RE: R for regulatory use
Hi Rubens,
Thanks for your questions, I'm always happy to have an open discussion about
ValidR.
Yes the R Foundation has released information to support the use of R for
regulatory work. But this only covers the Core & Recommended packages that come
with a basic installation. The 12,000+ packages that are available from CRAN,
BioConductor, R-Forge, Git or any other sources aren't covered.
Last year Mango carried out some analysis on the percentage of packages on CRAN
that had a formal test framework. The results showed that less than 22% of
packages had a formal test framework. As you're probably already aware, to
register a package on CRAN there are some checks required, but these don't
necessarily relate to the functions contained in a particular package.
In terms of the testing that Mango carries out as part of our validation, in
the 3.2.5 release of R we validated 400 packages for our customers. Out of
those packages we found Critical Bugs in 5 packages which meant they failed
validation and should not be used. Some of these were very well know packages
and bug reports were sent to the package maintainers and fixes have been made
to newer versions of these packages.
Mango has consulted the R Foundation and the FDA as part of our product
development. In addition to this Mango is also a founding member of the R
Consortium which works with and supports the R Foundation in promoting the
growth and development of R as a leading platform for data science and
statistical computing.
I hope this gives you some of the answers or further understanding that you
were looking for, but I'll be happy to talk more about the history, process and
examples of customers using ValidR. Alternatively, please join us on the
webinar on the 19th of April and I'll talk about this a lot more then as well.
Kind regards,
Ed Gash
Mango Solutions
Quoted reply history
From: [email protected] [mailto:[email protected]] On
Behalf Of Faelens, Ruben (Belgium)
Sent: 23 March 2018 15:36
To: Christina Halliday; [email protected]
Subject: [NMusers] RE: R for regulatory use
Dear Christina,
I would love to learn a bit more about this, and an open discussion on this
list is probably the best way.
Could you elaborate how specifically the open source nature of R causes concern?
See the nice documentation from the R project core team at
https://www.r-project.org/doc/R-FDA.pdf
It seems to me that solid controls are in place, and the self-evaluation of 21
CFR part 11 by the R Core team does not result in any cause for concern.
Perhaps I misinterpret or am too optimistic: Which parts of this
self-evaluation document would you consider insufficient, or cause for concern?
Also see https://www.r-bloggers.com/r-drug-development-and-the-fda/,
https://www.r-bloggers.com/fda-r-ok-for-drug-trials/, and especially
presentations/posters from people at FDA:
http://user2007.org/program/presentations/soukup.pdf and
http://blog.revolutionanalytics.com/downloads/FDA-Janice-Brodsky-UseR-2012.pdf
I am quite allergic to people sowing fear, uncertainty and doubt on open-source
software, especially when commercial off-the-shelf software is held to
different standards.
Best regards,
Ruben Faelens
From: [email protected]<mailto:[email protected]>
[mailto:[email protected]] On Behalf Of Christina Halliday
Sent: vrijdag 23 maart 2018 15:32
To: [email protected]<mailto:[email protected]>
Subject: [NMusers] R for regulatory use
Hi Everyone
As we know R has become the programming language of choice in many industries
due to its cutting edge capabilities.
However, R's open source nature can cause concern for heavily regulated
industries and companies that have strict policies around open source usage.
To overcome these concerns, Mango developed "ValidR". Mango's dedicated
Validation team have been supporting ValidR customers for a number of years.
ValidR delivers a controlled and validated version of open source R in line
with regulatory guidelines such as FDA 21 CFR part 11.
To find out more about ValidR, join our 30-minute free public webinar on
Thursday 19 April.
Register for your place here:
https://www.mango-solutions.com/validr/
Any questions please feel free to contact us at
[email protected]<mailto:[email protected]>
Kind regards
Christina
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