I agree with your points and if you notice I share your philosophical 
view. I was commenting more on what you call "mind" share. It is still 
real. 

However, also a minor point  - there is mention in the regs regarding COTS 
software (which I believe stands for Commercial of the Shelf software) ..






Frank E Harrell Jr <fharrell@virginia.edu>
04/17/2003 12:10 PM

 
        To:     partha_bagchi@hgsi.com
        cc:     v_bill_pikounis@merck.com, k.benjamin@retroscreen.com, 
r-help@stat.math.ethz.ch, a.mann@retroscreen.com, 
s.balasingam@retroscreen.com, r.lambkin@retroscreen.com, 
s.bossuyt@retroscreen.com
        Subject:        Re: [R] Validation of R


On Thu, 17 Apr 2003 10:38:06 -0400
partha_bagchi@hgsi.com wrote:

> However, the perception out there is the "SAS is the accepted software"
> especially for regulatory submission and especially in the US. Thus, I
> think validation usually means "Yeah, but did you use SAS to get the
> answer" , no matter how irrelevant the question is. For a
> non-statistician, or a person doing validation certain software do not
> need validation (Microsoft Word, SAS etc.) certain other , perhaps more 
so
> for open source, validation is essential.

SAS is NOT the accepted software for FDA, because FDA does not accept ANY 
brand of software.  This is really a "mind share" issue at pharma 
companies.  SAS is not validated in every sense; there is a huge list of 
current SAS bugs.

Validation is best done on a per-project basis as you can't anticipate all 
aspects of a particular dataset.  The validation can be done by 
independent calculations of pivotal findings.  For R there is an 
especially good opportunity because if you are using the base packages you 
can run essentially the same code in S-Plus to get an independent 
validation of the underlying calculations (but not of your S code).  The 
base code in R is independent of that in S-Plus (this is not true of most 
add-on packages by users).  There is no other "SAS" you can run.

---
Frank E Harrell Jr              Prof. of Biostatistics & Statistics
Div. of Biostatistics & Epidem. Dept. of Health Evaluation Sciences
U. Virginia School of Medicine  http://hesweb1.med.virginia.edu/biostat

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