9.10. Sign Off

Once the CAPA has been approved, the assigned reviewer will receive a notification in their Pending Tasks prompting them to to sign off on 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 Sign Off form. This form is largely a duplicate of the Execute the Root Cause Analysis form, with the exception being that most of the fields are disabled. For reviewing purposes, users are allowed to download attached files, view details inside supplemental forms, and export grids to Excel.

To avoid unnecessary repetition, only the notable aspects of the Sign-Off form will be listed below.

1. CAPA Effective Closure Date

In this section of the form, users can review additional details about the CAPA. If needed, they can adjust its effective closure date.

• CAPA Effective Closure Date: This field displays the current effective closure date for the CAPA. Users can modify this date as needed.

2. Actions

Users cannot make any direct modifications in this section of the form. They can, however, review the execution history of actions defined for the CAPA. They can also access the Notes field from the Check Effectiveness & Approve form. This field will contain any previously inputted notes.

• View ( ): This button allows users to view an action or budget item.
  • In viewing mode, users cannot make any modifications.
    • For actions, however, they can download attached files and access/download any available templates.
• Expand ( ): This button allows users to access the full action description.

!If an action item has been re-executed, its Times Rejected figure will be greater than 0.

*To access additional options or perform actions related to the above grids, please utilize the kebab menu ( ) located in the upper rightmost corner.

3. Sign-Off

At the bottom of the Sign-Off form, there is the following button:

• Sign-Off: This button allows users to sign off on the CAPA, bringing the workflow to an end.