Definition

A formal request from inspectors for specific documents, records, or data during a pharmacovigilance inspection.

Example

Inspector requests: 'Please provide 10 recent expedited case files with source documents, the signal detection procedure, and QPPV job description within 2 hours.'

Regulatory source

Inspection Procedures

Common mistakes

Not having an organized document management system enabling rapid retrieval during inspections.

Inspector question

How quickly can you retrieve requested documents? Show me your document management system.

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