New in 21R2.3

Release Date: September 24, 2021

We are pleased to bring you the following new functionality in this week’s release. See details about feature enablement below.

Working with Documents

Rich Text for Merge Fields

With this release, Vault supports Merge Fields for Rich Text fields in Microsoft Word. Merge Field tokens for fields of the Rich Text type resolve and display in Microsoft Word documents using the rich text formatting specified in the Vault Rich Text Editor field.

Merge Fields Multi Column Table Sort

With this release, Vault allows users to further sort Merge Fields data in tables in Microsoft Word documents. Multi Column Table Sorting allows users to sort data merged into tables based on multiple columns instead of a single one by leveraging an ORDER BY VQL clause for up to 3 fields on the mapped token.

Annotation Colors Restored to 12

This enhancement restores the number of available colors for annotations to 12, updates toolbars in external viewers to use Action UI, and adds an option to use the escape key to dismiss unsaved annotations.

EDLs: Create Document from Template

A new user action is available to create a document from a template directly from an EDL Item without navigating away. The newly created document automatically matches the EDL Item, just like uploading a document or creating a placeholder directly from an EDL Item.

Delete Document Relationships On Older Versions

With this release, Vault users can delete relationships on older versions of the document where the relationship is version-specific with the Edit Relationship permission on the document version the relationship is bound to. Previously, users were able to create document relationships on previous versions but were unable to delete them.

Vault Objects

Online Modifications to High Volume Objects

Previously, high volume objects with over 10,000 records required Admins to put the Vault into configuration mode, thereby locking out end-users from Vault in order to make metadata changes. With this feature, the metadata changes can now be made online without having to lock end-users out of the system. While a modification to a high volume object is in progress, the object will display an In Deployment status on the object configuration page.

To improve performance while paginating through high volume object records in related object sections and advanced search dialogs, we limit the number of records returned to 1,000. Users can use the Show in Tab feature and the corresponding filter support to help narrow down the list to arrive at the data they are interested in.

Lifecycle & Workflow

Workflow Cancellation Actions

Workflow Cancellation Actions allow workflow Admins to configure actions that trigger when a workflow is cancelled. This provides solutions for a number of scenarios involving actions to perform upon cancellation of an active workflow. We have provided a set of default cancellation actions such as Update Record/Document Field and Send a notification. This feature also allows the use of the SDK to add your own cancellation actions.

Workflow Cancellation Comment

Workflow Admins can now require that the cancelling user provide a comment when an active workflow is cancelled. By default, comments are not required when cancelling workflows. When a cancellation comment is required, the user cancelling the workflow needs to give the comment. Cancellation comments are also supported as part of the workflow cancellation API. Cancellation comments are shown in workflow timeline views. The maximum number of characters for a cancellation comment is 500.

View Workflow Start States

On the workflow details page, workflow Admins can view a clickable list of lifecycle states from which the workflow can be started using user actions.

Update Task Due Date on Object Date Field Update

Workflow Admins can configure active task due dates to automatically update based on changes to an associated object record date field. Previously, due dates were set or updated only at the time of task creation. With this release, any time the record field is updated, due dates of all active tasks dependent on that field are also updated. When task due dates are configured to be updated automatically, the Update Task Due Date action for such tasks is unavailable.

Set Tokens in Instructions

Workflow Admins can configure tokens in instructions for the Start and Task steps of a workflow. In workflows on objects, fields on the object can be configured as tokens. In workflows on documents, document name and document number fields are available for configuration. These document tokens show a value only if the workflow consists of a single document. This feature also adds no-link tokens for notification object message templates, allowing the subject line to show a list of document and workflow names.

Envelope Objects to High Volume Object

Our workflows on documents (previously multi-document workflows) use Envelope and Envelope Content objects to contain the documents. Envelope objects are moving to Vault’s High Volume Object framework to provide the scalability required to support a large number of workflows. Moving to the high volume data store brings many fundamental changes, including non-availability of record-level access control and sharing settings. Customers who have created Envelope or Envelope Content custom object tabs should carefully control the access to those tabs. Envelope records are also visible to any user that has access to the document when the document is in an active workflow. Such users won’t be able to see new documents or take any action they aren’t entitled to, but will be able to access the envelope viewer.

Start Step Rule: Required Controls

In previous releases, start step rules were only capable of hiding a control. In this release, workflow Admins can now configure start step rules to require a control. For example, this feature will now allow Admins to ‘require’ an otherwise-optional Participant Control. This is useful for customers that have used workflow participant rules in the past with legacy workflows.

Ignore Non Applicable Field in Content Action or Event Action

With this release, Vault now ignores fields which are not part of the document type of the current document instead of throwing an error during document Content Actions or Event Actions.

Fix Actions with Missing References

This feature allows workflow Admins to update any rule in Entry Actions, Event Actions, User Actions and Entry Criteria that may contain missing records after a Vault refresh. Vault only copies certain object records during a Vault refresh. For example, custom objects and some standard object records are not copied. This can create issues in the refreshed Vault if any Actions or Entry Criteria rules contain those records from the source Vault. Now, Admins have the option to either fix those rules by bringing those records into the Vault using API or Vault Loader, or ignoring those rules while moving the configuration back to the source.

Reporting & Dashboards

Formula Fields in Multi-Pass Reports

This feature allows users to define formula fields in Multi-Pass reports. Users can perform calculations across report views including on summary calculation fields defined in report views. Formula fields may be used to define conditional fields, report filters, and to group results, and may also be used in dashboard charts. This release includes support for object and document report types.

Rendition Reporting

This feature allows users to create reports on document renditions. Admins can create “Rendition” and “Rendition with Document” report types to enable end-users to generate reports on document renditions and associated documents. Admins can also create a “Document with Rendition” report type to enable end-users to create reports on documents and their related renditions.

Enable Filter and Column Aliases Flag Moved to Report Builder Page

This feature moves the “Enable filter and column aliases” flag from the report creator page to the report builder page. This allows users to enable the flag for existing reports as well as new reports. This flag controls users’ ability to change the name of columns and filters, and allows users to remove name columns.

Usability & UI Updates

Email to Vault

This feature enables customers to send emails to a Vault-owned email address and automatically create documents, records, and attachments in their Vault. Incoming emails are first converted into Email records within the Vault and then further saved as documents, attachments, and other records by Email Processors defined by Platform, Vault apps, and customers. Admins can define Vault-owned email addresses and configurations associated with each email address, including the related processor. All Vaults now include an Email Processor that can convert an email into an unclassified document.

Search Modifiers on Object Tabs

The Search Modifier feature, previously only available on Document search, has been extended to work with Object record search. When searching on any object tab, Vault will suggest a list of object field names that start with the characters typed by the user. After selecting a field, the user can add a value to quickly apply filters, or search within a single text field on that object. Search Modifiers work with Picklists, Object References, and Yes/no fields to filter results. You can use Search Modifiers for single-field scoped searches with Text, Long Text, and Rich Text fields.

Add Language Options to Language Field

The Language field on documents in multilingual Vaults now includes an additional 242 languages to better support work being done all over the world. To see a complete list of selectable languages, see Supported Languages.

Substring Matching for Contains Operator

The Contains operator available when filtering search results on a picklist or object reference field, will now match any part of a word or number. For example, filtering results where the Study Contains “B-1” will find results with Studies “AB-123” and “BB-124”.

Checklists

Checklists: Automation for Aggregate Checklist Updates

Now, when a new version of a checklist design is approved, an entry action will automatically create new, approved versions of all approved aggregate checklist designs containing that checklist design. This action saves customers from manually performing a click-heavy process of creating new versions of each aggregate checklist design.

Access Control

Allowed Users When Assigning New Document Owner

In previous releases, Vault did not restrict which users could be assigned as a new document owner (through manual assignment, bulk actions, or the Rest API). Starting from this release, Admins can configure the Owner lifecycle role to restrict who can be assigned as the new document owner. This feature does not impact the document creation flow, where the creator is automatically assigned as the document owner. Allowed users default to “All users and groups” at upgrade time, preserving the behavior of the previous release.

Details Page for Vault Users: Show in Tab Action on Related Object Sections

The details page for Vault Users (Admin > Users & Groups) now provides a Show in Tab action on related object sections.

Administration

Admin Configuration Tab Updates

Admins frequently use the Configuration tab to access various configuration pages to set up Vault. This tab has been updated to display a landing page with links to all the configuration pages available to an Admin. Admins can also search for a configuration page and easily add frequently used configuration to the Favorites list. A Recently Used section displays up to five (5) of the most recently viewed pages to allow Admins to quickly return to them. Learn more in Navigating the Business Admin and Configuration Tabs.

Standardize Escape Sequence for Special Characters

This feature standardizes the VQL escape character () and allows developers and Admins implementing Criteria VQL to reference supported special characters on all document fields, object fields, and other VQL endpoints. The supported list of characters includes: backslash (\), carriage return (r), double quote (“), line feed (n), percent sign (%), single quote (‘), asterisk (*), and tab (t). Vault will automatically convert existing Criteria VQL to use the standardized escape characters.

Saved View Admin

The new View Administration tools give Admins improved visibility and control over the Views that have been created in a Vault. A new “managed” property has been added to distinguish views created by users to use for themselves or share with other users, from views that are created by admins as part of the Vault’s configuration. Views that are configured to be both “managed” and “mandatory” can be configured as the default view of a tab. This is helpful for steering less frequent users towards results that are pre-filtered. For example, casual users may only expect to see Steady State documents when viewing the Library for the first time so a default view with this filter can be added to the Library tab. A new option has been added to create Views using VQL for search criteria rather than building the view from the tab. These views are always “managed” and behave much like standard views. When accessing the new View tool, all of the Views are available in a searchable list where admins can take the following actions:

  • View the search criteria and visibility details
  • Update which users the view is visible to
  • Reassign ownership of a view
  • Show the view in a tab
  • Set a view to be managed and/or managed
  • Created new views using VQL
  • Export the list of views
  • Delete

Previously, any user with the View Administration permission would be able to see all views marked as mandatory in the View Manager dialog. That permission has now changed to “Make Mandatory” which is limited to marking views as mandatory. To see all Views in the Vault, there is a new set of permissions in the Admin section of the permission set that gives Administrators access to the new View Administration tools.

Prevent Merge in Steady State Rendition Setting

This release allows Admins to control enablement of the Prevent Merge in Steady feature for renditions. This was previously only enabled by Veeva Support. With this setting and feature enabled, once a document reaches the Steady State, that document no longer merges document fields or related object fields when an action that triggers field merging occurs. The document does not merge while in its Steady State regardless of whether the merging event is triggered by the system or due to a manually performed action.

Re-Render of Previous Rendition Versions

With this release, Vault users with the Vault Owner Actions: Re-render permission can re-render the non-current version of a rendition.

Scheduled Data Exports: Reset Custom Amazon S3 Settings

With this release, Admins can remove their Custom Amazon S3 configuration in Scheduled Data Export Settings.

Vault Loader

Vault Loader Extract: Include All Rendition Types in CSV Export

When extracting Documents and Document Versions, Vault Loader CSV data exports now include metadata for all available rendition types when the Include Renditions option is selected.

Platform Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Platform data model to support new features:

The following components were added to Vault to support the Email to Vault feature:

  • The Email (email__sys) object was added with the following fields:
    • Recipient Email Address (recipient_email_address__sys)
    • Recipient Email Username (recipient_email_username__sys)
    • Sender Email Address (sender_email_address__sys)
    • Sender User (sender_user__sys)
    • Sender Person (sender_person__sys)
    • Sent Date (sent_date__sys)
    • Subject (subject__sys)
    • To (to__sys)
    • CC (cc__sys)
    • Message ID (message_id__sys)
    • Full Message ID (full_message_id__sys)
    • Link (link__sys)
    • Global ID (global_id__sys)
  • The Email Lifecycle (email_lifecycle__sys) system-managed lifecycle was added with the following states:
    • New (new__sys)
    • Processed (processed__sys)
    • Failure (failure__sys)
    • Inactive (inactive__sys)
  • The Emailed Document (emailed_document__sys) object was added with the following fields:
    • Email (email__sys)
    • Document (document__sys)

Vault Connections

The Vault Connection between the CTMS and CDMS Vault suites, supporting Study, Event, and Protocol deviations/issues sharing between the Vaults, now alerts the CTMS vault of any deleted Events (Subject Visits, for example), Procedures, Subjects, and Protocol deviations. This feature will give Clinical Operations personnel insight into the status of a clinical trial to adjust expectations while avoiding downstream process problems like Payments sent to Sites for canceled or deleted Subject Visits.

CTMS/CDMS: Support Query Object Rules

Veeva Vault Connection for CDMS and Clinical Operations Vaults sharing Study, Site, and Subject information now supports filtering of data shared between the two Vaults for filtering data transferred based on the customer’s unique requirements.

Clinical Operations

Site Connect: Allow Resending of Same Document Version

Site Connect customers now have the option to resend the same document version to a single Study Site.

Automate Milestone State Changes

This feature introduces a Vault-wide setting to automatically change the state of Milestones based on the population of specific date fields. To start, it will enable Milestones to be moved to their complete state when the Actual Finish Date is populated, without requiring additional actions in the lifecycle.

Clinical Operations Feature Flag Cleanup

This feature makes visible assorted Clinical Operations feature flags in the Settings section of Vault that were previously only available to Vault Support.

Site Connect: Manual Study Invitation Creation & Send

This feature adds support to manually create and send Site Connect Study Agreements directly from a Study Site record.

Site Connect: Prevent Document Upversion on Study Field Updates

With this enhancement, documents received from SiteVault will no longer lead to creating a new document version if the document content is the same. If the content is the same, Site Connect will only update the document’s Study, Study Country, and Study Site fields.

Site Connect: Reason for Rejection on Study Invitation

When the receiving side rejects Site Connect Study Invitations or TMF Transfer Agreements, a reason for rejection verdict is now required.

Site Connect: Request Document from Expected Document with Matched Document

With this feature, Site Connect customers can now request additional documents from an expected document even if there is already a matched document.

Safety Distribution: Email Notify SiteVault Sites

With this feature, Site Connect customers can designate that Safety Distributions send directly to Study Site personnel via email in addition to their delivery to SiteVault.

Site Connect: Send Site Packages from Study Site

This feature allows Site Connect customers to send Site Packages directly from the Study Site record.

Vault Payments: Site Advance Payments

This feature allows Vault Payments to support Site Advances. When designated as a Site Advance, the Fee will generate both credit and debit Payable Items, allowing Payments customers to issue Site Advances and track ongoing expenses for reporting and visibility.

Site Connect: Additional Vault Clinical Docs Support

This feature adds support to transfer new document types via Veeva Site Connect. The new Vault Clinical Docs artifacts that are now transferrable via Site Connect include the following:

  • Site Signature & Initials
  • Site Budget
  • Site Selection Letter
  • Study Team Member Contact List
  • IP Certificate of Destruction
  • Sample Storage Condition Log
  • Investigators Meeting Material

Site Connect: Connection Automation

With this Production-only feature, Site Connect customers can automatically establish Connections to SiteVault. Vault creates these standard Site Connect connections whenever you create an Organization record with a USN value.

Site Connect: Site Packages Improvements

This feature includes many enhancements to the Site Connect Site Packages flow including:

  • Increasing the limit for the number of documents that Vault can send to a Study Site.
  • Locking the Name column in the Preview Package screen.
  • Pulling in the name of each Study Site’s Principal Investigator to more easily identify each Site.

Site Connect: Study Invitation Welcome Text

Site Connect customers can now include custom Welcome Text when sending Study Invitations to Study Sites. SiteVault displays the Welcome Text to the Site during the Study Invitation acceptance flow. You can also set Welcome Text for TMF Transfer Agreements.

TMF Bot: Train Models from Production Data

This feature allows admins to train a Trained Model from a Sandbox, QA, or Pre-release environment using that customer’s related Production environment data.

TMF Viewer: Classification Filtering for View-Only Users

With this feature, users with view-only permissions can now utilize the Classification filter within the TMF Viewer.

Clinical Operations Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Clinical Operations data model to support new features:

Added the following field to the Study Site object to support the Safety Distribution: Email Notify SiteVault Sites feature:

  • Email Site when Connected (email_safety_connected__v)

Added the following fields to the Agreement object to support the Site Connect: Reason for Rejection on Study Invitation feature:

  • Reason for Rejection (rejection_reason__v)
  • Agreement Identifier (agreement_identifier__v)
  • Welcome Text (welcome_text__v)

Added the following eConsent objects to support future Site Connect enhancements:

  • Form Question (form_question__v)
  • Form Response (form_response__v)
  • Form Answer (form_answer__v)

Added the following components to support the Vault Payments: Site Advance Payments feature:

  • Site Advance (Y/N) (site_advance__v) field to the Fees, Fee Templates, and Payable Items objects

Commercial

Dedicated Medical Inquiry User Interface

This feature provides a modern and configurable user interface dedicated to medical inquiry that allows users to capture all the information related to the inquiry in one place. As well as core details about the case, the user can capture multiple requests, alongside each of which one or more responses can be logged, as well as any other related details communicated by the HCP such as an adverse event or product quality complaint. Doing so in a single screen drives speed and efficiency for MedComms users.

CLM Metadata Enhancements for Medical Affairs

With this release, through data model changes and industry best practices, MedComms captures far richer metadata at the point of content creation. This provides MSLs using Veeva CRM with an enhanced searching experience for CLM content, allowing them to identify what they are looking for more quickly and efficiently.

Document Level Rendition Type Selector for Single Doc Publishing for CLM Content

This feature allows users to select an alternative rendition type for a document being used with single document multichannel publishing for CLM Content. While the existing default rendition setting at the document type-level remains, this change allows users to override that default per document as required.

Content Modules: Hierarchical Copy

With this release, Content Modules allow the enablement of hierarchical or “deep” copy. The hierarchical copy allows users to clone a Content Module and all related records during the object record copying process. Users are still able to copy only the Content Module and not the related records.

Commercial Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Commercial data model to support new features:

The following component was added to PromoMats & MedComms Vaults to support the Document level rendition type selector for Single Doc Publishing for CLM Content feature:

  • Added new shared document field CRM Rendition Override (crm_rendition_override_v)

The following components were added to PromoMats & MedComms Vaults to support the CLM Metadata Enhancements for Medical Affairs feature:

  • Added new shared document field CRM Searchable Description (crm_searchable_description_v)
  • Made the shared document field Website (website__v) editable
  • Moved the following fields to the CRM Properties display section in the template:
    • CRM Org (crm_org__v)
    • CRM Product (crm_product__v)
    • CRM Product Group (crm_product_group__v)
    • Publish for Veeva CRM (CLM) (clm_content__v)
    • CRM Directory (crm_directory__v)
    • CRM Searchable Description (crm_searchable_description_v)
    • CRM Searchable Keywords (crm_keyword__v)
    • Start Date (crm_start_date__v)
    • End Date (crm_end_date__v)
    • Training (crm_training__v)
    • Enable Survey Overlay (crm_enable_survey_overlay__v)
    • Survey (crm_survey__v)
    • Presentation ID (crm_presentation_id__v)
    • Hide from CLM Library (crm_hidden__v)
    • Publish for Veeva CRM (URL) (shareable_as_an_approved_link__v)
    • Publish for Veeva CRM (WeChat) (wechat_content_wec__v)
    • Searchable in WeChat (shareable_in_wechat_wec__v)
    • Use China CDN (use_china_cdn__v)
    • Publish for Veeva CRM (Portals) (engage_content__v)
    • Publish for Veeva CRM (CoBrowse) (cobrowse_content__v)
    • Related Content Display Order (crm_related_content_display_order__v)
    • Website (website__v)
  • Added the following fields to the Multichannel Presentation document type:
    • CRM Org (crm_org__v)
    • CRM Product (crm_product__v)
    • CRM Searchable Description (crm_searchable_description_v)
  • Added the following fields to the Multichannel Slide document type:
    • CRM Org (crm_org__v)
    • CRM Product (crm_product__v)
    • CRM Directory (crm_directory__v)
    • CRM Searchable Keywords (crm_keyword__v)
    • CRM Searchable Description (crm_searchable_description_v)
  • Reordered the CRM Properties (crm_properties__c) field layout as follows:
    • CRM Org
    • CRM Product
    • CRM Product Group
    • Publish for Veeva CRM (CLM)
    • CRM Directory
    • CRM Searchable Description
    • CRM Searchable Keywords
    • Start Date
    • End Date
    • Training
    • Enable Survey Overlay
    • Survey
    • Presentation ID
    • Hide from CLM Library
    • Publish for Veeva CRM (URL)
    • Publish for Veeva CRM (WeChat)
    • Searchable in WeChat
    • Use China CDN
    • Publish for Veeva CRM (Portals)
    • Publish for Veeva CRM (CoBrowse)
    • Related Content Display Order
    • Website
  • Made the following inactive document fields active:
    • CRM Org (crm_org__v)
    • CRM Product (crm_product__v)
    • CRM Searchable Description (crm_searchable_description_v)
    • CRM Searchable Keywords (crm_keyword__v)
  • Added the field dependency rule: Within document type Multichannel Presentation, if Publish for Veeva CRM (CLM) equals Yes, fields CRM Org, CRM Product, CRM Directory, CRM Searchable Description, and CRM Searchable Keywords are required
  • Added the field dependency rule: Within document type Multichannel Slide, if Publish for Veeva CRM (CLM) equals Yes, fields CRM Org, CRM Product, CRM Directory, CRM Searchable Description, and CRM Searchable Keywords are required

Quality

Recurrence Check: Complaints

With this release, Vault QMS expands its Recurrence Check capabilities to Complaints and introduces an intelligent and streamlined process for end-users to check whether a Complaint is a recurrence of another. The previously complex manual process is replaced with a simple user action that quickly finds potential recurrences and displays them in an easy to scan list view. Once the recurrence check is complete, Vault QMS will automatically store the results which can then later be utilized for reporting and trending.

Standard Cycle Time Metrics for Quality Events

With this release, Vault QMS is able to automatically capture the following cycle time metrics for Quality Events:

  • Cycle Time: Duration in number of days between initiation and closure
  • Closure Delta from Original Due Date: Number of days a Quality Event closes before or after the original due date
  • Closure Delta from Current Due Date: Number of days a Quality Event closes before or after the current due date if the original due date was modified
  • Extensions Granted: Number of approved extension requests for a Quality Event

Display Key Quality Team Roles for Filtering, Reporting

With this release, QMS customers can now surface key Quality Team Role assignments as User fields, allowing them to appear and be used in related lists, searches, filters on library views, reports and more. This feature introduces the ability to declare which User object reference field on a given Quality Team-enabled object will be linked to a Quality Team Role’s membership. When the linked team role’s membership is changed, Vault updates the field to reflect the new team role membership. Once the feature is enabled, Admins can choose an update strategy that works best for their business teams to ensure that existing records’ fields are updated to match their pre-existing assignments’ values. This field linking is supported for any Quality Team Role with a Maximum Users value of one (1). Once linked to a team role, a given object reference field may not be updated by any mechanism other than via edits to the Quality Team Role it is linked to. You must configure this Quality Team Role field linking before it can be used. The Quality Team Role’s linked fields are updated asynchronously from the role membership changes themselves, which are instant, so users may need to wait a moment after saving Quality Team Role membership changes to see the updated team role assignments as user fields throughout the Vault. Learn more about setting up linked role fields.

Generate Quality Document from Record: Batch Release Process Support

QMS customers now have the ability to automatically create documents as part of a Batch Release/Disposition lifecycle, such as CoAs, CoCs, or other documentation artifacts. The ability to create documents based off of Formatted Outputs or Document Templates may be familiar to QMS customers who work regularly with Audits or Quality Events, for whom this functionality was introduced earlier this year. When creating the documents, Vault links the newly created document to the Disposition record which triggered its creation, as well as linking that Disposition record back to the document, establishing a bidirectional relationship. This feature requires configuration before it can be used. Learn more about Quality document generation from records.

Enable Reference Objects for Quality Suite Vaults

In the Quality Suite, certain objects are considered ‘core’, and require that a given application be deployed in order to be usable. With this release, we’ve revised Vault’s definition of which objects are considered ‘core’ to each of the Quality Suite’s sub-applications. Customers may now interact with objects like Organization (qms_organization__qdm), used for creating lists of suppliers or external organizations which can impact Quality operations, Context (context__qdm), or Department (department__v) regardless of which Quality Suite application(s) have been activated within their Quality Vault. While this change is automatically enabled, it requires configuration to impact end-users, as this feature does not impact existing permission sets or security profiles.

MDCC: Change Authorization Section

With this release, a new Change Authorization object can be leveraged to add one or many documents to a DCC for change authorization approval. Each document that is added to the Change Authorization can be tagged as Needs Revision or Make Obsolete as part of an impact assessment. Once the Change Authorization record has been approved, a document that needs revision will have a new draft version automatically created and added to the Documents to be Made Effective section of the DCC. Similarly, if a document is to be made obsolete, approval of the Change Authorization record automatically moves the document to the Documents to be Made Obsolete section of the DCC. Prior to this feature, a draft version of an effective document needed to be manually created before adding it to a DCC.

DCC Banner Utilizes Label of Document Change Control Object

The DCC banner that appears when a document is under a Document Change Control was previously hard-coded as “This document is currently governed by change control”. With this release, the “change control” portion of the message will now be replaced with the label of the Document Change Control object. This is helpful in Vaults where the Document Change Control object has been renamed.

Training Self-Enrollment

This feature allows Learners to self-enroll in Training Requirements that have been made available for self-enrollment by Training Admins. Once configured, Learners can browse or search for Training Requirements that interest them, then self-enroll in the courses. For example, a Learner may want to know about Good Documentation Practices. The Learner can find the course from the Learner Homepage, self-enroll, and complete it. Learners can unenroll from a course at any time. Learn more about self-enrollment.

Training Job Performance Improvements

This feature delivers various performance and reliability improvements for the Update Training Assignments job.

Increased Limit for Training Join Relationships

This feature increases the maximum number of Training Requirements per Curriculum to 100. The maximum number of Curricula per Learner Role has been increased to 60.

Training Content Set Object is Not Cloned

With this release, the Training Content Set object is no longer cloned during Vault provisioning.

Training Document Entry Actions Captured in Audit Trail

With this release, when the Issue Training Assignment, Create Training Requirement Impact Assessment, or Retire or Assess Impact on Training Requirements entry actions are executed on a document, the document’s audit trail is updated.

Validate Object Type for Imported Training Assignments

When importing Training Assignments, the application now validates that the Training Assignment object type matches the Training Requirement’s object type.

Direct Assignment Action: Document Trainability Validation

This feature ensures that the Direct Assignment action on a Training Requirement is not visible, and therefore cannot be performed, if documents in the Training Requirement are not in either the Steady State or Ready for Training state types. For a direct assignment on a Curriculum, Training Assignments are not assigned for Training Requirements within the Curriculum that have documents not in either the Steady State or Ready for Training state type.

AICC E-Learning Courses: URL Validation Refinement

In this release, when an AICC e-learning course is uploaded, Vault Training will set the value for E-Learning Standard for any URLs in the file_name (in course.au file) unless its value is “servername.com”.

Issue Training Assignment Entry Action Update

When the Issue Training Assignment action is executed on a document and a Training Requirement Impact Assessment does not exist, the action will now update the Training Requirement’s Training Content Set. This only occurs if there is one document in the Training Requirement.

Allow Description Field Requiredness on Curriculum & Learner Role Objects

For the Description field on Curriculum and Learner Role objects, Admins can now enable the User must enter a value (required) setting.

Rule References Upon Retiring Training Objects

When attempting to retire a Training Requirement or Curriculum which has defined prerequisite rules, the rule label and name are now included in the error message.

Direct Assignment Cancellation: Cancel Open Training Assignment Action & Curriculum Retirement

With this release, both the Cancel Open Training Assignment document entry action and changing a Curriculum to the Retired state cancels open Direct Assignment Training Assignment records.

Multi-Country Adverse Events Reporting

With this feature, Vault automatically creates Adverse Event Reports once the user finishes the Reportability Assessment based on the Country of Incident, Severity Outcome of the Complaint, the Product involved in the Incident, and Reporting Decision Rules.

VPS: Validation Results Storage

With this feature, users are able to see all the validation errors for an Adverse Event Report as object records. Vault directs the user to the specific section in the respective health authority form, making it easy for the end user to fix validation errors before submitting the report to health authorities.

VPS Data Model Changes

With this release, several data model changes were made to support Vault Product Surveillance features:

The following changes were made to support the VPS: Validation Results Storage feature:

  • The Adverse Event Report Validation object was added with following fields
    • Health Authority Section Number (ha_section__v)
    • Health Authority Field Name (ha_field_name__v)
    • Object Name (object_name__v)
    • Object Label (object_label__v)
    • Field Name (field_name__v)
    • Field Label (field_label__v)
    • Reason (reason__v)
    • Source Value (source_value__v)
    • Mapped Value (mapped_value__v)
    • Adverse Event Report (adverse_event_report__v)
    • Adverse Event Report Validation Type (validation_type__v)

The following changes were made to support the Multi Country Adverse Events Reporting feature:

  • Added the Product Marketed (product_marketed__v) object with following fields:
    • Product Variant (product_variant__v)
    • Country (country__v)
    • Auto-name Calculation (autoname_calculation__v)
  • Added the Reporting Requirement (reporting_requirement__v) field to the Reporting Decision Rules object.
  • Added the following fields to the Reportability Assessment Effects object:
    • Country (country__v)
    • Severity Outcome (severity_outcome__v)
    • Is Reportable? (is_reportable__v)
    • No of Days for Initial Report (no_of_days_initial_report__v)
  • Several fields were removed from Adverse Event Report object and added to the Quality Event object:
    • AE - Manufacturer Narrative (mfg_narrative__v)
    • AR Contact Person (ar_contact_person__v)
    • AR Contact Person’s Details (ar_contact_details__v)
    • Authorized Representative (authorized_representative__v)
    • CAPA Plan Summary (capa_plan_summary__v)
    • CAPA Schedule (capa_schedule__v)
    • Classification of incident (ae_classification__v)
    • Complainant (complainant__v)
    • Complainant Contact Information (complainant_contact_information__v)
    • Complainant Type (complainant_type__v)
    • Date of Death (date_of_death__v)
    • Date of Event (date_of_event__qdm)
    • Description of the Adverse Event (ae_description__v)
    • Final Comments (mfg_final_comments_cause__v)
    • Further Investigations (further_investigations__v)
    • Healthcare Facility Report Number (healthcare_facility_number__v)
    • How long device used? (how_long_device_used__v)
    • Importer (importer__v)
    • Incident - Healthcare Facility (incident_healthcare_facility__v)
    • Incident involves multiple devices? (multiple_devices__v)
    • Investigation Summary and Conclusion (investigation_summary_and_conclusion__v)
    • Latest Info Available Date (latest_info_date__v)
    • Manufacturer (manufacturer__v)
    • Manufacturer - Contact Person (manufacturer_contact_person__v)
    • Manufacturer Contact Details (mfg_contact_details__v)
    • Manufacturing Site (mfg_site__v)
    • Manufacturing Site - Contact Info (mfg_site_conatct_info__v)
    • Mfg Report # (mfg_report_number__v)
    • Non-Reportable Incident - Explanation (non_reportable_explanation__v)
    • Number of patients involved (number_of_patients__v)
    • Other Relevant History (other_history__v)
    • Outcomes Attributed to Adverse Event (adverse_event_outcomes__v)
    • Patient Consequences (patient_consequences__v)
    • Product Categorization (product_categorization)
    • Product Variant (product_variant__v)
    • Reporter - Occupation (reporter_occupation__v)
    • Reporter’s Contact Information (reporter_contact_info__v)
    • Root Cause Analysis (root_cause_analysis__v)
    • Root Cause Confirmed? (root_cause_confirmed__v)
    • Date of Event - To (date_of_event_to__v)
    • Importer Contact Details (importer_contact_details__v)
    • Role of Initial Reporter (initial_reporter_role__v)

Quality Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added and updated the following components to the Quality data model:

The following changes were made to support the Recurrence Check: Complaints feature:

  • The Complaints object type was added to the Record Check Result and Record Check Result Match objects.

The following changes were made to support the MDCC: Change Authorization Section feature:

  • Added the Change Authorization (change_authorization__v) object with the following fields:
    • Document Change Control (document_change_control__v)
    • Target Document (target_document__v)
    • Revise or Obsolete (revise_obsolete__v)
  • Added the Change Authorization Lifecycle.
  • Added the Change Authorization Change Control (change_authorization_change_control_v) shared document field.

The following changes were made to support the Standard Cycle Time Metrics for Quality Events feature:

  • Added the Cycle Time Start (cycle_time_start__v) and Cycle Time Stop (cycle_time_stop__v) standard state types.
  • Added the Quality Event Cycle Time Metric (quality_event_cycle_time_metric__v) object with the following fields:
    • Quality Event (quality_event__v)
    • Cycle Time Start Date (cycle_time_start_date__v)
    • Original Due Date (original_due_date__v)
    • Current Due Date (current_due_date__v)
    • Cycle Time Stop Date (cycle_time_stop_date__v)
    • Cycle Time (cycle_time__v)
    • Cycle Time Delta from Original Due Date (cycle_time_delta_original_due_date__v)
    • Cycle Time Delta from Current Due Date (cycle_time_delta_current_due_date__v)
    • Extensions Granted (extensions_granted__v)
  • Added the following object types for the Quality Event Cycle Time Metric (quality_event_cycle_time_metric__v) object:
    • Change Control (change_control__v)
    • Complaint (complaint__v)
    • Continuous Improvement (continuous_improvement__v)
    • Deviation (deviation__v)
    • External Finding (external_finding__v)
    • Internal Finding (internal_finding__v)
    • Lab Investigation (lab_investigation__v)
    • Medtech Complaint (mt_complaint__v)
    • Nonconformance (nonconformance__v)

The following changes were made to support the Training Self-Enrollment feature:

  • Added the following fields to the Training Requirement (training_requirement__v) object:
    • Available for self-enrollment? (allow_self_enrollment__v)
    • Completion Credit Given if Completed Via (completion_credit_if_completed_via__v)

Regulatory

Brexit: Add UK(NI) to Centralised Countries for Create Registrations

With this release, United Kingdom (Northern Ireland) (XI) will be included by default as one of the countries when creating registrations for European Union centralised procedure applications. This change is being made in response to Brexit.

Clinical/Nonclinical Study Content Plan Section Creation Update

With this release, when Study Type and/or Study Subtype are blank on the Submission Clinical Study or Submission Nonclinical Study used for content planning, Vault will no longer create the study for any Content Plan section with a defined Study Type/Subtype instead of repeating the study for every section with a defined Study Type/Subtype.

Dynamic Ordering for Correspondences

With this update, Correspondence documents will also be ordered by the Submission record’s Actual Submission Date when Show Correspondence in Viewer and Enable Dynamic Ordering within Submissions Archive Viewer Submissions Archive settings are enabled.

EAEU Import &Viewing R.022 XML

This feature allows customers to import and view EAEU (Eurasian Economic Union) electronic format submissions in the RIM Submissions Archive. EAEU submissions are supported with all current Submission Archive Import methods when the submission’s Dossier Format is set to EAEU.

Empty Section Indicator

With this release, Submissions Archive can precalculate which eCTD and EAEU submission sections are empty as a result of delete operations. In the Submissions Archive Viewer users will see an icon depicting which sections are empty as a result of delete operations. When Submissions are newly published or imported, the system will recalculate the impacted Applications. The feature is Administrator-enabled and cannot be undone.

Extend Content Plan Tokens

This feature extends tokenization support for Content Plan tokens so that text and object reference fields on submission relationship tokens are tokenizable. For example, if the token ${submission_pharmaceutical_product__rim.xml_drug_product__v} is applied on the Name, Title, or Published Output Location of a Content Plan or Content Plan Item record, the token in the field will be resolved with the value in the XML Drug Product field of the referenced Submission Product record. Previously, Content Plan tokens only resolved the name of the submission relationship, or the name or title of the matched document. Tokenization support for matched documents is also extended to two new standard document text fields: eCTD Title (ectd_title__v) and Output Name (output_name__v).

IDMP Data Model and Algorithm Updates (Per IG v2)

This feature updates the data model for Vault Registrations to support EU IDMP implementation guide versions 2.0 and 2.1. Updates include additions to source records, IDMP submission data records, and the data aggregation mechanism.

Manage Registered Details Enhancements

With this release, name-based object type mapping will provide Manage Registered Details the ability to add registered details with a mix of object types to the same registration, which is needed for Unique Device Identification (UDI) as well as combination products; this requires the internal names of the object types on the source and target objects to match. Also, Manage Registered Details will be able to add and update the following details on product registrations to support UDI: Registered Clinical Studies, Registered Organizations, Registered Authorizations, and Registered Regulatory Text. Finally, support will be added for copying and updating additional standard fields added to the preexisting registered details in 21R2 for UDI.

Publish with Overlays

With this release, users can now define an overlay on Publishing Elements and apply them to individual content plan items for submission content plans and report level content plans (RLCP). Additionally, users can define a default overlay. During RLCP or submissions publishing activities, Vault applies the defined overlay to the published output.

Update Copy into Content Plan Error Validation

With this release, an update has been made to the Copy into Content Plan feature. Users will be able to copy content plans without an associated submission or report level content plan into submission content plans and report level content plans. Previously, error validation prevented this action.

Support for Keyword Linking & Additional Link Types

With this release, users can define a library of keywords and alternative text and associated hyperlink targets. The user is then able to ‘Suggest Links’ on a document and automatically create Vault Link Annotations. Submissions Publishing and RLCP Publishing resolve the suggested links within the published output. Additionally, Vault Link Annotations that target permalinks and Vault Link Annotations that are bought forward from previous versions are now supported with Submissions Publishing and RLCP Publishing.

Process ZIP Import at the Submission Level

When admin enabled, this feature provides an ability to import and process all Zip file uploads via the Submissions Archive import as if the file contents were created at the submission level of the application. Unreferenced files at the root of the submission are grouped in the Unreferenced Files folder.

Informational Warnings in Email Notifications for All Import Methods

With this release, users receive post submission import email notifications in an updated format, which includes a new grouping with informational messages from the import pre-validation process.

File Format Icons Display in Active Dossier

With this release, the Active Dossier Viewer and Editor display the file format icon of the documents tracked within the Active Dossier.

21R3 RIM Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added and updated the following components to the Regulatory data model:

To support the Extend Content Plan Tokens feature, added document and object fields as follows:

  • Added Output Name (output_name__v) object field to the following submission join objects:
    • Submission Product (submission_pharmaceutical_product__rim)
    • Submission Active Substance (submission_active_substance__rim)
    • Submission Inactive Ingredient (submission_inactive_ingredient__rim)
    • Submission Indication (submission_indication__rim)
    • Submission Clinical Study (submission_country__rim)
    • Submission Nonclinical Study (submission_nonclinical_study__rim)
  • Added document fields:
    • eCTD Title (ectd_title__v)
    • Output Name (output_name__v)

Added the following new fields to support the Empty Section Indicator feature:

  • Empty Section Indicator Update Pending (esi_update_pending__v) document field to the Submissions Archive > Structure (structure__v) document subtype
  • Is Empty (is_empty__v) object field to the Submission Metadata object

Added the following fields to the Submission Metadata (submission_metadata__v) object to support the EAEU Import &Viewing R.022 XML feature:

  • XML Section ID (xml_section_id__v)
  • Document Creation Date (document_creation_date__v)

Added the following components to support the IDMP Data Model and Algorithm Updates feature:

  • Added the following objects:
    • IDMP Manufactured Item Description (idmp_manufactured_item_description__v)
    • IDMP AP Reference Strength (idmp_ap_reference_strength__v)
    • IDMP PV Reference Strength (idmp_pv_reference_strength__v)
    • IDMP Pack Size (idmp_pack_size__v)
    • IDMP Pharmaceutical Product Description (idmp_pharmaceutical_product__v)
  • Added the following document fields:
    • IDMP Alternate ID System (idmp_alternate_id_system__v)
    • IDMP ID System (idmp_id_system__v)
  • Added the following fields to the IDMP Attachment (idmp_attachment__v) object:
    • Alternate ID System (alternate_id_system__v)
    • Alternate ID System Code (alternate_id_system_code__v)
    • Alternate ID System Code Text (alternate_id_system_code_text__v)
    • Alternate ID System Term (alternate_id_system_term__v)
    • Alternate ID System Term Text (alternate_id_system_term_text__v)
    • Document Type Term (document_type_term__v)
    • Document Type Term Text (document_type_term_text__v)
    • Identifier System (identifier_system__v)
    • Identifier System Code (identifier_system_code__v)
    • Identifier System Code Text (identifier_system_code_text__v)
    • Identifier System Term (identifier_system_term__v)
    • Identifier System Term Text (identifier_system_term_text__v)
    • Language Term (language_term__v)
    • Language Term Text (language_term_text__v)
  • Added the following fields to the IDMP Classification System (idmp_classification_system__v) object:
    • ATC Flag (atc_flag__v)
    • ATC Flag Text (atc_flag_text__v)
    • ATC Term (atc_term__v)
    • ATC Term Text (atc_term_text__v)
    • GMO (gmo__v)
    • GMO Text (gmo_text__v)
    • Legal Basis Term (legal_basis_term__v)
    • Legal Basis Term Text (legal_basis_term_text__v)
    • Medicinal Product Category Term (medicinal_product_category_term__v)
    • Medicinal Product Category Term Text (medicinal_product_category_term_text__v)
    • Paediatric Use Term (paediatric_use_term__v)
    • Paediatric Use Term Text (paediatric_use_term_text__v)
    • XEVMPD Product Type Term (xevmpd_product_type_term__v)
    • XEVMPD Product Type Term Text (xevmpd_product_type_term_text__v)
  • Added the following fields to the IDMP Component (idmp_component__v) object:
    • Component Type Term (component_type_term__v)
    • Component Type Term Text (component_type_term_text__v)
  • Added the following fields to the IDMP Component Material (idmp_component_material__v) object:
    • Material Term (material_term__v)
    • Material Term Text (material_term_text__v)
  • Added the following fields to the IDMP Container (idmp_container__v) object:
    • Container Type Term (container_type_term__v)
    • Container Type Term Text (container_type_term_text__v)
  • Added the Registered Packaged Medicinal Product (registered_packaged_medcinal_product__v) field to the IDMP Container Data Carrier (idmp_container_data_carrier__v) object.
  • Added the following fields to the IDMP Container Material (idmp_container_material__v) object:
    • Material Term (material_term__v)
    • Material Term Text (material_term_text__v)
  • Added the following fields to the IDMP Container Reference Item (idmp_container_reference_item__v) object:
    • Device (device_reference__v)
    • Device Identifier (device_identifier__v)
    • Device Identifier Text (device_identifier_text__v)
    • Device Trade Name (device_trade_name__v)
    • Device Trade Name Text (device_trade_name_text__v)
    • Device Type (device_type__v)
    • Device Type Code (device_type_code__v)
    • Device Type Code Text (device_type_code_text__v)
    • Device Type Term (device_type_term__v)
    • Device Type Term Text (device_type_term_text__v)
    • Product (product__v)
    • Product Variant (product_variant__v)
    • Quantity Unit Term (quantity_unit_term__v)
    • Quantity Unit Term Text (quantity_unit_term_text__v)
    • Registered Product (registered_product__v)
    • Registered Regulatory Text (registered_regulatory_text__v)
    • Registration (registration__v)
    • Regulatory Text (regulatory_text__v)
    • Type of Combination (type_of_combination__v)
    • Type of Combination Code (type_of_combination_code__v)
    • Type of Combination Code Text (type_of_combination_code_text__v)
    • Type of Combination Term (type_of_combination_term__v)
    • Type of Combination Term Text (type_of_combination_term_text__v)
  • Added the following fields to the IDMP Ingredient Element (idmp_ingredient_element__v) object:
    • AP Active Substance Term (ap_active_substance_term__v)
    • AP Active Substance Term Text (ap_active_substance_term_text__v)
    • AP Inactive Ingredient Term (ap_inactive_ingredient_term__v)
    • AP Inactive Ingredient Term Text (ap_inactive_ingredient_term_text__v)
    • CHL Denominator Unit Term (chl_denominator_unit_term__v)
    • CHL Denominator Unit Term Text (chl_denominator_unit_term_text__v)
    • CHL Numerator Unit Term (chl_numerator_unit_term__v)
    • CHL Numerator Unit Term Text (chl_numerator_unit_term_text__v)
    • CLL Denominator Unit Term (cll_denominator_unit_term__v)
    • CLL Denominator Unit Term Text (cll_denominator_unit_term_text__v)
    • CLL Numerator Unit Term (cll_numerator_unit_term__v)
    • CLL Numerator Unit Term Text (cll_numerator_unit_term_text__v)
    • Composition Grouping Description (composition_grouping_description__v)
    • Composition Grouping Description Text (composition_grouping_description_text__v)
    • Ingredient Role Term (ingredient_role_term__v)
    • Ingredient Role Term Text (ingredient_role_term_text__v)
    • Origin of the Substance (origin_of_the_substance__v)
    • Origin of the Substance Code (origin_of_the_substance_code__v)
    • Origin of the Substance Code Text (origin_of_the_substance_code_text__v)
    • Origin of the Substance Term (origin_of_the_substance_term__v)
    • Origin of the Substance Term Text (origin_of_the_substance_term_text__v)
    • PHL Denominator Unit Term (phl_denominator_unit_term__v)
    • PHL Denominator Unit Term Text (phl_denominator_unit_term_text__v)
    • PHL Numerator Unit Term (phl_numerator_unit_term__v)
    • PHL Numerator Unit Term Text (phl_numerator_unit_term_text__v)
    • PLL Denominator Unit Term (pll_denominator_unit_term__v)
    • PLL Denominator Unit Term Text (pll_denominator_unit_term_text__v)
    • PLL Numerator Unit Term (pll_numerator_unit_term__v)
    • PLL Numerator Unit Term Text (pll_numerator_unit_term_text__v)
    • Quantity Operator (quantity_operator__v)
    • Quantity Operator Code (quantity_operator_code__v)
    • Quantity Operator Code Text (quantity_operator_code_text__v)
    • Quantity Operator Term (quantity_operator_term__v)
    • Quantity Operator Term Text (quantity_operator_term_text__v)
  • Added the following fields to the IDMP Manufactured Item (idmp_manufactured_item__v) object:
    • Manufactured Dose Form Term (manufactured_dose_form_term__v)
    • Manufactured Dose Form Term Text (manufactured_dose_form_term_text__v)
    • Manufactured Item Quantity Unit Term (manufactured_item_quantity_unit_term__v)
    • Manufactured Item Quantity Unit Term Text (manuf_item_quantity_unit_term_text__v)
    • Unit of Presentation Term (unit_of_presentation_term__v)
    • Unit of Presentation Term Text (unit_of_presentation_term_text__v)
  • Added the following fields to the IDMP Manufactured Item Ingredient (idmp_manufactured_ingredient_item__v) object:
    • CHL Denominator Unit Term (chl_denominator_unit_term__v)
    • CHL Denominator Unit Term Text (chl_denominator_unit_term_text__v)
    • CHL Numerator Unit Term (chl_numerator_unit_term__v)
    • CHL Numerator Unit Term Text (chl_numerator_unit_term_text__v)
    • CLL Denominator Unit Term (cll_denominator_unit_term__v)
    • CLL Denominator Unit Term Text (cll_denominator_unit_term_text__v)
    • CLL Numerator Unit Term (cll_numerator_unit_term__v)
    • CLL Numerator Unit Term Text (cll_numerator_unit_term_text__v)
    • Composition Grouping Description (composition_grouping_description__v)
    • Composition Grouping Description Text (composition_grouping_description_text__v)
    • Ingredient Role Term (ingredient_role_term__v)
    • Ingredient Role Term Text (ingredient_role_term_text__v)
    • Origin of the Substance (origin_of_the_substance__v)
    • Origin of the Substance Code (origin_of_the_substance_code__v)
    • Origin of the Substance Code Text (origin_of_the_substance_code_text__v)
    • Origin of the Substance Term (origin_of_the_substance_term__v)
    • Origin of the Substance Term Text (origin_of_the_substance_term_text__v)
    • PHL Denominator Unit Term (phl_denominator_unit_term__v)
    • PHL Denominator Unit Term Text (phl_denominator_unit_term_text__v)
    • PHL Numerator Unit Term (phl_numerator_unit_term__v)
    • PHL Numerator Unit Term Text (phl_numerator_unit_term_text__v)
    • PLL Denominator Unit Term (pll_denominator_unit_term__v)
    • PLL Denominator Unit Term Text (pll_denominator_unit_term_text__v)
    • PLL Numerator Unit Term (pll_numerator_unit_term__v)
    • PLL Numerator Unit Term Text (pll_numerator_unit_term_text__v)
    • PV Active Substance Term (pv_active_substance_term__v)
    • PV Active Substance Term Text (pv_active_substance_term_text__v)
    • PV Inactive Ingredient Term (pv_inactive_ingredient_term__v)
    • PV Inactive Ingredient Term Text (pv_inactive_ingredient_term_text__v)
  • Added the following fields to the IDMP Manufacturing Site (idmp_manufacturing_site__v) object:
    • Confidentiality Indicator Term (confidentiality_indicator_term__v)
    • Confidentiality Indicator Term Text (confidentiality_indicator_term_text__v)
    • Operation Type Term (operation_type_term__v)
    • Operation Type Term Text (operation_type_term_text__v)
  • Added the following fields to the IDMP Marketing Authorisation Element (idmp_marketing_authorisation_element__v) object:
    • Authorisation Status Term (authorisation_status_term__v)
    • Authorisation Status Term Text (authorisation_status_term_text__v)
    • Country Term (country_term__v)
    • Country Term Text (country_term_text__v)
    • Marketing Authorisation Regulator (marketing_authorisation_regulator__v)
    • Procedure End Date (procedure_end_date__v)
    • Procedure End Date Text (procedure_end_date_text__v)
    • Procedure Submission Start Date (procedure_submission_start_date__v)
    • Procedure Submission Start Date Text (procedure_submission_start_date_text__v)
    • Procedure Type Term (procedure_type_term__v)
    • Procedure Type Term Text (procedure_type_term_text__v)
    • Reg Application Procedure Type Term (reg_application_procedure_type_term__v)
    • Reg Application Procedure Type Term Text (reg_application_procedure_type_term_text__v)
    • Regulatory Application End Date (regulatory_application_end_date__v)
    • Regulatory Application End Date Text (regulatory_application_end_date_text__v)
    • Regulatory Authorisation Type Term (regulatory_authorisation_type_term__v)
    • Regulatory Authorisation Type Term Text (regulatory_authorisation_type_term_text__v)
  • Added the following fields to the IDMP Master File (idmp_master_file__v) object:
    • Master File Type Term (master_file_type_term__v)
    • Master File Type Term Text (master_file_type_term_text__v)
  • Added the following fields to the IDMP Medicinal Product Element (idmp_medicinal_product_element__v) object:
    • Authorised Pharmaceutical Form (authorised_pharmaceutical_form__v)
    • Authorised Pharmaceutical Form Code (authorised_pharmaceutical_form_code__v)
    • Authorised Pharmaceutical Form Code Text (authorised_pharmaceutical_form_code_text__v)
    • Authorised Pharmaceutical Form Term (authorised_pharmaceutical_form_term__v)
    • Authorised Pharmaceutical Form Term Text (authorised_pharmaceutical_form_term_text__v)
    • Combined Pharma Dosage Form Term (combined_pharma_dosage_form_term__v)
    • Combined Pharma Dosage Form Term Text (combined_pharma_dosage_form_term_text__v)
    • Domain Term (domain_term__v)
    • Domain Term Text (domain_term_text__v)
    • Legal Status of Supply Term (legal_status_of_supply_term__v)
    • Legal Status of Supply Term Text (legal_status_of_supply_term_text__v)
    • Medicinal Product Type Term (medicinal_product_type_term__v)
    • Medicinal Product Type Term Text (medicinal_product_type_term_text__v)
    • PMS ID (pms_id__v)
    • PMS ID Text (pms_id_text__v)
    • Role Term (role_term__v)
    • Role Term Text (role_term_text__v)
  • Added the following fields to the IDMP Medicinal Product Full Name (idmp_medicinal_product_full_name__v) object:
    • Country Term (country_term__v)
    • Country Term Text (country_term_text__v)
    • Language Term (language_term__v)
    • Language Term Text (language_term_text__v)
  • Added the following fields to the IDMP Medicinal Product Indication (idmp_medicinal_product_indication__v) object:
    • Language Term (language_term__v)
    • Language Term Text (language_term_text__v)
  • Added the following fields to the IDMP Name Part (idmp_name_part__v) object:
    • Name Part Type Term (name_part_type_term__v)
    • Name Part Type Term Text (name_part_type_term_text__v)
  • Added the following fields to the IDMP Package Authorisation Status (idmp_package_authorisation_status__v) object:
    • Authorisation Status Term (authorisation_status_term__v)
    • Authorisation Status Term Text (authorisation_status_term_text__v)
    • Country Term (country_term__v)
    • Country Term Text (country_term_text__v)
    • Regulatory Authorisation Type Term (regulatory_authorisation_type_term__v)
    • Regulatory Authorisation Type Term Text (regulatory_authorisation_type_term_text__v)
  • Added the following fields to the IDMP Package Description (idmp_package_description__v) object:
    • Language Term (language_term__v)
    • Language Term Text (language_term_text__v)
  • Added the following fields to the IDMP Package Marketing Status (idmp_package_marketing_status__v) object:
    • Country Term (country_term__v)
    • Country Term Text (country_term_text__v)
    • Marketing Status Term (marketing_status_term__v)
    • Marketing Status Term Text (marketing_status_term_text__v)
    • Restore Date (restore_date__v)
    • Restore Date Text (restore_date_text__v)
    • Risk of Supply Shortage (risk_of_supply_shortage__v)
    • Risk of Supply Shortage Comment (risk_of_supply_shortage_comment__v)
    • Risk of Supply Shortage Comment Text (risk_of_supply_shortage_comment_text__v)
    • Risk of Supply Shortage Text (risk_of_supply_shortage_text__v)
    • Status Reason (status_reason__v)
    • Status Reason Code (status_reason_code__v)
    • Status Reason Code Text (status_reason_code_text__v)
    • Status Reason Term (status_reason_term__v)
    • Status Reason Term Text (status_reason_term_text__v)
  • Added the following fields to the IDMP Packaged Medicinal Product Element (idmp_packaged_medicinal_product_element__v) object:
    • Legal Status of Supply Term (legal_status_of_supply_term__v)
    • Legal Status of Supply Term Text (legal_status_of_supply_term_text__v)
  • Added the following fields to the IDMP Pharmaceutical Product Element (idmp_pharmaceutical_product_element__v) object:
    • Administrable Dosage Form Term (administrable_dosage_form_term__v)
    • Administrable Dosage Form Term Text (administrable_dosage_form_term_text__v)
    • Medical Device Type Term (medical_device_type_term__v)
    • Medical Device Type Term Text (medical_device_type_term_text__v)
    • Unit of Presentation Term (unit_of_presentation_term__v)
    • Unit of Presentation Term Text (unit_of_presentation_term_text__v)
  • Added the following fields to the IDMP Name Part (idmp_name_part__v) object:
    • Reference Product Type Term (reference_product_type_term__v)
    • Reference Product Type Term Text (reference_product_type_term_text__v)
  • Added the following fields to the IDMP Product Cross Reference (idmp_product_cross_reference__v) object:
    • Reference Product Type Term (reference_product_type_term__v)
    • Reference Product Type Term Text (reference_product_type_term_text__v)
  • Added the following fields to the IDMP Regulatory Authorisation (idmp_regulatory_authorisation__v) object:
    • Orphan Designation Status Term (orphan_designation_status_term__v)
    • Orphan Designation Status Term Text (orphan_designation_status_term_text__v)
    • Regulatory Authorisation Type Term (regulatory_authorisation_type_term__v)
    • Regulatory Authorisation Type Term Text (regulatory_authorisation_type_term_text__v)
  • Added the following fields to the IDMP Route of Administration (idmp_route_of_administration__v) object:
    • Route of Administration Term (route_of_administration_term__v)
    • Route of Administration Term Text (route_of_administration_term_text__v)
  • Added the following fields to the IDMP Shelf Life (idmp_shelf_life__v) object:
    • Shelf Life Time Period Unit Term (shelf_life_time_period_unit_term__v)
    • Shelf Life Time Period Unit Term Text (shelf_life_time_period_unit_term_text__v)
    • Shelf Life Type Term (shelf_life_type_term__v)
    • Shelf Life Type Term Text (shelf_life_type_term_text__v)
  • Added the following fields to the IDMP Storage Precaution (idmp_storage_precautions__v) object:
    • Storage Precautions Term (storage_precaution_term__v)
    • Storage Precautions Term Text (storage_precaution_term_text__v)
  • Added the GMO (GMO__v) field to the Classification System (classifiation_system__rim) object and object page layout.
  • Added the IDMP Applicable Product Type (idmp_applicable_product_type__v) field to the Product (drug_product__v) object and object page layout.

Added the following components to support the Publish with Overlays feature:

  • Added the Include eSignatures (include_esignatures__v) field to the Content Plan Item (edl_item__v) object.
  • Added the Default Overlay (default_overlay__v) field to the Submission (submission__v) and Report Level Content Plan (report_level_content_plan__v) objects.
  • Added the Overlay ID (overlay_id__v) field to the Publishing Element (publishing_element__v) object.
  • The TocTemplate (toc_template__v) and Page Numbering (page_number__v) fields on the Publishing Element (publishing_element__v) object are no longer required.
  • Added an app control field (publishing_element_overlay__c) to the Publishing Element (publishing_element__v) object (enabled via Page Layouts).

Added the following components to support Manage Registered Details Enhancements:

  • Objects:
    • Registered Authorization (registered_authorization__v)
    • Registered Regulatory Text (registered_regulatory_text__v)
  • Impacted Record (impacted_record__v) picklist values:
    • Registered Authorization (registered_authorization__v)
    • Registered Regulatory Text (registered_regulatory_text__v)

Safety

Safety features are targeted for tentative availability on September 30, 2021.

Intake Enhancements on Inbox Item Auto-on

Manual intake and verification on Inbox Items is made easier with two new enhancements. Firstly, a New Info Date field will now be available in the Inbox grid to sort new Inbox Items by date and easily identify late Cases. Secondly, the display for imported long text fields (such as Case Narratives) is now wider to facilitate the verification of long text.

Most Conservative Product and Assessment Evaluation per Region Rules Configuration

Vault Safety administrators can now optionally configure reporting rule sets to evaluate rules against the most conservative Case Product and Case Assessment, when there are multiple suspect or interacting Case Products registered to a given reporting destination. Seriousness, expectedness, relatedness, and the drug role of the related Case Products are all considered when determining the most conservative Case Product and Case Assessment. Unless configured otherwise, pre-existing rule sets, such as the FDA and EMA ICSR rule sets, continue to evaluate rules based on the primary Case Product and Case Assessment.

In addition, when this feature is configured in a rule set, Vault Safety evaluates the “AE in Jurisdiction” rule parameter using the country specified on the primary Reporter Case Contact instead of the country on the primary Case Adverse Event. This is to align with ICH guidelines.

Learn More: Configure Reporting Rules Product Selection

Configurable Field Masking Exceptions for Masked Distributions: Blank, Sex, and Country Configuration

When turning on Patient Content Protection, Vault Safety now supports configurable field masking for blank fields, Reporter Country, Parent Sex, and Patient Sex. You can now pre-configure which of these PII / maskable E2B fields should be unmasked, while the remaining fields stay masked. In addition, when the Date of Birth field is masked, the system still populates the Age and Age Group field values during ICSR report generation, if available. This will be supported for all ICSR outputs, including E2B and PDF forms.

Learn More: Generate Masked Distributions: Exceptions to Patient Content Protection

ISO 8859-1 Validations for FDA E2B(R2) Configuration

Vault Safety now validates FDA E2B(R2) submission documents for character encoding. FDA E2B(R2) follows the ISO 8859-1 standard, which does not support UTF-encoded characters. An E2B(R2) Transmission with UTF-encoded characters bound for the FDA CBER or CDER gateway will now trigger validation errors and warnings. Furthermore, the system will automatically convert some UTF-encoded characters that map to ISO 8859-1.

Learn More: FDA Character Encoding Validation

MHRA E2B(R2) Dose Form Codes Auto-on

Vault Safety’s Dose Forms dictionary now supports the full list of approximately 400 MHRA Dose Forms, including their corresponding 1 to 3 digit codes. Encoded dose forms in E2B(R2) reports received from the MHRA and imported into Vault Safety will be mapped using the new dictionary entries.

Learn More: Enter Case Data: Dosages Section

Intake JSON API for Safety Customers

Vault Safety can now ingest calls from the Safety Intake AI endpoint to receive an Inbox Item from a JSON file:

POST /api/{version}/app/safety/ai/intake

Vaults no longer require Safety.AI to receive calls from this endpoint. Vaults without Safety.AI only support processing structured data (JSON). The system ignores unstructured data.

Learn More:

Feature Enablement Changes

Note the following feature with enablement changes in this release:

Feature Previous Enablement New Enablement
PT Aggregation in Periodic Reports Auto-On (21R2.2) Support (21R2.3)

Read more about this feature in New in 21R2.2.

SiteVault

Create Draft from Original

With this feature, SiteVault users can create a draft version of a document using the latest version of the original document that it is based on.

Support for Deleting Connected Study Documents

With this feature, SiteVault users can now hard delete documents that have been sent or received on a Connected Study.

New Exchangeable Document Types on Connected Studies

This feature adds support to transfer the following new document types from a sponsor or CRO’s vault for a Connected Study:

  • Budget
  • IP Destruction
  • Signature & Initials
  • Specimen Tracking
  • Sponsor/CRO Contact Information

Regulatory Document Request Improvements

With these improvements, SiteVault users can sort, search, and paginate the document sections of the Regulatory Document Requests page. Additionally, the Regulatory Document Request task is automatically closed after a user completes the last item in the Documents to Return section.

Veeva eConsent Additional Signatories

This feature adds support for additional signatories to consent electronically on behalf of or in conjunction with a study participant in MyVeeva for Patients.

Research Organizations Selectable in the Vault Selector

With this feature, all users can navigate to the context of their research organization using the vault selector. This feature only applies to SiteVaults using Extensible Permissions.

Scheduled Study Access for External Users

This feature enables Admins to schedule study access for external users by specifying start and end dates. External users automatically receive and lose access to the study on the scheduled start and end dates, respectively.

Share Non-eConsent Documents with Participants

This feature enables SiteVault users to designate IRB-approved, study-related documents as shareable with study participants or their signatories through MyVeeva for Patients.

SiteVault Setup Assistant

This feature introduces the SiteVault Setup Assistant. Users can use a new Setup tab to quickly enter data and documents to make the most use of SiteVault’s key features such as eRegulatory, Connected Studies, and Veeva eConsent. This first release enables users to create SiteVault users, upload user Profile documents, and add users to Studies in a single workflow.

Sync Study PI with Study Assignments

With this feature, when a user is added to a Study Assignment with the Principal Investigator (PI) role and is activated, the Principal Investigator field on the study is automatically updated to that PI.

SiteVault Data Model Changes

With every release, we update the SiteVault data model to better support evolving needs and new functionality. With this release, we’ve added the following components to the data model:

Added the Setup (setup_assistant_tab__v) tab and Setup Assistant Page (setup_assistant_page__v) page to support the SiteVault Setup Assistant feature. Added the following components to support the Share Non-eConsent Documents with Participants feature:

  • Added the Share with Participants document action
  • Added the Stop Sharing with Participants document action
  • Added the Shared with Participants (shared_document__v) document field

Added the following components to support the Veeva eConsent Additional Signatories feature:

  • Added the Signatory (signatory__v) object
  • Added the Signatory Relationship (signatory_relationship__v) object
  • Added the Signatory Role (signatory_role__v) picklist
  • Added the following fields to the Form Responses (form_response__v) object
    • Signatory
    • Signatory Role
  • Added the Signatory picklist to the Informed Consent Form (blank) (informed_consent_form_blank__v) document

Added the following fields to the Study Assignment (study_person__v) object to support the Schedule Study Access for External Users feature:

  • Study Access End Date (study_access_end_date__v)
  • Study Access Start Date (study_access_start_date__v)

Added the new Principal Investigator (principal_investigator__v) application role to all study-related document and object lifecycles to support the Sync Study PI with Study Assignments feature. Added the Create Draft from Original Document user action and the Based on (basedon__v) document field to support the Create Draft from Original feature. In addition to the changes supporting new features, we added or updated the following components:

  • Added the Notes (long_notes__v) Rich Text field to the Study (study__v) and Participants (subject__v) objects
  • Added the Role is External (is_external__v) field to the Study Role (study_person_role__v) and Access Level (access_type__v) objects

QualityOne

Control Charts for Inspection Management

This feature allows users to view inspection data of a Product in a Control Chart for assessment. This assessment helps to determine whether additional action is required to improve any manufacturing process, such as reducing sources of variation during production. Learn more about Control Charts.

Audit Program Planning

This feature allows the customer to initiate, plan, and approve Audit Programs to be executed for a given time period. Once the Audit Program is in execution, Vault automatically creates Audits from Proposed Audits. Learn more about QualityOne Audit Program Planning.

Create Related Record Entry Action Enhancement

This feature enhances the Create Related Record entry action by allowing Admins to automate the creation of related-child object records. Admins can configure the components between the Source-Child Inbound Relationship and the Related-Child Inbound Relationship and their field mappings. The Create Related Record object action can also be configured as a user action. Learn more about related-child object records.

Enhanced Configurability for Risk Management

In this release, we have added the ability for Admins to configure the attribute Allow hierarchical copy for the Risk Register (risk_register__v) field on the Risk Event (risk_event__v) object.

COA Analysis Multilingual Support

This feature allows users to ingest and process Certificates of Analysis (COAs) in multiple languages as part of the incoming inspection process. COA details are displayed with pre-loaded localizations for Characteristic, Test Result (Attribute Data), and Test Result Unit fields based on the user’s Vault locale. The languages currently supported are English, French, German, Spanish, Italian, and Portuguese. Learn more about COA Multilingual Support.

OSHA Reporting for Incident Management

This feature adds the ability to generate OSHA 301, OSHA 300, and OSHA 300A logs of HSE Events for OSHA reporting purposes. Learn more about OSHA Reports.

RegulatoryOne

RegulatoryOne features are targeted for tentative availability on October 5th.

Object Field Mapping for Relational Tokens

Admins can define field mappings between a source and target object and then link those field mappings to specific relational tokens. When Vault generates new records based on how those relational tokens resolve, those fields are automatically populated in the generated records based on values in the source record. Learn more about configuring object field mapping for relational tokens.

Recursive Relational Tokens

This feature allows Admins to create recursive relational tokens. When users trigger record generation based on those relational tokens, Vault recursively checks related records of the same object to include in record creation. Admins can also specify if any VQL Criteria on relational tokens is applied after the relational tokens resolve on all recursive records in the hierarchy. Learn more about configuring recursive relational tokens.

Formulation Composition Viewer

This feature allows Regulatory users to view the composition of a formula to determine whether constituent chemicals meet market requirements, allowing users to quickly approve the composition for use by their organization. Learn more about the Formulation Composition Viewer.

Enhanced Configurability for the Organization Object

In this release, we have added the ability for Admins to enable system-managed naming using the attribute System manages field value for the Name (name__v) field on the Organization (organization__v) object.

Veeva Claims

Veeva Claims features are targeted for tentative availability on October 5th.

Searching Statement Text in Local Adaptations

This feature allows users to search and filter by statement text in the Local Adaptation library. Users can also change the default statement text on a local adaptation by changing the reference to the statement from the global statement to one of its related statements. Learn more about searching statement text in local adaptations.

Selective Creation of Claims from Project

The feature allows users to create multiple Claims for the Statements and Products of their choice by enabling them to selectively control which Statements can be applied to one or all Products through a new user action. This feature reduces extra clicks caused by unwanted Claims generated when users can’t specify which Statement and Product combinations to create Claims for. When configured, users can now view the new action on the Project record(s) if there is at least one Statement and one Product in the project. After clicking the action, users can select the Statements under the Project in a new dialog for All or specific products. After users complete their selection, clicking Continue creates new Claim records and links them to the existing Project. If a Claim already exists for any of the Statement-Product combinations, the system will not generate duplicate records but will link the existing Claim record to the Project. Learn more about configuring the selective creation of claims from a project.

Enablement Details

     
Feature Enablement Application
Working with Documents    
Rich Text for Merge Fields Configuration Platform
Merge Fields Multi Column Table Sort Configuration Platform
Annotate Usability Refresh, Continued Auto-on Platform
EDLs: Create Document from Template Auto-on Platform
Delete Document Relationships On Older Versions Auto-on Platform
Google Drive Integration Admin Checkbox Platform
Vault Objects    
Asynchronous High Volume Object Modification Auto-on Platform
HVO Search Results Capped at 1000 Records Auto-on Platform
Lifecycle & Workflow    
Workflow Cancellation Actions Configuration Platform
Workflow Cancellation Comment Configuration Platform
View Workflow Start States Auto-on Platform
Update Task Due Date on Object Date Field Update Configuration Platform
Set Tokens in Instructions Configuration Platform
Envelope Objects to High Volume Object Auto-on Platform
Start Step Rule: Required Controls Configuration Platform
Ignore Non Applicable Field in Content Action or Event Action Auto-on Platform
Fix Actions with Missing References Auto-on Platform
Reporting & Dashboards    
Formula Fields in Multi-Pass Reports Auto-on Platform
Rendition Reporting Auto-on Platform
Enable Filter and Column Aliases Flag Moved to Report Builder Page Auto-on Platform
UI & Usability Updates    
Email to Vault Configuration Platform
Search    
Search Modifiers on Object Tabs Auto-on Platform
Add Language Options to Language Field Auto-on Platform
Substring Matching for Contains Operator Auto-on Platform
Checklists    
Checklists: Automation for Aggregate Checklist Updates Configuration Platform
Access Control    
Allowed Users When Assigning New Document Owner Auto-on Platform
Details Page for Vault Users: Show in Tab Action on Related Object Sections Auto-on Platform
Administration    
Admin Configuration Tab Updates Auto-on Platform
Standardize Escape Sequence for Special Characters Auto-on Platform
Saved View Admin Auto-on Platform
Prevent Merge in Steady State Rendition Setting Admin Checkbox Platform
Re-Render Previous Rendition Versions Auto-on Platform
Scheduled Data Exports: Reset Custom Amazon S3 Settings Configuration Platform
Vault Loader    
Vault Loader Extract: Include All Rendition Types in CSV Export Auto-on Platform
Platform Data Model Changes    
Platform Data Model Changes Auto-on Platform
Vault Connections    
CTMS/CDMS: Study Related Data Deletion Support Admin Checkbox CTMS<>CDMS
CTMS/CDMS: Support Query Object Rules Auto-on CTMS<>CDMS
Clinical Operations    
Site Connect: Allow Resending of Same Document Version Auto-on SiteConnect
Automate Milestone State Changes Admin Checkbox CTMS, SiteConnect, Study Startup, Vault Payments, eTMF
Clinical Feature Flag Cleanup Auto-on CTMS, SiteConnect, Study Startup, Vault Payments, eTMF
Site Connect: Manual Study Invitation Creation & Send Configuration SiteConnect
Site Connect: Prevent Document Upversion on Study Field Updates Auto-on SiteConnect
Site Connect: Reason for Rejection on Study Invitation Auto-on SiteConnect, eTMF
Site Connect: Request Document from Expected Document with Matched Document Auto-on SiteConnect
Safety Distribution: Email Notify SiteVault Sites Configuration SiteConnect
Site Connect: Send Site Packages from Study Site Configuration SiteConnect
Vault Payments: Site Advance Payments Configuration Vault Payments
Site Connect: Additional Vault Clinical Docs Support Configuration CTMS, SiteConnect, Study Startup, eTMF
Site Connect: Connection Automation Configuration CTMS, SiteConnect, Study Startup, eTMF
Site Connect: Site Packages Improvements Auto-on SiteConnect
Site Connect: Study Invitation Welcome Text Configuration SiteConnect, eTMF
TMF Bot: Train Models from Production Data Auto-on CTMS, SiteConnect, Study Startup, Vault Payments, eTMF
Clinical Operations Data Model Changes Auto-on CTMS, SiteConnect, Study Startup, Vault Payments, eTMF
Commercial    
Dedicated Medical Inquiry User Interface Support MedComms
CLM Metadata Enhancements for Medical Affairs Configuration MedComms, PromoMats
Document Level Rendition Type Selector for Single Doc Publishing for CLM Content Configuration MedComms, PromoMats
Content Modules: Hierarchical Copy Configuration PromoMats
Commercial Data Model Changes Auto-on MedComms, PromoMats
Quality    
Recurrence Check: Complaints Configuration QMS
Standard Cycle Time Metrics for Quality Events Configuration QMS
Display Key Quality Team Roles for Filtering, Reporting Configuration QMS
Generate Quality Document from Record: Batch Release Process Support Configuration QMS
Enable Reference Objects for Quality Suite Vaults N/A QMS, Quality, QualityDocs, Training
MDCC: Change Authorization Section Configuration QualityDocs
DCC Banner Utilizes Label of Document Change Control Object Auto-on QualityDocs, QualityOne
Training Self-Enrollment Configuration Training
Training Job Performance Improvements Auto-on Training
Increased Limit for Training Join Relationships Auto-on Training
Training Content Set Object is Not Cloned Auto-on Training
Training Document Entry Actions Captured in Audit Trail Auto-on Training
Validate Object Type for Imported Training Assignments Auto-on Training
Direct Assignment Action: Document Trainability Validation Auto-on Training
AICC E-Learning Courses: URL Validation Refinement Auto-on Training
Issue Training Assignment Entry Action Update Auto-on Training
Allow Description Field Requiredness on Curriculum & Learner Role Objects Auto-on Training
Rule References Upon Retiring Training Objects Auto-on Training
Direct Assignment Cancellation: Cancel Open Training Assignment Action & Curriculum Retirement Auto-on Training
Multi-Country Adverse Events Reporting Auto-on Surveillance
VPS: Validation Results Storage Auto-on Surveillance
VPS Data Model Changes Auto-on Quality, Surveillance
Quality Data Model Changes Auto-on QMS, QualityDocs, Station Manager, Surveillance, Training
Regulatory    
Brexit: Add UK(NI) to Centralised Countries for Create Registrations Auto-on RIM Registrations
Clinical/Nonclinical Study Content Plan Section Creation Update Auto-on RIM Submissions
Dynamic Ordering for Correspondences Auto-on RIM Submissions Archive
EAEU Import & Viewing R.022 XML Auto-on RIM Submissions Archive
Empty Section Indicator Admin Checkbox RIM Submissions Archive
Extend Content Plan Tokens Auto-on RIM Submissions
IDMP Data Model and Algorithm Updates (Per IG v2) Auto-on RIM Registrations
Manage Registered Details Enhancements Auto-on RIM Registrations
Publish with Overlays Configuration RIM Publishing
Update Copy into Content Plan Error Validation Auto-on RIM Submissions
Support for Keyword Linking and additional Link Types Configuration RIM Publishing
Process ZIP Import at the Submission Level Admin Checkbox RIM Submissions Archive
Informational Warnings in Email Notifications for All Import Methods Auto-on RIM Submissions Archive
File Format Icons Display in Active Dossier Auto-on RIM
21R3 RIM Data Model Changes Configuration RIM
SiteVault    
Create Draft from Original Auto-on SiteVault Enterprise, SiteVault Free
Support for Deleting Connected Study Documents Auto-on SiteVault Enterprise, SiteVault Free
New Exchangeable Document Types on Connected Studies Auto-on SiteConnect, SiteVault Enterprise, SiteVault Free
Regulatory Document Request Improvements Auto-on SiteConnect, SiteVault Enterprise, SiteVault Free
Veeva eConsent Additional Signatories Auto-on SiteVault Enterprise, SiteVault Free
Research Organizations Selectable in the Vault Selector Auto-on SiteVault Enterprise, SiteVault Free
Scheduled Study Access for External Users Auto-on SiteVault Enterprise, SiteVault Free
Share Non-eConsent Documents with Participants Auto-on SiteVault Enterprise, SiteVault Free
SiteVault Setup Assistant Configuration SiteVault Enterprise, SiteVault Free
Sync Study PI with Study Assignments Auto-on SiteVault Enterprise, SiteVault Free
SiteVault Data Model Changes Auto-on SiteVault Enterprise, SiteVault Free
QualityOne    
Control Charts for Inspection Management Configuration QualityOne
Audit Program Planning Configuration QualityOne
Create Related Record Entry Action Enhancement Configuration QualityOne
Enhanced Configurability for Risk Management Auto-on QualityOne
COA Analysis Multilingual Support Auto-on QualityOne
OSHA Reporting for Incident Management Configuration QualityOne
RegulatoryOne    
Object Field Mapping for Relational Tokens Configuration RegulatoryOne Registration & Dossier Management
Recursive Relational Tokens Configuration RegulatoryOne Registration & Dossier Management
Formulation Composition Viewer Configuration RegulatoryOne Compliance Management
Enhanced Configurability for the Organization Object Auto-on RegulatoryOne Registration & Dossier Management, RegulatoryOne Compliance Management, RegulatoryOne Regulatory Documents
Veeva Claims    
Searching Statement Text in Local Adaptations Auto-on Veeva Claims
Selective Creation of Claims from Project Configuration Veeva Claims
Enhanced Configurability for the Organization Object Auto-on Veeva Claims

See the following explanations for enablement options:

Enablement Description
Auto-On Automatically activated and no configuration is required before using the feature; note that in some cases, a new feature is dependent on another feature that must be enabled or configured.
Admin Checkbox Admins must turn on the feature with an Admin checkbox. Note that some "Auto-On" features have a checkbox setting that hides the feature; these will show "Auto-On."
Configuration Admins must configure the feature (separately from an Admin checkbox) before it is available to use or is active; for example, an Admin must add document templates before users can create documents from templates.
Support On/off option controlled by Support.