[R] FDA and ICH Compliance of R

Thomas Lumley tlumley at u.washington.edu
Wed Nov 26 17:24:12 CET 2003

On Wed, 26 Nov 2003, Antonia Drugica wrote:

> Does anybody know if R is FDA or ICH (or EMEA...) compliant? AFAIK S-Plus
> is but that means nothing...

Actually, "FDA compliant" means nothing. The FDA does not certify
statistical software and responsibility for validation is left entirely up
to the user.

Insightful Co, the S-PLUS vendors provide some tools to help you with
validation and some information on validation that pharmaceutical
companies have done.

The only validation tools provided with R are the tests used by the
developers.  These show which aspects of R have been tested and might
help other people develop tests to examine specific areas more carefully.


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