Santen Europe has selected Sparta Systems' TrackWise Enterprise Quality Management Solution (EQMS) to centralize the European management of its regulatory affairs processes.
The regulatory affairs processes include product registration tracking, commitment tracking and other functions required to meet global regulatory directives.
As a prescription provider of ophthalmic pharmaceuticals, Santen tracks registrations that comprise its portfolio and reports information on the products to authorities.
Santen regulatory submission and document manager Eeva Ryky said TrackWise met all the criteria needed for flexibility in a system, and the implementation proved to be quick.
"The solution has already resulted in significant improvements in our ability to manage product registration, regulatory commitments and all other related processes," Ryky added.
Sparta Systems industry solution director KR Karu said, ''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.''
TrackWise also views product information to provide solution for all regulatory works related to new products and lifecycle management as well as completes regulatory compliances by providing a methodology for regulatory audits and health authority inquiries.
