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:
QAD Enterprise Applications — Tailored for Regulatory Compliance
- 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 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
to support global life sciences companies.
For more information about QAD Enterprise Applications, please visit:
About QAD – The Effective Enterprise
QAD Inc. (NASDAQ: QADA) (NASDAQ: QADB), is a leading provider of enterprise software and services designed for global manufacturing companies. For more than 30 years, QAD has provided global manufacturing companies with an enterprise resource planning (ERP) system that supports operational requirements; including financials, manufacturing, demand and supply chain planning, customer management, business intelligence and business process management. QAD offers flexible deployment options like QAD On Premise software and QAD On Demand software-as-a-service. Customers can operate in a blended environment where some users can be deployed On Premise and some users deployed via On Demand while offering the same end-user experience. With QAD, customers and partners in the automotive, consumer products, food and beverage, high technology, industrial products and life sciences industries can better align daily operations with their strategic goals to meet their vision of becoming more Effective Enterprises.