Sofemed International, manufacturer of orthopaedic medical devices, recently selected their ERP platform, QAD Enterprise Applications, from QAD Inc. (NASDAQ:QADA) (NASDAQ:QADB), a leading provider of enterprise software and services. The deployment of QAD Enterprise Applications supported Sofemed International in quickly gaining ISO certification for quality and meeting the software validation requirements of cGMP regulations, a mandatory requirement for the medical device industry.
Sofemed International worked with CSI, QAD’s implementation partner, to acquire and establish the solution. “We are pleased to be able to support companies in Tunisia with the full impact of QAD’s ERP solution,” comments Ilhem BRINI, Business Development Manager with CSI. “Being part of QAD’s global team allows us to deliver great strength to our customers.” Since the implementation of QAD Enterprise Application and according to Mr. Yacine Guirat (CEO), Sofemed International has achieved: Quality certification according to ISO9001:2008, ISO 13485:2003 Product certification according to EU Directive 93/42/EEC Improved interdepartmental communication and coordination Better process monitoring Consistent and uniform information (Item and Customer Master data) Growth in their subcontracting business producing components for large European manufacturers QAD Enterprise Applications — Tailored for Regulatory Compliance QAD Enterprise Applications makes it simpler for medical device makers to achieve regulatory compliance and ensure product integrity by supporting manufacturers in achieving regulatory compliance and validation of Current Good Manufacturing Practices (cGMP), product traceability, post-market safety surveillance, recall management and safety alerts.
Enhanced Traceability in QAD Enterprise Applications Supports Patient Safety Patient safety is of critical concern for medical device manufacturers. In the case of an adverse event that leads to a product recall, QAD Enterprise Applications enables customers to efficiently manage and evaluate the effectiveness of a recall. It allows customers to trace a recalled item back to its original manufacturing batch or lot and then forward to locate potentially affected finished products still in inventory or the supply chain.
The Effective Enterprise in Life Sciences QAD enables life sciences companies to meet the critical quality requirements for manufacturing innovative, safe and effective healthcare products in compliance with global regulatory standards. QAD incorporates intuitive, easy to use, industry best practices that can be flexibly deployed either onsite or on demand to support global life sciences companies.
For more information about QAD Enterprise Applications, please visit: www.qad.com.
