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

From: Frank E Harrell Jr <>
Date: Fri, 08 Jun 2007 09:45:17 -0500

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?
> Giovanni

Search the archives and you'll find a LOT of responses.

Briefly, in my view there are no requirements, just some pharma companies that think there are. FDA is required to accepted all submissions, and they get some where only Excel was used, or Minitab, and lots more. There is a session on this at the upcoming R International Users Meeting in Iowa in August. The session will include dicussions of federal regulation compliance for R, for those users who feel that such compliance is actually needed.


Frank E Harrell Jr   Professor and Chair           School of Medicine
                      Department of Biostatistics   Vanderbilt University

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Received on Fri 08 Jun 2007 - 15:37:03 GMT

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