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2026 State of Validation Report
Donncadh Nagle
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Unlock the latest insights and trends in validation practices with the 2026 State of Validation report — now in its fifth year. Independently authored by Donncadh J. Nagle, Senior CQV Consultant at Jacobs Engineering and Lecturer at Technological University Dublin, the State of Validation comprises a broad quantitative and qualitative primary market research study, conducted directly with validation professionals worldwide.

The 2026 report surveyed 614 validation professionals across six continents and 30+ industries, capturing a comprehensive snapshot of the forces shaping the validation profession — and tracking how the industry has evolved since 2022.

From technological and regulatory change to organizational strategy, digital transformation, and AI adoption, the 2026 State of Validation report is the most comprehensive analysis of the global validation industry available.

Download Now to Explore:

  • Five-year trend analysis — year-over-year data from 2022 to 2026, revealing how validation priorities, practices, and technologies have shifted across the industry.
  • Key challenges — including compliance burden, audit readiness, data integrity, and the persistent pressure of rising workloads against constrained resources.
  • Digital maturity benchmarking — the first-ever ISPE[LW1.1] digital maturity benchmark for the validation industry, enabling organizations to measure and track their digital transformation progress.
  • AI adoption in GxP validation — 39% of respondents are already using or evaluating AI for validation, with 78% confident AI will be standard practice by 2030.
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About Kneat

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Kneat Solutions Inc. (TSX: KSI) provides leading companies in highly regulated industries with unparalleled efficiency in validation and compliance through its AI-assisted digital validation platform, Kneat Gx. We lead the industry in customer satisfaction with an unblemished record for retention and implementation, powered by our user-friendly design, expert support, and on-demand training academy.

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About the Author

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...