Difference between FDA(2204.1) and FDA Legacy (2010.1) Engine

s Sahil

on April 19, 2023

What is the difference between FDA(2204.1) and FDA Legacy (2010.1) Engine that we used while validating datasets/define.xml in pinnacle 21 and which Engine is preferable for FDA submission.

Forums: General Discussion

Sergiy

on May 2, 2023

P21

Hi Sahil, It's always…

Hi Sahil,

It's always recommended to use the latest available version of validation Engine. Pinnacle 21 team provides "Legacy" engine to finalize ongoing submission preparation process.

Keep in mind that a sponsor is still responsible for all issues in study data regardless if they are identified or not by your internal process.

Kind Regards,
Sergiy