Quality And Risk Management Software For Life Sciences

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Proactively manage risks of pharmaceuticals, medical devices and other products with TrackWise Digital. 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.

Risk Management and Quality Integrated With TrackWise Digital

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

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.

Risk Management System Capabilities

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 a graphical distribution of the risks and facilitates evaluation of the overall residual risk and benefit.

Nonconformance and CAPA

Nonconformance and CAPA records are 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 the accuracy of the risk evaluations, signal detection, and benefit-risk analyses.

Honeywell Process Solutions