Drug Safety Issue Tracking Software

Monitoring and tracking the efficiency and accuracy of organizations' drug safety reporting process can help to ensure issues are logged and investigated when they arise, avoiding delays and/or inaccurate reporting which can result in lack of regulatory compliance, monetary fines, and unwanted scrutiny. TrackWise by Sparta Systems' Drug Safety Issue Tracking solution offers a closed loop approach, managing the evaluation, investigation, analyses for root cause, and execution of CAPAs for all issues logged by users. In addition, TrackWise also tracks all necessary documents/ process changes through a corporate-wide change control system.

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.