Is there an Audit Trail that captures everything that happens during the process?
Yes. Scilife has an audit trail for every single module that complies with FDA 21 CFR 11 and data integrity principles. There is also an additional audit trail, which is the system log.
Is the effectiveness check mandatory in all CAPAs?
No, effectiveness check is an optional status in the CAPA workflow. QA can decide if it is necessary or not.
Can you also manage complaints for MD/IVD in Scilife with the same tool we have seen?
Yes, the Events module allows you to customize all the different quality events that you need to register and investigate within your Quality Management System.
Is there a way to have an overall view of the different incidents/complaints in your QMS?
Absolutely! There are 2 different ways to do this. One of them is through the list page of the Events module, using the filters. You will obtain the list with your different incidents, complaints. And you can export that into CSV or excel. The other way is using the KPIs module, where you will find the same filters with a set of predefined charts and you will be able to see the data.
I see you have tags. What are tags used for?
Tags can be used for many things, but primarily they are used to filter and classify information. You will find more information on the topic in our knowledge base.
