Santen Europe Centralizes Regulatory Affairs Processes With Sparta Systems’ TrackWise Solutions

Ophthalmic Pharmaceuticals Leader Automates Product Registration Tracking and Other Vital Functions With Industry Standard Enterprise Quality Management Solution
Hamilton, NJ Dec 4, 2012 – Sparta Systems, Inc., the market leader in enterprise quality and compliance management solutions, today announced that Santen Europe, a researcher, developer, manufacturer and marketer of ophthalmic products for physicians worldwide, has gone live with Sparta Systems’ TrackWise Enterprise Quality Management Solution (EQMS). Using TrackWise, Santen centralized the European management of its critical regulatory affairs processes, including product registration tracking, commitment tracking and other functions essential to ensuring compliance with global regulatory directives.
As a leading provider of prescription ophthalmic pharmaceuticals, Santen is required to track the hundreds of registrations that comprise its portfolio and report information on these products to authorities in a timely, efficient manner. After identifying an opportunity to automate this process with an electronic system, the Company selected the TrackWise software because the solution possessed the configurability and scalability Santen required to manage multiple regulatory affairs processes on a European scale. Upon implementing the solution and importing legacy data from a previous system, a process that took less than six months, Santen now maintains a centralized repository to track and manage its entire European product portfolio and report related data to the necessary authorities effectively and efficiently.
“TrackWise met all of our criteria for flexibility in a quality system, and the implementation proved to be quick and painless,” said Eeva Ryky, regulatory submission and document manager, Santen. “The solution has already resulted in significant improvements in our ability to manage product registration, regulatory commitments and all other related processes. We expect TrackWise to continue to demonstrate its value as we seek to extend its use across our regulatory processes.”
TrackWise regulatory quality management software provides Santen with views into product information, delivering a cost-effective solution for all regulatory tasks related to new products and lifecycle management. The solution’s commitment tracking functionality improves response time and completion of regulatory commitments by providing a rapid methodology for responding to regulatory audits and health authority inquiries. TrackWise regulatory affairs software effectively manages the highly complex product data relationships that are typical of registration data as well as integrate with other quality and compliance processes within the organization.
“Automated regulatory affair solutions help streamline processes and provide users with efficient tools to replace time consuming and error-prone manual tracking processes,” said KR Karu, industry solution director, Sparta Systems. “Forward-thinking companies like Santen understand this, and have deployed TrackWise as a vital solution for ensuring the effectiveness of their regulatory affairs processes. We look forward to working with Santen as they continue to reap the benefits from leveraging our EQMS and realize new efficiencies in their ability to track, manage and report product-related data to authorities around the world.”
To learn more about Sparta’s TrackWise for Regulatory Affairs solution, please visit