[R] Validation of R
Frank E Harrell Jr
fharrell at virginia.edu
Thu Apr 17 18:10:47 CEST 2003
On Thu, 17 Apr 2003 10:38:06 -0400
partha_bagchi at 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
More information about the R-help