Owen Mumford Slashes Audit Findings, CAPAs, And NCRs With ETQ Reliance

Owen Mumford, a prominent player in the medical device sector with a global footprint across the UK, USA, Europe, and Asia, is committed to enhancing patient care through innovative solutions. Renowned for its rigorous quality standards, the company has embraced a continuous improvement ethos in the development and manufacturing of medical devices. Faced with challenges related to FDA compliance and a cumbersome paper-based quality management system, Owen Mumford turned to ETQ Reliance® to streamline its internal quality processes.

This strategic shift has led to a remarkable reduction in audit findings, Corrective and Preventive Actions (CAPAs), and Non-Conformance Reports (NCRs). The transition to an electronic Quality Management System (QMS) was executed in phases, beginning with the integration of ETQ’s document control module with the existing Epicor enterprise resource planning system. This integration allowed for a more agile approach to managing quality, particularly during the heightened demands of the COVID-19 pandemic. The results have been impressive: since 2015, all manufacturing sites have passed FDA inspections without receiving any violations, and the company has achieved a 45% reduction in CAPAs and a 50% decrease in NCRs and customer complaints.

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