P21E - P21 2010.1 Engine

Pinnacle 21 Support SDTM
1

Hi, Hisada-san.

Please post the question to P21 Enterprise Service Desk under you company’s rule. This is not a place to talk about the P21 Enterprise.

Also, this question itself was answered by myself after the training. And the trainer in Japan was me, right?

Thank you for your understanding

Chikaaki NAKAO

2

Hi,

In PINNACLE21Enterprise, I know “P21 2010.1” Engine is useful to varidate PMDA check and FDA check simultaneously; however, in PINNACLE21 training in Japan, the trainer recommended not to use “P21 2010.1” for PMDA submission (i.e. P21E should be run with FDA Engine and PMDA Engine separately) because some PMDA specific checks can’t be fired.

Has it been resolved ?

Thanks.