Each year, the State of Validation report offers a window into how validation programs are evolving to meet shifting regulatory demands, technological advancements, and resource constraints. The 2025 edition reveals a sector in transition, with clear trends emerging across audit readiness, process efficiency, and digital transformation.
Audit readiness takes center stage
Primary Goals
A standout finding in the 2025 report is the elevation of audit readiness as the top priority for validation programs. Audit preparedness has overtaken process efficiency, signaling a strategic pivot towards ensuring organizations are inspection-ready at all times.
Audit readiness also emerged as the leading challenge validation professionals face today, surpassing compliance burden and data integrity concerns.
For the first time in the history of the State of Validation report, “introducing new technologies to improve validation” has entered the top three goals of validation programs in 2025. This shift reflects a growing industry imperative to modernize legacy systems and processes in response to increasing complexity, regulatory harmonization efforts, and the demand for faster speed-to-market.
The data suggests that as organizations mature their digital infrastructures and stabilize their resource models, regulatory-facing concerns have reclaimed top priority. Validation teams are responding by using digital validation systems that support real-time documentation access, automated traceability, and standardized processes that simplify audits and reduce preparation burdens.
Download our eBook “Be Audit Ready” to get tricks on how to prepare and share documents easier, build relationships with regulators, and use digital validation for faster, easier audit preparedness.
Process efficiencies remain a core goal
While audit readiness has taken the top spot, process efficiency remains a close second in the list of 2025 priorities.
Validation leaders continue to pursue streamlined workflows that balance compliance requirements with resource constraints. Process efficiency has consistently ranked among the top three goals since 2022.
The need for efficiency is further underscored by rising workload pressures. In 2025, 66% of State of Validation survey respondents reported increased validation workloads over the previous 12 months.
Despite these growing demands, validation teams remain lean, with 39% of organizations operating with three or fewer dedicated validation staff.
This dynamic highlights the ongoing importance of scalable systems, targeted outsourcing, and smart resource management. Many organizations are leveraging digital tools, managed services, and cross-functional collaboration to handle the rising complexity without proportionally expanding team sizes.
Digital validation adoption accelerates rapidly
Digital Validation System Adoption
The 2025 data paints a clear picture: digital validation has moved firmly into the mainstream. Adoption has surged across industries, with 58% of organizations now using or actively implementing digital validation systems — a notable jump from just 30% one year earlier, reflecting widespread acceptance of digital validation as both a compliance and business imperative.
Of the remaining respondents, 25% plan to adopt — including 9% within the next 12 months and 16% in two or more years, suggesting long-range planning is underway across the industry.
The most widely cited benefits of digital validation are improved data integrity, continuous audit readiness, and global standardization of validation practices.
Among those who have adopted digital validation, 56% report that return on investment (ROI) met or exceeded initial expectations. A substantial portion (21 %) selected “too early to tell,” suggesting that many implementations are still in progress or benefits have yet to fully materialize. 14% of respondents admitted they “did not set specific ROI” targets — highlighting a gap in strategic planning.
Discover the ROI of digital validation. Learn to measure time savings, productivity gains, and real-world results in “Digital Validation ROI” — this must-watch webinar for compliance leaders.
Final thoughts
The 2025 State of Validation report reflects an industry adapting to new realities. As validation professionals navigate this evolving landscape, those who embrace digital transformation, strengthen audit capabilities, and optimize their resources will be best positioned to meet both today’s demands and tomorrow’s challenges.
See digital validation in action
Discover how our digital validation platform Kneat Gx can help your organization achieve continuous audit readiness, streamline validation, and drive efficiency. Schedule a personalized demo today.
