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Practical Steps to implement Change Control within Scilife

Define changes, assess risks, and link Change Control with other critical modules

Agenda

04:02

Introduction and main challenges

 

23:35

Scilife's approach

24:53

Demo new features & best practices for change control

 

57:50

Q&A Session

 

In this free session, our experts will guide you through best practices for implementing Scilife's Change Control solution, helping you to deal with regulatory updates, process improvements, or unexpected modifications. We will cover how to:

  • Set up and launch the Change Control module
  • Define changes and assess risks effectively
  • Integrate Change Control with other modules like CAPAs, Equipment, Document Control, and Risk Assessment
  • Conduct effectiveness checks to ensure the success of implemented changes

Q&A's
from the session

Can we modify a change request during the change process? If so, how can we do it?

You can update the change request while it’s in the "Created" status. However, once it reaches the "Implementing" status, you can no longer edit the change request form itself or any details you defined initially.

What you can do is add additional tasks, which will expand the scope of the change request in the "Tasks" tab. Additionally, in the "Comments" tab, you can document any updates or changes you're making to the request.

It’s important to include this process in your change request procedure, ensuring that using the "Comments" tab for further elaboration or description is properly documented once the request reaches "Implementing" status.

 

Apart from uploading files,  is it possible to link either within Scilife or to external URLs?

Yes, absolutely.

For external URLs, you can add them in the various text areas available within the change request form.

As for linking other elements within Scilife, for instance, if you need to create a new qualification as part of the change request process, you’ll find a "Change Request" tab when creating the qualification, where you can link it.

This works the same with other solutions, like Risk Assessment. When creating a Risk Assessment, at the bottom of the form, you’ll find the option to link it to another process. You can choose "Change Control" and then select the relevant change control process from the field.

 

 

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