AUBURN HILLS, Mich., Oct. 8 /PRNewswire/ -- Plexus Systems, Inc., provider of Plexus Online software for the medical manufacturing enterprise, today announced a set of enhancements for medical device manufacturers. The new enhancements include an integrated program that will provide enterprise-wide compliance with Good Manufacturing Practices (GMP) and Quality System (QS) regulations mandated by the U.S. Food and Drug Administration.
Plexus Online enables medical device manufacturers to meet regulations and standards such as FDA 21 CFR Part 11, Part 820 Quality System Regulation and ISO 13485:2003. The Web-hosted, software as a service offering supports unparalleled levels of visibility, connectivity and integration -- from audit trails and electronic signatures, to supply chain management, production planning, shop floor controls, data-driven manufacturing quality management and more.
Medical device manufacturers rely on Plexus Online because the system offers a robust traceability feature-set, enabling end-to-end tracing of each specific product component, including raw materials, throughout the supply chain. With Plexus Online, the information is fast, visual and simple. Further, if a material defect is discovered and a root cause analysis completed, users easily identify and quarantine all other suspect material affected by the same issue.
Said Mark Symonds, President and CEO of Plexus Systems, Inc., "The medical device manufacturing sector turns to Plexus Online to achieve data-driven quality -- product quality that is based on real-time measurements and analysis during the complete manufacturing process. That is the strength of Plexus Online in helping the life sciences industry use real-time, accurate product data to meet and exceed strict quality mandates."
Plexus Online offers over 350 functional modules, providing medical
manufacturers instant access to vital information and management functions
using a simple Web browser
|SOURCE Plexus Systems, Inc.|
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