AI TRENDS

The industry is moving — but governance hasn’t kept pace

The 2026 State of Validation study captures insights from 614 validation professionals worldwide. 81% of life sciences organizations now use or plan to use AI in validation — yet 55% rate AI risk in GxP as High or Very High, and 36% have limited or no familiarity with current AI regulatory guidance. This whitepaper maps the gap between adoption and readiness, and delivers a practical framework for building governed, traceable, inspection-ready AI into your validation operations.

KEY TAKEAWAYS:

  • Why AI governance in GxP can't be an afterthought

  • What 614 validation professionals told us in 2026

  • The five pillars of a validated AI environment

  • How EU AI Act and Annex 22 are changing the rules

  • How Kneat AI delivers inspection-ready AI