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What's in the 2405.2 Engine update?

The FDA and P21 superset Validation Engines were updated to reflect changes to validation rules. Learn what's in them.

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

๐ŸŽ‰ New Engines: P21 & FDA

Pinnacle 21 announces the latest Validation Engine for submissions to US FDA and for use as the agency-agnostic "superset" P21 Engine. This update contains message updates and resolves bugs discovered in the previous engines P21 2405.1 and FDA 2405.1.

  • P21E clients on P21E 5.4.x and higher can now utilize this engine update for expanded standards support and validation rule enhancements.

๐Ÿ“ Note: This engine update introduces NMPA 2405.2.


๐Ÿง 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.


๐Ÿ‘ฃ What's Next?

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

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