9.2. Review CAPA

Once the New CAPA form has been submitted, the assigned reviewer will receive a notification in their Pending Tasks, prompting them to examine the CAPA.

*An email notification will also be sent to alert them of the task. For more information on email notifications and their role in the application, click here.

Clicking on either the subject in Pending Tasks or the button in the email will direct users to the Review CAPA form. In this form, users can review all the information previously entered for the CAPA and, where applicable, make necessary additions or modifications. Following this examination, users can decide whether to reject or approve the CAPA.

Highlighted below are the key features of the Review form:

1. Feedback & Collaboration

Similar to the starter task in the workflow, this form includes the Comment field, designed for feedback provision and collaboration. Users can offer notes or comments on the CAPA. They can also review and respond to any notes or comments left by its creator.

2. Reject / Approve

At the bottom of the Review form, there are the two following buttons:

• Reject: This button allows users to reject the CAPA.
  • If selected, the creator of the CAPA will be tasked with modifying it.
• Approve: This button allows users to approve the CAPA.
  • If selected, the assigned RCA Owner will be tasked with executing the root cause analysis.