TrackWise Digital and TrackWise QMS
Our leading QMS platforms embed quality across the supply chain to optimize manufacturing and quality performance.
- AI-Enabled Quality
- Digital Shop Floor
- Quality Content Management
- Post-Market Surveillance
- Manufacturing Quality
- Supply Chain Quality
- Integrated Risk Management
- R&D and Clinical Quality
AI-Enabled Quality >
AI has the greatest potential to transform quality systems and shift from reactive to proactive quality. Apply AI to augment decision-making by suggesting categories, risks, and reportability and correlating complaints and other quality events. See how our AI-powered QMS boosts productivity, reduces investigation time, and increases patient safety.
Digital Shop Floor >
Industry 4.0 meets Quality 4.0. Integrate and optimize operations using the latest technologies to connect quality and manufacturing data for actionable insights, improved product disposition, and efficient batch release.
Quality Content Management >
Centralize and digitize document management and training management on a single platform. Quality teams and stakeholders can instantly access documents and take action to gain efficient and effective quality, regulatory, and document lifecycle management
Post-Market Surveillance >
Gain valuable product insights and effectively manage customer complaints to reduce product safety risk, achieve regulatory reporting compliance, and improve the efficiency of post-market surveillance processes.
Manufacturing Quality >
Optimize manufacturing performance with fully integrated digital quality processes and intelligent workflows. Learn how our digital approach connects the data across manufacturing to efficiently manage all quality events.
Supply Chain Quality >
Virtualize and simplify supplier quality management . Seamlessly collaborate with your expanding network of suppliers and contract manufacturers on quality events, including CAPA, change requests, and audits. See how TrackWise Quality solutions can help you mitigate the complexity of modern global supply chains.
Integrated Risk Management >
Proactively manage risks of pharmaceutical products, medical devices, and other life science products with built-in templates to meet ISO 14971 and ICH Q9 requirements. Learn how our Life Sciences solutions provide the insights you need to mitigate risk and improve patient safety.
R&D and Clinical Quality >
Optimize quality processes to support GCP/GLP requirements and strengthen regulatory responsiveness. Discover how TrackWise Quality solutions help you ensure compliance and reduce costs and risk.
New Thought Leadership
Connecting you to key insights and resources for smarter quality management.
Shaping the Future of Proactive Quality
TrackWise QMS solutions help companies bring products to market by leveraging the highest level of quality management processes, including advanced QMR and PQR capabilities, and technology innovations to be ready for what’s next.
Quality Management System (QMS)
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TrackWise Digital
Our TrackWise Digital® QMS solution is an industry-leading quality management system with integrated modules that work together to support quality, compliance and more efficient and effective decision-making.
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TrackWise QMS
TrackWise® is the world’s leading on-premise QMS software. TrackWise offers several industry best-practice workflows, bringing all your quality processes together in a single place.
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TrackWise AI
The world’s first AI-enabled capabilities specifically designed to improve quality and support Good Manufacturing Practices (GMP).
Comprehensive Quality Management Beyond QMS
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TrackWise Product Quality Review
Modernize the Annual Product Quality Review (APQR) Process
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TrackWise Quality Management Review
Learn how Honeywell is transforming the quality management review process with HQMR
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TrackWise Recall Management
Streamlining the Recall Management Process
Customer Success Stories
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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
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: 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 Al will help increase our capacity, allowing us to scale up…
Saku Tuominen
Business Administrator | Orion Corporation
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
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
Quality Management Solutions
