Contract Organisations (CMO, CRO, CLO) in Life Sciences are required to create Corrective Actions/Preventative Actions (CAPAs) on the basis of sponsor/client feedback, audits, complaints, deviations, or inspections. The QUMAS Quality Management Solution will ensure that corrective action plans are aligned with the source of the issue, removing the need for duplication of effort. Automated forms, business rules and a dynamic workflow engine make up the basis of the QUMAS CAPA Management Solution process, allowing for a corrective action plan to be created and executed on. Full audit trail and electronic signature functionality ensures compliance with 21 CFR Parts 210-211, 820, and 606 and EU Annex 11 requirements. This includes data integrity, traceability, data security and electronic signatures. The system allows you to automate routine operations and enhance efficiency. This automated CAPA Management Solution ensures regulatory compliance across your entire company, which is essential for life science companies operating within strict GxP regulatory environments.
QUMAS preventative action software is designed to enable you to track and action CAPA deviations across multiple plants. The user-friendly interface allows you to create effective CAPA process controls.
For more information on managing CAPAs using the QUMAS solution, download this webinar on Driving Business & Quality Success with an Integrated QMS Platform, which outlines how to take control of your quality processes including CAPAs, Deviations, Change Control and Audits:
- CAPA creation
- Form filling, workflow execution
- Root Cause Analysis
- QA Approval