In August 2020, we released our new Pinnacle 21 validation engine “FDA (1907.2)” for preparing study data for FDA submissions. It includes the validation rules currently used by FDA’s DataFit, the agency’s implementation of Pinnacle 21 Enterprise.
The previous, outdated version of the validation rules is represented by our “FDA Legacy (1903.1)” engine. It will be available for the next few months until our next release. This window allows you to finalize your ongoing submission preparations.
Note: We advise you to use “FDA Legacy (xxxx.x)” engines only for submissions you will file in the next few months. Please do not use legacy engines for future submissions, as outdated engines may be retired at any moment.
As explained in our update process, our new engine “FDA (1907.2)” is automatically uploaded to all Pinnacle 21 Community 3.0.x versions that are using a Pinnacle ID and have internet connection. Otherwise, you will need to download and reinstall Pinnacle 21 Community v3.0.2 from our website.
For details, please see the CHANGELOG.txt file in this folder:
This summary highlights changes to the validation rules in the new engine “FDA (1907.2)” compared to the previous engine “FDA Legacy (1903.1)” available in P21 Community. For complete details, please see the CHANGELOG.txt file in this folder:
C:\Users\%USERPROFILE%\Documents\Pinnacle 21 Community\configs
SEND Validation was revised and tuned per new FDA requirements. Please see our blog post and webinar about these recent changes: How We Improved the SEND Validation Rules.
Tags:Blog Main Page
* Required Field