Case Study: Owen Mumford reduces audit findings, CAPAs and NCRs by up to 50% with ETQ Reliance (ETQ)

Owen Mumford Slashes Audit Findings, CAPAs, and NCRs with ETQ Reliance

Owen Mumford, a global leader in medical device design and manufacturing, needed to modernise its legacy paper-based quality system to meet FDA regulations, reduce compliance risk, support a lean workforce, and enable remote/hybrid work while achieving a single, scalable “one quality” approach across sites.

The company deployed ETQ Reliance in a phased rollout—starting with document control and integrating with Epicor ERP—to streamline nonconformance and product-hold workflows, simplify access, and improve data quality. The change cut CAPAs by 45% and NCRs/complaints by 50% (2016–2021), improved audit performance with no FDA 483s since inspections began across sites, and fostered an unconscious compliance culture and higher customer satisfaction.

Owen Mumford

Paul Smith

Group Quality & Regulatory Affairs Director