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_install()
pandoc_activate()

# Install the TinyTeX bundle plus the grfext package
install_tinytex(bundle="TinyTeX",
                force=TRUE,
                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())

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

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.