Deviation Management Software
TrackWise by Sparta Systems solution for deviation management software enables companies to track and manage a broad range of deviations from many sources, such as lab issues like Out of Specification/Out of Trend (OOS/OOT), manufacturing nonconformances, supplier nonconformances, and general data quality management software events such as employees not following procedures.
The deviation software also ensures the full lifecycle of a deviation is managed, from inception through investigation, root cause analysis, execution of corrective and preventive actions (CAPAs), and subsequent change controls and effectiveness analysis.
TrackWise gives you a fully configurable automated deviation software solution that has the flexibility to fit the specific needs of your corporate processes while providing a rigorous controlled environment that mitigates risk and facilitates compliance and regulatory conformance.
Benefits of TrackWise Deviation Management Software:
- Decrease cycle time and production/operation costs by increasing deviation management efficiency
- Increase deviation management transparency through automated alerts and extensive reporting capabilities featuring dashboards and executive dashboards
- Increase accountability though assignments, process step approvals and audit trails
- Reduce the risk of lost or incomplete data through a closed-loop deviation management process
- Decrease the risk of repeating errors and issues by improving root cause analysis using built-in decision trees and drill-down selection lists
- Facilitate compliance with pharmaceutical and biotech industry standards and regulations including ISO 9001 and 14001; 21 CFR parts 11, 210 and 211; ISO/IEC 17025:2005 and other international standards
- Integrate your deviation software system with other enterprise quality management software solutions such as enterprise resource planning (ERP) systems, manufacturing execution systems (MES), batch release systems and regulatory reporting systems