How can you handle other types of quality events such as deviations?
With document types, you do the same thing for events in Scilife: you define any sort of quality event that you had. For example, it could be nonconformity or pharmacovigilance, a GMP incident, a deviation, or a complaint. What you will be doing is defining what information you want to capture during the registration.
You can also customize what information you want to capture during the investigation. Fields like the root cause, the risk assessment, and the cause are common for all types of events. Then you can personalize with custom fields. These custom fields will allow you to create a set of data that you want to capture during a certain stage of the registration or investigation.
You can also add different types of metadata. For instance, you could ask for a date or you could ask for a dropdown option. There are plenty of options to personalize the difference in a nonconformity and deviation or any other quality event.
What remains standard is the workflow, which contains “register” or “create”, “investigate”, “signature by reviewer”, “signature by QA”, and “close”.
Can the actions be performed without a specific order?
Yes, the order is not defined, so it's completely up to you to suit exactly your situation and your processes. For example, you can create the CAPA from the risk assessment or straight away during the investigation of the event without going through that risk assessment.
The same applies to CAPA actions. You define the due dates, but there is no order for that. You can create the CAPA plan and define the actions at the beginning before implementing the CAPA. When you put the CAPA into implementation, you can then add more actions as well. The order can be set by you.
Is there any reason why the effectiveness check in the CAPA process is optional and not mandatory? And if it is optional, can it be set to mandatory by default?
Within our standard workflows, it cannot be set as mandatory as a default as it is a GMP requirement. Sometimes it depends on the issue, it might be non-critical. Besides, you can determine if there is no need to make an effectiveness check depending on the type of CAPA action. We prefer to leave it as non-mandatory, not only to comply with regulations, but also to comply with the requirements of some of our customers that have their specific procedures.
However, you can also create your own workflows. This means that if you are interested in having a CAPA workflow that has the mandatory effectiveness check, you would have two options.
The first one would be to create this from scratch, defining everything e.g. row statuses, forms, fields etc. And the second one is just to get one of the standard workflows we have from CAPAs and build on top of that, so you can use it as a basis to then customize that workflow. It could be the case that everything matches your process, but you might want to have a mandatory effectiveness check. You can do that with Quality Process Designer, which is part of our advanced package.
If the procedure of specification was already in place, but that procedure was wrong, would it be possible to force an update of this document through your CAPA solution? How does the system manage this?
Yes. Within the Quality Process Designer whenever you create a CAPA, you have two types of actions that can be defined. The first one is a custom action where you define whatever it is: Corrective, preventive actions, creating a document, fixing something… You describe it, define a due date, and set up a responsible user. If you already have that document and you simply want to update it, Scilife brings you a new layer of project management, asking you which document you want to update. It gives you access to the document repository to choose the document in question. You’ll need to add a due date and define what needs to be changed. The responsible roles will be notified on the dashboard and by email as well. This will be put automatically into draft whenever the implementation of that CAPA is approved. If you have been updating a document, whenever the approved version is released, the system will close the CAPA action automatically.
