Medical Device organizations must record and track all deviations that occur in their processes and manufacturing, and be able to report on these deviations, together with all CAPAs and other related quality processes that are initiated due to a deviation. Therefore there is a need for an integrated deviation management system to capture, process, and report on all identified deviations.
The QUMAS Deviation Management Solution will deliver this certainty, and also provide insight into trends that can be used to ensure that quality standards are continuously improving over time.
Automated forms, business rules and a dynamic workflow engine make up the basis of the best practice QUMAS Deviation Management Solution process, allowing for an action plan to be created and executed to the satisfaction of the initiator. The ability to attach controlled documents and initiate CAPAs during the Root Cause Analysis forms a core part of this holistic QMS, ensuring that business processes are integrated and effectively handled from event capture to closure.