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Abstract:
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In recent years, R has gained significant popularity as a statistical software in the academia mainly because it is free, open source, and vastly used in academic research. This popularity has reached the health sector and other regulated industries. As a consequence, an avalanche of concerns has been raised by statisticians, statistical programmers, quality assurance teams and others within the pharmaceutical industry about the use of R and selected R packages as primary tools for statistical analysis for regulatory submission work. To address such concerns, the R Consortium set in motion the R Validation Hub, a collaboration to support the adoption of R within a bio-pharmaceutical regulatory setting. In this paper, we will introduce the Risk Assessment Shiny Application, one of the tools currently in development by the R Validation Hub to aid in the validation of R packages in regulated environments.
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