Starting in 22R3, the Submissions Archive Viewer is enhanced with a new user interface that streamlines the submission review process with advanced searching, filtering, and document viewing capabilities.
This video demonstrates the Submissions Archive Viewer.
Settings & Enablement
The new Submissions Archive Viewer is enabled by default in all existing and new Submissions Archive Vaults as of 23R1 (22R3.4).
While the viewer itself does not have its own enablement setting, you can enable the viewer’s related settings, Enable identifying empty sections in the viewer and Show inactive Applications and Submissions in Viewer in Admin > Settings > Application Settings. See RIM Application Settings & Configuration Options for more information.
The new Submissions Archive Viewer is automatically available. Admins cannot disable the new viewer or re-enable the legacy viewer.
We encourage user feedback for future enhancements, which you can provide in the RIM Submissions and Submissions Archive Veeva Connect Community.
New Viewer Highlights
The new Submissions Archive Viewer gives regulatory reviewers a greatly-improved user interface for working with submission documents and data, similar to the experience of working with content plans and active dossiers.
Admins configuring the new viewer benefit from a lower implementation time, as it includes many previously-configured legacy viewer features.
Search & Filter in Hierarchy & Grid Views
The new Submissions Archive Viewer leverages the Submission Metadata object to present Application and Submission data in side-by-side hierarchy tree and grid views. This new format greatly improves upon the legacy viewer’s binder structure, as it allows users to:
- Search the Name column in the hierarchy tree to quickly filter nodes titled with keywords like “study reports”.
- Add, remove, and rearrange columns, corresponding to dossier metadata. Vault also remembers the selected columns and displays them each time users access the viewer.
- Expand and collapse the view at the Application root node when viewing applications with a large number of documents. Similarly, the Correspondence document node can be filtered to quickly hide or display Correspondence documents and folders tagged with an associated Application.
Users can apply filters to the hierarchy structure, then open documents directly in the viewer. When a user clicks a document, Vault maintains the hierarchy structure in the left-hand panel and displays the document on the right. The document view is similar to viewing a document in the Library, with bookmark, annotation, and search capabilities.
Users with appropriate permissions to use the legacy viewer are able to access the new viewer without any additional security configuration. However, we recommend Admins confirm the intended users are assigned a Full User Submissions Archive application license. (Unlike most Vault applications, application licensing directly controls user access to RIM Submissions Archive features.)
Users may have previously been able to access the new viewer with incomplete application licensing credentials. In 23R1, the licensing enforcement described here specifically includes the new viewer.
|Category||Viewer Feature||Legacy Viewer||New Viewer||Notes & Limitations|
|Filtering||Filter by Application fields||N||Y||Filter by fields to narrow Application list|
|Filtering||Filter by Name (keyword search)||N||Y|
|Filtering||Filter by Submission||Y||Y|
|Filtering||Filter by Submission related objects (join records)||Y||Y|
|Filtering||Filter on Submission fields||Y||Y||Added for the new viewer in 23R1 (22R3.4)|
|Filtering||Filter on Submission Metadata fields||N||Y||Actions menu includes an option to edit columns, and each column header is a filter. In 23R1 (22R3.4), the filter for the
|Filtering||Hide Application-level Correspondence||N||Y|
|Filtering||View inactive Applications and Submissions||Y||Y||Added for the new viewer in 23R1 (22R3.4)|
|Navigation||Collapse tree view at the Application root node||N||Y|
|Navigation||Expand all for a single Submission||Y||Y||Added for the new viewer in 23R2 (23R1.2)|
|Navigation||Expand all under a section||N||Y|
|Navigation||Expand and collapse section||Y||Y|
|Navigation||Navigate to Application and Submission record pages||Y||Y|
|Navigation||Navigate to embedded links||Y||Y|
|Navigation||Navigate to hyperlinks||Y||Y|
|Sorting||Sort Correspondence documents alphanumerically||N||Y|
|Sorting||Sort direct descendants alphanumerically||N||Y|
|User Settings||Custom layout||N||Y||Each metadata field column position and width can be manipulated|
|User Settings||Save user preferences||Y||Y|
|User Settings||Save view||Y||Y||Added for the new viewer in 23R1 (22R3.4)|
|View||Document and Section ordering||Y||Y|
|View||Empty Section Indicator||Y||Y||Added for the new viewer in 23R1 (22R3.4)|
|View||List view||Y||N||Not applicable to the new viewer, as it does not depend on Binder functionality.|
|View||Section cumulative view||Y||Y|
|View||Tree view display limit||N||Y||Users can view up to 3,000 nodes in the viewer, after which filtering must be applied.|
|View||View documents, including Correspondence documents||Y||Y||Embedded document viewer overlaid on the grid|
|View||View document hovercard||Y||Y|
|View||View historical lifecycle||Y||Y|
|View||View leaf details||Y||Y|
|View Export||Export Dossier tree view to Excel||N||Y||Users must select a single Submission for the export option to appear in the Actions menu, and exports do not respect filtering.|
|User Permissions||Automatic application licensing enforcement||Y||Y||Added for the new viewer in 23R1 (22R3.4)|
The following items are known limitations to or defects of the new Submissions Archive Viewer:
- The Submission object must have a corresponding object lifecycle enabled in the Vault. At a minimum, the object lifecycle must remain Active for the viewer to properly function.
- Vault does not respect any applied filters when exporting the hierarchy tree to Excel. Additionally, users must filter the grid to a single submission for the option to export to appear in the viewer’s Actions menu.
- Vault does not respect any applied filters when using the Expand All action. When a filter is applied, the the viewer expands all of the nodes underneath the Expand All section.
- While there are no limitations on the number of Submissions the viewer can display, users can only view up to 5,000 hierarchy nodes at a time. When the limit is reached, the viewer displays a message prompting the user to refine the view with filters. You can use the Collapse All action to remove sections so they do not count towards the 5,000 hierarchy node limit.
- In Vaults created on or after 23R1 (22R3.4), the legacy viewer’s related setting Show eCTD Metadata Mapping does not appear, and mapped fields are not available in the new viewer for selection or filtering. However, in existing Vaults, the Show eCTD Metadata Mapping and Enable Submission based Viewer Filter settings are contingent upon each other and subject to the following caveats:
- In Vaults where Show eCTD Metadata Mapping was previously enabled, the setting is still visible to Admins on the Application Settings page. It will be fully deprecated in a future 2023 release.
- In Vaults where Enable Submission based Viewer Filter was previously enabled, the Show eCTD Metadata Mapping setting is not visible by default: When submission-based viewer filters are in use, Vault disables and hides the mapping setting.