[R] About Validation of R

Marc Schwartz marc_schwartz at me.com
Thu Jul 21 19:10:59 CEST 2011


On Jul 21, 2011, at 9:36 AM, Daniel Ponce wrote:

> Dear Sr. of R-project:
> 
> In the document "R: Regulatory Compliance and Validation Issues. A
> guidance Document for the Use of R in Regulated Clinical Trial
> Environments", in the point 6.3 say that exist a set of validation
> test, that are localized in the test subdirectory. I search the place
> in the page www.r-project.org and not found this, can you say me where
> is the set?. I work in a pharmaceutical laboratory and i need to
> validate the software for use in analitical methodology validation; If
> you can guide me and give more information of the subject, i stay very
> grateful


Hi, thanks for taking the time to read the referenced document.

There is additional information in the R Installation and Administration Manual here:

 http://cran.r-project.org/doc/manuals/R-admin.html#Testing-a-Unix_002dalike-Installation

and specifically for Windows, here:

  http://cran.r-project.org/doc/manuals/R-admin.html#Testing-a-Windows-Installation

Beyond those default tests, any additional validation testing that you might require would have to be defined and implemented by you or others, based upon any existing Standard Operating Procedures that you may already have, or would need to be written for this purpose.

Regards,

Marc Schwartz



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