2025 State Of Validation: Validation Industry Annual Report

The 2025 State of Validation report, now in its fourth edition, delivers the industry’s most comprehensive look at global validation practices — and the transformation now underway. Powered by Kneat Solutions and developed with input from subject matter experts at Körber Pharma and MMR Consulting, this year’s report captures insights from 300+ professionals across pharma, biotech, medtech, and other regulated sectors.

Key takeaways from the 2025 report:

• Digital Validation Surges: 58% of organizations are now using a digital validation system—up from just 30% last year—marking a clear shift toward connected, compliant systems.
• Audit Readiness Tops the List: For the first time, “audit readiness” is ranked as the number one challenge, overtaking “compliance burden,” as companies prepare for evolving regulatory scrutiny.
• AI Adoption: While 16% of organizations have begun using AI in validation, 46% report no current plans — highlighting a significant opportunity for early adopters.
• Teams Under Pressure: With 66% of respondents reporting an increased workload, lean teams are increasingly turning to outsourcing and digital tools to meet demand.
• Data Integrity is Driving Change: When asked about the biggest benefits of digitization, “data integrity” and “continuous audit readiness” led by a wide margin— underscoring growing reliance on trustworthy, traceable systems.