9.3. Modify CAPA

If the reviewer rejects the CAPA, the creator will receive a notification in their Pending Tasks prompting them to make modifications.

*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 Modify CAPA form. This form is largely a duplicate of the New CAPA form, except that the fields are all populated with previously entered information. Users can revise these details, as needed, before sending the CAPA back for review.

Highlighted below are the key features of the Modify form:

1. Discussion & Collaboration

Users can provide notes or comments on the revised CAPA. They can also review or respond to comments left by the reviewer.

2. Send Back for Review

At the bottom of the Modify form, there is the following button:

• Send Back for Review: This button allows users to send the CAPA back for review.
  • If upon review, the CAPA is rejected again, this process will repeat.
  • If upon review, the CAPA is approved, the assigned RCA Owner will be tasked with executing the root cause analysis.