The following is latest release of Pinnacle 21® Community, which includes Validator, Define.xml Generator, Data Converter, and Miner. The download also contains the latest set of standard validation configurations.

Pinnacle 21® Community 4.0.2


Pinnacle 21® Community 4.0.2



CDISC Terminology

Pinnacle ID provides all CDISC Terminologies starting with Community 3.0. You can download CDISC Terminology for 2.1.3 and 2.2.0 here.

Define.xml Stylesheets

Right click to download.

Installation and Usage

The following are basic installation and usage instructions. For additional information, please refer to documentation.

Installing Pinnacle 21® Community
MedDRA Installation
WHODrug Installation
SNOMED Installation

Compatibility with Enterprise

Pinnacle 21 has executed a series of tests on Pinnacle 21® Community and Pinnacle 21® Enterprise in the Pinnacle 21 test environment, and the testing suggested compatibility between the validation results from the two products. The list of compatible versions are listed in the table below. However, due to the nature of open source projects, actual sponsor results may differ based on a variety of factors outside of Pinnacle 21’s control, including (but not limited to) the sponsor's environment and how Pinnacle 21’s products are deployed. You understand that Pinnacle 21® Community is a free, open source project, and is solely made available by Pinnacle 21 on an “As Is” and “As Available” basis. Therefore, Pinnacle 21 makes no representations, warranties or guarantees of any kind with respect to the validation results generated by Pinnacle 21® Community, including but not limited to any representation, warranty, or guarantee of accuracy or compatibility with any other products, standards, or requirements. You agree that Pinnacle 21 has no liability for any failure of Pinnacle 21® Community, and/or any inadequacy of the results generated by Pinnacle 21® Community, including but not limited to any failure of compatibility.

Community Version Enterprise Version Agency Engine Version Notes
4.0.0+ 5.1.2+ PMDA 1810.3 Validation engine for PMDA rules version 2.0. Valid for use with applications from April 1, 2020 through March 31, 2023 and maintained as backup only for past applications already under PMDA review. Full deprecation planned for March 31, 2025.
4.0.0+ 5.1.2+ PMDA 2010.2 Validation engine for PMDA rules version 3.0. Valid for use with applications from January 1, 2022 through March 31, 2025.
4.0.0+ 5.1.2+ PMDA 2211.1 Validation engine for PMDA rules version 4.0. Valid for use with applications from April 1, 2023.
4.0.0+ 5.2.1+ FDA 2204.1  


Pinnacle 21® Community is free software licensed under the Pinnacle 21 Open Source Software License. To learn more about our license check out the FAQ.

Source Code Repository

Pinnacle 21 uses the Bitbucket source code control system for all of its source code. Although only active contributors get write access to the repository, anyone can browse our repository anonymously at

Third Party Notices

This product includes all, or a portion of, or is derived from content from LOINC that is subject to a license from Regenstrief Institute, Inc. Your use of the LOINC content also is subject to this license, a copy of which is available at The current complete distribution is available for download at The LOINC Table and LOINC codes are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. The LOINC Table, LOINC Table Core, LOINC Panels and Forms File, LOINC Answer File, LOINC Part File, LOINC Group File, LOINC Document Ontology File, LOINC Document Ontology OWL File, LOINC Hierarchies, LOINC Linguistic Variants File, LOINC/RSNA Radiology Playbook, LOINC/IEEE Medical Device Code Mapping Table, and LOINC Consumer Name File, and LOINC Change Snapshot File are copyright © 1995-2019, Regenstrief Institute, Inc. All rights reserved. THE LOINC TABLE (IN ALL FORMATS), LOINC TABLE CORE, LOINC PANELS AND FORMS FILE, LOINC ANSWER FILE, LOINC PART FILE, LOINC GROUP FILE, LOINC DOCUMENT ONTOLOGY FILE, LOINC DOCUMENT ONTOLOGY OWL FILE, LOINC HIERARCHIES, LOINC LINGUISTIC VARIANTS FILE, LOINC/RSNA RADIOLOGY PLAYBOOK, LOINC/IEEE MEDICAL DEVICE CODE MAPPING TABLE, LOINC CONSUMER NAME FILE, AND LOINC CHANGE SNAPSHOT FILE ARE PROVIDED "AS IS." ANY EXPRESS OR IMPLIED WARRANTIES ARE DISCLAIMED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. LOINC® is a registered United States trademark of Regenstrief Institute, Inc. A small portion of LOINC content may include content (e.g., survey instruments) that is subject to copyrights owned by third parties. Such content has been mapped to LOINC terms under applicable copyright and terms of use. Notice of such third-party copyright and license terms would need to be included if such content is included.

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