Author and methodology
Research
Independently authored by a leading Academic Researcher, State of Validation comprises a broad quantitative and qualitative primary market research study, conducted directly with validation professionals around the world.
About the Author
2026 Author
DONNCADH J. 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 and 2024
- 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.
Study design
Methodology
State of Validation comprises a broad quantitative and qualitative primary market research study, conducted directly with validation professionals around the world.
Objective and Study Type
State of Validation develops a comprehensive industry data set to analyze the forces impacting the validation industry, its professionals, and organizations required to perform validation as a regulated function. This data set allows validation professionals to analyze, self-identify, and benchmark their own practices and experiences against industry standards.
State of Validation is an annual cross-sectional study. Over time, this study will enable longitudinal analysis of broader trends that impact the validation industry. Through consistent yearly analysis, it aims to establish and track these trends, providing valuable insights for the industry.
Participant Demography and Limitations
State of Validation’s target populace is any professional currently employed in any validation, quality, or compliance function, under which compliance to the following principles, guidelines and regulations are required:
- ALCOA++
- International Council for Harmonization (ICH)
- FDA 21 CFR parts 11, 210, and 211
- EU GMP Annex 11 and 15
- GAMP 5
Participants in theState of Validation study include validation professionals with a wide range of years of experience, job function, seniority/rank, geographic location, industry vertical, organization size, and team size. Participants include both professionals engaged directly in validation or those organizations providing equally regulated support services or products to relevant industries. All participants’ responses are vetted for relevancy.
Data
Capture
The capture of data is facilitated through an online survey, globally distributed and tested for question logic. The survey is served to many potential participants via a range of distribution channels, including email, in-person events, and hosted online on a dedicated survey website.
As an incentive to complete the survey, a small gift card is provided to eligible participants as compensation. To protect the integrity of the study, compensation is given only to participants with valid corporate email addresses. Quality analysis is performed on submissions. Submissions deemed to be invalid are excluded from the sample size.