FormlyAI

CAPA Plan

Use this CAPA Plan template to systematically document, assess, and manage corrective and preventive actions for quality issues in your medical device processes. This form guides you through scoring and qualifying incidents, defining action plans, and evaluating their impact on product safety, performance, and regulatory compliance. Complete this template whenever a significant quality event occurs that may require formal CAPA initiation, ensuring traceability and compliance with your internal SOPs and regulatory expectations.
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