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Icologiq Knowledge · Technology
Electronic Signature
An electronic signing action used to record a person's approval, review or other sign-off on an electronic record.
Also known as:
e-signature, electronic approval signature, digital approval signature
At a glance
Type
Technology
Topic
Document Control
Applies to
Cross-industry
Current version
Status
Last reviewed
September 29, 2026
Definition
An electronic signature is an electronic signing action used to associate a person with the approval, review, verification or other sign-off of an electronic record. In a quality management system, an electronic signature should be considered together with identity, authentication, the meaning of the signature, date and time, record integrity and auditability. Specific legal or regulatory requirements depend on the context and jurisdiction.
Why it matters
Quality systems rely on approvals for controlled documents, changes, investigations, training, audits and other records. When those approvals are electronic, organizations need confidence that the signer is identifiable, the approval is attributable to the correct record and version, and the evidence remains available during audits. In FDA-regulated environments, 21 CFR Part 11 is an important part of that assessment.
A traceable record of relevant system activities and changes showing what happened, when it happened and, where applicable, who performed the action.
Audit Trail
Technology/Compliance
· Document Control
The process of ensuring that approved documents are current, traceable, accessible to the right people and protected against uncontrolled change or use.
Document Control
Process
· Document Control
A document whose creation, approval, revision, distribution and withdrawal are managed through defined controls to ensure authorized and current information is used.
Controlled Document
Concept
· Document Control
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