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.
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.
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.
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.
