Business Details
TrackWise Quality Management Solutions for Life Sciences
For over four decades, we have served as a trusted partner to life sciences organizations, delivering comprehensive digital solutions to address complex quality, regulatory, and manufacturing challenges. Our TrackWise suite empowers companies to enhance operational efficiency, reduce risk, and accelerate time-to-market through AI-driven quality management, seamless QMS-MES integration, and proactive risk mitigation. With a proven track record across global enterprises, we combine deep industry expertise with cutting-edge technology to support digital transformation journeys.Our solutions ensure compliance with stringent regulatory standards while enabling data-driven decision-making, from product development to post-market surveillance. By bridging gaps in batch automation, paperless workflows, and real-time analytics, we help organizations achieve safer, more efficient production processes tailored to evolving industry demands.
Services
TrackWise Digital
TrackWise QMS
TrackWise AI
Manufacturing Execution System
Batch Historian
Electronic Logbook
Experion Batch
Product Quality Review
Recall Management
Quality Risk Management
Highlights and features
- We offer 40+ years of specialized expertise in life sciences quality management systems.
- Our AI-augmented platform provides proactive risk detection and automated analytics.
- We integrate QMS and MES for seamless data flow and compliance.
- Our solutions support global enterprises with multi-site deployments.
- We enable faster batch release and recall management with real-time insights.
What people say
2x efficiency gains
800+ hours saved annually
Global digital transformation
Streamlined workflows
Proactive risk management
Services
TrackWise Digital
Our cloud-based QMS leverages AI for auto-summarization and advanced analytics. It strengthens quality culture through proactive signal detection, automated reporting, and enterprise-wide performance optimization. Designed for life sciences compliance, it supports digital transformation across 17+ global sites.
Manufacturing Execution System
This modular platform orchestrates production workflows with batch historian and DCS integration. It improves throughput by bridging operator skill gaps, ensuring repeatable quality, and optimizing pharmaceutical and medical device manufacturing processes through real-time data contextualization.
Product Quality Review
Automates annual product quality reviews with collaborative workflows and error-free data aggregation. Reduces manual effort by 80% while maintaining GMP compliance, enabling faster regulatory submissions and data-driven quality decisions for biopharma operations.
Electronic Logbook
Digitizes logbook management to eliminate paper records and accelerate decision-making. Ensures compliance through instant data access, streamlined workflows, and integration with quality management systems for pharmaceutical manufacturing environments.
Recall Management
Streamlines recall processes with real-time deviation tracking and executive reporting. Reduces recall resolution time by 70% through automated analytics, team collaboration tools, and proactive risk identification aligned with ISO 14971 standards.
Questions
What industries does TrackWise serve?
TrackWise specializes in life sciences, supporting pharmaceutical, biotech, medical device, and CDMO organizations across small molecules, cell & gene therapies, and vaccines.
How does TrackWise improve compliance?
Our integrated solutions maintain error-free audit trails, automate regulatory reporting, and align with ISO 14971 and ICH Q9 standards to ensure continuous compliance readiness.
Can TrackWise integrate with existing systems?
Yes, TrackWise seamlessly connects QMS and MES platforms, enabling bidirectional data flow between quality management and manufacturing execution systems for holistic operations.
What AI capabilities does TrackWise offer?
TrackWise AI uses generative AI, NLP, and machine learning for signal detection, auto-summarization, and predictive analytics to enhance quality decision-making and operational efficiency.
How does TrackWise handle global deployments?
Our cloud-based architecture supports multi-site implementations with centralized data management, scalable infrastructure, and localized compliance features for 17+ global locations.
Reviews (1)
Jason Caprio
Oct 16, 2016
Report
I fix computers at this location often. They have a very efficient check-in process for visitors using a mounted iPad at the reception desk!
