This demo will show:
- Overview of Risk Register - TrackWise Digital supports the full contents of a risk management file from risk analysis to risk acceptability, as well as audit trail functionality and electronic signatures.
- The Hazard Analysis and FMEA, as well as data integrations between the two assessments.
- Evaluation of risk and visual representation of the Overall Residual Risk.
- Integration to TrackWise Digital Complaints - see how to directly link residual risks to the complaint records to share failure modes, hazardous situations, harms, and more.
Sparta Systems TrackWise Digital Risk Management
A systematic approach for risk analysis, evaluation, control, review, and post-market decision making is fundamental in managing the risks of pharmaceutical products, combination products, and medical devices. TrackWise Digital with Risk Management enables companies to seamlessly link risk management processes to other quality management processes and facilitates the implementation and maintenance of a risk management program in accordance with ICH Q9 and ISO 14971.