TrackWise by Sparta Systems' drug safety solution enables pharmaceutical / biopharmacutical companies of all sizes to reduce product safety risk, achieve compliance, and improve efficiency of pharmacovigilance processes.
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Brochure: TrackWise Enterprise Quality Management System
TrackWise by Sparta Systems' drug safety solution enables pharmaceutical / biopharmacutical companies of all sizes to reduce product safety risk, achieve compliance, and improve efficiency of pharmacovigilance processes. TrackWise offers a fully web-based drug safety system that allows organizations to accurately and efficiently record events, code terms against industry standard thesauri, conduct relatedness and listedness/expectedness assessments, and report adverse events to appropriate health authorities. TrackWise is industry-proven to meet complex and global regulatory requirements and is used worldwide by more than 100 pharmaceutical and biotechnology customers with hundreds of thousands of end users
TrackWise is the only product safety software tool on the market that offers a fully integrated, enterprise complaint management and drug safety system, enabling organization to process safety cases, perform reportability assessments and adverse event reporting, as well as manage and track customer call triage, complaint investigations, and CAPA planning execution and follow-up. In addition, TrackWise is fully compliant with international regulations and guidelines supporting case management, report preparation and electronic submissions. The electronic reporting platform in TrackWise provides flexible mapping and configuration to meet the complex and varying requirements of global regulatory authorities
- Standardizes and streamlines processes for Drug Safety reporting
- Ensures compliance to global and local drug safety reporting requirements through workflow and automation
- Track and manage the global processing of all drug safety cases
- Ensures on-time reporting of all cases for expedited and periodic reporting via safety dashboards, alerts, and notifications
- Submits and track paper reporting and electronic submissions via E2B
- Supports risk management by automating safety surveillance and signal identification processes
- Tracks reporting non-conformances into the quality management process for investigations and corrective actions.