Apotex Selects TrackWise As Its Global Regulatory Affairs Tracking System

Holmdel, NJ - Sparta Systems, Inc. (Sparta), a leader in enterprise quality and regulatory compliance management software for the life sciences and other highly regulated industries, announced that Apotex Inc. (Apotex), a Canadian-owned pharmaceutical company, has selected TrackWise as its global solution to capture and track all regulatory information required for new products and product lifecycle management.

TrackWise is a web-based software platform that allows organizations to implement a secure, robust and expandable tracking solution to manage regulatory compliance data, activities and work processes. With its ability to centralize quality processes into a single, integrated system, TrackWise helps organizations gain efficiencies and achieve compliance by integrating related events and actions, automating workflow, and facilitating trending and reporting across regulatory activities.

Apotex produces more than 300 generic pharmaceuticals in over 4,000 dosages. Apotex pharmaceuticals can be found in virtually every pharmacy and healthcare facility in Canada, and its products are exported to over 115 countries around the world. The TrackWise system will provide Apotex with an electronic, integrated solution to manage Product Life Cycle Management (PLCM) activities required to meet the needs of an ever-expanding global market. The system will be used to manage submissions, amendments, change notices, periodic safety reports, commitments and other regulatory activities.

"The vision of this system is to create an efficient, cost effective, global solution to track all required regulatory information pertaining to new products and product lifecycle management," stated Michael Davidson, Chief Information Officer for Apotex, Inc. "Apotex selected TrackWise because it meets our functional requirements, and it provides our organization with a scalable and configurable web-based architecture, which has the ability to adapt and grow as our company's needs evolve."

"Sparta is pleased to be awarded this contract, and looks forward to a long lasting partnership with Apotex" stated Steve Cagle, Vice President of Marketing and Product Development at Sparta Systems, Inc. "Improving regulatory affairs tracking systems enables companies to be more efficient and effective in their product approval process. We expect TrackWise to help Apotex improve its time to market and decrease costs associated with meeting ever-increasing regulatory compliance requirements."

SOURCE: Sparta Systems, Inc.