🎉 New Engines: P21 & FDA
Pinnacle 21 announces the latest Validation Engine update for submissions to US FDA and for use as the agency-agnostic "superset" P21 Engine. This update includes several algorithm changes, message updates, new BIMO rules, and resolves bugs discovered in the previous engines P21 2405.0 and FDA 2405.0.
P21E clients on P21E 5.4.x and higher can now utilize this engine update for expanded standards support and validation rule enhancements.
📝 Note: NMPA will release Engine 2405.x in a separate, standalone Engine update, but this is not yet available.
🧐 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
Learn more in the Validation & Issue Management Collection.
Email questions or feedback to support@pinnacle21.atlassian.net.