Apotex, the largest Canadian-owned pharmaceutical company, has selected Sparta Systems’ TrackWise web-based software platform to capture and track all regulatory information required for new products and the entire span of product lifecycle management.

Apotex produces more than 300 generic pharmaceuticals in more than 4,000 dosages. The company’s pharmaceuticals are in virtually every pharmacy and healthcare facility in Canada, and its products are exported to more than 115 countries around the world.

The TrackWise system will provide Apotex an electronic, integrated solution for product lifecycle management 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, Sparta officials told PIR Sept. 11.

Apotex sought a configurable, integrated, web-based and expandable solution to deal with the regulatory complexities that result from producing its generic pharmaceuticals.

A key point for Apotex was that the system it chose had to be configurable, requiring no source code customization or changes to the database schema. The company was also looking for a solution that could adapt and grow to their other business based on the architecture and licensing structure.

To ensure edata accuracy, Apotex also required that the system be able to capture maintenance processes, have triggers in place to review data changes, and automatically drive enforcement of field level verification and format control.

Apotex also demanded a system to monitor and track all required regulatory affairs management information, including esubmissions and action items.

In making its selection, Apotex sought a system that met all 21 CFR Part 11 requirements, including esignature and audit trails.

Apotex scored products based on their abilities to address the company’s needs. In addition, Apotex sought vendor references as well as feedback from industry analysts. It then brought in a few finalists for product demonstrations.

Sparta’s TrackWise is designed to allow organizations to implement secure, robust and expandable tracking solutions to manage regulatory compliance data, activities and work processes. With its ability to centralize quality processes into a single, integrated system, TrackWise aims to help organizations gain efficiencies and achieve compliance by integrating related events and actions, automating workflow, and facilitating trending and reporting across regulatory activities.