R software is not allowed in Mexi­co? [Software]

posted by d_labes  – Berlin, Germany, 2019-02-02 13:50 (626 d 07:06 ago) – Posting: # 19842
Views: 3,967

Dear Rosy,

» » We had already some problems in interpreting Mexican requirements. Can you give the complete sentence in Spanish, please?
»
» There is not sentence, this was an spoken recommendation, nothing written. In a few words: R software is not allowed :-|
emphasis by me - dlabes

IMHO such an statement is absolutely nonsense or at least outright bizarre.
Much more bizarre is the fact that there is no written statement about such a recommendation.

Regarding the regulatory acceptance of PowerTOST in other jurisdictions you may find this thread.
Look into this post to find what an opinion the FDA has regarding the use of the R language at all.

Maybe this gives you some arguments which help in an other audit to convince the auditor(s) in respect of using R packages.

Any other Mexican member out there with same observation?

Regards,

Detlew

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