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

From: AJ Rossini <blindglobe_at_gmail.com>
Date: Sat, 09 Jun 2007 17:32:59 +0200

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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