Stephen Ferrell

Co-Founder and Chief Product Officer

Stephen Ferrell is Co-Founder and Chief Product Officer of Valkit.ai, an AI-native digital validation platform serving the pharmaceutical, biotech, and medical device industries. With more than 25 years of experience in GxP compliance and computer system validation, he has worked extensively with global regulators including the FDA, MHRA, and NMPA.

Stephen serves as Chair of GAMP Americas and sits on the GAMP Global Steering Committee. He is a contributing author to GAMP 5 Second Edition, the ISPE GAMP Guide on Artificial Intelligence, and the ISPE Digital Validation Guide. He also serves as a Beachhead Advisor for New Zealand Trade and Enterprise, supporting Kiwi companies expanding into global life sciences markets. A frequent speaker and author, he presents regularly at industry conferences on digital validation, AI regulation, and data integrity, and has published research analyzing FDA enforcement trends in validation.