Proactive Risk Reduction for Enhanced Patient Safety
Quality risk management is crucial in the life sciences industry to ensure patient safety and product quality. Sparta Systems TrackWise offers a proactive approach to managing risks associated with pharmaceuticals, medical devices, and other products. By prioritizing risk management, manufacturers can prevent quality issues and enhance patient safety throughout the product lifecycle.
Integrated Risk Assessments for Holistic Management
TrackWise Digital provides integrated top-down and bottom-up risk assessments, including Hazard Analysis and FMEA. These assessments help in identifying potential risks at various stages of the product lifecycle, allowing for holistic quality and product risk management. By visualizing severities, occurrences, and residual risks on a risk matrix, manufacturers can evaluate overall residual risk and benefits effectively.
Improved Risk Assessments and Data Utilization
With Sparta Systems TrackWise, manufacturers can improve existing risk assessments and evaluations using data gathered throughout the platform. The system allows for production and post-production reviews, enabling the enhancement of risk management strategies based on real-time information from quality processes.
Enhancing Product Quality Through Integrated Risk Management
By integrating quality risk management with the quality management system, manufacturers can reduce harm to patients and enhance product quality. TrackWise Digital ensures that all risk-based decisions and actions within the QMS are consistent and data-driven, leading to proactive risk reduction and improved patient safety.
Comprehensive Risk Management Capabilities
Sparta Systems TrackWise supports quality risk management for compliance with standards like ICH Q9 and ISO 14971. The system includes features such as a risk registry, risk analysis tools, risk evaluation and control mechanisms, visual representation of residual risks, and integration with nonconformance and CAPA processes.