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).