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Function documentationRemediating CAPA Issues Locate this document in the navigation structure

 

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 Note

CAPA remediation is available for the following:

  • Manual testing of controls

  • Automated and semi-automated testing of controls

  • Self-assessment of controls

End of the note.

Features

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