8. CAPA Application Forms and Workflows

In the sections of the manual that follow, we will be delving into the various forms and workflows of the CAPA application.

The CAPA application is comprised of one central workflow.

• CAPA

This workflow consists of nine primary stages: New CAPA, Review CAPA, Modify CAPA (1), Execute the Root Cause Analysis, Verify CAPA, Modify CAPA (2), Execute Action Items, Check Effectiveness & Approve, and Sign Off.

*A CAPA can triggered independently, via the Quality Event application, or via the Audit application. When triggered from the Quality Event or Audit application, the first step of the CAPA workflow is Review CAPA.

** Although both Modify CAPA forms are part of the workflow, they are only issued if the CAPA is rejected by the reviewer.

*If any action items are rejected in the Check Effectiveness & Approve stage of the workflow, the Execute Action Items task will be re-issued to the assigned action item owner(s).