An inspection is not the time to discover a gap. A mock inspection recreates the scope and pressure of a real FDA (BIMO) or EMA GCP inspection — document review, system walkthroughs and staff interviews — then hands you a prioritized list of what to fix while you still have time.
I tailor the mock inspection to the type expected (sponsor, site or CRO; pre-approval or routine) and to the study's risk profile.
What the audit covers
- TMF and essential-document review
- Source-document and data-integrity review
- Systems and 21 CFR Part 11 walkthrough
- Staff interviews and inspection-behavior coaching
- Inspection-readiness narrative / storyboard review
- Front-room / back-room process dry run
What you receive
- Mock-inspection report with risk-ranked findings
- Prioritized, time-boxed CAPA / readiness plan
- Readiness briefing for leadership and staff
Why it matters
Teams that rehearse inspect better. A mock inspection reduces surprises, builds staff confidence, and turns a high-stakes event into a managed one.
Standards & frameworks
Frequently asked questions
What is a mock FDA inspection?
A mock FDA inspection is a simulated regulatory inspection conducted by an independent auditor that mirrors the FDA's approach — reviewing documents and systems and interviewing staff — to identify and fix gaps before the real inspection.
How far before an inspection should we run a mock?
Ideally several weeks to a few months ahead, so there is time to remediate findings and verify CAPAs. A focused readiness check closer to the date can confirm the fixes held.