Software Helps Medical Device Manufacturers Comply FDA Regulation

Plexus Systems Inc., provider of Plexus On Line software for Medical Equipment manufacturer, recently announced enhancement of their software to suit better compliance for Good Manufacturing Practices which is mandated by Food and Drug Administration of USA. Plexus On Line. Plexus Online(TM) is (SaaS) software as a service for the medical manufacturing enterprise that enables businesses to meet regulatory mandates, improve production and quality.

The new enhancements also facilitates better in terms of audit trails and electronic signatures, chain management, production planning, shop floor controls, data-driven manufacturing quality management and more. The software follows FDA standard  such as FDA 21 CFR Part 11, Part 820 Quality System Regulation and ISO 13485:2003. The main features of the solution are 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.

“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,” said Mark Symonds, President and CEO of Plexus Systems, Inc.

Source: ThomasNet

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