Generic drug and API manufacturers 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.
Generics Drug and API Manufacturers are required to create Corrective Actions/Preventative Actions (CAPAs) on the basis of 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. 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.
Deviations, CAPAs, and Change Control are essential elements of a good QMS. But too often organizations use paper forms and manual processes to manage this critical data. This results in inefficiencies and risk of audit observations.