GAMP 5 2nd Edition (July 2022) key updates + FDA Computer Software Assurance (CSA) coordination. AI/ML SYSTEMS: dedicated guidance on validation of AI/ML in pharma (predictive maintenance + image analysis + drug discovery + clinical decision support); training + validation + retraining cycles + monitoring + bias detection + explainability + adaptive AI/ML controlled-change management; coordinated with FDA AI/ML Software as a Medical Device (SaMD) Action Plan + EU AI Act + IMDRF AI Working Group. CLOUD COMPUTING + SaaS: shared-responsibility model + supplier qualification + business continuity + data sovereignty + multi-tenant considerations + IaaS/PaaS/SaaS lifecycle differences; integrates with FedRAMP-like sector certifications + ISO 27001/27017/27018 + ISPE cloud guidance. AGILE + ITERATIVE DEVELOPMENT: scrum/kanban/SAFe adaptation; sprint-level documentation + risk assessment + acceptance criteria + lifecycle artifacts in sprint outputs; balance regulatory compliance with iterative speed. DEVOPS + CI/CD: automated testing + deployment pipelines + version control + infrastructure-as-code + automated validation; emphasis on test automation reducing manual qualification effort. FDA COMPUTER SOFTWARE ASSURANCE (CSA) - 2022 Draft Guidance: risk-based + critical-thinking-driven + assurance-by-assessment + reducing reliance on prescriptive testing for low-risk systems; coordinated with GAMP 5 critical-thinking emphasis. CRITICAL THINKING EMPHASIS: throughout 2nd Edition + replacing some prescriptive testing requirements with judgment-based assurance.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.