Case Study: Human Genome Sciences, Inc. achieves 50%+ faster CAPA closure and scalable quality management with Sparta Systems' TrackWise

Human Genome Sciences An Evolution from Deviation Tracking to an Enterprise Quality and Compliance Management System

Human Genome Sciences (HGS), a 1,000‑employee biopharmaceutical company focused on protein and antibody drugs, was outgrowing manual quality systems. Spreadsheets and departmental databases led to lost records, duplicate documents, overdue investigations and compliance risk, so quality and IT teams sought a web‑based, workflow‑driven solution with strong audit trails and integrated reporting to improve visibility and accountability.

HGS implemented Sparta Systems’ TrackWise, initially for deviations, CAPAs and OOS investigations, using automated email alerts, dashboards and AutoReports to replace manual reporting and enforce workflows. The system cut deviation and corrective action closure time by more than 50%, eliminated data duplication, and—within a year—was expanded to manage over 23 cGxP areas, enabling faster rollouts, better metrics and increased user self‑sufficiency.

Human Genome Sciences, Inc.

Regina Grochowski

Sr. Manager, QA Compliance Human Genome Sciences, Inc.