How Validation Is Evolving in 2025: Key Trends Revealed
Validation professionals are under pressure — from rising workloads to new regulatory demands. Backed by four years of industry data, this year’s State of Validation report — authored by leading life sciences market research Jonathan Kay — reveals how organizations are tackling challenges like audit readiness, resourcing constraints, and the shift to digital systems. Discover benchmarks, best practices, and real-world insights that can inform your 2025 strategy.
This industry report explores the major shifts observed in the 2025 State of Validation survey, now in its fourth year and powered by Kneat.
Drawing from the perspectives of 300+ professionals in 14 highly regulated industries — most from within the life sciences sector — the report highlights how teams are adapting their validation programs to align with evolving regulatory expectations, operational realities, and peer benchmarks.
Key takeaways include:
- Why audit readiness has overtaken compliance burden as the top challenge
- The rapid rise in digital validation adoption (up 28 percentage points in 2024)
- Where organizations stand on AI integration
- Budget pressures, outsourcing trends, and limited internal capacity shaping how teams approach validation
- Actionable next steps for validation teams navigating complexity in 2025
About Kneat
Kneat Solutions Inc. (TSX: KSI) provides leading companies in highly regulated industries with unparalleled efficiency in validation and compliance through its 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.
