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News

MED-EL selects Sparta's TrackWise software to manage compliance practices

Sparta Systems : 09 June, 2008  (Application Story)
MED-EL Medical Electronics in Innsbruck, Austria, has selected Sparta Systems’ TrackWise software to standardise its quality assurance and compliance practices across the organization to improve product quality and better serve its customers.
“Having one integrated quality management electronic system can greatly reduce costs associated with compliance and quality, and can improve our organization’s overall operational efficiency.” said Kerri-Anne Bowers, quality assurance manager with MED-EL. “We are looking forward to the implementation of TrackWise and believe it will greatly reduce bureaucracy and increase efficiency across the company. We fully expect TrackWise to revolutionise our quality management system.”

The company plans to use TrackWise for a variety of purposes including ensuring quality compliance, increasing QA efficiency, reducing risk, and to save time by harmonizing quality management processes throughout the company. MED-EL is replacing a paper-based QA system that was costing the company significant resource expenditure when organizing and archiving non-electronic records.

“Manufacturing of hearing implants is a precision-based business that relies heavily on quality assurance and compliance standards to ensure production of the highest quality products,” said Yaniv Vardi, vice president, operations, Sparta Systems Europe. “We are quite pleased to be able to support MED-EL in delivering this peak level of performance to its customers.”

With the new TrackWise system, MED-EL intends to effectively manage Corrective Action and Preventive Actions (CAPAs), Investigations, assess potential adverse events for safety risk problems, and comply with authority reporting requirements, including FDA requirements. In addition, MED-EL will use TrackWise for change management and training management.

The company seeks to roll out the application in two phases, starting in the second quarter of this year and finishing in the third quarter.
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