Engine

Pinnacle 21 is happy to announce the latest Validation Engines for submissions to Japan PMDA, US FDA, and China NMPA!

P21 has invested much in developing these engines for/with regulatory agencies, and now the industry—whether as users of P21 Community (P21C) or clients of P21 Enterprise (P21E)—can utilize them for expanded standards support, e.g., the first time PMDA has implemented ADaMIG 1.2 & 1.3 and Define-XML 2.1, in their eData submissions to the the global regulatory bodies.

Key details are as follows:

P21 is proud to announce that support for CDISC Open Rules Engine (CORE) is now available in P21 Community 4.0. We have expanded CORE’s reference implementation to let you execute machine-readable CDISC Conformance Rules within the familiar P21 toolkit. This new CDISC Engine can run from the desktop GUI or command-line interface (CLI) on any platform in which you have already installed P21 Community.

New PMDA Engine

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The previous, outdated version of the validation rules is represented by our “FDA Legacy (1903.1)” engine.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.