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

Pinnacle 21 General General Discussion
1

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

2

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.