Sparta Systems of Holmdel, NJ has used its regulatory software to help a division of the Czech drug maker Pliva. Sparta’s TrackWise system is enabling PLIVA to electronically manage quality and regulatory processes. TrackWise is currently deployed at PLIVA’s corporate Brno center of excellence for oncology products. The implementation itself, from planning to production, took less than four months. TrackWise is an off-the-shelf, fully configurable, enterprise web-based tracking software platform used to electronically log, manage, query, report and monitor quality and regulatory incidents and action items. TrackWise helps organizations increase efficiencies and achieve compliance by linking and consolidating related events and actions, automating workflow, implementing business rules, and facilitating trending and reporting across quality systems and related work areas. The system also complies with Part 11, which governs electronic records and electronic signatures.