CAPA Creation

Overview

Standard CAPA creation records the steps needed to correct an issue and prevent it from recurring. You define the problem, identify the cause, and document the actions required to address both the immediate condition and the underlying factor.

This process creates a structured record that supports consistent evaluation and provides traceability for quality and compliance activities. It ensures each CAPA starts with clear information that supports later review and verification.

Additional Resources

ComplianceQuest

• Creating CAPAs