Corrective and Preventive Action (CAPA) is a regulatory concept within Good Manufacturing Practice (GMP). It focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence. Process Control enables you to use CAPA remediation processes in your compliance and regulatory initiatives.
Note
CAPA remediation is available for the following:
Manual testing of controls
Automated and semi-automated testing of controls
Self-assessment of controls
The CAPA remediation process has the following features:
Root cause analysis
Corrective actions
Preventive action
Audit trail
E-signature
CAPA plan approval
CAPA plan execution approval
Verification of appropriateness and effectiveness