The European Medicines Agency (EMEA) has selected Sparta Systems’ TrackWise software to support its integrated quality management system. The agreement was signed early this year 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. The EMEA will also use the software to manage SOPs and risk assessments within its 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.

“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.”