Martin Maechler
2008-Sep-25 20:57 UTC
[R] R Foundation adopts Certification/Validation document
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 finished document! - - - - - For The R Foundation for Statistical Computing, Martin Maechler ETH Zurich Note: As an exception, we are announcing this through R-announce. _______________________________________________ R-announce at stat.math.ethz.ch mailing list https://stat.ethz.ch/mailman/listinfo/r-announce
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