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Mastering CAPAs in Scilife – A Beginner's Guide

A hands-on guide to managing quality issues effectively with Scilife's CAPA module

Agenda


03:40
Introduction to CAPA process

14:45
Main challenges to effectively manage CAPAs

24:05
Scilife approach

25:50
Case Study in Scilife

1:01:00
Conclusion

In this complimentary Deep Dive, our experts explored the fundamentals of the CAPA module within Scilife's eQMS platform. They demonstrated how to enhance accountability and streamline compliance workflows through two primary CAPA approaches:

  • Understanding simple CAPAs for streamlined, single-user management
  • Implementing advanced CAPAs for larger teams with delegated tasks
  • Setting up and configuring CAPAs with responsible users
  • Organizing multiple actions with due dates
  • Conducting effectiveness checks to ensure quality improvement

Q&A's from the session

If multiple users are assigned to a task, do all users need to perform and sign off? 

All assigned users must complete and sign off on the task. Under Signature Settings, you can configure sign-off requirements within the CAPA module settings. You can make it mandatory for all QAs or Approvers to sign off on the CAPA. Additionally, if you enable the "Sign off sequence" option when multiple approvers are required, you can establish a specific order for approvals.

 

Are actions that are added to the implementing status effective immediately? 

Yes, actions added while the CAPA is in Implementing status take effect immediately and don't require Approver sign-off. Responsible Users will receive immediate notification when an action is added to the CAPA at this stage.

 

Can I create a CAPA report to share with internal stakeholders? 

Yes, you can generate CAPA reports. This requires creating a report template with CAPA module variables, which can be used when downloading specific CAPAs. To save time, you can set a default report export template in the CAPA Module Settings using either a Document Type template or a regular approved document. Document Types are available immediately after creation, while regular documents must be approved before use.

 

 

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