Sparta Systems, Inc., a provider of compliance management software, today announced that the leading global provider of innovative home and long-term care medical products, Invacare Corporation, selected Sparta?s TrackWise Quality Management Solution (QMS).
Invacare Selects TrackWise to Streamline eMDR Submissions for Complaints and
Improve Customer Service Levels Worldwide
Holmdel, NJ – August 6, 2008 – Sparta Systems, Inc., the market leader in enterprise quality and compliance management software, today announced that the leading global provider of innovative home and long-term care medical products, Invacare Corporation, selected Sparta’s TrackWise Quality Management Solution (QMS). Invacare will use TrackWise to enhance and optimize its eMDR Electronic Submission of Post-Market Medical Device Reports (MDRs) and to improve customer service levels globally.
Invacare required a solution to electronically track and manage product issues, complaints, adverse event assessments and associated regulatory reporting processes. TrackWise was chosen based on its ease of use, ease of configuration, scalability and expected return-on-investment. In addition, due to the forthcoming FDA mandate which will require Electronic Medical Device Reporting (eMDR), Invacare looked to Sparta Systems for an eMDR solution. TrackWise eMDR will enable Invacare to submit its MDRs through the FDA Electronic Submissions Gateway (ESG) accurately and efficiently, while eliminating the need for paper MDRs.
”We evaluated several QMS options and TrackWise was a clear choice for Invacare based on Sparta’s experience and best practices that are pre-built into the solution,” said William J, Braun, vice president of global quality, Invacare. “Sparta and the TrackWise solution are unique because they understood that our vision for quality incorporates product safety as well as improving dealer and end-customer satisfaction by addressing product issues throughout the supply chain. We expect a significant improvement in customer satisfaction levels and a strong return–on-investment as we roll TrackWise out globally at Invacare.”
Invacare selected TrackWise under Sparta Systems’ Secure Transition Program, which includes special incentives and professional service consulting to help companies make the transition from legacy quality management applications and ”point” solutions to a more secure and scalable TrackWise QMS platform.
“Through the Secure Transition Program and the pre-sales process, Sparta Systems’ staff demonstrated that they understood our business challenges and were willing partner with us to help us achieve our goals and objectives,” said David Mewes, CIO, Invacare. “They helped us outline a plan to quickly and efficiently transition off of our current QMS application. Sparta sales and professional services staff understood our business challenges and they are dedicated to our success. We look forward to leveraging their experience and knowledge as we deploy TrackWIse globally at Invacare for multiple quality and regulatory management processes.”
“TrackWise is leading the industry with its comprehensive complaint handling and adverse event reporting solution which includes a fully integrated eMDR platform,” said Mike Jovanis, VP product management at Sparta Systems. “We are pleased that Invacare has selected Sparta Systems and TrackWise to manage its global complaints and to streamline the eMDR regulatory reporting process. We feel confident that we can help Invacare gain visibility into product issues and that TrackWise will contribute significantly into improving Invacare’s customer service metrics globally.”
About Sparta Systems
Sparta Systems, Inc. is the industry leader for global quality and compliance management systems. Its TrackWise product is a Web-based software application used by quality, manufacturing, and regulatory affairs professionals to manage quality and compliance issues across the enterprise. The company has more than 14 years of experience and an extensive customer base in the life sciences and other highly regulated industries. Sparta Systems offers its customers a complete solution for global quality management needs, including the onsite support required throughout the project lifecycle. More information about Sparta Systems, TrackWise® and the Secure Transition Program can be found at www.sparta-systems.com <http://www.sparta-systems.com/> or by calling 888-261-5948.
Invacare Corporation (NYSE: IVC), headquartered in Elyria, Ohio, is the global leader in the manufacture and distribution of innovative home and long-term care medical products that promote recovery and active lifestyles. The company has 5,700 associates and markets its products in 80 countries around the world. For more information about the company and its products, visit Invacare website at www.invacare.com.