What is the most common Part 11 failure in practice?

Shared or generic accounts, followed by weak audit trails that do not capture old/new values and reasons for change. These undermine record trust quickly.

Part 11 Readiness

Part 11 Readiness — What Your MES/QMS/EBR Must Prove for Electronic Records & Signatures

Q: Do we need electronic signatures to be Part 11 ready?

Not necessarily. If you rely on electronic records without electronic signatures, you still need controls for record integrity, attribution, audit trails, and retention. If you use e-signatures, you must also control signature meaning, authentication, and linkage.

Q: How do we prove Part 11 readiness during validation?

Test and document roles and permissions, audit trails (including change capture), electronic signature workflows, record locking/corrections, retention and retrieval, and change control/regression processes.

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

Updated December 2025 • 21 CFR Part 11 readiness, electronic records, electronic signatures, audit trails, access control, validation, record retention • Regulated Manufacturing (USA)

Part 11 Readiness means your organization can rely on electronic records and electronic signatures as compliance evidence—and defend them under scrutiny. It’s not a checkbox. It’s a set of technical controls, procedural controls, and validation evidence showing that records are trustworthy, attributable, and protected against unauthorized change. If your MES, QMS, WMS, or EBR is going to replace paper signatures and batch binders, then 21 CFR Part 11 readiness is the foundation that keeps the digital system from becoming “faster chaos.”

“Part 11 is not about being digital. It’s about being defensible when the evidence is digital.”

TL;DR: Part 11 readiness requires: unique user identity, role-based access, secure audit trails, controlled e-signatures, validated intended use, record retention and retrieval, and disciplined procedures (SOPs) around system use and change control. If any of these are weak, your electronic evidence chain is vulnerable.

1) What Part 11 is actually trying to prevent

Part 11 is aimed at preventing three practical failure modes when records go electronic:

“No one knows who did it.” Shared logins, generic users, and unclear roles destroy attribution.
“We can’t trust the record.” Records can be edited without trace, or audit trails are incomplete.
“We can’t retrieve what we need.” Data exists but isn’t readable, searchable, or preserved for required retention periods.

In other words: Part 11 is a data integrity regulation in practice, even when it’s formally “electronic records and signatures.”

Hard truth: If you can’t explain exactly how your system prevents undetected record changes, you’re not Part 11 ready—regardless of what the vendor brochure says.

2) KPIs that indicate Part 11 readiness (or weakness)

Shared Account Rate
Count of shared/generic accounts. Target: zero in regulated workflows.

Audit Trail Coverage
% of critical actions with attributable audit trail entries (who/what/when/why).

Signature Traceability
% of signatures linked to a specific record, meaning, timestamp, and authentication event.

Evidence Retrieval Time
Time to retrieve a complete batch packet and audit trail extracts for a time window.

3) Part 11 readiness control map (what must exist)

Control area	What must be true	What you should test/prove	Related anchors
Unique user identity	Each user is uniquely identifiable; no shared accounts in regulated actions	Provisioning/deprovisioning, password policy, lockout, session timeouts	UAM
Role-based access control	Users can only perform actions appropriate to their role and training	Permissions, segregation of duties, privilege review, override controls	RBAC, Access Provisioning
Audit trails	Critical actions are recorded with old/new values, user, timestamp, reason	Audit trail completeness, immutability, filtering/export, review process	Audit Trail
Electronic signatures	Signatures are linked to records, include meaning, and require authentication	Signature meaning (approve/review/execute), re-authentication, reports	E-Signatures
Record integrity & security	Records are protected from unauthorized change; controlled edits are traceable	Record locking, controlled correction workflow, tamper-evidence	Data Integrity
Time synchronization	Timestamps are reliable across systems, devices, and interfaces	Clock sync policy, time zone handling, interface ordering correctness	Record Retention
Retention & retrieval	Records remain readable, searchable, and retrievable for retention periods	Archive access, export formats, audit trail retention, disaster recovery	Data Archiving
System validation	The system is validated for its intended use (risk-based)	URS/RTM, IQ/OQ/PQ evidence, change control and regression approach	CSV, URS
Procedural controls (SOPs)	People follow defined processes for access, signatures, reviews, corrections	SOP set, training evidence, periodic reviews, deviation handling	SOP

4) What Part 11 readiness looks like on the floor

In daily operations, Part 11 readiness should feel like “normal disciplined work,” not like bureaucracy:

Operators cannot sign as each other. The system requires unique login and signature authentication.
Critical steps are hard-gated. You can’t skip required checks or sign off a step without required evidence.
Corrections are controlled. If a value must be corrected, the correction is captured with reason and approval—never as an invisible edit.
QA holds are enforced. Quarantined or held lots can’t be consumed or shipped without controlled override.
Audit trails are reviewable. QA can easily review what changed, why, and who approved it.

“Part 11 is successful when your fastest path is also your compliant path.”

5) Part 11 readiness checklist (practical, not theoretical)

Step 1 — Define “Part 11 relevant” records

List which records are used as GMP evidence: batch records, QA releases, deviations, CAPA, training sign-offs, calibration approvals, supplier approvals, etc. If the record supports a quality decision, treat it as Part 11 relevant.

Step 2 — Enforce unique users and roles

Implement role-based access with unique users. Remove shared logins. Establish a user provisioning and deprovisioning SOP with periodic access review.

Step 3 — Lock down audit trails and corrections

Ensure audit trails are enabled for all critical actions (create, edit, approve, release, void). Ensure corrections require a reason and are traceable. Confirm audit trails are tamper-evident and exportable.

Step 4 — Implement controlled electronic signatures

Define signature meaning (execute/review/approve), require re-authentication where appropriate, and ensure signatures are permanently linked to the signed record and timestamp.

Step 5 — Validate intended use (risk-based)

Use CSV or CSA-style validation to prove controls work: permissions, audit trails, signatures, record locking, hold/release gating, and retrieval. Keep evidence traceable to requirements.

Step 6 — Prove retention and retrieval

Test that records and audit trails remain readable and retrievable for the retention period. Confirm backups, archiving, and disaster recovery procedures are defined and tested.

Reality: If you can’t retrieve records reliably under pressure (audit/recall), you don’t have compliant electronic records—you have electronic storage.

6) Common Part 11 readiness failures (what inspectors notice fast)

Shared accounts or “shift logins.” This undermines attribution immediately.
Audit trails that don’t capture old/new values. “Something changed” is not enough; the record must show what changed.
Editable records without control. If batch record values can be silently edited, the record is untrustworthy.
Signatures without meaning. If signatures don’t indicate what was approved/reviewed/executed, they lose value.
No periodic access review. Orphaned accounts and excessive privileges accumulate quietly.
Weak change control. System updates happen without impact assessment or regression tests.
Poor time management. Unsynced clocks create impossible timelines and suspicion.

Rule: If a smart person can change a record without leaving a trace, the system is not Part 11 ready—no matter how “secure” it feels.

7) Buyer checklist: what to demand from Part 11-ready MES/QMS software

Must-have capability	What to demand in a demo
Attributable users	Unique accounts, lockouts, password policy, session controls; show access logs
Role enforcement	RBAC that prevents unauthorized approvals and changes; demonstrate segregation of duties
Audit trail quality	Show old/new values, timestamps, reasons, and exportable audit reports for key records
Signature controls	Signature meaning, re-authentication, signature-to-record linkage, signature reports
Record locking + corrections	Controlled correction workflow with reason/approval; no silent edits
Retention + retrieval	Searchable records, exportable batch packets, archive access, retention rules
Validation support	Vendor evidence, configuration versioning, change logs, and a testable environment

8) How people search for Part 11 readiness (and what this page answers)

Buyer-intent searches include: 21 CFR Part 11 compliant software, Part 11 audit trail requirements, electronic signatures Part 11, Part 11 readiness checklist, Part 11 for electronic batch records, and Part 11 validation. This guide explains what systems must prove and what controls you must have before relying on electronic records as compliance evidence.

9) How this maps to V5 by SG Systems Global

V5 supports Part 11 readiness through controlled records, attributable actions, and traceable governance:

Controlled execution evidence: V5 MES supports electronic batch record capture with step controls, audit trails, and signature-ready approvals.
Quality governance: V5 QMS supports deviations, CAPA, approvals, and controlled release decisions tied to audit trails.
Status enforcement: V5 WMS supports quarantine/hold/release enforcement so restricted lots cannot be consumed or shipped.
Integration and evidence links: V5 Connect API supports integration to ERP/LIMS/devices so records are captured at the source with traceable interfaces.

For the platform landscape, see the V5 solution overview.

10) Extended FAQ

Q1. What does “Part 11 compliant” actually mean?
It means electronic records and signatures are trustworthy and defensible: attributable users, secure audit trails, controlled signatures, record integrity, retention and retrieval, and validated intended use with supporting SOPs.

Q2. Is Part 11 only for pharma?
Part 11 applies when FDA-regulated organizations rely on electronic records and electronic signatures for required records. Many supplement, food, device, and other regulated operations adopt Part 11-style controls to meet audit expectations for electronic evidence and data integrity.

Q3. Do we need electronic signatures to be Part 11 ready?
Not necessarily. If you use electronic records without electronic signatures, you still need controls for record integrity, attribution, audit trails, and retention. If you use e-signatures, you must also control signature meaning, authentication, and linkage.

Q4. What’s the #1 Part 11 failure seen in practice?
Shared or generic accounts, followed closely by weak audit trails (missing old/new values and reasons for change). Those two failures undermine trust immediately.

Q5. How do we prove Part 11 readiness during validation?
Test and document the controls: roles and permissions, audit trails (including change capture), electronic signature workflows, record locking/corrections, retention and retrieval, and change control/regression processes.

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