FDA ERP Validation (21 CFR Part 11): Practical Checklist & Templates

When a life‑sciences manufacturer asks me, “Is our ERP actually validated for Part 11?” they’re really asking whether electronic records, signatures, and data integrity controls hold up to audit—in the way we use the system every day. B

elow is a practitioner’s guide for what to validate, what to leave in UAT, and how to execute without letting scope balloon.

Why Part 11 matters in ERP

Part 11 governs electronic records and signatures in GxP environments. In ERP, that translates to role‑based access control, unique identities, re‑authentication before e‑signing, immutable audit trails, human‑readable records/prints, and reliable retention/backup. In practice, you’ll verify those controls during OQ and PQ with traceability back to requirements and a clear Validation Master Plan (VMP).

What to validate vs. what to leave in UAT

A common failure mode is dragging business‑convenience topics (like cosmetic report formatting) into validation. Keep validation focused on compliance‑critical and product‑quality‑critical functions. Use a simple risk matrix (severity × likelihood) to decide: high‑risk items get robust scripted testing; medium‑risk items get moderate assurance; low‑risk items can be covered by configuration checks or UAT. Maintain a risk log and traceability to IQ/OQ/PQ.

Examples of criteria teams use to determine validate or UAT

• Validate - Electronic signatures (identity + meaning + time), re‑auth before signing, audit trails for create/modify/delete, lockouts, inactivity timeout, user deactivation, release permissions, record integrity/tamper evidence.

  • Validate if process‑critical or GMP‑relevant: receiving by lot with quarantine/release, picking restrictions for non‑conforming items, license‑plate label printing tied to traceability, QC sampling/inspection if it drives accept/reject decisions.

• Handle in UAT - General “sync complete” status notifications, convenience dashboards, and non‑regulated custom reports—unless they directly drive GMP decisions.

  
  

The practical checklist

A. Governance & documents (Day 1)

• Validation Master Plan (VMP) defining lifecycle (IQ/OQ/PQ), roles, deliverables, and traceability matrix from requirements to tests and evidence.

• Risk Assessment SOP and a risk traceability matrix linking specs to assurance level.

• Change Management SOP (ticketing, code review/PR approvals, release notes) to protect the validated state post‑go‑live.

• Document Control SOP (numbering, approvals, revision control, obsoletion).

• Data Storage/Backup/Recovery SOP covering backup cadence, retention, restore testing, and audit trails (e.g., daily full + log backups and S3 lifecycle policies).

  
  

B. IQ (Installation Qualification)

• Environment documented and approved; identity provider wired in; roles/permissions loaded; time sync configured; backups scheduled per SOP; evidence collected.

  
  

C. OQ (Operational Qualification) - Part 11 core controls

Scripted tests with objective evidence (screens, logs). Examples that auditors expect to see:

1. Electronic signature linkage & tamper evidence

   • Sign a record; verify signature metadata (name, date/time, meaning) and that the record is linked to a content‑integrity check (e.g., hash). Attempt tamper to confirm detection.

2. Re‑authentication before e‑sign

   • After login, attempt to apply a regulated signature; system prompts for re‑auth (password/MFA).

3. Credential strength & lockouts

   • Password complexity enforced; 10 bad attempts → account lock (and log event).

4. Session management

   • 30‑minute inactivity → session requires re‑sign‑in before access continues.

5. User lifecycle

   • No duplicate usernames; deactivated user cannot log in; event is audit‑trailed (including IdP login events).

6. Audit trail content & readability

   • Create/modify/delete actions captured with who/what/when/why; records viewable and printable in human‑readable form.

     
     

D. PQ (Performance Qualification) - process fit in your workflows

Prove the ERP supports real GMP operations end‑to‑end

• Receiving & status control (PO→receipt→quarantine→release). Validate lot/expiry capture, status transitions, and evidence of rejectivity where required.

• Picking restrictions (prevent picking non‑conforming inventory).

• Labeling / license plate printing where it drives traceability.

• QC sampling/inspection where sampling results drive accept/reject (AQL or equivalent); document the business rule and expected decision logic.

• Batch/eBR release controlled by authorized roles (e.g., QA) with signatures and timestamps.(These flow tests roll up into your final validation overview and closure.)

  
  

E. Data integrity, retention & restoration

Backups executed per SOP (daily full + frequent logs), restore tested, and audit trails retained for the defined lifecycle; access to scripts/logs is restricted via IAM/MFA and is traceable. Document one restore scenario as objective evidence.

F. Execution quality (ALCOA+)

Use approved, version‑controlled scripts; record actual outcomes, not just “Pass”; attach dated screenshots/logs; stop and raise a deviation if behavior differs; never edit the script mid‑run.

A small “starter” protocol excerpt (for your use as a template)

Test - Re‑authentication before e‑signature

• Precondition: Tester is logged in with a role authorized to e‑sign GMP records.

• Steps: 1) Open a controlled record. 2) Select Sign. 3) Provide credentials/MFA.

• Expected: System prompts for re‑auth; signature applies only after successful re‑auth; audit trail logs name, date/time, and meaning.

Test - Session timeout

• Steps: 1) Log in. 2) Remain idle for 30 minutes. 3) Attempt navigation.

• Expected: Access is blocked until re‑authentication; no data loss.

Test - User deactivation

• Steps: 1) Deactivate a test user in the IdP. 2) Attempt login/use.

• Expected: Login denied; denial logged in both ERP and IdP audit logs.

Test - Record integrity & print

• Steps: 1) Retrieve a signed record; 2) Print it; 3) Verify human‑readable content and unaltered signature details; 4) Confirm tamper evidence (e.g., hash mismatch on alteration).

  
  

Traceability in one page

Req ID → Risk (H/M/L) → Assurance (IQ/OQ/PQ) → Test ID → Evidence link → Result → Deviation link. This aligns with the V‑model and keeps every requirement covered to closure.

Common pitfalls (and how to avoid them)

• Validation bloat - Don’t fold business timing or convenience features into Part 11 scope; keep those in UAT unless they drive GMP decisions. Use the risk matrix to defend scope.

• Weak change control - If changes aren’t ticketed/reviewed with traceable approvals, you’ll erode validated state. Enforce PR approvals and release notes.

• Backups without restorations - Backups alone don’t prove data is available/retrievable. Include a documented restore test and retain logs.

• Document chaos - Unclear numbering/ownership causes people to run the wrong script. Lock down document control and approvals.

  
  

Annex 11 vs. 21 CFR Part 11 with FDA Validation for ERP

For most ERP controls, the same test case can satisfy both frameworks if you map your requirements accordingly—design once, test once, cross‑reference in the protocol.

Want a copy‑paste checklist?

ERP Part 11 Validation Checklist

☐ VMP approved; traceability matrix created

☐ Risk Assessment log and matrix approved

☐ Change Management SOP & Document Control SOP referenced

☐ Backup/Restore SOP referenced; one restore scenario planned

☐ IQ evidence - Environment, roles, time sync, backups

☐ OQ tests scripted - E‑sig linkage/meaning/time, re‑auth, password complexity, lockout, inactivity timeout, no duplicate usernames, deactivation denied, audit trail content/readability, tamper evidence, printouts

☐ PQ flows: receiving→quarantine→release; picking restrictions; license‑plate labels; QC sampling/inspection; batch release by authorized role

☐ Execution meets ALCOA+; deviations handled; screenshots/logs attached

☐ Final report + validation overview completed; all deviations closed

If you don’t have the hours (or desire) to herd vendors, write test scripts, and keep traceability pristine, an outsourced internal ERP project/validation lead can coordinate vendors, hold quality lines, and keep scope lean while you focus on operations.

In this blog - 21 CFR Part 11 ERP validation, FDA Part 11 ERP, Annex 11 computerized systems, ERP audit trail validation, ERP electronic signature re‑authentication, IQ OQ PQ ERP, GMP ERP receiving and quarantine, ERP QC sampling validation, ERP batch release controls, risk‑based CSV/CSA.