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AI in CQV: Navigating Innovation and Regulation
Donncadh Nagle
Joseph McCloskey
Sarah Rogers
Michael Brown
blue-hero-Jacobs

Artificial intelligence (AI) presents new opportunities to strengthen Commissioning, Qualification, and Validation (CQV) activities across Life Sciences. This paper outlines how deterministic, static AI models— aligned with emerging regulatory guidance—can responsibly support document‑heavy, repetitive CQV tasks while preserving traceability, compliance, and human oversight. It synthesizes regulatory expectations, industry readiness, cross‑sector lessons, and practical near‑term applications that reduce administrative burden without altering the core principles that define CQV.

Introduction 

The effective integration of AI within regulated pharmaceutical environments requires rigorous attention to regulatory compliance, robust data integrity practices, comprehensive risk management, and the complex challenges inherent to emerging technologies. Traditional CQV workflows rely heavily on manual document review and rigid, predefined processes. CQV engineers spend significant time analyzing drawings, technical packages, specifications, and traceability records – time that could otherwise be directed toward higher value work such as assessing risks, troubleshooting, and integration oversight. 

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About the Author

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Donncadh Nagle
Consultant / Lecturer
Jacobs Engineering / TU Dublin
Donncadh Nagle is a pharmaceutical industry professional based in Ireland. Currently working as a Senior CQV consultant with Jacobs Engineering, he is also a Lecturer...
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Joseph McCloskey
Computer System Validation Engineer
Jacobs Engineering Group Inc
Joe McCloskey is a seasoned Computer System Validation Engineer with more than 32 years of experience developing, testing, and validating process equipment, automation systems, and...
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Sarah Rogers
Senior Manager of Tools and Analytics, LSNA
Jacobs Engineering Group Inc
Sarah Rogers, is a seasoned project controls and digital delivery leader with more than 15 years of experience implementing tools, analytics, and project control systems...
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Michael Brown
Senior Vice President of Enterprise AI
Jacobs
As Senior Vice President of Enterprise AI at Jacobs, Michael oversees global AI strategy, guiding the responsible and impactful adoption of AI across diverse markets...