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There is consensus across industry that software used for regulatory submission needs to be validated. However, there are few industry accepted guidelines on what is specifically required to meet the bar of validation for Open Source tools and user-contributed extensions, specifically R and R packages.

There are two deliverables from this project: a White Paper and an R package. The White Paper will serve as a reference for industry on how to perform validation for user-contributed extensions of programming software. It will detail the elements that need to be met for the extension to be validated, and ways to document the process in a reusable, efficient, and sharable fashion. The R package will be developed to provide the tools and guidance for validating an R package. It will show how to take advantage of the tools that exist in the R language, and it will be based on the White Paper to ensure the baseline requirements are achieved.

With these tools, there will be a standard to reference on how to approach validation of extensions to the R language. Additionally, by demonstrating how to perform validation, the framework can be more generally applied to software extensions in other languages.

Eli Miller

Ellis Hughes

ellishughes@live.com