CAPA: Effectiveness Check Pending status

Editing a CAPA while in Effectiveness Check Pending status 

When a CAPA reaches Effectiveness Check Pending status the CAPA cannot be edited.

At this point only the Effectiveness Check Due Date can be modified by Creator, Responsible Person or QA.

Changing Effectiveness Check Due Date

1. Click on the calendar icon in the CAPA Details Page.

In the Change Effectiveness Check Due Date window:

1. Set a New Due Date (the current Due Date will be shown in the field).
2. Give a Reason for changing the Due Date.
3. Save changes.

You will then be asked to confirm and finally you will get the notification: Effectiveness Check Due Date updated successfully.

Effectiveness Check Conclusion

Before the CAPA can be set to Effectiveness Pending Approval, the Effectiveness Check Conclusion must be introduced.

The Effectiveness Check Conclusion can be introduced by the Responsible Person and by QA.

1. Go to the Actions Tab in the CAPA Details Page.
2. Introduce an Effectiveness Check Conclusion.
3. Upload a file if relevant.
4. Save

In the CAPAs signing form window, the User who has introduced the Effectiveness Check Conclusion will then be asked to:

1. Sign off.
2. Save.

The system will confirm with the following notification: Effectiveness Check saved successfully.

Changing CAPA status

Depending on the role of the User who tries to change the CAPA Status, the options will vary:

• The Responsible Person will only be able to set the CAPA to Effectiveness Pending Approval.
• QA will only be able to Set the CAPA to Closed.
• If the User is configured in the CAPA as both Responsible User as well as QA then the User will have both options: set to Effectiveness Pending Approval and Set to Closed.

Responsible Person: Setting CAPA to Effectiveness Pending Approval

1. Only the Responsible Person can set the CAPA to Effectiveness Check Pending Approval in the CAPA Details Page.
2. Click on the Effectiveness Check Pending status button.
3. Set to Effectiveness Pending Approval.

In the Effectiveness Pending Approval window:

1. Sign off electronically 
2. Save.

The system will then give the following notification: CAPA signed successfully by Responsible Person. Status updated to Effectiveness Pending Approval.

QA: Setting CAPA to Closed

1. In the CAPA Details Page, click on the Effectiveness Check Pending status button.
2. Set to Closed. Only QA will see this option.

In the Set to Closed window:

1. Sign off.
2. Save.

The system will then give the following notification: CAPA signed successfully by QA. Status updated to Closed.

Changing status when QA and Responsible Person are the same User 

1. When QA and Responsible Person are the same User they will get both options in the CAPAs Details Page.
2. In order to change status click on the Effectiveness Check Pending status button.
3. Set to either Effectiveness Pending Approval or to Closed.