AI-Enabled quality

AI-augmented decisions to achieve proactive quality

Harness the value of operational and quality data to augment and accelerate decisions

TrackWise AI combines generative AI technology with natural language processing (NLP) and machine learning (ML) to augment quality management processes. This combination not only can help enhance signal detection and operational efficiency but also help improve patient safety

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, TrackWise AI can quickly identify high risk events and correlated quality records.

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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.

Comprehensive summaries

Utilize generative AI algorithms to automatically generate summaries based on the content of quality event records. This helps ensure consistency and accuracy in summarization outputs, reducing errors and discrepancies commonly associated with manual summarization efforts.

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

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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

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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

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Embracing innovation 

We are dedicated to driving innovation that empowers organizations to confidently navigate complex quality management landscapes. Through the integration of AI technology, we assist in improving efficiency, accuracy, and operational excellence within your quality management processes. Learn more on our AI-enabled quality management 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​.

IMPROVE COMPLETENESS AND CONSISTENCY

Generate more standardized summaries, enhancing overall quality and compliance.

ENHANCED CAPA EFFECTIVITY

Verify CAPA effectiveness by helping to ensure similar quality events are not repeating across the organization.

REDUCE DUPLICATE INVESTIGATIONS

Identify related quality events and ​assist in avoiding duplicate investigations.​

ADVERSE TREND IDENTIFICATIONS

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

AI-Enabled quality resources

WHITE PAPER

99% of life sciences organizations are embracing AI. Are you?

Life sciences organizations are enthusiastically embracing AI, but concerns over talent, skills, and data quality highlight the limitations of an in-house approach. Download this latest white paper to learn more.

WEBINAR

Revolutionizing life science recalls

Explore how the latest innovations in data fabric technology can revolutionize product recall management, ensuring future-ready, agile and effective recall processes.

 

ON-DEMAND

Expert exchange series: The role of AI in quality management

Join Fabrizio Maniglio, Director of Industry and Business Development at Honeywell, and Rex Van Horn, Enterprise IT Architect at Boehringer Ingelheim USA, in our 3-part Expert Exchange Series focusing on the Role of AI in quality management.

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 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.

Check Out Other Honeywell Life Sciences 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.

DEVIATION 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.