Patients and regulators have high expectations for complaint handling and effective quality event management of pharmaceuticals, medical devices, and other life science products. With ever-increasing volumes of quality records and growing product, process, and supply chain complexity, quality teams are pressed to stay on top of critical issues and consistently make the right decisions, efficiently and effectively. By leveraging innovations in digital quality, organizations can uncover new insights from today’s quality data.  

TrackWise Digital with QualityWise.ai provides powerful, AI-assisted workflows to automatically suggest categories and correlate complaints and quality events, unlocking the value of quality data and augmenting decisions made by quality teams. 

View the TrackWise Digital QualityWise.ai Datasheet

With Auto-Categorization and Insights, QualityWise.ai provides robust solutions to decrease cycle-times, speed up response times, and deliver on customer expectations.

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QualityWise.ai Auto-Categorization suggests classifications of complaints and quality events across the QMS.  Auto-Categorization for complaints suggests complaint type, reportability, and severity, to help quality teams quickly triage and ensure timely action.  

  • Natural Language Processing (NLP) 
    Leverage NLP to analyze and convert unstructured data into actionable classifications for complaints and quality events based in historical records, standardizing and removing bias at the earliest stages to improve accuracy. 
  • Signal Detection 
    Readily detect signals of potential high-risk patient impacts for increased prioritization and responsiveness 
  • Right First Time 
    Avoid unnecessary investigations by improving right first time categorization of complaint classification, reportability, and risk. 
  • Confidence Levels 
    View confidence levels of AI suggestions to indicate the likeliness of correct recommendations


QualityWise.ai provides effective autocorrelation of quality records by rapidly searching through all available current and historical data to instantaneously identify correlations, trends, and patterns that were previously invisible across related events.  With Insights, avoid duplicate investigations of complaints and quality events, including out of specifications, deviations, non-conformances, and CAPAs. 

  • Avoid Duplicate Investigations 
    Leverage QualityWise.ai Insights to identify related quality events and avoid repeating the same investigation multiple times, reducing Remediation Costs and the overall Total Cost of Quality. 
  • Adverse Trend Identification 
    Improve current adverse trend identification processes by holistically capturing all related events, ensuring all decisions by quality personnel are made with the maximum amount of relevant data. 
  • Quality Correlation 
    Efficiently and effectively connect disparate items of quality data, including complaints, out of specifications, deviations, non-conformances, and CAPAs, that are often integrally linked by cause and effect. 
  • Shared Quality 
    Ensure there is visibility of outcomes of quality events throughout the organization, regardless of the business unit or location, to improve efficiency and effectiveness of investigations and other quality activities. 

Delivering World-Class Security and Compliance 

For information on Sparta Systems Security and Compliance, visit https://www.spartasystems.com/trust 

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