R Foundation adopts Certification/Validation document
maechler at stat.math.ethz.ch
Thu Sep 25 22:57:40 CEST 2008
The Board of the R Foundation would like to announce the unanimous
adoption of the document entitled:
"R: Regulatory Compliance and Validation Issues. A Guidance Document for
the Use of R in Regulated Clinical Trial Environments"
The updated version of the document, dated August 17, 2008, is available
from the main R web page (http://www.r-project.org/) via the
Certification link, listed under Documentation.
The document provides extensive background and detailed guidance for the
use of R within the regulated framework of human clinical trials,
covering GxP and 21 CFR Part 11 issues. This document should serve R
users as a key reference for their internal regulatory activities
relating to the use of statistical software for clinical trials.
We would like to thank all of those whose hard work has resulted in this
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For The R Foundation for Statistical Computing,
Note: As an exception, we are announcing this through R-announce.
More information about the R-announce