How can I add an effectiveness check to a change request?
At this moment the Effectiveness Check step that we have for CAPAs is on the roadmap as well for Change Requests.
Meanwhile, what you can do is add an additional task to the Change Request for “Effectiveness Check”. This task will be the last one to be closed before the Change Request escalates to Under Signing by QA.
If you detect during the Effectiveness Check that some of the tasks were not carried out correctly or that more tasks are needed, new tasks can be added at this stage until the Effectiveness Check task can be signed off with the conclusion that the Change Request implementation was effective.
If you already have a CAPA, in which you will have actions listed in the CAPA and in the Change Request, how can you deal with this duplication?
If a Document is included both in the Update Document Action of a CAPA as well as in the Update Document Task of a Change Request, the users who have a role within the document will verify which updates are needed in relation to the CAPA, as well as to the Change Request.
They will ensure that the Document is not signed OFF until all the updates are made.
The email notifications provided by Scilife are a good aid at this point
The users with a role in the document will get an email notification for Update Document Actions/Tasks, ensuring they the know the document needs to be updated for a CAPA or Change Request
The notification on the dashboard is very visual.
Lastly, the audit trail will make it clear as well that the document is being updated due to a Change Request or CAPA.
How can a change request be reopened?
Depending on the Modules Settings that have been configured on your end by Administrators and Managers, it may be possible to reopen a Change Request. In that case, once the Change Request is closed you will see an arrow in the status button, indicating that you can reopen the Change Request. You simply need to provide a reason and define which status you would like to reopen it to.
How can I view the ongoing change request task?
Below the Change Request section in the main menu, there is another section for Change Request tasks where all tasks will be listed. You can filter the listing according to task status.
Is it mandatory to link a change request to a CAPA?
No, it is not mandatory to link a Change Request to a CAPA, these can be created independently of each other.
