New in Vault Basics 24R2

Release date: August 9, 2024

We are pleased to bring you 24R2. Read about the new features below.

All Applications

Keyboard Shortcuts

New keyboard shortcuts have been implemented for List pages, Record Detail Pages, and the Global Header. On any page, you can use the new key combination Ctrl + / to bring up a list of available keyboard shortcuts for the current page.

Improved Color Contrast

To improve accessibility, several updates have been made to the Vault user interface to enhance color contrast and improve clarity and visibility.

Enhanced Permission Set for Technical Setup

Renamed the “SSO Setup” permission set and application role to “Technical Setup”. Added permissions for creating Security Policies and enabling Collaborative Authoring to the renamed permission set.

Improved OCR for Images

Vault’s Optical Character Recognition (OCR) functionality has been improved to better detect text from images, resulting in more precise text recognition.

Saved Page Rotation

After rotating pages in the Document Viewer, users with the appropriate permission can save that rotation, which applies to any user when viewing the document, or downloading the Viewable Rendition.

Show Document Name & Latest Version Link in Document Viewer

When viewing a document in Vault Mobile, users can now see the name of the document at the top, and if they are not viewing the latest version, they will also see a link to the current version. Similarly, if a user is viewing a minor version, and a steady state version exists, users will see a link to the latest steady state version.

A new message has been added to inform users about Vault Mobile and make it easy for them to download it. The message will include a hyperlink to a landing page where users can learn about Vault Mobile and use QR codes to download it.

Limits search term to 2 wildcards per search term and up to 10 total wildcards across the entire search text.

Allow Fields & Relationships to Be Copied for Large Documents

For source files over 4 GB, Vault will copy the fields and relationships, but will not copy the large source file.

Vault Clinical Basics

TMF Bot Enablement

Once a Vault has 1500 documents classified and approved in the Library, the Bot will begin to suggest classifications for any unclassified documents. The Bot will improve its accuracy by learning from suggestions you have accepted and rejected.

A new “Download as PDF” action is available to generate a downloadable PDF, based on the current layout for the user.

Vault RIM Basics

Streamlined User Licensing Management

The License Type field has been removed from the page layout, and all user licensing is now managed via Application Licensing.

RIM Bot Enablement

Once a Vault has 1500 documents classified and approved in the Library, the Bot will begin to suggest classifications for any unclassified documents. The Bot will improve its accuracy by learning from suggestions you have accepted and rejected.

Commitments

Commitments allow you to track key information for Regulatory Commitments, such as owners, commitment due dates, commitment status, and much more.

Commitment Reports

The following Commitment-based Reports have been added: Commitment Status Report, Overdue Commitments, Open and Ongoing Commitments by Application, Commitments Due in the Next 6 Months

Submission Description Field

Vault RIM Basics users now have the ability to populate a value for the Submission Description.

Summary Fields

Key Fields are available on the top of the page for Applications, Submissions, and Commitments.

Optimized Renditions for PDF Merge Use Cases

Vault optimizes downloadable renditions where multiple PDFs are being merged into one. It eliminates duplicate fonts, images, and other elements, producing a smaller PDF file.

A new “Download as PDF” action is available to generate a downloadable PDF, based on the current layout for the user.

China Non-eCTD Import Handling

Submissions Archive supports import of China NeeS submissions that include index.xml and index-sm3.txt files, as made effective by National Medical Products Administration in March 2024. Vault recognizes these dossiers as Non-eCTD.

EAEU latest updates

Submissions Archive supports display of EAEU’s latest amendments for sections, including updates to existing section names and introduction of new section names. Submissions Archive Viewer displays section names in alignment with EAEU guidance.

South Africa eCTD v3.0

Submissions Archive supports import, display, and export of South African Health Products Regulatory Authority’s (SAHPRA), eCTD 3.0 format.

Vault Quality Basics

QualityDocs

Streamlined User Licensing Management

The License Type field has been removed from the page layout, and all user licensing is now managed via Application Licensing.

Fields Editable to Migration Administrators

Migration Administrators are able to edit additional fields required for document migrations.

Manual Closure of DCC

Manual closure is available to users for Approved Document Change Controls, allowing for manual closure in case a DCC was approved without a document associated.

QualityDocs & Training

Standardized Secondary Task Due Dates

When multiple tasks are dependent on the same date, the secondary task allows 3 days for completion.

Updated Vault Admin Permissions

Updated Vault Admin permissions to the following:

  • Can edit group membership.
  • Cannot power delete documents.
  • Cannot create unclassified documents.

Updated User Setup

  • “Document User” Security Profile relabeled to “Full User”.
  • “Training Admin” moved from a Security Profile to a System Assignment.
  • “Learner” and “QMS User” added as System Assignments.
  • Implemented validation to ensure the correct license is selected for certain scenarios.

Training

Individual Learner Role

Individual Learner Roles can be created that are tied to one specific Learner. This allows for Curricula to be linked directly to an individual Learner without having to be grouped into roles.

Learner Homepage History Tab: Assignment Due Date

Due Date column is now displayed on the History tab of the Learner Homepage.

Learner Homepage History Tab: Export Completed Assignments

Learners can now export, in PDF format, completed Training Assignments from the History tab.

Learner Homepage: Update Filter Permission Behavior

Learners have the ability to use the filters on the Learner Homepage.

My Team Page

The My Team page displays a manager’s direct reports, enabling them to view their training status.

My Team: Individual Learner Page

The Individual Learner Page allows managers to access their direct reports’ learning history by clicking on the Learner card on the My Team page. Managers can learn about the status of an employee’s current training assignments.

Removed Issue Training Assignments Entry Action

Removed automatic reissuance of Training Assignments from Draft to Approved and Initial to Final lifecycles. This would create a conflict with TRIA, which will instead be the mechanism for determining when Training Assignments should be created.

Training Limits Updated

The number of selectable Learners per Direct Assignment is now 500.

Training Matrix View

A “Training Matrix View” section was added to Training Requirements and Learners. This section displays any related Curricula and Learner Roles for the given record, in an easy to understand matrix format.

Training Requirement Impact Assessment Automation Enhancements

When a Training Requirement Impact Assessment (TRIA) is created, it now captures whether the Training Requirement has an E-Learning document, multiple documents, assignments, and/or Quiz.