Manufacturing Execution Systems
Software helps medical device manufacturers meet FDA compliance.
Press Release Summary:
Plexus Online software provides enterprise-wide compliance with Good Manufacturing Practices and Quality System regulations mandated by FDA, enabling manufacturers to adhere to required standards. Web-hosted product handles documentation, audit support, and data security and includes Corrective Action/Preventive Action and Process/Product PQ capabilities. It also features quality and problem resolution management and ERP, MES, and SCM functions.
Original Press Release:
Plexus Online Enhances Functions for Medical Device Manufacturing Regulatory Compliance
AUBURN HILLS, Mich., Oct. 8 / / - 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. The on-demand solution handles documentation, audit support and data security to be compliant with TS13485 and ISO 9001 mandates; CFR and FDA compliance; audits; and corrective Action/Preventive Action (CAPA) and Process/Product PQ functionality. The system features quality management and problem resolution management, enterprise resource planning (ERP) functions such as accounting and finance modules, manufacturing execution systems (MES) functions such as production scheduling and machine integration and supply chain management (SCM) functions such as supplier quality and traceability.
About Plexus Systems, Inc.
Since 1995, Plexus Systems, Inc. (Auburn Hills, Mich.) has maintained a singular vision - to drive significant cost, quality and productivity improvements for manufacturers, from the shop floor to the top floor. Plexus Online(TM) is (SaaS) software as a service for the medical manufacturing enterprise enabling businesses to meet regulatory mandates, streamline production, improve quality, speed product development and serve the other unique and critical priorities of the user. In 2006, Apax Partners (www.apax.com) made a strategic investment in Plexus Systems, joining the founding investment group as stakeholders in Plexus. For more information, visit www.plex.com
Source: Plexus Systems, Inc.
CONTACT: Peggy Fenwick for Plexus Systems, Inc., +1-734-516-6490, pr@plex.com
Web site: www.plex.com/
