9.5. Verify CAPA

Once the Execute the Root Cause Analysis form has been submitted, the assigned reviewer will receive a notification in their Pending Tasks prompting them to verify the CAPA.

They will also receive an email notification informing them of the assigned task.

Clicking on either the subject in Pending Tasks or the link in the email will direct users to the Verify CAPA form. This form, largely mirroring the Execute the Root Cause Analysis form, presents most fields in a read-only format. Users can review the root cause analysis and all actions related to the CAPA.

To avoid unnecessary repetition, only the notable aspects of the Verify CAPA form will be listed below.

1. CAPA Closure Dates

In this section of the form, users can specify the re-planned and effective closure dates for the CAPA.

• CAPA Re-Planned Closure Date: This is a date picker that allows users to input/select the re-planned closure date for the CAPA.
• CAPA Effective Closure Date: This is a date picker that allows users to input/select the effective closure date for the CAPA.

2. Comment

In this section of the form, users can provide notes or comments on the CAPA. They can also review or respond to previous comments left by stakeholders involved in the workflow.

3. Reject / Approve / Save

At the bottom of the Verify CAPA form, there are the following buttons:

• Reject: This button allows users to reject the CAPA.
  • If selected, the RCA owner will be tasked with modifying the CAPA.
• Approve: This button allows users to approve the CAPA.
  • If selected, the assigned action item owner(s) will be tasked with executing the action items.

    **If any of the action items are external, users will be tasked with creating SCAR at the same time as the Execute Action Items task. (If there is only one action item and it is external, users will only be tasked with creating SCAR—meaning that they will not receive the Execute Action Items form). For more details on the SCAR workflow, click here.

• Save Form: This button allows users to save the form.
  • It will remain in the Pending Tasks folder.