Chromatography Forum

I have spend the morning searching online to find any documentation to support a claim of a new chemist at our company. They have stated that JMP is pre-approved by FDA and does not need any form of internal validation.

We are not compiling clinical data, just basic laboratory test data for Method Validation use in the Generic OTC environment. Their claim is that without using JMP software it will take too long to perform the calculations needed to Validate a method.

Does anyone know if FDA approves all uses of JMP as a pre-validated platform?

http://www.fda.gov/cder/present/dia198/viiic.pdf(1998)

I would advise you to look more at www.fda.gov for guidance on this issue. The link above (among others) would lead me to believe that the FDA has made regular use of both JMP and SAS for quite a while, but the articles mentioned dealt with clinical data (lots of data)...

That was one of the items turned up in my search this morning. I don't believe that what this chemist is wanting to address really falls under 'lots of data' or even remotely can be compared to the need for JMP's modeling usages.

But I will continue searching...and hoping for some magical answer to come flying out of the sky.

I already heared the same thing about SAS, but it seems untrue, altough SAS is used many times as THE reference.

If you have some time, take a look at the discussions at:
http://search.r-project.org/cgi-bin/nam ... xname=docs

It's a forum of R, a open source statistical software, which I use regulary.

Bart