CAPA Management (Corrective and Preventive Actions)

A well-functioning CAPA process guarantees quality and efficient developing and operating processes.

CAPA management for regulatory compliance

The FDA warns companies of the importance of establishing and maintaining corrective and preventive action. It is vital that your CAPA system is able to minimise risk and prevent problems, otherwise your company will suffer during a regulatory inspection, if not before.

CAPA management with Platina QMS

Electronic CAPA management is a part of Platina QMS solution, enabling flexible management of activities related to quality and change management. Platina QMS software solution allows for the optimal documentation of all steps, including investigation, testing, review, approval and closure cycles.

Visibility within CAPA management

Platina QMS provides managers with real-time visibility into critical processes, and also allows for all employees to actively participate in the quality work through simplet-to-use and pre-defined forms that begin a CAPA process. The integrated QMS system also provides seamless traceability to related processes, such as change control and training.

Benefits of using Platina QMS for CAPA management:

• Reduced lead-times through automated stages in the CAPA process
• Easy-to-access reports that can be seen in real-time for faster analysis and closure of open CAPA cases
• Time and cost-effective regulatory compliance through electronic signatures and audit trails
• Allows for compliance with 21 CFR Part 11, EU Annex 11
• Offers pre-defined and configurable CAPA process workflows
• Provides seamless integration and traceability to related quality processes

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