MEDINDIA
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Plexus Online enables medical device manufacturers to meet regulations andstandards such as FDA 21 CFR Part 11, Part 820 Quality System Regulation andISO 13485:2003. The Web-hosted, software as a service offering supportsunparalleled levels of visibility, connectivity and integration -- from audittrails and electronic signatures, to supply chain management, productionplanning, shop floor controls, data-driven manufacturing quality managementand more.
Medical device manufacturers rely on Plexus Online because the systemoffers a robust traceability feature-set, enabling end-to-end tracing of eachspecific product component, including raw materials, throughout the supplychain. With Plexus Online, the information is fast, visual and simple.Further, if a material defect is discovered and a root cause analysiscompleted, users easily identify and quarantine all other suspect materialaffected by the same issue.
Said Mark Symonds, President and CEO of Plexus Systems, Inc., "The medicaldevice manufacturing sector turns to Plexus Online to achieve data-drivenquality -- product quality that is based on real-time measurements andanalysis during the complete manufacturing process. That is the strength ofPlexus Online in helping the life sciences industry use real-time, accurateproduct data to meet and exceed strict quality mandates."
Plexus Online offers over 350 functional modules, providing medicalmanufacturers instant access to vital information and management functionsusing a simple Web browser. The on-demand solution handles documentation,audit support and data security to be compliant with TS13485 and ISO 9001mandates; CFR and FDA compliance; audits; and corrective Action/PreventiveAction (CAPA) and Process/Product PQ functionality. The system featuresquality management and problem resolution management, enterprise resourceplanning (ERP) functions such as accounting and finance modules, manufacturingexecution systems (MES) functions such as production scheduling and machineintegration and supply chain management (SCM) functions such as supplierquality and traceability.
About Plexus Systems, Inc.
Since 1995, Plexus Systems, Inc. (Auburn Hills, Mich.) has maintained asingular vision -- to drive significant cost, quality and productivityimprovements for manufacturers, from the shop floor to the top floor. PlexusOnline(TM) is (SaaS) software as a service for the medical manufacturingenterprise enabling businesses to meet regulatory mandates, streamlineproduction, improve quality, speed product development and serve the otherunique and critical priorities of the user. In 2006, Apax Partners(www.apax.com) made a strategic investment in Plexus Systems, joining thefounding investment group as stakeholders in Plexus. For more information,visit www.plex.com
SOURCE Plexus Systems, Inc.
