Definition

Ongoing state of compliance and documentation such that the organisation can host a regulatory inspection at any time with complete, accurate, and retrievable records.

Example

Routine self-inspections, document indexing, trained escorts, and a clear inspection SOP support inspection readiness.

Regulatory source

Best practice; FDA/EMA expectations

Common mistakes

Preparing only when an inspection is announced. Poor document retrieval or untrained staff.

Inspector question

How do you maintain inspection readiness? When was your last internal or mock inspection?

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