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Holmdel, NJ – March 10, 2009 –
Sparta Systems, Inc., the market leader in enterprise quality and compliance management software, today announced that Netherlands Vaccine Institute (NVI), an agency charged with guaranteeing the supply of vaccines against infectious diseases for the Dutch population, has selected the TrackWise Enterprise Quality Management solution. NVI will use the TrackWise platform to ensure compliance with EU Good Manufacturing Practices (GMP).
For government agencies, ensuring the health and livelihood for a country’s citizens is a daunting but critical mission. As such, NVI is tasked with not only supplying high-quality vaccinations to the country’s citizens, but also researching and developing better treatments and offering them at affordable prices. To do this efficiently and affordably without compromising quality, the agency required a comprehensive system to manage quality across the organization in compliance with GMP.
NVI had previously leveraged a homegrown solution comprised of Microsoft Excel, Microsoft Access and paper-based documents, which did not provide the centralized, holistic document management capabilities that the agency sought or the level of oversight necessary to ensure quality across the full spectrum of the organization. NVI chose Sparta Systems’ TrackWise solution to manage its quality and compliance processes beginning with a Phase 1 document management implementation – including a migration of 20,000 legacy documents into the TrackWise system – with a full quality management implementation scheduled for Phase 2 deployment. Additional benefits of TrackWise that led to NVI’s implementation include its built-in multi-language functionality and fully configurable, extensive training capabilities, which will combine to allow for a seamless transition to the new system for all of the company’s end users.
“For NVI, delivery of high-quality, affordable vaccines and treatment options is our highest priority,” said Marijke Vendrig, quality assurance systems manager at NVI. “With Sparta’s expertise in the global pharmaceutical market, we know we have a partner to help us manage quality across the supply chain, which helps us ensure the well-being of the citizens we serve. The company’s extensive European customer base and long history of success in this market made it a clear choice to meet our quality management needs, and the company’s best-of-breed approach in offering a single validated system will help streamline and strategically grow our operations in the years to come.”
TrackWise software gives organizations a Web-based platform that can be easily configured to manage all facets of the supply quality spectrum, including deviations, corrective and preventative actions (CAPA), complaint handling and change control. Since its introduction in 1994, TrackWise software has become the life sciences industry standard with its flexibility through configuration, ease of integration and unmatched functionality.
“Pharmaceutical companies need to be prepared to deal with incidents and deviations during every single step of the manufacturing process-incidents that may significantly impact the business and potentially hinder innovation,” said James E. McGowan, president and CEO, Sparta Systems. “Global pharmaceutical companies are realizing that in using TrackWise Enterprise Quality Management Solutions they can efficiently manage quality across the global supply chain, for the benefit of both their business and consumers alike.”
About Netherlands Vaccine Institute
The Netherlands Vaccine Institute (NVI) was created in 2003 as the result of the merger between the former Vaccine Division of the National Institute for Public Health and the Environment (RIVM) and the government-run vaccine production unit SVM. This new government-based agency reflects thereby more than 100 years of extensive knowledge and experience gained through vaccine research and production. NVI’s mission is to guarantee (by procurement or own production) the supply of vaccines necessary to protect the Dutch population against infectious diseases. To achieve its mission, the institute strives to enter into strategic collaborations with various partners such as international pharmaceutical companies. Such collaborations include the exchange of knowledge and products, and cooperation in research and product development.
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 and TrackWise® can be found at