RISK ANALYSIS
Integrated top-down and bottom-up risk assessments, such as the Hazard Analysis and FMEA, for holistic quality and product risk management.
QUALITY RISK MANAGEMENT
Prioritizing risk management increases patient safety and product quality
RESIDUAL RISK
Visualize severities, occurrences and residual risks on a risk matrix to facilitate evaluation of the overall residual risk and benefit.
PRODUCTION AND POST-PRODUCTION REVIEW
Improve existing risk assessments and evaluations through data gathered throughout TrackWise Digital.
About Risk Management Systems
WEBINAR
An Integrated Approach to Quality Risk Management
Industry experts from Axendia and Honeywell discuss the value of quality risk management and its practical applications.
BLOG
6 Signs of a Flawed Risk Management Process
The ability for the risk management process to create long term quality value for manufacturers is hindered by legacy processes that are a messy result of ad-hoc changes and hasty compliance initiatives.
DATASHEET
Medical Device Risk Management
Effectively Manage Medical Device Risks With TrackWise Digital
BLOG
Beyond Compliance: The Benefits of Integrated Risk Management
To reduce harm to patients and users, quality risk management must successfully integrate with the quality management system.
WHITE PAPER
Quality Risk Management: A Data-Driven Approach
Insights into the methods and benefits of digitally integrating a quality risk management program to the quality management system.
Risk Management and Quality Integrated With TrackWise Digital
TrackWise Digital Risk Management System Testimonials
Quote: The outcome is clear. An integrated Quality and Risk Management program can maximize the use of QMS data supporting enhanced Risk Management and mitigation and improved product quality that delivers the maximum benefit to the patient.
Axendia
Dan Matlis | President
Risk Management System Capabilities
Supporting Quality Risk Management for ICH Q9 and ISO 14971
Risk Management File
Risk registry provides traceability of each hazard through risk analysis, evaluation, and control for specific products, product families, or a product platform. Electronic signatures and audit trail functionality, in accordance with 21 CFR Part 11.
Risk Analysis
Hazards Analysis and Failure Mode and Effects Analyses (for Use, Design, and Process) for a complete risk analysis. Save time and resources when building a risk analysis for similar new products, or product line extensions, with the ability to leverage portions of existing risk analysis into a new risk analysis.
Risk Evaluation and Control
Consistent risk evaluations to determine risk control. Track risk control activities for completion with team assignments and due dates. Evaluate residual risks to monitor risk reduction after risk control measures have been implemented.
Overall Residual Risk
Visual representation of individual residual risks on a risk matrix shows graphical distribution of the risks and facilitates evaluation of the overall residual risk and benefit.
Nonconformance and CAPA
Nonconformance and CAPA records directly linked to individual residual risks within the risk management file to aid in root cause analysis.
Production and Post-Production
Collect information throughout the product’s lifecycle to improve accuracy of the risk evaluations, signal detection and benefit-risk analyses.
Risk Management System FAQs
Yes. The built-in templates, such as the Hazard Analysis and FMEA, can be tailored to align with a manufacturer’s current manual-based templates. Furthermore, manufacturers can keep their existing risk evaluation and acceptability criteria, including severity and occurrence categories, to drive a seamless risk management digital transformation.
Yes. From risk management planning to risk review, manufacturers can implement a state-of-the-art risk management program using TrackWise Digital Risk Management. Documentation and verification of risk control activities, as well as the use of real-world evidence from post-market surveillance to improve risk evaluations, are just some of the capabilities that manufacturers can leverage to achieve compliance.
Yes. TrackWise Digital with Risk Management enables manufacturers to seamlessly link the risk management process to other quality management processes, including complaints, nonconformances/deviations, and CAPAs, as well as performer supplier risk analysis. This allows manufacturers to make consistent, risk-based decisions across the QMS for risk analysis, evaluation, control, and acceptability of residual risks.
Risk Management System Resources
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