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How to validate Microsoft R Open per 21 CFR part 11 RRS feed

  • Question

  • Dear All,

    Please guide me the necessary steps for Microsoft R Open to comply with 21 CFR part 11. 

    Thank you,

    Thursday, December 15, 2016 10:10 AM

Answers

  • Since Microsoft R Open is based on CRAN R, this guide from the R Foundation may be useful:

    https://www.r-project.org/doc/R-FDA.pdf

    Mango Solutions is also a specialist in this area, if you need assistance:
    http://www.mango-solutions.com/wp/products-services/r-services/r-validation/

    Thursday, December 15, 2016 5:22 PM