European Medicines Agency (EMEA) Goes Live With Sparta Systems’ TrackWise Quality and Compliance Management Software
HOLMDEL, N.J., Oct. 10 /PRNewswire/ — Sparta Systems, Inc., 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 completed implementation of TrackWise(R) software. TrackWise is now in production at the EMEA and will support its integrated quality management (IQM) system.
TrackWise is a 21 CFR Part 11 compliant, web-based tracking software tool for electronically logging, managing, and trending quality and regulatory issues and action items. With its ability to centralize quality processes into a single, integrated system, TrackWise helps organizations increase efficiencies and achieve compliance by linking and consolidating related events and actions, automating workflow, and facilitating trending and reporting across quality systems and related organizational areas.
The implementation of TrackWise at the EMEA was completed in only four months, meeting all project timelines and budget goals. EMEA implemented TrackWise to electronically manage critical quality-related processes including Audit Management, Audit Observations Tracking, Action Item Tracking and management of Standard Operating Procedures. TrackWise replaced numerous paper-based and Microsoft Excel-based systems that were previously used by the agency.
Based on its success with the initial implementation, the EMEA now plans to further deploy TrackWise to manage global risk management analysis and other activities related to the IQM system.
“We are proud to have the EMEA in production with TrackWise,” said Yaniv Vardi, Vice President, Operations of Sparta Systems Europe, Ltd. “The four month implementation is a testament to the collaborative, success-oriented working relationship between Sparta Systems and the EMEA, as well as to the flexibility and performance of TrackWise. We are excited that the EMEA is already reaping the benefits of its investment.”
“We are pleased with the quick and smooth implementation and the overall breadth of the TrackWise solution,” stated Claus Christiansen, Integrated Quality Management Auditor of the EMEA. “TrackWise software has been chosen by pharmaceutical and device customers to improve quality and increase efficiency. We are excited to use TrackWise to help us improve operations in our organization as well.”
The EMEA’s success story will be featured in the keynote presentation at this year’s Inaugural European TrackWise User Conference, November 13-15, in Barcelona, Spain. Claus Christiansen will be presenting.
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 12 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 http://www.sparta-systems.com.
