Introduction to rqualify

The primary goal of rqualify 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.

Once the rqualify package is installed, executing the validation script is as simple as running the function:

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

Ensure the folder you specify does not already include a folder named R-validation. See ?rqualify for more info.

How does rqualify work?

The rqualify function performs the following steps:

1. Creates the folder tree R-validation/IQ-OQ-TestOutput at the specified path_save.
2. Installs TinyTeX and necessary LaTeX packages (if setup_tinytex=TRUE).
3. Installs Pandoc (if setup_pandoc=TRUE).
4. Copies R-validation.Rmd to the R-validation folder.
5. Executes the IQ-OQ by rendering R-validation.Rmd to R-validation.tex.
6. Compiles R-validation.tex to R-validation.pdf.

In case you are developing a process for user-level qualification, the file R-validation.Rmd located in the root directory of this package at qualify_r/R-validation.Rmd can be used as a template for your own validation document. Note, if viewing on Github, the R-validation.Rmd file is located at inst/qualify_r/R-validation.Rmd.

Tips for a Successful Qualification

• Best practice is to Install and execute the qualification code on a new and fresh installation of R, prior to installing additional packages.
• Install and validate on a new minor release of R, e.g., upgrading from 4.4.3 to 4.5.1; notice the bold numbers indicate the minor releases.
• If unwilling to install and validate on a new minor release of R, e.g., upgrading from 4.4.1 to 4.4.2, the validation may fail.
• If running the validation a second time within the same R-validation folder, remove or rename the IQ-OQ-TestOutput subfolder that was created.