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HEALTHCARE | CAPABILITIES |
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Quality & Regulatory Systems |
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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.
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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.
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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.
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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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