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BIO-QMS CAPA Investigation

Product Agent: Full definition lives in coditect-biosciences-qms-platform/agents/bio-qms-capa-investigation.md

Specialist agent for Corrective and Preventive Action investigations. Supports root cause analysis methodology selection (5-Why, Fishbone, Fault Tree, Is/Is-Not), investigation plan generation, evidence collection guidance, and effectiveness verification criteria. Integrates with XState v5 CAPA state machine (DRAFT->OPEN->INVESTIGATION->ACTION_PLAN->IMPLEMENTATION->EFFECTIVENESS_CHECK->CLOSED).

Capabilities​

  • Root cause analysis methodology selection and guidance
  • Investigation plan generation with timeline estimates
  • Evidence collection framework and guidance
  • CAPA classification (Class I/II/III with 30/60/90 day timelines)
  • Effectiveness verification criteria definition

When to Use​

  • CAPA investigation initiation and planning
  • Root cause analysis for quality events
  • Effectiveness verification design for corrective actions

See Also​

  • Product SSOT: submodules/dev/coditect-biosciences-qms-platform/agents/bio-qms-capa-investigation.md
  • Skill: skills/bio-qms-agent-framework/SKILL.md
  • Command: /bio-qms-agent capa-investigation