Computer System Validation

⚡ 1-Minute Summary: Computer System Validation ( CSV ) is the documented, regulated process of proving that a computerized system reliably does what it was designed to do for its intended use. In a pharmaceutical Manufacturing Execution System ( MES ) , validation covers master recipes, batch execution, Electronic Batch Records (EBR) , Audit Trails , enterprise interfaces (such as ERP and Salesforce Life Sciences Cloud ), automated calculations, and role-based user access. A compliant validation strategy connects business requirements, risk assessment, protocol testing, objective evidence, quality review, and formal approval into a single unbroken chain. Validation is much broader than software testing—testing is just one verification step inside a full system lifecycle. Throughout this guide, we use a practical pharmaceutical batch scenario ( Batch B10025 ) to show exactly how a critical MES function is proven before going live in ...