11.50(a) must be subject to the same controls as for electronic records + must be included as part of any human readable form of the electronic record (such as electronic display or printout). Section 11.70 (Signature / Record Linking): electronic signatures + handwritten signatures executed to electronic records must be linked to their respective electronic records to ensure that the signatures cannot be excised + copied + or otherwise transferred to falsify an electronic record by ordinary means. The §11.70 linking requirement is foundational - the signature must be cryptographically or otherwise bound to the specific record + cannot be reused or moved.