Drug Safety Software Adverse Event Reporting

TrackWise by Sparta Systems' Adverse Event Reporting solution tracks reported adverse events and manages the processing of all cases from initial triage through reporting and case closure. Drug Safety users can accurately and efficiently record events and products (suspect, company, prior, and concomitant), code terms against industry standard thesauri, conduct seriousness, causality, and listedness/expectedness assessments, and determine reportability of adverse events to appropriate health authorities.

For safety cases that are reportable, TrackWise supports a multitude of standard drug safety reports for paper and electronic reporting to meet expedited and periodic reporting requirements. TrackWise's electronic reporting platform provides flexible mapping and configuration to meet the complex and varying requirements of global regulatory authorities

Sparta System's TrackWise is the leading enterprise software solution for your global pharmaceutical and biotechnology quality management needs. Using the best-of-breed technology, TrackWise seamlessly integrates with your current systems, streamlining every aspect of your quality process. And with the domain expertise of our onsite solutions delivery support, you'll have the assistance needed each step of your entire project lifecycle.

TrackWise quality management and compliance software solution tackles the needs of highly regulated pharmaceutical and biotechnology companies. It centralizes and consolidates tracking, workflow management, and regulatory reporting for all critical business processes affecting global pharmaceutical and biotechnology manufacturing operations. TrackWise seamlessly integrates with current processes, such as ERP, to tackle all issues, actions, and changes enterprise-wide. That enables companies to control risk, streamline processes, consolidate redundant systems and reduce manual operations. It efficiently manages deviations and incidents, corrective actions, change control, complaint handling, and audits. The result: top-line revenue generation, efficient innovation, and quality assurance.