Capa Officer

Capa Officer

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

Optimized workflow

This edition turns the source methodology into a repeatable agent workflow with explicit inputs, checkpoints and deliverables.

Quality standard

• Confirm scope and missing inputs before execution
• Ground decisions in available evidence and preserve source constraints
• Return an actionable result with assumptions, risks and next steps

Agent compatibility

The same core method is packaged for Claude, Codex, GPT, Gemini, Cursor and OpenCode.