Pinnacle 21 is happy to announce the latest Validation Engine for submissions to Japan's PMDA! 🇯🇵
P21 has spent many months developing this Engine with and for the PMDA, and now the industry—whether as users of P21 Community (P21C) or clients of P21 Enterprise (P21E)—can utilize it for expanded standards support, e.g., ADaMIG 1.1, in their eData submissions to the Japanese health agency.
(Originally published on October 6, 2020. Last Updated on October 30, 2020)
Effective October 1st, 2020, China’s NMPA will accept CDISC submissions. To support this initiative, Pinnacle 21 has released a new Chinese-language validation engine, available now in both Enterprise and Community. This engine supports datasets with Chinese-encoded characters and displays rule messages and descriptions in Chinese translation.
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The previous, outdated version of the validation rules is represented by our “FDA Legacy (1903.1)” engine.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.
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