4.2.2. Comprehensive Visibility of Audit Observations in Linked/Triggered CAPAs

To enhance visibility and understanding of the factors contributing to a CAPA, we have improved the display of related audit information within the CAPA workflow.

• Now, when a CAPA is triggered directly from the Audit application, the forms automatically show all related major observations.
  

  **This improvement eliminates the previous manual selection process, providing users with instant access to these observations in the grid.

• In cases where the CAPA is initiated from the Quality Event application following an audit-triggered or audit-linked event, the forms now provide a more comprehensive view. They present all relevant audit findings and observations, including general findings, non-conformities, minor observations, and major observations.
  

  **While major observations alone can directly trigger a CAPA, any type of finding or observation from an audit can trigger a quality event. This improvement ensures that when escalating a quality event to a CAPA, all findings and observations captured during the audit process remain visible and accessible.

• To enhance flexibility, when a CAPA is linked back to an audit plan, rather than directly triggered, the forms now show all related audit findings and observations.

All audit information is conveniently presented within the Observation(s) grid.

• Audit > CAPA — Major Observations Only
  
• Audit > QE > CAPA — All Related Findings & Observations
  
• CAPA > Audit — All Related Findings & Observations