Quality & Regulatory Systems

A commitment to quality leadership, worldwide, permeates Nypro Healthcare's quality systems. ASQ certified quality engineers transform quality from a cornerstone philosophy to a way of life....a way of life that touches all planning, development and manufacturing activities.

At the core is the Nypro Worldwide Quality System (NWQS), a web-based electronic application that integrates document generation, approval, and CAPA across all Nypro locations. Consistent execution insures stability of supply and minimizes risk on a global basis.

Our operations are registered to ISO 13485 in full compliance with cGMP, the QSR and applicable CFR's. We meet these standards with mature systems that are rigorously audited and calibrated with industry expectations on a continual basis. Our Lean Six Sigma philosophy is woven into the fabric of our operations.

Our quality team has a rich understanding of global regulatory and industry trends. Our goal is to work with your development and quality/regulatory groups to apply processes and pre-launch rigor that will reduce approval time, time to market, and post-launch issues.

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From Jabil's Blog

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