EMEA Office
Louizalaan 489
1050 Brussels
Belgium
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:
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.
EMEA Office
Louizalaan 489
1050 Brussels
Belgium
US Office
Scilife Inc.
228 E 45th St. RM 9E
New York, NY 10017
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EMEA Office
Louizalaan 489
1050 Brussels
Belgium
US Office
Scilife Inc.
228 E 45th St. RM 9E
New York, NY 10017
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