(Kneat: Limerick, Ireland) -- Kneat, a global leader in digital validation and quality process automation, announced the findings of its annual study of the practices, trends, and challenges in the validation space, State of Validation 2026. Informed by more than 600 responses from validation professionals around the world, the report paints a picture of an industry facing intensifying workload demands while continuing to advance in digital validation and AI adoption.

Despite the progress the industry has made digitizing its validation data, with nearly two-thirds either fully using or actively implementing a dedicated digital validation tool, the report shows that full digital maturity is still limited. With only 13% of respondents saying their organization is fully digital across all record types, there remains considerable ground to cover.

Paper still dominates core GxP records in 2026.

Other findings in the 2026 State of Validation study

Validation workload pressure is rising

80% of respondents say their organization’s validation workload increased over the past year, with 45% describing that increase as significant. This steep ramp in requirements reinforces the need for scalable and more efficient operating models, especially considering that paper remains persistent in critical documentation. 41% of respondents say logbooks are still primarily paper-based, 35% say the same of batch records, and 33% cite validation protocols.

Digital investment is generating measurable operational value

Among respondents with implemented or in-progress systems, 74% say ROI has met or exceeded their initial predictions. Within that group, 53% say ROI has exceeded initial predictions, including 30% who say it has significantly exceeded expectations.

Logbooks, batch records, and validation protocols are the most frequently cited record types where paper persists.

AI is being adopted in GxP environments, with governed, human-reviewed use cases favored over fully autonomous ones: 78% of respondents are confident that AI will become a standard part of validation by 2030, and nearly 40% of organizations are either using or actively evaluating AI in a GxP validation or quality setting right now. The most widely accepted use case is AI used for drafting or summarization with mandatory human review, selected by 53% of respondents. AI and automation ranks last as a driver of future improvement.

This doesn’t indicate that AI is considered unimportant—the preceding sections demonstrate strong and growing AI engagement. Rather, it reflects the sequential logic of practitioners:
• Digital transformation and data integrity must come first.
• AI and automation build on that foundation.

Acceptance declines as autonomy increases:
• 38% consider AI decision support with human approval acceptable.
• 37% accept deterministic rules-based automation.
• 29% accept AI that executes workflow actions automatically with an audit trail.
• 16% accept AI making or changing GxP decisions autonomously without human approval.

Digital maturity is emerging as a prerequisite for responsible AI deployment in regulated environments. Digital transformation is seen as the most transformative development for improving validation, while AI ranked last.

This prioritization signals that AI and automation must build on a solid, trusted digital foundation, and it is. Among organizations that have fully implemented a digital validation tool, 64% are currently using or piloting AI in validation or quality activities, compared with 13% of those with no plans to adopt a digital validation tool.

Eddie Ryan, CEO Kneat Solutions, says, “We thank every respondent who contributed their time and expertise to the 2026 study. These findings, drawn from professionals across six continents and more than 30 industries, paint a picture of a profession under pressure—but responding with growing sophistication, strategic investment, and a clear eye on what comes next.”