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Prepare for audit season with Scilife

Get ahead of managing incoming and internal audits 

Agenda


04:25
Introduction 

20:24
Key challenges

 

33:35
Case Study in Scilife

59:05
Q&A session

In this Deep Dive session, our experts will give you a comprehensive overview of Scilife's Audit module, sharing top tips to set you up for a smooth and stress-free audit season. Starting with the basics, they’ll go through all the core features you need for smooth audit management. They’ll cover how to: 

  • Track, organize, and execute your internal audits with ease.
  • Stay prepared for external reviews and regulatory inspections.
  • Make audit season stress-free with Scilife’s Audit module. 

Q&A's from the session

Would you close an internal audit only if all defined CAPAs were closed? Or is it sufficient for audit closure that CAPAs are defined and tracked via the CAPA system?

When we set the audit to "closed," the system provides a heads-up, notifying us that the CAPA created in relation to this audit has not yet been closed. We already know that we left the CAPA in an "effectiveness check pending" status, so we are not looking to close it at this stage.

However, we do want to proceed with closing our internal audit, so we would simply click "Yes." The system isn't blocking us, it's just giving us a notification. At this stage, we would mention "effectiveness check pending" in the "Reason (For Not Closing CAPAs)" field.

 

Can I find the audit agenda and the checklist already prepared inside Scilife?

You need to first create the document types and then create the documents. You can find them in the Document Control tool, where you can link them to the specific audit.

The audit agenda and checklist will be available in the Document Control tool. When creating the audit, you will need to link these documents to your audit.



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