New in Vault Basics 24R3

Release date: December 6, 2024

Vault Quality Basics

The Vault Quality Basics team are excited to release the following major features in the 24R3 release.

  • Vault Training: Vault Basics training materials will be available as E-Learning directly in the Vault Library.
  • QMS: A new Standalone CAPA module has been added for customers licensed with QMS.

There are many other minor enhancements across the application, refer to the lists below for each app, or go to the Release Summary if you need a full overview.

All Quality Applications

  • Vault Quality Basics Reports were added and enhanced.
  • Admins no longer need to select a license type for new users.

QMS

  • QMS Dashboards are now available for key QMS processes.
  • The Change Action Approver(s) will no longer default to the QA Approver(s) from the related Change Control, as the approver could be an SME.

QualityDocs

  • Documents will be released to Issued on an hourly basis rather than overnight.
  • Attachments, as supporting documentation, are now available on documents. These attachments are not subject to any Vault workflows or version control.
  • Users now have the ability to cancel an Authoring task.
  • The Stand-Alone CAPA document subtype was relabeled to Standalone CAPA to align with the new QMS module and future product direction.

Training

  • A Pending Full User Training security profile was added that should be assigned to users who are intended to be a Full User or Vault Admin but should temporarily have read-only permissions while they are completing training.
  • Individual Learner Roles will be automatically created when a Learner is added to Vault.
  • Vault document training requirements have a new section, Supplemental Materials, which allows Training Admins to add supporting documentation.
  • Fields such as Training Records, Training Requirements, Impact Assessments, and Quizzes, will display conditionally, as required.
  • In order to provide supporting documentation for the completion of a training assignment, Training Admins can now upload attachments to Facilitated Training records.
  • Training Admins can now edit the Verification Required? and Proof Required? fields for an individual training assignment.
  • All users can now preview E-Learning content, even if they haven’t been assigned a task.
  • Support information and links were added to the bottom of the My Learning page.
  • Upon completion, training assignments are stamped On Time or Late via the Completion Status field.

Vault Clinical Basics

The Vault Clinical Basics team are excited to release the following major features in the 24R3 release.

  • CTMS: The CTMS application introduces the ability to manage Study Milestones, Monitoring, Subject Enrollment, Issue Management, and Site Communications.

There are many other minor enhancements across the application, refer to the lists below for each app, or go to the Release Summary if you need a full overview.

  • Users can now trigger the Archival job from an Archived Study, moving any unarchived Countries, Sites, and Documents to the Archived state.
  • Study Site Personnel section on the Study Site is now called Site Personnel.
  • An additional role called Site Staff will be available when tracking Site Personnel.
  • TMF Bot now accepts documents in languages other than English and the training model is refreshed with each major release.

Vault RIM Basics

The Vault RIM Basics team are excited to release the following major features in the Submissions application in the 24R3 release.

  • Submission Planning and Tracking Dashboard is now available for Vault Admin and Submission Manager users.
  • Users can now track Regulatory Objectives for a given application, key dates, status, and the submissions that support each objective.
  • Health Authority Questions and Responses can now be tracked, along with relevant information, status, and relationship to correspondences.
  • Health Authority Questions can now be extracted from Correspondence documents to create one or more records from a given correspondence document.

There are many other minor enhancements across the application, refer to the lists below for each app, or go to the Release Summary if you need a full overview.

All RIM Applications

  • The Submission Mgmt Tab Collection now contains two new menu items: Submission Mgmt, which contains Applications, Submissions, and Regulatory Objectives, and Health Authority Communications, which contains Health Authority Questions and Commitments.
  • A new role within the system, the Document Participant, allows users to access documents they have uploaded, any documents for which they are active participants in the workflow, or documents that have been manually shared with them.
  • The RIM Bot has been optimized to enable better results.

Submissions

  • Country and Language document fields are now editable.
  • The Copy From Content Plan action is enhanced to only copy relationships that are used for Content Planning from the source Submission to the target Submission.

Submissions Archive

  • Correspondence documents in Submissions Archive Viewer can be filtered by Regulatory Objective(s). A new Correspondence column grouping displays Regulatory Objectives.
  • Submissions Archive now supports the import, viewing, and export of submissions using:
    • EU eCTD v3.1 Document Type Definition (DTD)
    • ECOWAS (WA) eCTD v1.0 Document Type Definition (DTD)
    • WHO eCTD v1.1 Document Type Definition (DTD)
  • The Submissions Archive Import Notification has been enhanced to show errors relating to missing required document fields.
  • The Mini-Browser window width has increased. Launching the Mini-Browser simultaneously displays the document’s Viewable Rendition and Information panel.

All Basics Applications

  • Customer Vaults will be updated to the local time zone of each customer. End users will not notice a difference as a result of this change.
  • The Document Viewer has been simplified and optimized, moving all tools and options to a single-line toolbar.
  • The Dashboard interface has been enhanced to improve color contrast, clarity, and visibility. These changes aim to provide a more visually distinct and user-friendly experience.