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GMP Events Management in Scilife

Elevate your GMP event creation and management skills with Scilife.

Agenda

02:35

Introduction and key challenges

 

21:28

Scilife's approach

27:00

Case Study

 

56:25

Q&A Session

In this free session, we will explore how you can effectively create and manage GMP events with Scilife. We will teach you how to: 

  • Configure events in line with GMP requirements in Scilife.
  • Create and analyze which customizable fields you need to include in the event registration and investigation phases.
  • Link events with a CAPA and perform thorough risk assessments to mitigate potential issues.
  • Track and analyze key performance indicators and filter by root cause or impact level.

Q&A's
from the session

In the CAPA module, can actions be "tagged" as correction, corrective, preventative, etc without including them in the title?

For now, it's not possible. We do have the differentiation between custom actions and updated document actions. So if you want to tag them specifically either one way or the other, you need to include it in the title.

 

After investigation, sometimes the impact of the Event turns out to be different than initially entered. What is the best practice in this situation?

The best practice in this situation would be to document in their process that they have an Impact Review at the end of the investigation before the investigator signs off, to support that process they could create custom fields to record the event that the Impact Level was Reviewed and Confirmed or Reviewed and Updated. They could even add a Text Area custom field to add remarks about this change. As custom fields have variables, they can add them to their Event templates so everything is documented when downloading the Event Report. It is also worth mentioning that the Impact Level can only be edited while the Event is Under Investigation.

 

Can I add custom fields to my events list?

Indeed. One thing that is very interesting is when you're working with a listing page, and you want to filter or search for a specific custom field or its contents, you could potentially add those custom fields just by clicking “fields” and the drop-down menu will appear. You will see that first, you have the default columns, which would be the default Scilife fields, and as you go down there are the custom fields as well. 

So, for example, if you would like to find a specific field, you can select it in this menu and filter by that field. And if you'd like to work with these data in an Excel spreadsheet, you can simply export the list and you will have all the custom fields within the spreadsheet.




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