You can add Update Documents Actions to a new CAPA or to an already existing CAPA.
Actions can be added to an existing CAPA while the CAPA is either in Created or in Implementing status.
Administrators can add Actions to a CAPA regardless of having a role in the CAPA or not.
Managers and Regular Users can only add Actions to a CAPA if they have a role in it as Creator, Responsible User, Approver, or QA.
Adding an Update Documents Action to a new CAPA
- Go to CAPAs > CAPAs.
- Click on the + icon.
In the CAPA Form, you will see the page is divided into two parts, on your left-hand side you can include all relevant CAPA details.
On the right-hand side, you will be able to add all the necessary Actions to your CAPA.
In the Add Action section:
- Click on the + Add Action icon.
- Per default the Action Type drop-down is always set to Custom Action, change it to Update Documents.
- In the Action Documents field, you can add as many Documents as you need to. Once you click on the field, all available Documents will appear, these will be all the Documents that have been assigned to the same Group(s) as the CAPA.
- It can be helpful to add an Action Description, detailing what needs to be modified in the selected Documents.
- Save the CAPA once you finish editing and adding all necessary Actions.
Adding an Update Documents Action to an existing CAPA
Update Document Actions can be added to an existing CAPA in two ways:
- In the CAPA Form.
- In the Actions Tab in the CAPA Details Page.
Adding Actions to an existing CAPA in the CAPA Form
- Go to CAPAs > CAPAs.
- Use the Filters and/or Search field to find the CAPA to which you want to add Actions.
- Hover over the CAPA until the Action button appears and Click on the Edit icon.
In the CAPA Details Form, add an Update Documents Action by clicking on the + Add Action icon:
Follow steps 1 - 5 mentioned in the section above (adding Actions to a new CAPA).
Once you have added the Update Documents Action, save the CAPA.
Adding Actions to an existing CAPA from the Actions Tab of the CAPA Details Page
- Go to CAPAs > CAPAs.
- Use the Filters and Search field to find the CAPA you wish to edit.
- Click on the Title of the CAPA.
In the CAPA Details Page:
- Go to the Actions Tab.
- Click on the + Add Action button.
- If no Actions have been added to the CAPA, the Actions Tab will look like the screenshot above and include a text area for Performed Actions.
- If Actions have already been added to the CAPA, the Actions Tab will be similar to the screenshot below.
After clicking on the Add Action button in step 2 above, the Add New Action window will appear:
- Per default the Action drop-down is always set to Custom Action, change it to Update Documents.
- Give your Action an Action Title.
- It can be helpful to add an Action Description, detailing what needs to be modified in the selected Documents.
- Assign a Responsible User.
- In the Action File field, you can add as many Documents as you need to. Once you click on the field, all available Documents will appear: these will be all the Documents that have been assigned to the same Group(s) as the CAPA.
- Click on Save if you just want to add 1 Action.
- Click on Save & New if you wish to add more than 1 Action to the CAPA.
After creating each Action the system will ask you to confirm, and then you will be notified that the new Action was added successfully.
- You can add as many Update Document Actions as you need to a CAPA. Although it is possible to add many Documents in one same Action, it can be useful to separate the Update Document Actions into various Actions if the updates to be made in the different Documents are not the same and the Action Description needs to be different.
- You must assign Responsible User(s) to the Update Documents Action. The responsible Users are those who already have a role in the Document(s) (Author(s), Reviewer(s), Approver(s), QA(s).
- If the Update Documents Action was added to the CAPA while it was in Created status then the Responsible Users will receive an email notification indicating that the Document(s) need to be updated when the CAPA reaches Implementing status.
- If the Update Documents Action was added to the CAPA while it was in Implementing status then the Responsible Users will receive an email notification indicating that the Document(s) need to be updated as soon as the Action is saved.
- When the Update Documents Action is implemented, the Documents will go back to Draft status. If the Action was added when the CAPA was in Created Status then this will happen once the CAPA reaches Implementing status, if the Action was added to the CAPA when it was in Implementing status then the Document will go back to Draft as soon as the Action is saved.
- If the Documents included in the Action are not in Draft or Published status when the Action is implemented, then the Action will not be completed until the documents have finalized the Approval Cycle they are currently in and are then pushed through another full Approval Cycle. In other words, the Documents need to go through a full approval cycle before the Action is completed. The Action will be marked automatically as closed by the system once this happens.
- You can add and delete Update Documents Actions to a CAPA while it is in Created and in Implementing status.
- You can only edit Update Document Actions while a CAPA is in Created status.
- Even if it has been activated in module settings that QA must sign off on all Actions this does not mean that QA will have to sign off on Update Document Actions. These are closed the moment the Document finalizes a full new Approval Cycle.
- Actions that are added to the CAPA while it is in Created status will be not be implemented until the CAPA has been Signed off by Approver(s) and QA(s) and reaches Implementing status.
- Actions that are created while the CAPA is in Implementing status do not have to be Signed off by Approver nor QA, they will be implemented right away.