Electronic Signatures

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated December 2025 • Part 11 / Annex 11 Controls, Approvals & Attribution • QA, Compliance, IT, Operations

Electronic signatures are legally meaningful approvals and sign-offs executed within an electronic system, where the signature event is uniquely attributable to a specific individual and bound to a specific record and meaning (e.g., “reviewed,” “approved,” “performed,” “released”). In regulated manufacturing and quality systems, an electronic signature is not just a checkbox or typed name. It is a controlled event that must prove identity, intent, and record linkage so that the signed record is trustworthy and defensible during audits and investigations. That is why electronic signatures are closely tied to 21 CFR Part 11, EU Annex 11, data integrity, and an attributable audit trail that records who signed, what they signed, when they signed, and what the signature meant.

Electronic signatures matter because they convert electronic records into compliance-grade evidence. If signatures are weak—shared accounts, ambiguous meaning, missing attribution, or records editable after signing—then the system becomes difficult to defend, even if the underlying process is good. Strong electronic signatures enable paperless operations, faster release cycles, controlled workflows, and reliable accountability across batch execution (eBMR), deviations, CAPA, document control, training, and supplier/quality decisions. The goal is simple: the electronic record must stand up the same way a signed paper record would—often better—because the evidence is time-stamped and traceable.

“An e-signature is only valuable if it proves identity, intent, and an unbreakable link to the exact record that was signed.”

1) What an Electronic Signature Actually Proves

A compliant electronic signature must prove three things:

• Identity: the signer is uniquely identified (no shared credentials) and authenticated.
• Intent: the signer intended to sign and understood what the signature means (reviewed/approved/performed/released).
• Record binding: the signature is linked to the specific record at the time of signing and cannot be separated or misapplied.

When these elements are present, the electronic signature becomes stronger than a handwritten signature because it is time-stamped, attributable, and linked to system context (role, workflow step, record version). When these elements are missing, an “e-signature” becomes just a UI artifact with weak evidentiary value.

2) Electronic Signatures vs Electronic Records

An electronic record is the data itself: a batch record, a deviation, a CAPA, a test result, a controlled document, a training completion. An electronic signature is an approval or attestation action applied to that record. The two must work together. A record without controlled signature might be incomplete for release. A signature without a controlled record is meaningless.

This is why Part 11 is often summarized as “electronic records and electronic signatures.” You must control the record (integrity, retention, audit trails) and the signature (identity, intent, binding). If one side is weak, the compliance posture collapses.

3) Why Electronic Signatures Exist in Regulated Operations

Electronic signatures exist because regulated manufacturing is built on documented decisions. Approvals define what is allowed: which batch steps were performed, which deviations are accepted, which CAPAs are closed, which specs are effective, which lots are released. Without signatures, decisions are ambiguous. With signatures, decisions become attributable and defensible.

Electronic signatures also enable paperless operations and reduce process friction. Instead of printing and scanning forms, the organization can capture signatures at the point of action, with immediate linkage to the record and audit trail. When done well, this improves both compliance and efficiency because it reduces transcription errors and reduces the time gap between action and documentation.

4) Signature Meaning: “Reviewed” Is Not the Same as “Approved”

Signature meaning is one of the most overlooked requirements. A signature must have a defined intent. Common signature intents include:

• Performed: “I performed this step/action.”
• Verified: “I verified this result/step meets requirements.”
• Reviewed: “I reviewed the record and found it acceptable.”
• Approved: “I approve this record/decision for use.”
• Released: “I release this lot/batch/document into the next state.”

The system should make meaning explicit and consistent. If everything is just “signed,” the signature is weak because it’s unclear what the signer attested to. Strong systems capture signature meaning as metadata and show it clearly in the record and in audit trails.

5) Authentication Controls: Making Identity Defensible

Identity is foundational. The strongest signature program collapses if authentication is weak. At minimum, a defensible program requires:

• Unique user accounts: no shared logins, no generic “operator” accounts.
• Strong authentication: password standards, MFA where appropriate, and controls for resets.
• Controlled provisioning: governed access provisioning and deprovisioning.
• Role-based permissions: only authorized roles can sign and only for allowed actions (RBAC).

Many systems also require “re-authentication at signature” (e.g., re-enter password or confirm identity) for high-impact signatures such as batch release or deviation approval. The goal is to make intent and identity explicit at the moment of signing, not just at login.

6) Record Binding and Post-Signature Change Control

A signature must be bound to the record state at the time of signing. The core problem is “post-signature edits.” If a record can be changed after approval without traceability, the approval is meaningless. A defensible approach typically includes:

• Locking: once signed, critical record fields are locked or become revision-controlled.
• Revision control: post-signature changes require creating a new revision with new approvals (ties to document control and change control).
• Audit trail visibility: any changes after signing are recorded and visible, including who changed what and why.
• Signature invalidation logic: certain changes automatically invalidate prior signatures and require re-sign.

Binding also includes attachment control. If a record references attachments (reports, PDFs, images), the signature should apply to the record package, not just a single field.

7) Where Electronic Signatures Are Used (Common Use Cases)

Electronic signatures appear wherever decisions must be attributable and defensible. Common use cases include:

• Batch execution: step completion, in-process checks, line clearance confirmation, and final batch sign-off in the eBMR.
• Hold/release: placing and releasing quarantine/hold status for lots and batches.
• Deviations and investigations: deviation approval, investigation conclusions, and effectiveness checks.
• CAPA: CAPA approval, action completion sign-off, and closure.
• Change control: change request approval, implementation approval, and post-implementation review.
• Document control: SOP approval, effective date authorization, obsolescence approvals.
• Training: training completion attestation and competency confirmations.
• Supplier and quality decisions: MRB dispositions and supplier corrective action approvals.

In each case, the signature must reflect the correct meaning and must be constrained by roles so unauthorized users cannot sign high-risk decisions.

8) Audit Trail Expectations for Signature Events

Signature events must be traceable. A defensible audit trail for electronic signatures typically captures:

• Signer identity: user ID and, where appropriate, printed name.
• Timestamp: date/time of signature (including timezone consistency).
• Meaning: reviewed/approved/performed/released.
• Record reference: what record and which version/revision was signed.
• Authentication method: whether re-authentication occurred at signing for high-impact steps.

Auditors also care about signature failures and overrides: failed login attempts, signature cancellations, password resets, and any admin actions that could compromise attribution. That is why signature systems must be tied to controlled access provisioning and monitored for unusual patterns.

9) Common Failure Modes (How E-Signatures Become Weak)

Electronic signature programs tend to fail in predictable ways:

• Shared accounts: destroys attribution and makes signatures non-defensible.
• Ambiguous meaning: “signed” without defined intent.
• Editable records after signing: approvals become meaningless if records can be altered without controlled revisioning.
• Over-broad signing rights: too many users can approve high-impact steps, weakening segregation of duties.
• Weak provisioning: role creep and stale access lead to unauthorized signing capability.
• Poor audit trail review: signature events exist but are not monitored; suspicious patterns go undetected.

The fix is governance and design: strong identity controls, clear signature intent, enforced record locking/revision rules, and role-based permissions aligned to the quality system.

10) Practical Blueprint: Implementing Defensible Electronic Signatures

A practical implementation blueprint looks like this:

• 1) Define signature points: list which workflows require signatures (batch steps, release, deviations, CAPA, change control, docs).
• 2) Define signature meanings: reviewed/approved/performed/released, and ensure the system records them.
• 3) Define roles: map signature rights to roles and enforce segregation of duties.
• 4) Enforce identity controls: unique accounts, strong authentication, controlled provisioning.
• 5) Bind signatures to records: lock or revision-control signed records; preserve attachments and context.
• 6) Capture audit trails: signature events logged, reviewable, and retained for required periods.
• 7) Monitor and review: periodic access reviews and audit trail monitoring for signature anomalies.

This blueprint turns electronic signatures into a compliance strength rather than a “checkbox feature.” The goal is to make signatures natural to use and hard to misuse.

11) How This Fits with V5 by SG Systems Global

Controlled execution and approvals. In the V5 platform, electronic signatures support governed execution across modules: MES step sign-offs into an inspection-ready eBMR, WMS holds and releases, and QMS approvals for deviations, CAPA, MRB, and change control. RBAC and controlled provisioning ensure only authorized roles can sign specific decisions.

Auditability. Signature events are captured with attribution, meaning, and timestamps, strengthening audit trails and supporting Part 11/Annex 11-aligned evidence. Records can be locked or revision-controlled so signatures remain bound to the correct record state.

Bottom line: V5 uses electronic signatures to enforce accountability and protect data integrity—turning approvals into defensible, inspection-ready evidence without paper.

12) FAQ

Q1. Are electronic signatures legally valid?
In many regulated contexts, yes—when implemented with proper controls for identity, intent, and record linkage, and when aligned to applicable regulations and organizational policies.

Q2. Do electronic signatures require re-entering a password?
Often for high-impact signatures. Some systems require re-authentication at the moment of signing to make intent explicit. The specific approach should match your risk model and regulatory expectations.

Q3. Can a signed record be changed later?
It should not be changeable without traceability. Typically, signed records are locked or changes require a new revision and re-approval, with a complete audit trail showing what changed and why.

Q4. What breaks electronic signatures the fastest?
Shared accounts, ambiguous signature meaning, broad signing permissions without segregation of duties, and the ability to edit records after signing without controlled revisioning.

Q5. Where should e-signatures be used first?
Start with high-value control points: batch step completion and release, deviation/CAPA approvals, change control approvals, and controlled document approval. These are the signatures auditors and investigations rely on most.

Q6. What must be captured in the audit trail for a signature?
Who signed, when, what record/version was signed, what the signature meant, and (where applicable) how authentication was performed. The trail must be retained and retrievable.

Related Reading
• Core Requirements: 21 CFR Part 11 | Annex 11 | Data Integrity | Audit Trail
• Access Controls: Role Based Access | Access Provisioning | User Access Management
• Workflow Context: eBMR | MES | V5 QMS | Change Control