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.
AI-Enabled quality
AI-augmented decisions to achieve proactive quality
TrackWise Digital delivers first purpose-built AI-enabled quality capabilities
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
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
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
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
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.
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.