k Kent


On https://www.pinnacle21.com/projects/validator/engine-compatibility  you have the following guidance on Engine compatibility

  • FDA - Validation engine currently deployed at FDA. Use to prepare for imminent submission.
  • PMDA - Validation engine for PMDA rules v2.0. Valid for use with applications from April 1st, 2020.
  • PMDA Legacy - Validation engine for PMDA rules v1.0. Valid for use with applications from October 1st, 2016 through March 31, 2021.


I suspect there may be a typo as it would appear for PMDA submission from April 1 2020 to March 31, 2021 that two difference ENGINEs should be selected.    Can you confirm what is correct in this situation?




Forums: General Discussion

on May 8, 2020

Hi Kent, 

It's correct. For PMDA submissions filled during 2020-04-01 through 2021-03-31 you can select either PMDA (1810.3 engine) or PMDA Legacy (1511.6) rules. Be sure that you utilize the same version of rules (P21 engine) for all studies within your submission.

Please see PMDA Guidance documentation for details. You can start with links provided at https://www.pinnacle21.com/useful-links

Kind Regards, 


Want a demo?

Let’s Talk.

We're eager to share and ready to listen.

Cookie Policy

Pinnacle 21 uses cookies to make our site easier for you to use. By continuing to use this website, you agree to our use of cookies. For more info visit our Privacy Policy.