AI-Enabled Quality

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.

 

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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, QualityWise.ai 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.

 
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
AI can detect and address challenging quality problems by recognizing signals and quality issues well in advance of what we can do today.
Dan Matlis
Axendia President
Sparta Systems is the first EQMS vendor to respond to Quality 4.0 by embedding AI into core quality management workflows. AI predicts the risk and makes recommendations, but subject matter experts make the ultimate decision. The value of this approach is in streamlining workflows and routing, allowing quality experts to prioritize high-risk areas.
Matt Littlefield
President | LNS
 
 

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.

 
 
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 Resources

 
 
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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

 
 
Complaint Management Software

The complaint handling QPA provides the ability to log, respond to and investigate complaints. 

Supplier Quality Management (SQM)

The supplier quality management QPA enables organizations to manage and collaborate with suppliers and contract manufacturers across your supply chain. 

Quality Risk Management

Risk Management enables companies to seamlessly link the risk process to other quality management processes. 

Audit Management

The audit management QPA helps companies monitor critical processes, identify gaps and improve quality. 

Corrective and Preventive Action (CAPA)

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.   

Nonconformances

The nonconformance QPA records data about situations in which a product or device has not conformed to standards. 

Document Management

Access, edit, approve, store and share the latest version of quality documents throughout the value chain 

Training Management

With training management, automate company-wide training policies and regulatory requirements, where training activities are scheduled and tracked through completion

Out of Specification

Document and track results of in-process or finished product testing falling out of specified limits using the Out of Specification (OOS) QPA. 

Change Management

The change management QPA manages change at every level of the supply chain to ensure quality and compliance requirements are not affected.

Deviations and Quality Events

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

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