This release introduces several new features as outlined below.

When a document is signed using the DocuSign integration, it automatically appends the document with the signing manifest from DocuSign and adds the envelope details to Kivo's audit trail. This new feature flag allows the manifest page to be suppressed from the signed PDF. This is a workspace setting and applies to all signed documents. The default is for manifests to be included on signed documents and this release does not change that behavior.
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PDFs in an eCTD submission with hyperlinks to other files in a submission (e.g. M2 to M5 hyperlinks) are now navigable in eCTD Viewer. Destination files are displayed with a "Back to Previous Leaf" button to easily navigate back to the source file.

Kivo now supports adding metadata to folders. Documents created in a folder with metadata will inherit the metadata settings. Folder metadata is not intended to be user-facing or populated during a document authoring flow. Kivo Support or a Workspace Manager can define folder-level metadata during implementation and then documents created in that location can inherit Document Type, Category, Artifact and any additional metadata values defined during creation.

In addition, folder templates can pre-populate metadata values when a structure is created in the DMS (e.g. a study folder can populate Study-ID, Phase, etc.), or if a folder is created from an Activity like Correspondence or a CAPA.

This release includes a significant update to user properties in Kivo.

Kivo has expanded the number of roles and standardized how all roles are applied to users. Previously some roles, like "Inspector" were a user setting instead of a discrete role. Roles are now tied into license tiers to match contracts and make it easier for customers to track how many user licenses are available to new users.

Full details on user roles and their possible permissions can be found here.

Users can now be added into groups and access settings can be applied to either the group or user. For example, a group can be created for "Clinical" that has access to eTMF and Site Management. Within each eTMF the Clinical group can be granted Read access, with individual users selected to have Edit access if they have an Editor or Reviewer License.

The updated permission model in this release is not applied automatically in a workspace. Contact Kivo Support to schedule maintenance to enable these features.

A full list of changes will be loaded into your Validation folder in Kivo. Look for the validation documentation for release 2024.Q3.4.