HOLMDEL, N.J., Sept. 11 Sparta Systems, Inc., (Sparta),the maker of TrackWise(R), and the market leader in enterprise quality andcompliance management software, today announced that NAMSA, the world'sleading company specializing in the safety evaluation of medical devices,deployed TrackWise to lower compliance risks and improve operational control.The go-live implementation, including validation, was completed within sixmonths.
NAMSA deployed TrackWise to manage all aspects of its quality managementapplications including Nonconformance, Good Laboratory Practices (GLP),Complaint Handling, Corrective and Preventive Actions (CAPA), Audit Findingsand Risk Assessments.
TrackWise is a configurable, web-based software management tool forelectronically managing, tracking and trending quality, regulatory andorganizational compliance processes. TrackWise enables companies to reducecosts and streamline business operations by replacing disparate systems andinefficient paper-based processes with a centralized electronic workflow andreporting system.
"At NAMSA, we understand the complex compliance requirements of theindustry and we were looking for a centralized solution that would handle allof our NCR, CAPA and quality management needs," said Michael Oberle, Directorof Quality Assurance at NAMSA. "After examining several Quality ManagementSystems we chose Sparta Systems' TrackWise due to its flexibility. TrackWisewas flexible and scalable enough to handle eleven different process areaswithin our organization. The solution's rapid application deployment quicklyprovided us with centralized and consolidated tracking, workflow management,and reporting for our critical business processes."
"NAMSA operates in a highly regulated arena, supporting the medical deviceand pharmaceutical industries through extensive testing services to ensurequality and compliance. TrackWise provided a centralized quality managementsolution with minimal configuration, reducing operational and compliance riskswhile streamlining operations," stated Ran Flam, President & CEO at SpartaSystems.
About Sparta Systems
Sparta Systems, Inc. is the industry leader for global quality andcompliance management systems. Its TrackWise product is a web-based softwareapplication used by quality, manufacturing, and regulatory affairsprofessionals to manage quality and compliance issues across the enterprise.The company has more than 12 years of experience and an extensive customerbase in the life sciences and other highly regulated industries. SpartaSystems offers its customers a complete solution for global quality managementneeds, including the onsite support required throughout the project lifecycle.More information about Sparta Systems and TrackWise can be found atwww.sparta-systems.com.
NAMSA is a multinational company with laboratories in the United Statesand France. NAMSA serves the health care industry by offering testing servicesto device manufacturers, raw material suppliers, pharmaceutical and biotechcompanies, sterilizers and other related industries.
The U.S.A. laboratories are certified to ISO 13485 and Biomatech, inFrance, is accredited according to ISO 17025. NAMSA also manufacturessterility assurance products such as biological indicators, growth promotiontest suspensions, and chemical process indicators.Media Contact: Jon Rabinowitz Phone: (732) 203-0400 x121 Email: [email protected]
SOURCE Sparta Systems, Inc.