Electronic Signature (e-signature)

Definition

An electronic signature is a legally binding digital equivalent of a handwritten signature, used within an EBR or QMS to authorize, approve, or attest to a specific record or action. Under 21 CFR Part 11, an electronic signature must be uniquely linked to its signer and cannot be reused or transferred to another individual.

Benefits

Electronic signatures eliminate the bottlenecks of physical sign-off, no waiting for a paper form to be routed and physically signed, while maintaining the same (or stronger) legal and regulatory weight as a wet-ink signature, when implemented to Part 11 standards.

Use Case

A production supervisor completes a batch step and applies an electronic signature, which requires re-entry of a unique password as a second authentication factor, immediately time-stamping the approval and linking it inseparably to that specific record within the audit trail.

Frequently Asked Questions (FAQ)

Related Terms

• 21 CFR Part 11
• Audit Trail
• User Access Controls