The 2025 State of Validation report offers a compelling look into the structure, skills, and pressures shaping validation teams around the globe. With insights from 300+ professionals across industries, the “People and Organizations” section of the report reveals both the strengths and the stresses facing today’s validation functions.
Here are three top takeaways:
1. Small but mighty teams are the norm
Team size
Despite increasingly complex workloads, validation teams remain lean. Thirty-nine percent of companies report having fewer than three dedicated validation professionals. Even at scale, organizations are managing regulatory compliance, system qualifications, and audit preparation with minimal headcount. This trend underscores the need for scalable processes and external support.
And with 66 percent of respondents noting a year-over-year increase in validation workload, it’s clear that resource-strained teams are being asked to do more with less. That pressure is pushing organizations to rethink their operational models and invest in smarter resourcing strategies.
2. Strategic outsourcing is on the rise
Validation outsourcing
Outsourcing continues its upward climb, with 70 percent of companies now relying on external partners for at least some portion of their validation work. Notably, 25 percent of organizations outsource more than a quarter of their validation activities.
It appears this isn’t just a workaround for understaffing — it’s a strategic shift toward accessing specialized expertise, reducing internal bottlenecks, and driving agility. The data points to outsourcing as a core element of validation strategies today, helping organizations stay responsive in a highly regulated and resource-constrained environment.
Want to explore these trends in more depth? Watch the on-demand webinar “2025 State of Validation” — featuring Kneat CEO, Eddie Ryan, Sr. Manager Customer Success Engineering, Jamie O’Donnell, Oliver Czempiel, Sales Director, Körber Pharma, and Michael Rodionov, Principal, MMR Consulting — and get expert analysis and firsthand insights from the 2025 State of Validation study.
3. Audit readiness takes center stage
Team challenges
In a shift from previous years, audit readiness has emerged as the number one challenge facing validation teams in 2025, overtaking compliance burden and data integrity. With increased scrutiny from regulators and evolving expectations around electronic audit trails, organizations are feeling the heat.
This heightened focus on audit success is influencing everything from team structure to investment in digital tools. It’s also amplifying the need for rigorous documentation practices and cross-functional alignment to ensure inspection readiness at all times.
Final thoughts
Today’s validation teams are navigating a high-stakes environment with limited internal resources and rising expectations. As organizations continue to digitalize and adopt technology, the findings from this section of the report make it clear: building resilient, audit-ready validation teams requires smarter strategies, scalable systems, and stronger partnerships. Want more insights like these? Explore the full 2025 State of Validation report now.
