Report

GLOBAL TRENDS AND BENCHMARKS FROM THE 2026 STUDY

The industry’s only benchmark of validation practices worldwide.

KEY 2026 TAKEAWAYS:

  • Workload at a five-year high: 80% of validation professionals report increased workloads in 2026 - the highest figure since the study began.

  • Digital adoption accelerates: 64% of organizations are now using or actively implementing a dedicated digital validation tool - up from 58% in 2025.

  • ROI exceeds expectations: Of those who could assess return on investment, 74% say digital validation met or exceeded their initial predictions.

  • AI has arrived: 39% of organizations are now using or actively evaluating AI for GxP validation - and 78% believe it will be standard practice by 2030.

Validation Industry Insight

The 2026 State of Validation report is the industry’s most comprehensive benchmark of validation practices worldwide. Based on insights from 614 professionals across life sciences and other regulated industries – the largest sample in the study’s five-year history – the report reveals how teams are navigating mounting workload pressures, accelerating digital transformation, and the unmistakable arrival of AI in GxP environments.

Each year, the study highlights where the industry stands today – and what’s ahead.

About the 2026 Author

Donncadh Nagle

Donncadh Nagle is a pharmaceutical industry professional based in Ireland. Currently working as a Senior CQV consultant with Jacobs Engineering, he is also a Lecturer with the School of Chemistry and BioPharmaceutical Sciences at Technological University Dublin (TU Dublin).

He is an experienced validation engineer with over 18 years of experience in all areas of validation including: process/product validation, equipment/automation qualification, facilities qualification, computer system validation, test method validation, and cleaning validation.

A published author, Donncadh has ambitions to become an industry leader within the pharmaceutical industry and is part of the Pharmaceutical Regulatory Science Team (PRST), Dublin, Ireland, currently researching and exploring the role emerging technologies, artificial intelligence and digitalization can play within the pharmaceutical industry. This research involves exploring possible use cases using these technologies while assessing potential regulatory impacts within the pharma and life sciences industries.

Other notable achievements and positions held include:

  • Published author with IVT/JVT (USA), KENX (USA), and TU Dublin
  • Winner of the 2019 Noel Whelan Memorial award (HPRA Academic Award)
  • KENX Insight Editorial Board member
  • Chair of the BPCI Validation group, Ireland
  • Kneat Gx trained and guest speaker at Kneat VALIDATE 2023, 2024, and 2026
  • Designed new Digital Validation Module for TU Dublin 2024

Donncadh has also an additional nine years’ experience working as a Project and Process Engineer in the medical device and electronics industries.