[R] "R is not a validated software package.."

[AJ Rossini]

On Friday 08 June 2007, Giovanni Parrinello wrote:
> Dear All,
> discussing with a statistician of a pharmaceutical company I received
> this answer about the statistical package that I have planned to use:
>
> As R is not a validated software package, we would like to ask if it
> would rather be possible for you to use SAS, SPSS or another approved
> statistical software system.
>
> Could someone suggest me a 'polite' answer?
> TIA
> Giovanni

You can't validate any complex software package, i.e. computer programming 
language complexity (SAS, R, S-PLUS, SPSS, PERL, Python, Ruby, Java....)

You can qualify a software package, and validate code written in it.

As a "statistician" in a very large pharmaceutical company based in Basel 
which happens to be bigger than the other large pharma in Basel, I can say 
that we should have most of the paperwork done for qualification, at some 
point this year, for use as part of submission packages.  Whether it will be 
used is another matter, which will be driven by business needs :-).

So your colleague is right, only in the sense that whatever the company has 
approved is appropriate, and qualification in the "computer systems 
validation" context is expensive, time and man-power wise.  But that holds 
true for any software package.

Your colleague should have technically said:  "As R is not a qualified 
software package at my company, we would like to ask if it would be possible 
for you to use software which my company has approved and done 
the /risk-management/ paperwork for and gotten approval from our Clinical 
Quality group to use". 

This is an issue -- however, whether R could pass that is not an issue, it 
clearly could be done if they wanted to do it.
 
best,
-tony

blindglobe at gmail.com
Muttenz, Switzerland.
"Commit early,commit often, and commit in a repository from which we can 
easily
roll-back your mistakes" (AJR, 4Jan05).
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