AI-Enabled Quality

AI-augmented decisions to achieve proactive quality

Harness the value of operational and quality

data to augment and accelerate decisions Auto-Categorization and Insights applies natural language processing (NLP) and machine learning (ML) throughout the QMS to improve signal detection, increase operational efficiency and ensure patient safety.


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TrackWise Digital Delivers first purpose-built AI-Enabled Quality Capabilities

Effective Signal Detection and Trending

With ready access to all quality data across your entire supply chain, can quickly identify high risk events and correlated quality records.

Increase Efficiency and Customer Satisfaction

Improve productivity by reducing duplicate investigations and cycle time for complaint resolutions to minimize downstream risk and customer impact.

Minimize Errors and Compliance Risk

Faster and more accurate decision-making by leveraging AI to objectively decipher large and complex quality data sets. Effectively reduce human bias, compliance risk and associated regulatory actions.


Auto-Categorization and Insights applies ML and NLP to suggest categories and identify related complaints and quality events. Learn more about our AI-enabled quality solutions.

Complaint Categorization

View suggestions on type, reportability and severity, to help teams quickly triage and ensure timely action.

Signal Detection

Prioritize high risk issues with AI-augmented categorization of reportability and risk​.

Early Risk Detection

Auto-categorization of complaints and quality event severity ensure timely action.

Enhanced CAPA Effectivity

Verify CAPA effectiveness by ensuring similar quality events are not repeating across the organization.

Avoid Duplicate Investigations

Identify related quality events and avoid repeating the same investigation multiple times.

Adverse Trend Identifications

Improve trend identification by holistically capturing similar events across multiple sites and product lines.

AI-Enabled Quality FAQs


Leveraging industry-leading AI capabilities from Amazon Web Services (AWS) and AWS SageMaker, the TrackWise Digital 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 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. 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.

Learn how our AI-enabled QMS can work for you

Find out how our
AI-enabled solutions can augment quality decisions today.