Crafting a Robust Validation Report: Structure, Traceability & Regulatory Elements Explained How to Write a Robust Validation Report: Structure, Traceability & Regulatory Compliance Validation reports are a critical culmination of the pharmaceutical validation lifecycle. Whether it’s a cleaning validation, equipment qualification (IQ/OQ/PQ), or process performance qualification (PPQ), the validation report documents the executed work, data analysis, deviations, conclusions, and final assessment of validated status. This article provides a comprehensive guide on writing a robust and audit-ready validation report — with focus on structure, traceability, data integrity, and regulatory compliance, in line with FDA, EMA, and ICH Q9 expectations. 1. Purpose…