On Friday 16 March 2007 09:36, Delphine Fontaine wrote: > Thanks for your answer which was very helpfull. I have another question: > > I have read in this document > (http://cran.r-project.org/doc/manuals/R-intro.pdf) that most of the > programs written in R are ephemeral and that new releases are not > always compatible with previous releases. What I would like to know is > if R functions are already validated and if not, what should we do to > validate a R function ?
Validation is in the eye of the beholder. In particular, for clinical studies, from the corporate or institutional point of view, "what we should do to validate an R function" should be answered by the local Standard Operating Procedures (SOPs) for "what should we do to validate a computer programming language function". If you are working with clinical trials as part of a health authority submission process, you should have those in place. Of course, what you probably are interested in is an approach where you qualify R, and validate programs and packages written for R, which might be another better approach, in which case the same applies. Your SOPs should apply to both. (Now, assuming that you've done a reasonable job on the processes, as per Mats' answer, the point is that "R" vs. anything else is a simple red herring, as there is nothing in the spirit of the regulations which differentiates any of the characteristics of R with any other reasonable piece of software, for appropriate definitions of reasonableness). <digression title="semi-relevant, on SOPs and commercial software"> I should point out that a certain large company I'm familiar with, who uses a certain "famous" piece of statistical software for activities perhaps described above, can't use the most recent version because of interesting issues with its "self qualification" tool, which prevents it from self-qualifying the new version on any installation on a certain operating system originating near where I used to live, when the previous version of the famous software had been installed. This feature, if not reverted, would necessitate total disk wipe of ALL computers requiring qualification running this operating system, where the new version of this famous piece of software would be installed, if this certain large company wants to follow it's SOPs. This is apparently a feature, not a bug, and demonstrates clearly the benefits and joys of commercial support when millions of swiss francs of licensing fees are involved. </digression> I'm not a lawyer, nor am I speaking for any corporation indirectly referenced above, nor will I provide sufficient justification to help anyone else take any of the statements as a fact. best, -tony [EMAIL PROTECTED] 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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