Woman using a tablet to access AI enabled QMS software

Innovation for
a Healthier Future

Accelerating operational efficiency and data-driven outcomes across quality, regulatory and manufacturing

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TRACKWISE QUALITY MANAGEMENT REVIEW

Transforming the Quality Management Review Process

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TRACKWISE MANUFACTURING
EXCELLENCE PLATFORM

Combine modular visualization, Manufacturing Execution System (MES), and Batch Historian to digitalize, orchestrate, and optimize production.

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TRACKWISE AI
AI-ENABLED QUALITY

AI-augmented decisions to achieve proactive quality.

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TrackWise Digital and TrackWise QMS

Our leading QMS platforms connect quality across the supply chain to optimize manufacturing and quality performance.
AI-Enabled Quality
Manufacturing Quality
Digital Shop Floor
Supply Chain Quality
Quality Content Management
Integrated Risk Management
Post-Market Surveillance
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.

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.

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.

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.

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.

Two users sharing screen to access applications 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.

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.

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.
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Shaping the Future of Proactive Quality

TrackWise QMS solutions help companies bring products to market leveraging the highest level
of quality management processes and technology advances to be ready for what’s next.
Simple, Smart Quality Management

Proactive quality hinges on the power to harness quality data and apply advanced technologies—generative AI, natural language processing, advanced analytics—to manage quality issues and reduce downstream risks. Augment decision-making and gain real-time insights to proactively detect and address issues before they become more impactful. ​

Unmatched Expertise

Quality is our foundation. Leading companies have trusted and relied on our quality solutions and expertise for nearly three decades to meet rigorous standards and turn quality into a strategic advantage.  

Everything You Need, All in one Place

Gain a single source of truth and view of quality events. From the shop floor to the boardroom and across the value chain, monitor performance and streamline reporting with on-demand digital dashboards, optimized workflows and real-time insights. 

Faster Value and Harmonization

Simplify, standardize, optimize. Whether you’re just getting started or need to harmonize globally, our intelligent fit-for-purpose quality processes built on industry best practices support GxP compliance and deliver rapid value.

Establish a Culture of Quality

Quality is everyone’s responsibility. Our solutions make it easy to access and collaborate on quality documents with both internal and external partners. With our modern interface, users can quickly navigate and manage quality from any device, anytime, anywhere. 

TrackWise Quality

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
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).
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Customer Success Stories

2X EFFICIENCY GAINS

Reduced outstanding training records to less than 1% and the investigation routing and approval time dropped from 2 to 3 days down to less than 1 day.
+800 HOURS PER YEAR SAVED

All the change records are at our fingertips now. Streamlined workflows improve the timeliness and overall change control process with CMOs.
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
25K
DOCUMENTS
400
AUDITS

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 

Read more about their success

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
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
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 Inc.
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
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
SEE MORE STORIES

Quality Management Solutions

Audit Management
CAPA
Change Management
Complaints Management
Deviations and Quality Events
Document Management System
Nonconformance
Out of Specification
Quality Risk Management
Supplier Quality Management
Training Management

Let’s talk about how TrackWise Quality and Manufacturing Suite can help

No matter where you are in your digital journey,
we have solutions for you
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