CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.

医疗器械质量管理体系中的CAPA系统管理，涵盖根本原因分析、纠正措施规划、有效性验证和CAPA指标，适用于CAPA调查、5Why分析、鱼骨图、根本原因判定、纠正措施跟踪、有效性验证及CAPA方案优化