Leveraging industry-leading AI capabilities from Amazon Web Services (AWS) and AWS SageMaker, the TrackWise AI technology stack and algorithms are purpose-built for quality, and support the use of GxP compliant data. For more information, contact an account executive for Sparta System’s Security and Compliance White Paper
TRACKWISE AI
The world’s first AI-enabled platform designed to augment quality management decision-making
TrackWise AI provides powerful, AI-augmented quality processes, unlocking the value of operational data to improve decision-making. TrackWise AI applies generative AI, natural language processing (NLP) and machine learning (ML) throughout the QMS to improve signal detection, help increase operational efficiency and advance employee productivity.
Auto-Categorization
Powerful, AI-assisted recommendations to classify and categorize and help streamline complaints triage, quality event handling and complaint intake.
Auto-Summarization
Leverages generative AI to automate quality event summaries, reducing the time spent gathering and synopsizing information, while helping improve the quality and consistency of these entries.
Insights
Enhancing quality-related decision-making capabilities by helping quality teams identify correlations, trends and patterns.
Root Cause Advisor
Assists quality teams to identify root cause using historical data to correlate similar anomalies and find a common link.
Quote: On average, we handle four hundred and fifty thousand complaints per year and are on track to handle at least five hundred thousand this year. The AI will help increase our capacity, allowing us to scale up…
Saku Tuominen
Business Administrator | Orion Corporation
1
/
03
Quote: We chose to implement AI to manage quality events and wanted to test its capabilities in addressing recurring deviations in our production, laboratory processes, and supply chains… it’s interesting to see how AI can automate this process for us.
Dio Fernandez
CI & Post-Market Product Support Manager | Insulet
2
/
03
Quote: We can deploy our AI-QMS-enabled continuous flow reactors…with built-in confidence of high quality, an approach that won us praise from the FDA Emerging Technology Team. In addition to our core mission of making rare, orphan, and children’s medicines, we have also been able to pivot and respond at-scale to help address the wide-spread drug shortages created by the Covid-19 crisis.
Tony Quinones
CEO | Bright Path Labs
3
/
03
TrackWise AI Enables Proactive Quality
TrackWise AI Thought Leadership
TrackWise AI FAQs
TrackWise AI is the only solution that supports the full breadth of the quality management system, including Complaints, Deviations, Nonconformances (NC), Corrective and Preventive Actions (CAPA), Change Control, and Audit.
TrackWise AI augments human decision making and assists in quality records, but never replaces human decision making. All AI-assisted quality records require human approval and are identical to manually processed records, and audit-trails show human accountability.