Software Facilitates FDA Compliance
Sparta Systems TrackWise
The mission of Human Genome Sciences Inc. is to discover, develop, manufacture and market innovative drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs. The company manufactures drugs for clinical and commercial use and is making rapid progress toward the commercialization of cutting-edge products for the treatment of viral and autoimmune diseases.
As a fast-growing company with many new products, HGS found itself outgrowing its manual systems for tracking deviations, corrective actions and out-of-specifications (OOS). The use of spreadsheets and departmental databases created the potential for lost records, overdue investigations and duplicate documents, and presented the risk of not meeting compliance regulations. Realizing its paper systems and databases wouldn't meet growing business needs, HGS' quality and information technology departments set out to find a management solution to replace the company's obsolete compliance systems.
HGS required a user-friendly, Web-based system that would enforce its workflows and employ a powerful audit trail to increase accountability and compliance. Management also wanted the ability to quickly retrieve accurate and reliable information through a fully integrated reporting system. This would increase visibility and enable the organization to make more timely decisions to improve the closure time of open issues. To meet these needs, HGS chose TrackWise software from Sparta Systems Inc.