Approaches to Assay Processing Package Validation
summary
Five concrete steps for validating internal R packages at SCHARP: write numbered specifications, annotate functions with ownership metadata, author human-readable test cases, have a third party implement tests, and compile results into a single validation artifact. Workflow uses roxygen2 for ownership tags, testthat for executable tests and reporter objects, and rmarkdown to generate a signed PDF that maps specifications to pass/fail outcomes, supports FDA 21 CFR 11 style needs, and is used on live trial data.
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chapters (7)
- 0:00Start
- 4:53Specifications What are the requirements of the package?
- 5:24Recording specifications Record Specifications in markdown
- 7:03Documenting code ownership
- 9:33Documenting Test Cases
- 10:12Modular Test Case Documentation
- 10:32Test Coding Implement Test Cases
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