Risk Based CSV Validation Approach for AI Enabled Computerised Systems in GxP Environments
Risk Based CSV Validation Approach for AI Enabled Computerised Systems in GxP Environments AI-driven computerised systems are rapidly entering GxP-regulated environments (QC labs, manufacturing, supply chain and more). As they do, traditional computer system validation approaches and legacy Computerised Software Validation (CSV) methods are struggling to keep pace. This is why the FDA promotes the […]