Release Q3.2022.5 is focused on support for Submission Templates, expanded eCTD Viewer functionality, and Submission Builder enhancements.

Submission Builder now support templates for submissions. Users are presented with a Template drop-down in the Create Submission pop-up. Currently only the "Default" (5 module) template is available, but templates for common US and EU submissions will be rolled out in the coming weeks as part of individual organizational configurations.

Submission templates can be exported and imported by Kivo support enabling customers to define their own templates, publishing vendors can request moving templates between organizations, etc. Kivo Support will work with individual customers to implement the templates relevant to each organization.

The eCTD Viewer now supports associating documents in an eCTD to their corresponding version in the DMS. To associate a document, select a file in the eCTD, then click on the Source tab.

If a document is not yet associated with the eCTD leaf you can search or navigate to the document in the DMS, select the version and drag and drop it into the Source tab

Once added the document information will appear in the tab. This functionality is limited to users with Editor role in eCTD Viewer. Readers can view associations to the DMS, but not create or edit one.

The document browser in Submission Builder now supports expanding the view of a document to display each version and enables you to select which version to add to the submission. The expanded view displays the version, source, PDF, and description. Clicking on the icon for source (Src) or PDF will open the document in a new tab to preview.

Clicking the

icon will open the document in the DMS in a new tab so that you can view all of the details about the document.

A full list of changes will be loaded into your Validation folder in Kivo. Look for the Change Control documentation for release Q3.2022.5.