According to the company, the new enhancements include an integrated program that will provide enterprise-wide compliance with good manufacturing practices and quality system regulations mandated by the FDA.
The company said that 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 reportedly supports better 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, etc.
The company claims that Plexus Online offers over 350 functional modules, providing medical manufacturers instant access to vital information and management functions using a simple web browser. The system features quality management and problem resolution management, enterprise resource planning functions such as accounting and finance modules, manufacturing execution systems functions such as production scheduling and machine integration and supply chain management functions such as supplier quality and traceability.
Mark Symonds, president and CEO of Plexus Systems, said: 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.
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