Can I change the due date of the CAPA while it is in implementing status if more time is needed?
Yes, you can extend it, but you need to take into account these aspects:
- If we extend the date, we need to provide a clear reason why we're doing that.
- It can only be done by an administrator or by QA.
- When you extend the due date of the CAPA, you always need to provide a reason. Otherwise, you cannot proceed.
- For effectiveness, check the due date. When you extend the due date, you always need to prove so
In the operative process, it’s very visual and clear how many times we extended the due date. And in the audit trail, you will see when the cap due date was extended and the reason for the extension.
Is it possible to reopen a CAPA?
Yes, you can create a new CAPA, link it, reopen it, and add additional actions to a created one.
When you open the CAPA, you can push it back to creative status while all the actions that you have already carried out are left closed. The same thing happens when you are reopening the entire cover. You can reopen the custom actions or push it back to created and add in additional actions while leaving this.
You can also select the status and you can open it back all the way to credit status or set it back implementing and add those actions that you consider were missing.
There's only one aspect to consider: the actions you add when you are implementing don't need the approval step. If you push it back to created status, you will get the approval, both the approval and FQA, for these new actions.
What happens if we don’t work with creating specific Actions and assigning these to various people?
You define your CAPA plan field. When creating the CAPA, you define everything that needs to be carried out. When the CAPA reaches implementing status, there's only one person who is responsible, the overall responsible person who fills out this performed actions field and can then indicate if the actions performed were effective.
As soon as the responsible person signs off, this gets recorded within the system, and you can edit this field with interesting data that is good to know. You can edit it as you go along. And when you finally feel that the CAPA performed actions have been updated and you've added all the details you need, you simply sign off on the CAPA.
So it's a much simpler workflow. You don't have all these actions where people get the notification as you go along that they need to carry out something. It just depends on one small person.
How would you deal with missed due dates?
Remember, when we're working with the listing pages, we have the option to add in the due date for the effectiveness check and the due date of the CAPA. This way, it is very easy to see both on the listing pages. Also, the CAPA actions listing is available so we can see due dates throughout the system and keep a close track of them.
If the responsible persons of the CAPA see that the due date is approaching and they don't have enough time, we can simply go into the CAPA, which is an implementing status, and extend the due date.
Which roles can close a custom CAPA action?
The person who closes a custom CAPA action is always the responsible user. It's either one or several users who need to close the action, and it's the users who are actually assigned the action.
How can you link a CAPA with a change control request?
You can link a CAPA to an existing Change Request from the CAPA form. Moreover, when creating the CAPA, Scilife offers you the option of saving the CAPA and immediately creating a linked Change Request.
Is it possible to customize the CAPA Report?
It is very easy to customize your CAPA Report using the Scilife variables. In the Document tool, you can create a Document Type, to which you then upload a template that includes all the variables for the CAPA information you wish to display in your report. The variables will transfer the metadata from Scilife to your report.
What will be the final due date for a CAPA when there is an Effectiveness Check?
If you have the required Effectiveness Check, the final due date of the CAPA will be that of the Effectiveness Check.
