
Whitepaper
AI in validation governance
In this whitepaper you will learn
- 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
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.

Industry-leading validation
Kneat is trusted by 8/10 world’s largest life sciences companies to provide digital validation and GDP solutions across their entire manufacturing lifecycle.
Uncompromised data protection
We protect data integrity across the entire validation lifecycle with password protected signatures, automatic timestamps, and a comprehensive audit trail.
Maximize efficiency
Kneat is proven to reduce validation cycle times by 50% across multiple validation disciplines through online test execution, remote approval, and more.
Seamless audit preparation
We set you up for audit success from the start with automatic audit trails and easy paperless handovers to make it easier for audits and remote inspectors.
AI in validation governance
Download the whitepaper now and get the data, framework, and guidance you need.
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