rqualify

Installation

You can install the package via CRAN:

install.packages("rqualify")

The package can also be installed from this Github repository using the following:

# If needed install.packages("remotes")
remotes::install_github("Medtronic-Biostatistics/rqualify")

Purpose

The purpose of this package is to ease the R software validation steps required for regulatory submissions. The rqualify function automates the generation of a validation document that can be used to demonstrate that an R environment is suitable for use in a regulated setting.

R Software Qualification

Once the rqualify package is installed, there are a few ways to execute the validation process. For instance, you can install Pandoc and TinyTeX as follows:

library(rqualify)

# Install and activate Pandoc
pandoc::pandoc_install()
pandoc::pandoc_activate()

# Install the TinyTeX bundle plus the grfext package
tinytex::install_tinytex(bundle="TinyTeX",
                force=FALSE,
                extra_packages="grfext")
              
rqualify(path_save     = tempdir(),
         setup_tinytex = FALSE,
         setup_pandoc  = FALSE)

Alternately, a more convenient approach to execute the entire validation process can be used, where the Pandoc and TinyTeX installation process are wrapped inside the function:

library(rqualify)
rqualify(path_save = tempdir())

Another alternative is to use Quarto, especially if you want to execute the validation process from within RStudio:

library(rqualify)
rqualify(path_save     = tempdir(),
         setup_tinytex = FALSE,
         setup_pandoc  = FALSE,
         engine        = "quarto")

In any case, ensure that the path_save location does not already include a folder named R-validation. See ?rqualify for more info.

Pass details = TRUE to return the overall status, per-suite results, report paths, and tool versions. The same information is saved as validation_result.rds in the output folder. A status of "ok" requires a complete, valid summary with all tests passing.

Quarto uses its bundled Pandoc and Typst; the TinyTeX and Pandoc setup arguments apply only to the LaTeX engine. Existing tools are reused when available.

Special Thanks

We would like to thank Marc Schwartz for allowing us to modify R-IQ-OQ into the RMarkdown file made available by this package. As the original code was released under the GNU GPL version 2 license, we are adhering to the licensing and releasing this package under GNU GPL version 2 as well.