TrackWise Digital
An AI-enabled digital quality ecosystem to support the promise of proactive quality
Enabling a digital ecosystem to drive proactive quality across the supply chain
TrackWise Digital is an industry-leading, cloud-based quality management system (QMS) with integrated modules that work together to support quality, compliance, and more efficient and effective decision-making. Enhanced with AI-augmented capabilities such as auto-summarization and auto-categorization, TrackWise Digital helps enhance organizational productivity and efficiency goals for quality management. With reporting and advanced analytics across all quality processes, users can leverage quality data to strengthen their culture of quality and impact company-wide performance.
TrackWise Digital thought leadership
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Webinar
Alert to action: how connected digital execution turns pharma data into decisions
In this session, Honeywell Life Sciences expert Zillery Fortner and Arshad Azwad explore how digitally connected execution ecosystems move manufacturers from reactive response to proactive control, enabling faster decisions, fewer errors, and inspection-ready operations by design.
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Brochure
TrackWise® Digital QuickTrack
TrackWise Digital QuickTrack delivers the power of enterprise QMS without the complexity or cost—getting you compliant and operational faster. A streamlined solution and delivery approach designed specifically for startups, small, and medium-sized businesses.
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Blog
Rethinking Life Sciences quality & manufacturing operations in the age of ai and connected systems
Quality decisions in life sciences rarely fail because people don’t care. They fail when signals arrive too late, in the wrong place, or without enough context to act confidently. By the time an issue becomes a deviation, an investigation or even a recall, the early warning signs were usually there – they just weren’t connected, visible or actionable.
TrackWise Digital helps deliver high quality products
- Simplifying quality management
- Connecting stakeholders and suppliers
- QMS expert in enabling proactive quality
- Intuitive quality for the digital worker
Reduce the complexity of quality and break down silos with TrackWise Digital, a flexible, scalable and integrated quality management solution that is robust and configurable to manage both simple and complex processes. The system is AI-enabled to make quality even smarter and more intuitive.
TrackWise Digital lowers risk, increases efficiency and keeps consumers safe while allowing manufacturers and suppliers to collaborate in a seamless and integrated environment. Connect internal and external teams to work together in sync and get visibility into all quality processes. The result is a culture where quality is infused into every aspect of the organization—from the shop floor to the supply chain.
TrackWise Digital applies the latest innovation technologies, including generative AI and advanced analytics, to help eliminate inefficiencies with manual processes, enabling a digital ecosystem and faster decisions. Coupled with our deep expertise and best practice processes, gain rapid implementation, encourage adoption and ensure success.
TrackWise Digital’s interface is user-friendly and helps drive efficiency and simplify quality from end-to-end. From instant notifications to efficient reporting, TrackWise Digital helps drive productivity for the end user. Mobile capabilities enable you to manage quality on the go, no matter where you are. Break down silos and get everything you need, in a central location, always at your fingertips.
Why TrackWise Digital?
Innovation built for quality management
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Quality process accelerators
Based 25+ years of experience, TrackWise Digital’s Quality Process Accelerators (QPAs) provide rapid value and streamline end-to-end digital quality.
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AI enabled quality
TrackWise Digital is the industry’s first QMS to leverage AI for enhancing quality related decision-making capabilities, providing a shift from reactive to proactive quality.
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World-class technology platform
Leveraging industry leading platform to provide cloud based, SaaS QMS built on the Salesforce platform to provide the highest levels of security, scalability, mobility and ease of use.
Global digital transformation of quality
Digitalization of quality management across 17 global sites and larger partner network to improve operational efficiencies, capacity, turnaround times and customer service.
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SGS implemented TrackWise Digital to digitize and eliminate over 25,000 items, moving from a heavily paper-based and document-centric environment to connect over 17 sites and hundreds of partners on a state-of-the-art digital platform. Here’s why SGS chose TrackWise Digital.
- Intuitive user interface and easy-to-navigate dashboards
- Outstanding reputation and high use in the Life Science industry
- Comprehensive module with quality, complaints, documents, training, supplier quality and CAPA
- Robust audit management features that enable direct submission of audit replies, making it easier to conduct over 400 audits per year
Quote: With the upgrade to TrackWise Digital, we can advance our mission of providing Excellence in Quality within our organization and improve traceability throughout our supply chain.
Nick Walp
VP, Quality Affairs | American Regent
Quote: TrackWise Digital, right out of the box, fits McKesson’s business model very well and it’s been a pleasure for me…as a former TrackWise user, to show the benefits and the user experience of TrackWise Digital.
Barry Cook
VP of Quality Operations | McKesson
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
Quote: With their deep expertise in quality management and innovative digital quality platform, we gain full visibility of quality topics across the entire product lifecycle and the right partner to support our future growth and product pipeline.
Judy Coddington
Vice President, Quality Assurance | Daiichi Sankyo
Quote: TrackWise Digital was the only QMS solution that met our selection criteria. Their unrivaled reputation for expertise in GMP compliance and validation instilled us with confidence that we would enjoy a successful implementation and long-lasting partnership.
Jasmin Jivraj
Head of Quality Assurance | Bene Arzneimittel GmbH
Core quality processes
Quality events
Digitize and connect quality events to quickly act on issues.
Nonconformance and Out of Specification
Manage and trend nonconforming product, investigations and approval of resulting actions and product dispositions.
Deviations
Manage deviations in a centralized location, with associated investigations, approvals and resulting records.
Corrective And Preventive Actions
Fully integrated CAPA system with automated routing, notification, delivery, escalation and approval capabilities.
Audit management
An integrated tracking and workflow engine that automates audit findings, responses, corrective actions, approval and reporting.
Change control
Manage changes from request, through pre-approvals, change execution, follow-up approvals and implementation.
Complaint handling
Manage the entire complaint lifecycle, from investigation to resolution, and gain insights for continuous improvement.
Product registration tracking
Significantly reduce the time, cost and resources needed to track product submissions with regulatory agencies around the globe.
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