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Create a CAPA from a Quality Event during its assessment, or as a standalone document, and start it in the Draft state of the Planning phase.

Creating a CAPA

In the Planning phase the CAPA is drafted, authored, and its corrective and preventive actions are defined, then sent for review or approval.

CAPA Planning

When Planning approval is complete, the CAPA moves to In Execution and the corrective and preventive actions are carried out and completed.

CAPA Execution

A review applies in the Planning and Execution phases when the CAPA type requires it. The reviewer checks the content and marks the review complete.

Reviewing the CAPA

An approval applies in the Planning and Execution phases when the CAPA type requires it, and is captured with an electronic signature.

Approving the CAPA

Learn how to assess the effectiveness of the CAPA after the due period is passed.

Assessing the Effectiveness of the CAPA

When the effectiveness check concludes the CAPA was not effective, the system reopens it as a new version so further actions can be planned and executed.

Reopening the CAPA if not effective

Learn how to create CAPAs and how corrective and preventive actions are managed from initiation to closure.

CAPAs

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