[R] Regulatory Compliance and Validation Issues

Thomas Lumley tlumley at u.washington.edu
Sun Aug 19 17:50:17 CEST 2007

On Fri, 17 Aug 2007, Cody Hamilton wrote:

> I have a few specific comments/questions that I would like to present to 
> the R help list.
> 2. While the document's scope is limited to base R plus recommended 
> packages, I believe most companies will need access to functionalities 
> provided by packages not included in the base or recommended packages. 
> (For example, I don't think I could survive without the sas.get() 
> function from the Design library.)  How can a company address the issues 
> covered in the document for packages outside its scope?  For example, 
> what if a package's author does not maintain historical archive versions 
> of the package?  What if the author no longer maintains the package? 
> Is the solution to add more packages to the recommended list (I'm fairly 
> certain that this would not be a simple process) or is there another 
> solution?

This will have to be taken up with the package maintainer.  The R 
Foundation doesn't have any definitive knowledge about, eg, Frank 
Harrell's development practices and I don't think the FDA would regard our 
opinions as relevant.

Archiving, at least, is addressed by CRAN: all the previously released 
versions of packages are available

> 3. At least at my company, each new version must undergo basically the 
> same IQ/OQ/PQ as the first installation.  As new versions of R seem to 
> come at least once a year, the ongoing validation effort would be 
> painful if the most up-to-date version of R is to be maintained within 
> the company.  Is there any danger it delaying the updates (say updating 
> R within the company every two years or so)?

It's worse than that: there are typically 4 releases of R per year (the 
document you are commenting on actually gives dates).  The ongoing 
validation effort may indeed be painful, and this was mentioned as an 
issue in the talk by David James & Tony Rossini.

The question of what is missed by delaying updates can be answered by 
looking at the NEWS file. The question of whether it is dangerous is 
really an internal risk management issue for you.


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