Preparing for an FDA or MHRA Inspection: Validation Documentation That Stands Up
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When the FDA or MHRA walks in, your validation documentation is one of the first things they’ll ask for. Whether it’s a system validation, equipment qualification, or software verification, auditors want proof that your systems do what they’re supposed to do, and that you can demonstrate control.
This blog explains what inspectors look for, how to organize your validation packages, and how to present evidence confidently. It also includes a practical CSV audit checklist you can use before your next inspection.
Why Validation Documentation Is Scrutinized During Inspections
Both FDA and MHRA see validation documentation as the backbone of data integrity and product quality. If your validation package is weak, they’ll assume your system control is weak too.
Recent enforcement trends support this. The FDA’s 2023 inspection data showed that 21 CFR Part 211.68 (“automatic, mechanical, or electronic equipment”) ranked among the top five citations for GMP violations. The MHRA’s 2023 deficiency report listed computerized system validation (CSV) findings in nearly one-third of GxP inspections.
In practice, most findings come down to the same issue: incomplete validation evidence or poor documentation control.
Auditors don’t expect perfection, they expect consistency, traceability, and clear decision-making. They want to see a story: how you planned, tested, and justified your conclusions.
Core Validation Documents Auditors Expect
Auditors don’t review everything you’ve ever written, but they will expect to see the full validation lifecycle. A complete package usually includes:
URS, FS, DS, IQ/OQ/PQ, Summary Report
- User Requirements Specification (URS): Defines what the system must do. It should be concise, traceable, and approved by QA.
- Functional Specification (FS): Describes how requirements will be met through functionality or configuration.
- Design Specification (DS): Explains the technical implementation, architecture, components, and interfaces.
- Installation Qualification (IQ): Verifies that the system and environment are installed correctly.
- Operational Qualification (OQ): Tests functions under controlled conditions.
- Performance Qualification (PQ): Confirms real-world performance and user workflows.
- Validation Summary Report (VSR): Summarizes results, deviations, and conclusions about system fitness for use.
Each document should link logically to the next. For example, every URS requirement must map to at least one test case, and every test result must trace back to a requirement. GAMP 5 (Second Edition) calls this “traceability by design.”
Auditors also check version control, approval signatures, and change control references. Missing or mismatched document versions are among the most common red flags.
How to Organize and Maintain Validation Packages
An organized validation package makes inspections smoother. Here are simple practices that stand up under scrutiny:
- Use a consistent structure. Group documents by phase (planning, testing, reporting).
- Maintain a validation index. Include a single table listing document names, versions, and approval dates.
- Archive superseded documents. Don’t delete older versions; keep them controlled and marked as obsolete.
- Link change controls. For each system change, reference which documents were updated and which were impacted.
- Centralize access. Keep records in a validated electronic repository, not scattered network folders.
Digital validation platforms such as Validfor help maintain audit trails and document traceability automatically.
Even if you’re using paper, you can adopt the same principles: version control, cross-references, and index summaries.
Some Findings and How to Avoid Them
Auditors tend to ask the same questions again and again. Here are the most frequent findings related to FDA inspection validation and MHRA audit CSV, and how to prevent them.
| Common Finding | Why It Happens | How to Avoid It |
| Missing traceability matrix | Requirements and tests tracked separately | Use an automated or linked matrix |
| Outdated or unsigned test scripts | Version control lapses | Freeze versions before execution |
| No documented rationale for test coverage | Overreliance on vendor documentation | Include risk-based justification |
| Lack of periodic review evidence | Validation treated as one-time event | Schedule annual reviews and document outcome |
| Gaps in training records | New users added post-validation | Tie access control to training completion |
| Poor data integrity controls | Shared accounts, no audit trail checks | Enforce unique logins and regular log reviews |
One pattern appears in nearly every inspection: companies overestimate what vendors provide. Vendor IQ/OQ evidence is helpful, but auditors expect you to demonstrate your own testing for intended use.
Tips for Presenting Evidence During an Inspection
How you present validation evidence can influence the tone of an inspection. A few points you should be aware of:
- Start with your validation index. It shows control and helps the auditor navigate.
- Have your documents ready. Inspectors don’t want to wait too long for the requested item to be provided.
- Don’t overshare. Only provide documents requested. Too much information can create unnecessary questions.
- Answer factually, not defensively. If something’s missing, explain what’s being done to correct it.
- Ensure all staff know their roles. The system owner, QA approver, and validation lead should align on key messages.
During FDA inspections, the investigator may refer to 21 CFR 211.68 and 21 CFR 820.70(i) for computer validation requirements. The MHRA typically checks compliance with EU GMP Annex 11 and EudraLex Volume 4, Chapter 4.
A calm, organized approach shows confidence. Many inspectors say they notice how teams behave under questioning as much as what’s written on paper.
Validation Audit Checklist
Here’s a condensed CSV audit checklist you can adapt:
| Area | Question | Ready? |
| Validation Master Plan | Is there a current VMP describing scope and responsibilities? | ☐ |
| URS | Are user requirements approved, traceable, and current? | ☐ |
| Risk Assessment | Is there documented rationale for risk classification? | ☐ |
| Test Evidence | Are IQ/OQ/PQ protocols approved, executed, and summarized? | ☐ |
| Traceability | Can each requirement be traced to a test case and result? | ☐ |
| Deviation Control | Are deviations logged, investigated, and closed? | ☐ |
| Change Management | Are system updates validated or assessed for impact? | ☐ |
| Periodic Review | Is there a procedure and record for periodic system review? | ☐ |
| Training | Are user and admin training records complete? | ☐ |
| Data Integrity | Are audit trails enabled, reviewed, and retained? | ☐ |
Building a Culture of Readiness
Strong validation documentation is more than a compliance requirement, It’s a reflection of your organization’s quality culture.
When validation packages are current, consistent, and easy to navigate, inspections become predictable instead of stressful. You’ll spend less time reacting and more time demonstrating control.
The best companies don’t prepare for inspections once a year, they build readiness into daily operations.
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