Validation Protocol Development
Validation Protocol Development is a formal academic concept within the discipline of Process Validation that denotes the systematic design and documentation of a predefined plan specifying the procedures, acceptance criteria, and statistical rationale required to verify that a manufacturing process consistently produces a product meeting its predetermined quality attributes.
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2.1K
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183
Authors
111
Institutions
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2017–2026
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Acceptance Criteria SpecificationDocument Control For ValidationProtocol Approval CriteriaProtocol Deviation HandlingProtocol Lifecycle ManagementRisk-based Validation PlanningStatistical Methods For ValidationTest Script DevelopmentValidation Master Plan DevelopmentValidation Plan Development
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Processus de preuve et situations de validation
Nicolas Balacheff · Educational Studies in Mathematics · 1987 · 273 citations · Full text
Improving Validation Practices in “Omics” Research
John P. A. Ioannidis, Muin J. Khoury · Science · 2011 · 247 citations · Full text
Recommendations of the wwPDB NMR Validation Task Force
G.T. Montelione, Michaël Nilges, Ad Bax et al. · Structure · 2013 · 173 citations · Full text
An improved protocol validation technique
Jack Rubin, Colin H. West · Computer Networks (1976) · 1982 · 102 citations
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National Institute of Standards and Technology, United States
1 publications · 18 citations
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Delft University of Technology
Delft, The Netherlands
3 h-index
3 publications
103 citations
Vrije Universiteit Brussel
Brussels, Belgium
2 h-index
2 publications
213 citations
Wageningen University & Research
Wageningen, The Netherlands
2 h-index
2 publications
61 citations

Radboud University Nijmegen
Nijmegen, The Netherlands
2 h-index
4 publications
50 citations
Joint Research Centre
Ispra, Italy
2 h-index
4 publications
346 citations
National Institute for Public Health and the Environment
De Bilt, The Netherlands
2 h-index
5 publications
191 citations

University of Liverpool
Liverpool, United Kingdom
1 h-index
1 publications
13 citations
University of Patras
Pátrai, Greece
1 h-index
1 publications
13 citations
1–8 of 111
Repository · 2 publications · 43 citations
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1 publications · 37 citations
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FSI · 1 publications · 18 citations
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1 publications · 247 citations
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1 publications · 10 citations
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