Electronic Signatures Part 11

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

Updated December 2025 • electronic signatures, 21 CFR Part 11, electronic records, audit trails, signature meaning, data integrity • Regulated Manufacturing (USA)

Electronic Signatures under Part 11 are not “a checkbox” you add to software. They are a controlled act: a regulated person asserting intent (execute, review, approve) on a regulated record. If you rely on electronic approvals as compliance evidence—batch release, deviations, change control, supplier qualification, document approvals—your e-signature implementation must be defensible under scrutiny.

Most teams get Part 11 e-signatures wrong in one of two ways. They either overbuild (everything requires a signature, operators hate it, and bypass behavior appears), or they underbuild (a typed name and timestamp are treated like a signature, and the evidence collapses under audit). The goal is not “more signatures.” The goal is credible attribution, clear intent, and tamper-resistant records that stand up in investigations and inspections.

“An electronic signature is only as strong as the identity model and audit trail behind it.”

1) What US buyers really mean by “Part 11 electronic signatures”

When regulated manufacturers ask for “Part 11 electronic signatures,” they usually mean one (or more) of these real business needs:

• We are going paperless and need approvals that replace wet-ink signatures on controlled records.
• We want faster release (QA review and disposition without chasing paper packets).
• We need defensible evidence for customer audits, inspections, and investigations.
• We have remote teams (multi-site, contract manufacturing, distributed QA) and approvals must be secure and attributable.
• We have too many “informal approvals” in email and Slack that don’t survive scrutiny.

It’s important to say out loud: Part 11 is not “a feature.” It’s a compliance posture. The software must enforce a set of data integrity behaviors so your electronic approvals are credible. If the identity model is weak (shared logins, generic accounts, no governance), the signatures are weak no matter how good the UI looks.

2) Define success before selection: KPIs that matter

Good e-signature implementations produce measurable operational changes. These KPIs tell you whether Part 11 controls are actually working:

3) What Part 11 electronic signatures are (and are not)

Part 11 electronic signatures are about two things: identity and intent. When someone signs electronically, the system must demonstrate:

• Identity: the signer is uniquely identified (no shared accounts) and authenticated at the time of signing.
• Intent: the signature has meaning (execute/review/approve) and is linked to the record being signed.

What Part 11 e-signatures are not (common misconceptions):

• Not a typed name in a text box. A typed name without controlled authentication is just text.
• Not “a timestamp means it’s compliant.” Timestamps without attribution and context don’t prove intent.
• Not “a PDF stamp.” Stamping a PDF does not replace system controls like audit trails and role authority.
• Not optional governance. If anyone can sign anything, your signatures are decorative.

4) The control model: the minimum set of behaviors you must enforce

Think of Part 11 e-signatures as a stack of controls. If any layer is weak, the whole system becomes hard to defend.

• Identity unique users, governed onboarding/offboarding (access provisioning)
• Authorization signatures restricted by role-based access and job function
• Authentication secure login, session controls, re-authentication for signing when required
• Signature meaning execute/review/approve meaning tied to workflow and record type
• Record linkage signature is bound to the exact record/version being approved
• Record locking post-signature edits are blocked or strictly governed
• Audit trail complete audit trail for changes and signing actions
• Retention searchable long-term retention (data retention / archival)
• Validation evidence that the system performs as intended (CSV/V&V)
• SOPs + training controlled procedures and user training to prevent “policy drift”

Here’s a practical “prove it” table for selection. Don’t accept promises—force demonstration.

5) When you actually need Part 11-style electronic signatures

Not every click needs a signature. The right approach is risk-based: use e-signatures where the act represents a regulated decision or responsibility.

Typical “high-value” signature use cases in regulated manufacturing include:

• Batch record execution and review: electronic batch record sign-off and approvals (EBR/eBMR).
• Lot disposition decisions: hold/release, reject, rework authorization.
• Deviation and investigation approvals: deviations, root cause confirmation, containment approval.
• CAPA approvals and closure: CAPA plan approval, effectiveness check closure.
• Change control approvals: change control impact assessment and implementation authorization.
• Document approvals: controlled SOP/spec approvals under document control with approval workflow.
• Supplier quality decisions: supplier qualification and COA approval workflows (COA).

6) Audit trails + e-signatures: why they must work together

A signature is a claim: “this record is correct, and I accept responsibility for this decision.” The audit trail is the evidence that makes that claim credible. If you implement e-signatures without strong audit trails, you create a dangerous gap: records can change, and you can’t prove what was true at the time of approval.

At minimum, a defensible e-signature system should ensure:

• Signature events are logged: attempt, success, failure (wrong role, bad credentials), and any overrides.
• Post-signature changes are governed: either blocked, or require controlled re-approval with reason-for-change.
• Audit trail is queryable: you can filter by record, user, date, and event type (audit trail).
• Audit trail review exists: you can demonstrate routine oversight of critical events (access changes, overrides, critical edits).

7) Implementation strategy: how to roll out without creating bypass behavior

Part 11 e-signatures often fail because teams design them like paper, then copy/paste that workflow into software. That creates too many signature prompts, slow screens, and frustration. People then invent workarounds, which is the exact opposite of what you want.

A rollout strategy that works looks like this:

1. Start with the highest-value approvals. Typically: QA disposition, deviation approvals, change control approvals, and batch review signatures.
2. Define signature meanings. Don’t let “sign” be generic. Use clear meanings (execute/review/approve) and map them to roles.
3. Design the signature ceremony. Decide when re-authentication is required, what rationale is required, and what happens after signing (record lock).
4. Make exceptions structured. Overrides, rework, and deviations must be handled as governed workflows, not informal notes.
5. Prove retrieval. Before you go live, prove you can export signature + audit packets fast.
6. Train and enforce identity discipline. No shared logins. Ever. Use user access management properly.
7. Validate what matters. Build test scripts around critical signature use cases and failure modes (CSV).

8) The vendor demo script (copy/paste) + scorecard

Run the same script with every vendor. It prevents “Part 11 theater” and exposes weak identity/audit behaviors immediately.

9) Selection pitfalls (how Part 11 e-signature projects quietly fail)

• Too many signatures. If everything needs a signature, users will hunt for bypass paths. Reserve signatures for decisions.
• No signature meaning. “Signed” without meaning is weak evidence. Use execute/review/approve meanings.
• Shared logins. This destroys attributable evidence. Fix identity discipline first.
• Optional reason-for-change. For critical edits, rationale must be required or quality will degrade under pressure.
• Post-signature edits are possible. If records can change after approval without controlled re-approval, the signature is undermined.
• Audit trail exists but can’t be searched. If you can’t query and export it, you can’t operate it.
• Admins can rewrite history. Even if never abused, it erodes trust and creates audit risk.
• No integration strategy. If signatures exist in one system but the process evidence is in another, investigations become manual stitching.

10) How this maps to V5 by SG Systems Global

V5 is designed around controlled workflows and attributable evidence across execution and governance—so Part 11-style signature behaviors can be applied where decisions matter.

• Governed approvals and quality workflows: V5 QMS supports governed approvals (deviations, CAPA, document approvals, change workflows) where electronic signatures and audit trails are critical.
• Execution evidence and sign-off points: V5 MES supports controlled execution evidence and exception handling where signature and audit trail integrity matter (e.g., overrides and critical confirmations).
• Status enforcement: V5 WMS supports enforceable lot status behaviors (hold/quarantine/release) that must align with signed quality decisions.
• Integration layer: V5 Connect API supports structured exchange (API/CSV/XML) so external systems can be connected without losing traceability context.
• Platform view: V5 solution overview shows how execution + quality governance connect as one operational system.

11) Extended FAQ

Q1. What’s the difference between an electronic signature and a typed name?
A typed name is just text. A compliant electronic signature is a controlled act tied to unique identity, authentication, signature meaning, and an audit trail that proves intent and integrity.

Q2. Do we need Part 11 e-signatures if we still print and sign records?
If you truly rely on paper as the official record and electronic actions are not used as decision evidence, you may not need formal e-signature controls for those approvals. But as soon as electronic approvals become the record of decision, Part 11-style controls become relevant.

Q3. What is “signature meaning” and why does it matter?
Signature meaning defines intent (execute/review/approve). Without meaning, a signature is vague. With meaning, it is a clear responsibility statement tied to the workflow and the record state.

Q4. Can a record be edited after it is signed?
Practically, it should be blocked or tightly governed. If changes are allowed post-signature, they should require controlled rationale, audit trail capture, and often re-approval—otherwise the original signature’s integrity is compromised.

Q5. What’s the fastest way to spot weak e-signature implementations?
Look for shared logins, optional reason-for-change, poor audit trail detail, and inability to export a readable signature + audit packet on demand.

Related Reading
• Core Concepts: 21 CFR Part 11 | Electronic Signatures | Audit Trail | Data Integrity
• Access & Control: Access Provisioning | Role-Based Access | User Access Management
• Governance Workflows: Document Control | Approval Workflow | Change Control | Deviation Management | CAPA
• Validation: Computer System Validation (CSV) | GAMP 5 | V&V
• V5 Products: V5 Solution Overview | V5 QMS | V5 MES | V5 WMS | V5 Connect API