TrackWise AI

TrackWise AI is a quality management platform from Honeywell (Sparta Systems) designed for life sciences organizations. It applies generative AI, natural language processing (NLP), and machine learning (ML) throughout the quality management system (QMS) to improve signal detection, increase operational efficiency, and advance employee productivity. The platform is positioned to help organizations shift from reactive to proactive quality management by unlocking the value of operational data for more informed decision-making.

TrackWise AI supports the full breadth of quality management records, including Complaints, Deviations, Nonconformances (NC), Corrective and Preventive Actions (CAPA), Change Control, and Audit. All AI-assisted records require human approval, and audit trails maintain human accountability — the platform augments rather than replaces quality personnel decision-making.

Core AI Capabilities

• Auto-Categorization: Provides AI-assisted recommendations to classify and categorize quality records, helping to streamline complaints triage, quality event handling, and complaint intake.
• Auto-Summarization: Uses generative AI to automate the creation of quality event summaries, reducing the time spent gathering and synopsizing information while improving consistency and quality of entries.
• Insights: Supports quality-related decision-making by helping quality teams identify correlations, trends, and patterns across quality data.
• Root Cause Advisor: Assists quality teams in identifying root causes by using historical data to correlate similar anomalies and find common links between recurring issues.

Quality Management Outcomes

• Enables a shift from reactive to proactive quality management through actionable, data-driven insights.
• Supports alignment with current Good Manufacturing Practices (CGMP) by combining best practices with modern AI technologies.
• Improves efficiency and effectiveness across quality processes at all levels of the organization.
• Helps organizations scale quality operations — one customer, Orion Corporation, handles approximately 450,000 complaints per year and uses TrackWise AI to increase processing capacity.
• Supports management of recurring deviations in production, laboratory processes, and supply chains, as noted by Insulet.

Compliance and GxP Considerations

• The technology stack and algorithms are purpose-built for quality management and support the use of GxP compliant data.
• Built on AI capabilities from Amazon Web Services (AWS) and AWS SageMaker.
• All AI-assisted quality records are identical in structure to manually processed records, with audit trails reflecting human accountability and approval.
• A Security and Compliance White Paper is available through Sparta Systems account executives for further detail on GxP compliance support.

TrackWise AI is deployed using infrastructure from AWS and AWS SageMaker, and is applicable across the full quality management lifecycle in life sciences settings. The platform has been used by organizations including Bright Path Labs, Orion Corporation, and Insulet across complaint management, deviation handling, and post-market product support functions.