Project Scope

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

Project Leads


Ellis Hughes 

Lauren White (PHUSE Project Coordinator)
Objectives and DeliverablesTimelines

Develop and submit a white paper detailing the elements that would be required for any open source technologies user-contributed extensions.

Q3 2021 

Develop an R package that would provide the necessary tools and guide the user through the necessary steps to achieve a validated R package. 

Q4 2021 


White Paper published on the PHUSE Website, project concluded. 

Project Members 


Aiming Yang


Chris Battiston Women’s College Hospital
Drew Foglia Veeva Systems

Hanming Tu

Frontage Laboratories

Heidi CurinckxJanssen Research & Development

Katherine Ostbye  

(SCHARP) Fred Hutchinson
Kelci MiclausVeeva
Kostas LymperisOmicron

Marie Vendettuoli

(SCHARP) Fred Hutchinson

Mike Stackhouse

Atorus Research

Paul Stutzman 

(SCHARP) Fred Hutchinson
Pavan ReddyGENINVO

Peyman Eshghi

Janssen Research & Development
Philip Bowsher


Rafael Kuttner(SCHARP) Fred Hutchinson

Shrishaila Patil

Navitas Life Sciences
Srinivasa PilarisettyAstraZeneca 
Stella Guo Bayer
Ting Zhang


Yoni Sidi


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