BOULDER, Colo., May 27, 2025 /PRNewswire/ — In response to the mounting regulatory, operational, and reputational pressures facing pharmaceutical companies and clinical research organizations (CROs), QI Path announced today the official launch of its AI-driven, purpose-built risk governance platform for the life sciences industry. Designed to transform how companies anticipate, mitigate, and manage operational risk proactively, QI Path delivers structured, real-time visibility into the areas that matter most: inspection readiness, protocol compliance, manufacturing integrity, and clinical execution.
Designed from the ground up to serve the needs of regulated environments, QI Path enables organizations to proactively identify, prioritize, and mitigate operational risk across the full development and manufacturing lifecycle. The platform integrates cross-functional risk data from Quality, Clinical, Regulatory, and Manufacturing teams to provide a unified view of exposure—ensuring that risks, deviations, change controls, and CAPAs are treated not as isolated incidents, but as part of a dynamic and traceable risk ecosystem.
Where traditional quality systems are reactive, QI Path is proactive—mapping systemic vulnerabilities, surfacing unresolved issues before audits, and continuously updating multi-dimensional risk analysis based on real-world data. The result is a smarter, faster, and more resilient quality function—built not just to survive inspections, but to lead organizations into a new era of operational excellence where risks are proactively identified and prevented. The launch comes at a time of industry-wide transformation, where increasing protocol complexity, decentralized clinical trials, third-party outsourcing, and digital manufacturing demand greater transparency, consistency, and inspection readiness than ever before—particularly in light of recent FDA guidance on the use of AI in drug development.
“With the explosive growth in biologics over the last few years, therapies are more complex and development models are more distributed, making operational risk exponentially harder to govern,” said Dr. Jonathan Vaught, CEO of QI Path. The life sciences industry is entering a phase where the evolving risk landscape surrounding AI in life sciences is no longer a theoretical concern—it’s a strategic imperative. QI Path’s platform is built to ensure that companies aren’t caught flat-footed by operational blind spots, offering instead a living, evolving picture of risk that supports both daily decision-making and long-term growth.
From protocol deviations and optimization in clinical studies to GMP compliance in cell and gene therapy manufacturing facilities, QI Path is transforming how the life sciences industry views and manages operational risk. In doing so, it is helping organizations not only protect patients and products—but also unlock greater speed, efficiency, and confidence in how they bring therapies to the world.
About QI Path, Inc.
QI Path is a category-defining risk intelligence platform that empowers organizations in regulated industries to proactively govern operational risk, ensure regulatory compliance, and accelerate decision-making across the enterprise. Headquartered in Boulder, Colorado, the company was founded with a mission to prevent avoidable failures in clinical and manufacturing environments—delivering technology that helps life sciences companies move faster, safer, and smarter in a world where precision and compliance can’t be compromised.
Company Press Contact:
Jonathan Vaught, PhD
[email protected]
SOURCE QI Path, Inc
