The European Medicines Agency (EMEA) Selects Sparta Systems’ TrackWise Quality and Compliance Management Software
Sparta Systems, Inc. (Sparta), the leader in enterprise quality and compliance management software for the life sciences and other highly regulated industries, announced today that the European Medicines Agency (EMEA), Europe’s governing agency for the promotion and protection of public and animal health in a global environment, has selected Sparta’s TrackWise(R) software to support its integrated quality management system. The agreement was signed in early 2006 through Sparta Systems Europe, Ltd.
The EMEA will initially use TrackWise to manage audits, along with resulting observations, opportunities for improvements and follow-up actions. In addition, the EMEA will use TrackWise to manage SOPs and risk assessments within their organization. TrackWise will replace paper-based and Microsoft Excel-based systems that are currently used by the agency.
“The EMEA is a progressive organization that is committed to developing world-class authorization procedures to ensure safety and consistency in medicinal product approvals, surveillance and inspections while encouraging competitiveness in the global marketplace,” said Yaniv Vardi, Vice President, Operations of Sparta Systems Europe, Ltd. “Not only will the EMEA realize the benefits of TrackWise, but the innovation and transparency of the improved approval process will benefit our global customers as well.”
“The EMEA evaluated more than 25 vendors before selecting TrackWise as its quality management and tracking system,” stated Claus Christiansen of the EMEA. “Ease of configuration and the ability to integrate with existing software, such as EMC’s Documentum, were key factors in our decision. Sparta’s well-documented audit trail and electronic signature experience, gained through developments for the industry, fulfilled the technical specifications set by the European Medicines Agency for workflow management with electronic signatures and secure audit trail.”
“We are very excited to have the EMEA as a customer,” said Sahaf Flam, Managing Director of Sparta Systems Europe, Ltd. “The agency’s selection of TrackWise is an affirmation of TrackWise’s worldwide recognition as the standard in Quality and Regulatory Compliance Management.”
TrackWise is a web-based quality management software platform, which allows organizations to implement a secure, robust and expandable quality and regulatory compliance management solution. TrackWise’s configurable architecture allows each tracking application to employ its own workflow process and business rules without impacting other workflows. Point-and-click configuration tools also enable the TrackWise administrator to create an unlimited number of user-defined fields, configure workflow rules, define security permissions, set system flags, and determine notification rules. TrackWise supports embedded multi-language functionality, utilizes Universal Time Code (UTC), provides the ability to create extensive reports and define fully configurable application areas and security groups.
About the European Medicines Agency (EMEA)
The European Medicines Agency is a decentralized organization with the main responsibility of protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The EMEA coordinates the evaluation and supervision of medicinal products throughout the European Union (EU). The agency brings together the scientific resources of the 25 EU Member States in a network of 42 national competent authorities. It cooperates closely with international partners, reinforcing the EU contribution to global harmonization. More information on the EMEA can be found at http://www.emea.eu.int/.
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 11 years of experience and an extensive customer base in the highly regulated life science industries. Sparta Systems offers its customers a complete solution for global quality management needs, including the onsite support required throughout the project lifecycle. Information about Sparta Systems’ products and services can be found at http://www.sparta-systems.com/.
Web site: http://www.emea.eu.int/
Web site: http://www.sparta-systems.com/
