Preparing Validation Docs for Regulatory Inspections: Structure, Indexing & Readiness Tips Preparing Validation Documentation for Regulatory Inspections: Structure, Indexing & Readiness Tips Regulatory inspections from authorities like the FDA, EMA, or WHO place significant emphasis on the completeness, traceability, and structure of validation documentation. A well-organized and audit-ready validation file demonstrates control over the pharmaceutical validation lifecycle and can make the difference between a smooth inspection and a 483 or warning letter. This article provides a comprehensive guide on how to prepare, organize, and present validation documents for regulatory inspections. From file structures and indexing systems to readiness tips and…