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Plexus Software Simplifies Compliance

Plexus Systems, Inc., Auburn Hills, Mich., announced enhancements to its Plexus Online software for medical-device manufacturers. An integrated program provides enterprise-wide compliance with Good Manufacturing Practices (GMP) and Quality System (QS) regulations mandated by the FDA. Plexus Online lets medical-device manufacturers meet regulations and standards such as FDA 21 CFR Part 11, Part 820 Quality System Regulation, and ISO 13485:2003. The Web-hosted software supports audit trails and electronic signatures, supply chain management, production planning, shop floor controls, data-driven manufacturing, and quality management. The system offers a traceability feature-set that makes possible end-to-end tracing of each specific product component, including raw materials, throughout the supply chain.

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© 2012 Penton Media Inc.


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