Speaker
Description
The use of R packages in a regulated environment as in pharmaceutical companies might require a formal validation of the R package.
The Validation Hub introduces best practices and insights from pharmaceutical industries for the validation of R packages for use within the biopharmaceutical regulatory setting.
We will contribute to this effort by presenting a git-based workflow to automate the creation of validation form of a R package with the help of the pkgTesteR R package.
The validation form of any R packages containing tests created with the testthat R package and tracked with git can be created with the R package.
The user requirements, extracted from the tests descriptions, are consistently and incrementally numbered since a base (production) version of the package based on the git history, to ensure consistency of the form across versions. The review of the validation form for an updated version of the package is facilitated thanks to the identification of new tests between package versions (~ git tags).
The workflow for the creation and the use of such validation form by the package will be demonstrated on R packages developed for interactive medical oversight reporting in R.
Additional Material or Paper
https://github.com/openanalytics/pkgTesteR
If you used AI tools or services to support the preparation of this submission, please state the name and reason for using each of them.
No AI tools/services were used.
| Keywords: Please list up to 5 keywords to help us find the right session for your contribution. | package validation, git, production, regulatory environment |
|---|---|
| Virtual Option | This submission is for onsite presentation primarily, but I would also like it to be considered for pre-recorded virtual presentation if I don't get an onsite slot |
| Video Recording | Video sharing is fine |
| The author(s) agree(s) to take responsibility and be accountable for the contents of the submission and is/are authorized to present it. | Confirm |
| Interested in serving as reviewer? | laure.cougnaud@openanalytics.eu |