2022
80% of professionals reported increased workloads - the benchmark was set.
Five Years of Validation Industry Insight
The State of Validation is an annual validation industry report, powered by Kneat Solutions, that aims to shed light on the practices, progression, and pitfalls of the validation industry globally.
From 2022 to 2026, the State of Validation has surveyed over one thousand validation professionals across six continents – capturing how the industry has changed, adapted, and accelerated.
Fivefold Growth in Digital Validation
From 12% to 64% in five years. The shift is structural. Digital validation adoption has grown more than fivefold since 2022, with 64% of organizations now using or actively implementing a dedicated solution. Full adoption nearly doubled in a single year - from 16% to 30% - signaling that the industry has passed a tipping point (see graph below).
Using or implementing
Key Validation Challenges
In 2026, for the third consecutive year, audit readiness ranks as the number one challenge facing validation teams - followed closely by compliance burden and data integrity. These three regulatory-facing challenges have now held the top three positions since 2024 while sample participation has varied, confirming a sustained industry-wide focus on inspection preparedness and documentation integrity (see table below).
| Rank | 2026 | 2025 | 2024 | 2023 | 2022 |
|---|---|---|---|---|---|
| #1 | Audit readiness | Audit readiness | Compliance burden | Shortage of human resources | Shortage of human resources |
| #2 | Compliance burden | Compliance burden | Audit readiness | Efficiency | Efficiency |
| #3 | Data integrity | Data integrity | Data integrity | Lack of tech resources | Lack of tech resources |
Five Years, Five Signals
2023-2024
Digital adoption tripled from 12% to 30% as organizations moved from planning to implementation.
2025
A surge to 58% adoption as previously in-progress organizations crossed the finish line.
2026
Workload returns to its 2022 peak - but 67% now report greater efficiency than a year ago.
2022-2026
Audit readiness and data integrity have anchored the top challenges for three consecutive years.
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