FDA Validation Rules 1.6

m Michael

on April 14, 2023

Hello All,

FDA Validation rules 1.6 were published in December 2022.

I wonder if the newest FDA engine 2204.1 in P21 Community v4.0.1 includes these? I haven't found any documentation so far.

Thanks,

Michael

Forums: SEND

Sergiy

on April 18, 2023

P21

Hi Michael, Yes, P21…

Hi Michael,

Yes, P21 engine 2204.1 (FDA) covers FDA rules v1.6.

What documentation are you looking for?

Thank you,
Sergiy

m Michael

on April 19, 2023

Hello Sergiy, Thanks for…

Hello Sergiy,

Thanks for the response and the confirmation.

By 'documentation' I meant any log file (accessible from the help menu), release note or similar stating that the newest engine covers the newest FDA rules.

Thanks,

Michael

k Kou

on May 17, 2023

The rule sheet attached to the Pinnacle 21 Community 4.0.2 validation report does not seem to include the rules for SENDIG v3.1.1, AR v1.0, and DART v1.1 that were added in FDA Validator Rule v1.6. The change history in Engine also shows only the history up to before VR 1.6 was issued.
Has the content of VR 1.6 been applied?

Thank you,
Kou

y yang

on May 18, 2023