Research

Now in its fifth year: the world’s only annual survey and research study of validation professionals.

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.

The 2026 data opens with one of the study’s strongest signals yet — workload pressure has returned to its highest recorded level (see graph below).

Validation Workflow Pressure

% reporting increased workload, 2022–2026

100%
75%
50%
25%
0%
2022
2023
2024
2025
2026

Eighty percent of validation professionals reported increased workloads in 2026, matching the five-year high set in 2022. The brief easing seen in 2023-2025 has reversed sharply, with 45% now characterizing the increase as significant - the highest proportion in the study's history.

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 establishes and tracks 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++
  • EU GMP Annex 11, 15
  • FDA 21 CFR Part 11, 210, 211
  • ICH
  • EU AI Act

  • EU GMP Annex 22
  • GAMP 5
  • FDA discussion papers
  • MHRA guidance
  • PIC/S guidance

Methodology

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.

Participants in the State 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.

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. 

2026 State of Validation