Users with Editor permissions can now view PDFs using embedded Adobe Acrobat instead of the default PrismViewer
This feature is disabled by default, but will be enabled upon request, or in conjunction with rolling out eCTD Viewer or the upcoming review and e-signature features.
Locked documents now show the reason the document is locked
To make document status clearer to all users the lock icon now includes an indication of what process is in progress. This includes Edits or Collaboration.
Audit Trail Improvements
Audit trails can now be downloaded as an Excel document
The Audit trail report has additional sorting capabilities now including sorting by version number
Document Alias Improvements
Document Aliases now have multiple options. Aliases can be created linking to a specific version, all versions of a document, or only display approved versions. These options are especially helpful when linking documents like a Protocol to an eTMF to ensure that sites only have access to approved versions of a document.
Reason for Deletion
The system can now support capturing a reason for deletion on versions, documents, folders, and cabinets. This is an optional feature that can be enabled at your organization level. It is turned off by default for existing accounts. Contact Support to enable and discuss configuration options.
eCTD Viewer Improvements (Beta)
The eCTD Viewer now supports US DTD 3.3
The DMS now shows a new 'Where Used' report to indicate in what submissions a version of a document appears.
Folder Templates, Submission Templates, can be imported and exported
This is largely a support-focused feature, but it enables Kivo to import and export submission and folder structures between organizations. This is helpful to re-use submission structures or to upload custom cabinet structures for areas like Quality.
New Investigator Role
Kivo now supports a new class of user called "Investigator." Investigators can be used for Virtual Inspections, Audits, Due Diligence, or other scenarios where you need to significantly restrict access to data.
Investigator access limits:
Investigators can only see approved versions of documents
Investigators will not see empty folders in a cabinet
Investigators cannot download, copy, or print documents, audit trails, etc.
Investigators can see Placeholder documents including who the document is assigned to and the expected date for content.
Investigators cannot access Submission Builder an can only have Read-only access to the DMS and eCTD Viewer
Usability Improvements
The center pane in submission builder now scrolls correctly with very long lists of documents
The Folder Share button now has a larger target to ensure the folder path is correctly copied to the clipboard
There are a host of small UX improvements related to document upload to ensure documents upload more reliably; the system notifies users correctly if there is a failure, and reduce the likelihood of duplicate documents being created.
A full list of changes will be loaded into your Validation folder in Kivo. Look for the Change Control documentation for release Q3.2022.7.