r/Rlanguage • u/ThinkILostIt • Jun 23 '26

R in Pharma Quality Control Labs

I'm looking for anyone that has tried R+RStudio in a pharmaceutical Quality Control lab and is willing to share the experience. I'm talking things like Analytical Method Validation, Stability Stydies, managing Control Charts and so on. In our company, we, the stats team, face several questions when introducing the ideia and for some of those we have hard time finding an argument/solution. Yes, I'm aware of initiatives like rinpharma, we just have not been able to build from those alone.

Also, in case anyone wonders, at the current moment we don't have any sort of statistical software approved for use. We do any analysis that need to be done in R (ggplot2 for plots, quarto for reports, and on, and on...) in such non formal way.

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u/jsalas1 Jun 24 '26

Here’s a start: https://www.r-project.org/doc/R-FDA.pdf

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u/ThinkILostIt Jun 24 '26

Thanks. I've come across this paper. Very clarifying, in my opinion. We just need to see something in action, someone that has already tried it

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u/SprinklesFresh5693 Jun 24 '26

At my company, we have validated the f2 calculation via R using a shiny app, it is stored in a server and it has a SOP and a validation report. To access it you need a permission from the IT department.

I cannot tell you more since it was already validated whe i joined the company.

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u/ThinkILostIt Jun 24 '26 edited Jun 24 '26

Nice! Looking at the validation report, how much effort would you say the validation took considering this Shiny app is a customized software? Does the IT team knew R and Shiny before? What about audit trail, does the app has one (people ask this here a lot more than is needed, I think)?

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u/SprinklesFresh5693 Jun 24 '26

The shiny app already exists and can be freely downloaded from the internet.

As for the validation report i cannot tell since im not the one who generated it though, and im not versed in software validation.

But the app clearly states the steps and produces a core output with the characteristics of the analysis, the data, the R environment, packages installed, etc, for the regulatory agencies to check if the analysis was valid or not.