Insight Brief ยท Inspection Readiness

Mock inspections:
what internal review cannot find.

Internal review confirms documents exist. A mock inspection tests whether decisions can be explained under pressure. The gap between the two is where most PAI and MHRA observations originate.

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The Gap

What internal review
cannot replicate.

A mock inspection six weeks before an FDA Pre-Approval Inspection surfaced three observations that internal review had missed entirely. Not missing documents. Decisions that were technically recorded but practically indefensible when questioned out loud under mild pressure.

01
Internal review finds what's absent, not what's unexplainableDocument review confirms signatures, completeness, template compliance. It does not test whether the rationale behind a risk decision holds up when questioned by someone unfamiliar with the programme.
02
The three types of gap a mock inspection typically surfacesMitigations recorded as "complete" without verification evidence. Deviation closures with conclusions but no visible rationale. Evidence retrievable in principle but not in practice under timed conditions.
03
The client outcome from that engagementAll three observations were remediated in the four weeks before the PAI. The FDA inspection resulted in no observations on computerised systems. One day of preparation. Zero CSV observations.
What to Test

What a well-run mock
inspection puts under pressure.

The mock inspection is not about finding disasters. It is about finding the things that are technically compliant but practically indefensible, and surfacing them before a regulator does. The verbal exercise is the point, not the written report that follows.

01
Evidence retrieval under timed conditionsCan your team retrieve the full validation package for a named system within two minutes? Is it coherent when assembled, or spread across four shared drives and someone's email? Evidence retrieval is a skill that must be practised, not assumed.
02
Risk decision explainabilityCan the person who assigned a risk level explain the rationale in plain language, without referring back to the document? Inspectors expect consistency between what is written and what is said. Inconsistency triggers deeper sampling.
03
Narrative coherence across documentsDoes the validation plan describe the same system, with the same scope and intended use, as the test scripts and the summary report? A coherent narrative across documents is the foundation of an inspection-ready package.
Common Questions

Frequently asked.

How far in advance should we run a mock inspection?
Six weeks is a reasonable minimum
Six weeks allows time to remediate observations before the inspection date without compressing the timeline to the point of creating new risks. Earlier is better: the most effective programmes run mock inspections as part of BAU, not only as pre-inspection preparation.
Does it need to be a full day?
Scope to your highest-risk systems
A full-day mock inspection covering all CSV systems is valuable. A focused half-day on your two or three highest-risk validated systems provides the greatest return on time. The verbal questioning exercise is the core; documents are the starting point, not the product.
Should the same person who did the validation run the mock inspection?
Independence is the point
The value of a mock inspection comes from unfamiliarity with the programme. An inspector who has not been involved in the validation will ask questions the team has never been asked, which is exactly the exercise. Internal review by the validation team does not replicate this.

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