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pharmaR / case_studies

The repository contains case studies contributed from companies and individuals, who are implementing a risk-based approach to validate R packages. Disclaimer: This are public content and not part of any R Validation Hub beliefs.
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General: SDLC document #4

Open jmanitz opened 2 years ago

jmanitz commented 2 years ago

Generally which SDLC document is mostly created for packages? like GxP assessment, Validation pla, IQ, OQ and then PQ? did you consider GAMP category for package or for overall software? Or the SDLC validation is just limited to package selected for installation. So only test related to package which affect overall functionality is considered for documentation.?

bizzinho commented 2 years ago

We do not perform a GxP assessment w.r.t. packages because the context of use cannot be inferred from the package itself. Such an assessment is only done for the derived product.

We perform IQ and OQ for all pre-installed packages, and additional PQ tests for high-risk packages. The risk assessments together with collected evidence is uploaded into a DMS and referenced in our deployment reports.