Validation in Transition: Why 2025 is the Turning Point for the Industry
The validation industry is entering a transformative era. Amid rising regulatory scrutiny, evolving team structures, and a strong push toward digitalization, professionals across the life sciences are being called to do more, with leaner teams and tighter timelines.
Validation Landscape on the Move
According to Kneat’s 2025 State of Validation report —the pharmaceutical industry’s largest annual benchmark study—the validation landscape has shifted.
Audit readiness is now the top challenge validation teams face, rising above compliance burden and data integrity for the first time in four years. As global regulatory requirements grow more complex, teams are expected to demonstrate a constant state of preparedness.
When asked, “What are the primary challenges you validation team faces?” the top three responses were audit readiness, compliance burden, and data integrity.
Figure 1: Validation Team Challenges in 2025
What are the primary challenges your validation team faces? Please rank all answer choices in order of preference, 10 being the highest.
Yet while the pressure is increasing, many organizations are working with limited internal resources. In fact, 39% of companies report having fewer than three dedicated validation staff, and 66% say their validation workload has increased over the past 12 months.
The message is clear: validation is more business-critical than ever, and it’s being managed by leaner, faster-moving teams.
Adoption of Digital Validation Tools (DVTs) is on the Rise
One of the most notable shifts revealed in Kneat’s 2025 State of Validation report is the mainstream adoption of digital validation tools. Participants were asked, “To what extent has your organization adopted digital validation systems?” In just one year, the number of organizations using a digital validation system jumped from 30% to 58%, with another 35% planning to adopt one in the next two years.
Figure 2: DVT Adoption Rate in 2025
That means nearly every organization (93%) is either using or actively planning to use DVTs — a tipping point for the industry.
Why the Uptake? DVTs Address the Industry’s Biggest Pain Points
The advantages are substantial. Digital systems enable centralized data access, streamline document workflows, support continuous inspection readiness, and offer a range of additional benefits that enhance efficiency, consistency, and compliance across validation programs. Notably, data integrity and audit readiness were cited by 2025 State of Validation survey respondents as the two most valuable benefits of digitalizing validation.
Three Takeaways You Can Expect in the Webinar
Presenters will walk through the most important trends revealed in Kneat’s 2025 State of Validation report and what they mean for your organization. Here’s a preview of what attendees will take away:
1. Understand Today’s Top Challenges
Presenters will explore the top challenges facing validation teams in 2025, from the shift toward continuous audit readiness to managing growing workloads with limited staff and budget. Attendees will get a clear view of how your peers are coping and where gaps still exist.
2. Benchmark Programs
See how current validation practices compare to peers—including insights into team size, outsourcing levels, validation workload, and structure. Learn which tools teams are leaning on to stay compliant.
3. Explore Digital Adoption and Best Practices
Hear what’s driving success for companies that have already gone fully digital—and what those still in planning mode need to know. We’ll share lessons learned from the field, including how to overcome barriers like process harmonization, change resistance, and rollout complexity.
The webinar “Validation in Transition: 2025’s Top Trends, Tools, and Takeaways”—a live panel discussion with questions and answers on Tuesday, 5 August, will help industry professionals make sense of these shifts. The webinar will unpack key findings from Kneat's 2025 State of Validation report and share actionable insights to help you navigate today’s evolving validation landscape. This webinar is your opportunity to benchmark, learn, and connect with others who are facing the same validation pressures and challenges.
Save a Seat
Join the live webinar on Tuesday, 5 August 2025, at 1100 EST for “Validation in Transition: 2025’s Top Trends, Tools, and Takeaways.”
Secure a spot now and gain the data, context, and practical takeaways needed to lead a validation program with confidence in 2025 and beyond!
Learn more about DVTs
The ISPE Good Practice Guide: Digital Validation considers how increased adoption of DVTs in the life sciences industry can support a growing commitment to data integrity, operational efficiency, and regulatory compliance. This Guide offers practical guidance and best practices for navigating the complexities of implementation and operation.
Learn more about The ISPE Good Practice Guide: Digital Validation
Disclaimer:
iSpeak Blog posts provide an opportunity for the dissemination of ideas and opinions on topics impacting the pharmaceutical industry. Ideas and opinions expressed in iSpeak Blog posts are those of the author(s) and publication thereof does not imply endorsement by ISPE.
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