Editing a CAPA with Actions while in Implementing status
While the CAPA is in Implementing status it is still possible to edit some of the details of a CAPA. At this point it is also possible to add additional Actions to the CAPA.
Editing CAPA Details
- Click on the edit button in the CAPA Details Page.
The CAPA Details Form will open. Users defined in the CAPA as Creator, Responsible Person, Approver and QA. will be able to edit the CAPA Details Form.
When the CAPA reaches Implementing status the following details can be edited:
- Groups: You can assign the CAPA to more Groups but you cannot remove the Group to which the CAPA was originally assigned.
- Events: You can link additional Events to the CAPA and/or remove Events that were linked to the CAPA in Created status.
- CAPAs: You can link additional CAPAs to the CAPA and/or remove CAPAs that were linked to the CAPA in Created status.
- CAPA Due Date can be modified.
- Client/Vendor/Contact field can also be modified.
- Tags can be removed and new ones added.
- You can modify QA and/or add additional QAs.
The remaining fields cannot be edited.
Adding Actions to a CAPA
Both Custom Actions as well as Update Documents Actions can be added when the CAPA is in Implementing Status.
These can be added either by:
- Clicking on the +Add Action button in the Actions Tab in the CAPA Details Page.
- Clicking on the edit button in the CAPA Details Page.
By clicking on the + Add Action button the Add New Action window will open and all the Action details can be included.
By clicking in the edit button the CAPA Details Form will open and the Actions can be added in the right hand side of the Form.
Before the CAPA can proceed to Under Signing by QA all Actions must be marked as closed.
Closing Custom Actions
The Responsible User of the Custom Action must mark the Action as closed:
- Go to the Actions Tab of the CAPA Details Page.
- Close the Action by clicking on the check mark icon in the Actions Column.
In the Update Action window:
- Sign off electronically.
- Add Remarks.
- If relevant, upload files.
If it is not required for QA to sign off on all Actions then you will get the message: Action closed successfully. In the Action Tab of the CAPA Details Page the Action will appear as Closed in the Status Column.
If system settings require for QA to sign off on all Actions, you will get the message: Action status set to pending approval successfully. In the Action Tab of the CAPA Details Page the Action will then appear as Pending Approval in the Status column.
QA must then go to the Actions Tab in the CAPA Details Page:
- Check which Actions are Pending Approval in the Status column.
- Accept the Action by clicking on the check mark in the Actions column.
In the Update Action window QA must:
- Sign off.
QA will then get the message: Action closed successfully. Thereafter:
- The Action will appear as Closed in the Actions Tab.
- As soon as the Action(s) in the CAPA are closed, the status of the CAPA will automatically change to Under Signing by QA.
Update Documents Actions
In this case the Actions will be completed as soon as the Documents included in the Action have gone through a full approval cycle. The Action will be marked automatically as closed by the system once this happens.
It is not necessary for QA to sign off on this Action even if the Action Sign off for QA switch is turned ON.
Setting the CAPA to Under Signing by QA
CAPAs that have specific Actions assigned to them will automatically be set to Under Signing by QA as soon all the Actions are closed. In other words it is not necessary for the Responsible Person to manually change the status from Implementing to Under Signing by QA.