Prioritizing risk management increases patient safety and product quality
Risk analysis
Integrated top-down and bottom-up risk assessments, such as the Hazard Analysis and FMEA, for holistic quality and product risk management.
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.
Industry experts from Axendia and Honeywell discuss the value of quality risk management and its practical applications.
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.
Effectively manage medical device risks with TrackWise Digital
To reduce harm to patients and users, quality risk management must successfully integrate with the quality management system.
Beyond compliance: The benefits of integrated risk management
Insights into the methods and benefits of digitally integrating a quality risk management program to the quality management system.
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 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.
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.
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.
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.
Collect information throughout the product's lifestyle to improve accuracy of the risk evaluations, signal detection and benefit -risk analyses.
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
Webinar
Alert to action: How connected digital execution turns pharma data into decisions
In this session, Honeywell Life Sciences expert Zillery Fortner and Arshad Azwad explore how digitally connected execution ecosystems move manufacturers from reactive response to proactive control, enabling faster decisions, fewer errors, and inspection-ready operations by design.
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Brochure
TrackWise® Digital QuickTrack
TrackWise Digital QuickTrack delivers the power of enterprise QMS without the complexity or cost—getting you compliant and operational faster. A streamlined solution and delivery approach designed specifically for startups, small, and medium-sized businesses.
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