TrackWise® by Sparta Systems for Pharma & Biotech Industries
TrackWise is the de facto leader in providing Enterprise Quality Management Solutions (EQMS) to global organizations in the Pharmaceutical/Biotechnology space. For more than 15 years TrackWise holistic EQMS has been successfully enabling companies both big and small to streamline quality processes, consolidate redundant systems and reduce manual operations to generate top-line revenue. TrackWise is the only solution that leverages best-of-breed technology to provide centralized and consolidated tracking, workflow management and regulatory reporting for all critical business processes affecting global pharmaceutical and biotechnology manufacturing operations.
TrackWise Complaint Management and Regulatory Reporting Solutions enable medical device manufacturers to effectively implement a global and consolidated approach to managing customer complaints and medical device reporting. TrackWise ensures compliance, reduces product safety risk, and streamlines workflow processes. The system integrates complaint handling and medical device reporting into the overall quality management system, allowing users to benefit from a single interface and eliminating the need for complex and costly custom integration.
The TrackWise Nonconformance solution ensures product non-conformances are properly and efficiently handled through an integrated process that tracks and manages the complete process from the initial report, to the investigation process and root cause analysis to any resulting actions and follow up verification of effectiveness.
The TrackWise corrective action and preventative action (CAPA) solution automates CAPAs generated independently or through other quality processes. TrackWise tracks and manages the process of generating and carrying out CAPA plans, verifies completion, automates follow-up effectiveness tasks, and, when applicable, closes the loop with the incident record for which the CAPA was created.
The TrackWise Supplier Quality Management solution increases quality throughout the supply chain by managing the process of qualifying, selecting, and monitoring suppliers and supply chain partners by offering features such as supplier scorecards, supplier qualification workflows, and tracking systems for supplier non-conformances and resulting actions.
The TrackWise Auditing solution promotes validation of regulatory compliments by ensuring all activities are within standard operating procedures. TrackWise tracks and manages audits across the enterprise, from supplier and partner audits to internal and external audits, to GLP and GCP audits, by tracking observations, findings, and recommendations and the resulting action plans and automatically managing periodic and ad-hoc audit schedules.