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What is in P21 Engine 2411.1?

Updates to the P21 Engine superset of rules in P21E, how to get them, and where to learn more about the metadata

Wendy Young avatar
Written by Wendy Young
Updated over a week ago

🎉 P21 Engine Update

Pinnacle 21 announces the latest Validation Engine for in-progress studies for use as the agency-agnostic "superset" P21 Engine. This includes support for PMDA Rules Version 6.

  • P21 has spent many months developing these Engines with and for the FDA, PMDA, and NMPA.

  • Our P21E clients on P21E 5.4.x and higher can now utilize them for expanded standards support and validation rule enhancements.


🧐 Technical Details

On the Data Package Configuration page, click the radio button for each Engine to see instructional notes, applicable dates, etc.

P21's default stance is to promote "the latest and greatest" standards, Engines, and best practices. If you have any questions, or would like counsel for your upcoming submissions, reach out to your Customer Success representative or our Enterprise Service Desk.


👣 What's Next?

Email questions or feedback to support@pinnacle21.atlassian.net.

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