Pharma/Bio Organizations deal with unplanned and planned deviations within their daily operations, and know that their customers and regulatory agencies will audit their deviation system, to ensure that all deviations are logged, routed, analysed, and correctly responded to, in accordance with the associated SOP. 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.
For more information on managing Deviations 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 Deviations, CAPAs, Change Control and Audits:
- Deviation creation
- Form filling, workflow execution
- Root Cause Analysis
- QA Approval