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.

"A key reason for our decision to use TrackWise was not just its ability to address all of HGS' requirements, but also its ability to do much more," says Ken Koeser, HGS senior developer and analyst. "While we initially intended to purchase a system to manage our quality records, once we took a closer look at TrackWise, we realized that it could address a number of other processes that were currently paper-based. What we did not realize then was just how many applications would end up in TrackWise."

HGS initially implemented TrackWise to manage all aspects of its deviation-tracking, corrective action and OOS processes. The implementation was completed in November 2003, and used automatic e-mail notifications to designated HGS employees to provide critical information for real-time updates to the system. In addition, managers began receiving proactive alerts to notify them of records that were not progressing on a timely basis. This enabled them to address the most urgent issues and avoid late investigations.

TrackWise's AutoReports feature improved HGS' processes by providing automatic, up-to-date status reports of investigations to managers, as well as comparing current results with past metrics. Items are color-coded in the reports, highlighting the most important or urgent issues. Previously, it took HGS employees several hours each week to compile these comprehensive reports. Now, they're automatically e-mailed without any manual intervention. As a result, HGS decreased deviation- and corrective-action closure time by more than 50 percent.

News of the success of the limited implementation of TrackWise at HGS spread throughout the organization, and the quality team was flooded with deployment requests. In less than a year, HGS expanded its use of TrackWise from its deviation and its corrective and preventive action (CAPA) systems to an integrated quality and compliance management system that now manages more than 23 cGxP tracking areas. Some additional processes that are now managed by TrackWise include change control, alarm notification, cleaning validation alert, metrology discrepancy, supplier corrective action and critical-utility event notification.

The dashboard tool is another TrackWise feature that has helped HGS monitor status and key performance indicators. The tool provides up-to-date metrics to the company's quality department, allowing it to assess its performance against various goals. Management has instant access to all of these figures and CAPAs, and can immediately see how many quality records are outstanding based on different levels of criticality. These reports have become an essential part of status meetings at HGS.

"The flexible and configurable nature of the system, and the fact that it does not require us to purchase additional software modules to implement new processes, enables us to quickly roll out additional tracking areas in a matter of a few weeks," says Regina Grochowski, HGS senior quality assurance compliance manager. "This has allowed us to implement solutions quickly using internal resources."

Sparta Systems TrackWise

Benefits

• Fully integrated quality-tracking system
• Manages deviations, CAPA and more
• Web-based
• Powerful audit trail

www.sparta-systems.com or www.hgsi.com