How is P21 Community Updated?

At Pinnacle 21, it’s our mission to help companies of all sizes prepare for efficient and trouble-free submissions. This mission is what drives us to continuously improve and support our open source solution, Pinnacle 21 Community. Every mission has challenges – we have learned over the years that providing free software, free service, and frequent updates is a big ask for a small team. Historically, this challenge has been complicated even further by simultaneously supporting different version of Community because when multiple versions of a product are supported, we spend more time on support and less time fixing actual issues. We also see some companies using older versions of Community that are no longer compatible with FDA and PMDA. To ensure your get issues fixed quickly and that you stay compatible, we introduced auto-updates in 3.0. With this release, auto-updates will provide you the latest controlled terminologies, dictionaries, validation engines, and application updates. Read below to learn how each component of Community is updated.

Controlled Terminology and Dictionary Updates

Updates for CTs, UNII and NDF-RT/MED-RT are provided to all users with a Pinnacle ID. When you open up the tool, the new CT or dictionary will automatically be available for you to choose in the dropdown selection within 5 business days of publication.

Validation Engine Updates

A validation engine is a combination of our open source P21 Validator and our open source implementation of FDA or PMDA published rules (learn more). There are two types of Validation Engine updates:

•    patch - bug fixes and cosmetic refinements (up to once per month)
•    major - introduction of new rules and standards (up to twice per year)

When a validation engine is updated, the new engine will be automatically downloaded and available for you to select in the engine dropdown. We apply bug fixes (patches) automatically and deprecate old major versions. However, deprecated engines are still available for use if needed. The tables below display how the engine dropdown could change for patch engine updates and major engine updates. 

Table 1. Sample engine dropdown menus for patch update
Before Update Patch FDA Engine Update
(Example only)

1903.1 (FDA)

1810.3 (PMDA)

1903.2 (FDA)

1810.3 (PMDA)

 

 

 

 

Table 2. Sample engine dropdown menus for major update
Before Update Major FDA Engine Update
(Example only)

1903.1 (FDA)

1810.3 (PMDA)

1907.0 (FDA) 

1903.1 (FDA) (deprecated)

1810.3 (PMDA)

 

 

 

 

 

Application Updates

The Community application contains the desktop graphical user interface (GUI), Define.xml Generator, Data Converter, and Clinical Trials.gov Miner. Application updates come in three forms:

•    patch - bug fixes and cosmetic refinements (up to once per month)
•    minor – introduction of minor functionality such as support for new a dictionary (up to three times per year)
•    major - introduction of major functionality such as Pinnacle ID and auto-updates (up to once per year)

The application will be automatically updated when a new version is available. When this happens, after you restart your application, you will receive a notification that your application is updating. You can view which Application Version (i.e. 3.0.0) you currently have installed by going to Help > About Pinnacle 21 Community.

Release notes for updates are available on our download page. If you have any questions about the update process for Community 3.0, please post to our forum.