With its latest release, Veeva continues to enhance the Regulatory Information Management (RIM) suite.

RIM Registrations – What’s new?

Bulk Create & Manage Event Detail

In this release, Administrators can configure Change Types, such as a Shelf-Life Change or a Manufacturing Site Change, to simplify Event detail creation. Users can run the Create Event Details action from an Event record, select one or more Change Types that apply to that Event, and populate the information needed for those types of changes.

Once done, users can generate a preview to refine the proposed Event details before creating them. Additionally, users can run the Manage Event Details action from an Event record to generate a preview to refine the Event’s existing details without adding new ones.

How will this help Vault users?

As Events can require the creation of dozens or even hundreds of Event details, this feature streamlines the creation and management of these details.

Bundling and Splitting

With the 24R1 release, Regulatory Objectives and Submissions created with the Bundling or Splitting wizards are related directly to the Events of any selected Activities, enhancing end-to-end visibility. Messaging from the Wizard has been updated to ensure users are aware of how relationships will be carried forward on the bundled Regulatory Objective.

The Bundling action has been enhanced to respect the global-to-local mappings of the Site Role values. This means that when users perform Bundling from an Activity or Regulatory Objective, Vault converts the global Site Role value from the Event-related records to the appropriate local values on the new Regulatory Objective-related records.

How will this help Vault users?

These improvements help to streamline processes, including enabling users to save time from manually updating the Site Role values from the default value to the local value.

When mapping global and local Site Roles in Bundling, Vault creates records with a placeholder value if the global Site Role value from the Event-related records cannot be matched to local values on the new Regulatory Objective-related records. This ensures records are created and users can update the value.

Data Model Updates

An expanded data model better captures Product and Device details. Additions to the data model in these areas enable more details to be captured, improves efficiency and accuracy of entries.

RIM Registrations and Submissions – What’s new?

Global Content Plan

24R1 sees the introduction of the Global Content Plan Dispatch by Country feature. Users will be able to select Countries, Submission Groupings or All, Automatic generation of the Active Dossier records upon dispatch of the Global Content Plan based on the documents dispatched is now supported.

Global Content Plans that are removed from an Event record can now be added back. When the field is cleared, users can select the appropriate Global Content Plan on the Event field to associate it back to the original Event record.

Enhancements have been made to Global Content Plan synchronization including updating the Comparison Viewer, validation on missing permissions when matching target Submission Content Plan sections.

A new notification alerts Submission Owners when a new Submission Content Plan is created from a Global Content Plan.

How will this help Vault users?

These enhancements provide for a more accurate Active Dossier for regulatory use cases outside of the normal submission and approval cycle, such as changes that can be implemented before submission or without a submission. In addition, this feature provides earlier visibility for those documents that are dispatched and internally ready for use to build the next document version from when there are concurrent changes.

The new notification means that Submission Owners do not have to monitor the system and dispatch messages for newly created Submission Content Plans requiring attention.

RIM Registrations, Submissions and Submissions Archive – What’s new?

Active Dossier

The Active Dossier Hovercard now displays a Dispatched icon for items with a Dispatched status and has been reformatted to display the Event and Activity fields.

All Vaults will be migrated to the Active Dossier Template which was launched in the previous release, utilising the Active Dossier Consolidated Sections feature. Upon completion of the updating records, end-users will see the condensed Active Dossier Viewer layout for new and existing Active Dossiers.

How will this help Vault users?

These updates improve the functionality of the Active Dossier Hovercard and streamline viewer layouts for Active Dossier records.

RIM Submissions – What’s new?

Matched Document Enhancements

Content Plans will now expand to the match document level (up to a maximum of 2000 documents) instead of stopping at the Content Plan Item.

When working in Submission Content Plans, users can now execute a range of Content Plan Item actions from within Match Document Mode, including reordering matched documents, splitting a Content Plan Item, Updating the Expected Steady State Count and matching documents in bulk.

Enhancements have also been made to improve the speed of document matching. Users will now see approximate document counts and page numbers, similar to those used in Vault Library, to reduce the time spent loading potential matches.

How will this help Vault users?

As well as streamlining the ability to suggest matches, and to view matched documents, these enhancements support a smooth and efficient flow for managing and manually matching documents within the Content Plan Viewer. Users can now perform all the steps needed to manually manage documents for a Submission Content Plan within one convenient interface.

PDF Standardization

The introduction of PDF Standardization as a Vault-wide Rendition Profiles allows for standardization to be applied Vault-wide, without the need for additional configuration using custom Rendition Profiles.

24R1 also sees some improvements in Inactive Bookmark Handling during PDF Standardization to ensure functionality in source files is based on the first child bookmark in the hierarchy.

How will this help Vault users?

All new documents will be standardized when new versions are created, thus ensuring consistency. Existing documents can also be re-rendered using Vault Loader.

Content Plan Creation

This feature introduces two new fields on the Content Plan related objects: XML ICH DTD / XSD Version and XML Regional DTD / XSD Version, along with updates to the Submission Content Plan creation processes to respect the Submission’s XML Version fields.

How will this help Vault users?

This allows for the generation of a more relevant content plan for Content Plan Templates that apply to multiple different XML versions.

RIM Submissions Archive – What’s new?

In the Submissions Archive Viewer, users can now share URLs to one or many specific Submissions in an Application. Previously, the URL only contained the Application ID, regardless of any applied Submission filters, and so sharing was limited to the Application view. Now, the viewer URL includes Application ID and Submission IDs.

Enhancements to the user defaults in the Document Viewer in 24R1, apply to the Submissions Archive Viewer meaning that documents will open with Select mode automatically enabled. This means that videos can be rendered in the Viewer and that text can also be copied from the Viewer. This changes how Submissions Archive users navigate through documents, particularly documents with hyperlinks: With the Select mode enabled by default, users who wish to click on a hyperlink in the Viewer can hover over the link, then select the resulting pop-up to open the link. Users can also enable Grab mode, allowing them to directly click the link in the document.

With this release the document viewer header in the Submissions Archive Viewer is updated to display the document version and the document lifecycle state.

RIM Submissions Archive users are also able to view and filter the leaf source file path field metadata in the viewer grid.

How will this help Vault users?

These enhancements streamline document access, improve usability, and enhance the overall experience for users of the Submissions Archive.


RIM Publishing – What’s new?

24R1 sees some enhancements to the Link Evaluator functionality, allowing users to perform more tasks directly from the Link Evaluator interface. The navigation for the interface has been improved, making it easier to return to the Content Plan or access the Submissions Archive directly from the page. A new Suppress Links action allows users to delete valid or invalid hyperlinks, individually or in bulk and the Retarget action gives users the option to choose a specific rendition for the target document. Both Retarget or Supress link actions can now be undone, individually or in bulk. Using the Link Overrides function. Supressed and retargeted links can now also be filtered.

Note that with this release, Vault Publishing will no longer automatically create Reference Leafs when the same document is matched multiple times in a non-eCTD Submission. Vault Publishing will disable the Reference Leaf functionality for any non-eCTD submissions (where ICH/DTD is not equal to 3.0 or 3.2), allowing the same document to be published multiple times.

And finally, to better support customers publishing and submitting very large files, the maximum file size limit has been increased to 500GB on all RIM Vaults.

How will this help Vault users?

Being able to complete a range of tasks from a single screen, rather than returning to each source document improves efficiency and productivity when creating and reviewing hyperlinks.

Quality RIM Connections – What’s new?

The Quality-RIM Document Exchange feature introduces the automated crosslinking of documents between Quality and Regulatory Vaults when documents of specified type/subtype/classification reach a major version steady state. The CrossLink is created by the system when the initial version of a document reaches steady state and then is automatically upversioned as new major versions of the document reach steady state. Previous CrossLink versions will be superseded when a new major version is created. Existing crosslinks become automatically obsolete if the existing document is made obsolete.

How will this help Vault users?

This allows documents that are authored in a Quality Vault, but need to be included in submissions, to be automatically transferred to a RIM Vault as a CrossLink. It also means that documents that originate in RIM Vaults, such as Product Specifications, Labeling/Artwork Documents and CMC Documents, for example, can be automatically transferred as CrossLinks to Quality Vaults. This helps to ensure that there is one source of truth and eliminates the need to create crosslinks manually.

What next?

If you’d like any more information about how these features, or any of the 24R1 enhancements, affect your Vault users, please get in touch.

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