AI-augmented decisions to achieve proactive quality
Harness the value of operational and quality
data to augment and accelerate decisions
QualityWise.ai 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.
TrackWise Digital Delivers first purpose-built AI-Enabled Quality Capabilities
With ready access to all quality data across your entire supply chain, QualityWise.ai can quickly identify high risk events and correlated quality records.
Improve productivity by reducing duplicate investigations and cycle time for complaint resolutions to minimize downstream risk and customer impact.
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
QualityWise.ai applies ML and NLP to suggest categories and identify related complaints and quality events. Learn more about our AI-enabled quality solutions.
View suggestions on type, reportability and severity, to help teams quickly triage and ensure timely action.
Prioritize high risk issues with AI-augmented categorization of reportability and risk.
Auto-categorization of complaints and quality event severity ensure timely action.
Verify CAPA effectiveness by ensuring similar quality events are not repeating across the organization.
Identify related quality events and avoid repeating the same investigation multiple times.
Improve trend identification by holistically capturing similar events across multiple sites and product lines.
AI-Enabled Quality Resources
AI-Enabled Quality FAQs
Leveraging industry-leading AI capabilities from Amazon Web Services (AWS) and AWS SageMaker, the TrackWise Digital QualityWise.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
QualityWise.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.
QualityWise.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.
Check Out Other Sparta Solutions
The complaint handling QPA provides the ability to log, respond to and investigate complaints.
The supplier quality management QPA enables organizations to manage and collaborate with suppliers and contract manufacturers across your supply chain.
Risk Management enables companies to seamlessly link the risk process to other quality management processes.
The audit management QPA helps companies monitor critical processes, identify gaps and improve quality.
The CAPA QPA enables organizations to track and manage the process of carrying out CAPA plans, automate verification of effectiveness over time, and provide seamless traceability to related quality processes, including change control and training.
The nonconformance QPA records data about situations in which a product or device has not conformed to standards.
Access, edit, approve, store and share the latest version of quality documents throughout the value chain
With training management, automate company-wide training policies and regulatory requirements, where training activities are scheduled and tracked through completion
Document and track results of in-process or finished product testing falling out of specified limits using the Out of Specification (OOS) QPA.
The change management QPA manages change at every level of the supply chain to ensure quality and compliance requirements are not affected.
Respond to adverse events faster with the quality events QPA and reduce the amount of time it takes to act on quality and safety issues.
Learn how our AI-enabled QMS can work for you
AI-enabled solutions can augment quality decisions today.