How to Prepare for Regulatory Inspection of CSV Systems How to Prepare for Regulatory Inspection of CSV Systems In the realm of pharmaceuticals, compliance with regulatory standards is paramount to ensure product safety, efficacy, and quality. The Schedule M guidelines set forth by the Central Drugs Standard Control Organisation (CDSCO) in India stipulate rigorous requirements for various processes, including Analytical Method Validation and Computer System Validation (CSV). This article will provide a step-by-step guide to prepare for regulatory inspections focusing on these critical areas. Understanding the Importance of Schedule M Compliance Schedule M serves as a framework to maintain Good…