Engine Compatibility in Pinnacle 21 Community
Community provides different Validation Engines so that you can stay compliant with regulatory agencies. To do this, simply select which Engine you would like to use from the dropdown. By selecting the appropriate Engine, other dropdowns will be filtered to only show the standards and configurations that are compatible with the agency. For example, you won't find SEND in the standard dropdown for any PMDA Engine because the PMDA does not support SEND.
- FDA - Validation engine currently deployed at FDA. Use to prepare for imminent submission.
- FDA Legacy - Prior version of FDA engine. Provided for reference only. Do not use for imminent submission.
- PMDA - Validation engine for PMDA rules v3.0. Valid for use with applications from January 1, 2022.
- PMDA Legacy - Validation engines for older PMDA rules v1.0 and v2.0.
- NMPA - Beta validation engine for NMPA. Supports datasets with UTF-8 encoded Chinese characters and displays rule messages and descriptions in Chinese translation.
The number listed beside the Engine lets you know when the Validation Engine was release. For example, 1511.5 was released in November of 2015 and has been patched 5 times.
The Validation Summary tab of the Validation Report will warn you if an incompatible engine has been used. The most common reasons for validation with incompatible engines are:
- Validation was ran using an unsupported configuration file
- A depreciated engine that is no longer compatible by PMDA or FDA was used
If this happens, ensure you are connected to the Internet and that you have the latest version of Pinnacle 21 Community. To see your version, go to "About Pinnacle 21 Community". After you have verified your Internet connection and release version, re-run the validation and choose a non-depreciated Engine from the dropdown and ensure the configuration file you select has not been modified or customized.