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Sebbe

21 CFR Part 11 compliance

Status: New

Working in an GxP environment in the pharma industry, any initiative to make NI software products more compliant with the FDA guidelines would be most welcome. One such relatively simple measure would be to enable "sealing" of TDM files, such that any tampering with the data is either impossible or logged.

 

I believe I have passed this idea on to NI several years ago and I apologize if it has been implemented already.

 

Yours

 

Sebbe

Cygnus Data, Göteborg, Sweden