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

From: <>
Date: Fri, 08 Jun 2007 09:53:20 -0700

As I read 21 CFR 11, the regulation deals more with ensuring the security of the electronic health record itself. Thus, it seemed to me that so long as the software (SAS, R, Splus, etc.) could not alter the data base in any way then you're fine (this may be naive, but that's how I understood it). The 'software validation' referred to in the document seems to be concerned with software that is directly related to the device (i.e. software that is part of the functionality of the device). How on earth could you really validate every process that a stat software package is capable of anyway? It seems to me that we would be better off focusing our attention on the quality of the programming/data manipulation rather than on the 'validation of the software' (which in terms of verifying its complete functionality isn't possible anyway). I'm also curious that the open source (i.e. non-black-box) nature of R hasn't struck more of a chord with regulatory bodies.

I tried to make the case above to our software quality people, but they insisted on a full OQ/IQ/PQ plan (which I'm in the process of drafting - possibly my most boring task ever). In addition, my boss insisted on using Splus instead of R because I couldn't convince him that R would be acceptable (even though the OQ/IQ/PQ requirements would have been the same and R would have saved money). That said, I would have had to write new OQ/IQ/PQ plans every time there was a new version of R available (ouch). I have no complaints with regards to Splus, but R would have been free.

One last thought to add to Bert's - I think one other thing that is holding up the spread of S to the pharma/device companies is the availability of S programmers (SAS programmers are plentiful). I tried to get 'has experience in S' added to our next job opening, but my boss insisted that we would never find a person with experience in SAS and S. I countered by asking if we could just ask for S experience (and drop the SAS requirement), but he gave me a dirty look. :)

Cody Hamilton, PhD
Edwards Lifesciences

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