The R package RPACT will be a fully documented and validated product, including
- user requirements specification,
- functional specification,
- technical design specification,
- test plan,
- installation guides,
- user guides, and
- release notes.
The validation of the R package will be done compliant to FDA/GxP guidelines and to the validation process of “Base R” and “Recommended Packages” as described in: “R: Regulatory Compliance and Validation Issues, A Guidance Document for the Use of R in Regulated Clinical Trial Environments” (The R Foundation for Statistical Computing, December, 2014).