FDA ERP Validation Checklist & Templates for 21 CFR Part 11

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. Below is a practitioner’s guide for what to Validate, what to leave in User Acceptance Testing (UAT), and how to execute without letting scope balloon.

Why 21 CFR Part 11 matters in ERP

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

What to confirm during Validation versus what to leave in UAT

A common failure mode is dragging business “nice to have” features like cosmetic report formatting into the validation discussion. Keep validation focused on compliance critical and product quality critical functions. Use a simple risk matrix, as pictured below, severity versus  likelihood, to decide which controls need the most rigor. 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 Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Examples of the criteria teams use to determine whether this is a medium to high risk Validation need or a low risk UAT need:

• Validate electronic signatures including identity, meaning, and time, plus reauthentication before signing. Validate audit trails for create, modify, and delete, along with lockouts, inactivity timeouts, user deactivation, release permissions, and record integrity and tamper evidence.

• Validate in IQ, OQ, and PQ if the process is critical or GMP relevant. Examples include receiving by lot with quarantine and release, picking restrictions for nonconforming items, license plate label printing tied to traceability, and QC sampling and inspection when it drives accept and reject decisions.

• Handle in UAT general sync complete status notifications, convenience dashboards, and nonregulated custom reports, unless they directly drive GMP decisions.

A practical checklist

A. Governance & documents, Day 1

• Validation Master Plan (VMP) defining the lifecycle, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), plus roles, deliverables, and a traceability matrix from requirements to tests and evidence.

• Risk Assessment Standard Operating Procedure (SOP) and a risk traceability matrix linking specifications to assurance level.

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

• Document Control SOP, numbering, approvals, revision control, and obsoletion.

• Data Storage, Backup, and Recovery SOP covering backup cadence, retention, restore testing, and audit trails, for example daily full plus log backups and Simple Storage Service (S3) lifecycle policies.

  
  

B. IQ (Installation Qualification)

Environment documented and approved. Identity provider (IdP), wired in. Roles and permissions loaded. Time sync configured. Backups scheduled per SOP. Evidence collected.

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

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

1. Electronic signature linkage and tamper evidence - Sign a record. Verify signature metadata, name, date and time, and meaning, and confirm the record is linked to a content integrity check, for example a hash. Attempt tamper to confirm detection.

2. Reauthentication before e-sign - After login, attempt to apply a regulated signature. The system prompts for reauthentication, password or multi-factor authentication (MFA).

3. Credential strength and lockouts - Password complexity enforced. Ten bad attempts lead to account lockout and a logged event.

4. Session management - Thirty minute inactivity requires resign in before access continues.

5. User lifecycle - No duplicate usernames. A deactivated user cannot log in. The event is audit trailed, including IdP login events.

6. Audit trail content and readability - Create, modify, and delete actions captured with who, what, when, and why. Records are viewable and printable in human readable form.

   
   

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

Prove the ERP supports real GMP operations end to end

• Receiving and status control, PO to receipt to quarantine to release. Validate lot and expiry capture, status transitions, and evidence of rejectivity, where required.

• Picking restrictions, prevent picking nonconforming inventory.

• Labeling and license plate printing where it drives traceability.

• Quality Control (QC) sampling and inspection where sampling results drive accept and reject decisions, Acceptable Quality Level (AQL) or equivalent. Document the business rule and expected decision logic.

• Batch and electronic batch record (eBR) release controlled by authorized roles, for example Quality Assurance (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 plus frequent logs. Restore tested. Audit trails retained for the defined lifecycle. Access to scripts and logs restricted via Identity and Access Management (IAM) and Multi Factor Authentication (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 and 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 reauthentication 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 or MFA.

• Expected: System prompts for re authentication. Signature applies only after successful reauthentication. Audit trail logs name, date and time, and meaning.

Test session timeout:

• Steps: 

  1. Log in.

  2. Remain idle for 30 minutes.

  3. Attempt navigation.

• Expected: Access is blocked until reauthentication; 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 and print:

• Steps: 

  1. Retrieve a signed record

  2. Print it

  3. Verify human‑readable content and unaltered signature details

  4. Confirm tamper evidence, for example hash mismatch on alteration.

     
     

Traceability in one page

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

Common pitfalls and how to avoid them

• Validation bloat - Do not fold business timing or convenience features into 21 CFR Part 11 scope. Keep those in UAT unless they drive GMP decisions. Use the risk matrix to defend scope.

• Weak change control - If changes are not ticketed and reviewed with traceable approvals, you will erode validated state. Enforce PR approvals and release notes.

• Backups without restorations - Backups alone do not prove data is available and retrievable. Include a documented restore test and retain logs.

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

  
  

If you do not have the time or capacity to coordinate vendors, write validation scripts, and keep traceability clean, John Hannan LLC can step in as a client side ERP advocate and validation lead. We help life sciences teams keep  21 CFR Part 11 and GMP scope disciplined, convert requirements into defensible IQ, OQ, and PQ evidence, and enforce change control so the validated state holds after go-live. If you are planning an ERP software selection, implementation, or remediation effort, we can help you reduce delivery risk and turn compliance expectations into working outcomes. Contact us today to learn how we can help you!