2024 Report
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ABOUT STATE OF VALIDATION
VALIDATION INDUSTRY INSIGHT
State of Validation 2024 is the third of an annual series of state of the industry reports powered by Kneat Solutions, that aims to shed light on the practices, progression, and pitfalls of the validation industry globally.
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 worldwide.
The study captures a snapshot of the forces impacting the validation industry and track trends over time. From technological and regulatory change to commercial and market influences, organizational change and strategy, professional development and more, the State of Validation studies are a comprehensive analysis of the validation industry.
About the Author
Author
Jonathan Kay
Jonathan Kay is a trusted advisor to life sciences and digital health companies. He has supported the successful development, launch, and commercialization of dozens of medical devices, diagnostics, vaccines, and therapeutics to address unmet needs in cancer, cardiovascular disease, infectious disease, rare disease, and more. His mission is to advance new technologies that save and improve lives and expand access, equity, and value. He does that by helping industry to understand complex landscapes through market research. In 1999, Jonathan co-founded one of the first online medical market research firms, helping to digitally transform that industry. He has served in leadership roles in the US and globally in WPP agencies, including PSB Research, where he formed the healthcare practice and led it for a decade, TNS Healthcare, and Kantar Health (now Cerner Enviza / Oracle). Jonathan earned a B.A. from Cornell and a Master in Public Policy from the Harvard Kennedy School of Government. He is fascinated by the application of artificial intelligence to healthcare and completed studies of ‘Artificial Intelligence: Implications for Business Strategy’ at MIT. Jonathan is also a board member of the Brem Foundation to Defeat Breast Cancer and a volunteer mentor to CEOs of start-ups at the Maryland Tech Council.
Study design
Methodology
State of Validation comprises a broad quantitative and qualitative primary market research study, conducted directly with validation professionals worldwide.
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+
- EU GMP Annex 11, 15
- FDA 21 CFR Part 11, 210, 211
- GAMP 5
- International Council for Harmonisation (ICH)
Participants in the 2024 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. 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.