Integrated Risk Management

Increased patient safety and product quality starts with proactive risk management

A digital, integrated risk management solution

Proactively manage risks of pharmaceuticals, medical devices and other products. The built-in templates comply with ISO 14971 and ICH Q9 allowing manufacturers to manage risks throughout the entire product lifecycle directly within TrackWise Digital.

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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. 

TrackWise Digital Integrates Quality and Risk Management

 
 
Proactive risk reduction

Increase patient safety and improve product and process quality with effective risk management visibility across the organization and supply chain, allowing manufacturers to quickly prevent or mitigate quality issues.

 
 
Built on TrackWise Digital

Ensure all risk-based decisions and actions within the QMS are handled using consistent criteria for risk analysis, evaluation, control and acceptability of residual risks. Leverage data from core TrackWise Digital quality processes. 

 
 
Risk Management for the entire lifecycle

Manage risks from concept development to production and post-production with a living risk management file that reflects the latest data from the QMS and the supply chain.

 
 

 

Key Capabilities for Integrated Risk Management

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 & Post-production

Collect information throughout the product’s lifecycle to improve accuracy of the risk evaluations, signal detection and benefit-risk analyses.

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.

Learn more about the benefits of integrated risk management

Request a demo to learn more about how TrackWise Digital risk management can meet your organization’s needs