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.
Use authentication and account controls appropriate to the significance of the action so the signature can be attributed to a person.
Identify the signer
•
Make clear what the person is approving, acknowledging or authorizing at the moment of signature.
Capture signing intent
•
Keep the signature associated with the specific document, version, transaction or approval state it applies to.
Bind the signature to the record
•
Retain relevant date, time and workflow context so the approval sequence can be reconstructed.
Record time and context
•
Prevent undetected alteration of the signed record or make subsequent changes visible through versioning and Audit Trail.
Protect integrity after signing
•
Assess electronic-signature requirements in the jurisdictions and regulated processes where the signature will be relied upon.
Apply relevant legal or regulatory rules
•
Technology explained
What an Electronic Signature needs to support
An Electronic Signature links a person's electronic approval or authorization to a specific record or action. Its legal or regulatory sufficiency depends on the applicable framework, but good implementation also needs identity assurance, intent, record integrity and traceable context.
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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