What's New in 21R1 | Vault Release Notes

Pre-Release Date: March 22, 2021 | Release Date: April 9 & April 16, 2021

We are pleased to bring you Vault 21R1. Read about the new features below. You can find information on enabling new features in 21R1 Release Impact Assessment. Information on developer features (API, VQL, etc.) is in the Developer Portal.

Working with Documents

Link Annotations to Permalinks

Admins can enable an option that allows users to create link annotations that target permalinks rather than creating version-specific links to documents and anchors. Link annotations to permalinks utilize the Permalink object in Vault and always navigate to the latest available version of the target document.

To create a link annotation to a permalink, users must select the Permalink option from the drop-down next to the cursor mode icons. When users select document content, Vault opens a Select targets dialog, in which users can select whole documents, as well as pages, bookmarks, and named destinations within documents. Learn more about creating link annotations to permalinks.

Audio & Video Renditions for CrossLinks

With this release, CrossLinks support audio and video renditions, allowing users to easily review CrossLinks where the source document is an audio or video file.

Document Inbox Enhancements

Document Inbox Drag & Drop

This feature allows users to drag and drop files into the Document Inbox to create new unclassified documents. Users can track the progress of their upload in a new dialog, which they can minimize so they can continue working in Vault while the upload is in progress. In Clinical Operations Vaults, Vault prompts users to enter the Study, Study Country, and Study Site after they drop a file into the Document Inbox. Users can opt in or out of this prompt in the Document Inbox Actions menu. Learn more about Creating Unclassified Documents.

Always Display the Document Inbox

In Vaults with Document Inbox enabled, users with the Create permission on at least one document type always see the Document Inbox in their Library, even when there are no unclassified documents in the Document Inbox. The Document Inbox view still displays in the Library for users who have view access to at least one unclassified document. This enhancement supports the Document Inbox Drag & Drop feature.

Document Inbox Improvements

This feature includes several enhancements to the Document Inbox, including:

Updated Tabular View user interface
The Classify action is now called Complete
A new button to Complete your documents and move them to your Library
The ability to upload up to 250 documents at a time via drag and drop

Updated UI for Add Renditions

With this release, the Add Rendition modal UI supports uploading Large Size Assets using the Vault File Manager desktop application. As part of this change, users can now select the Large Size Asset rendition type in the UI if the selected document type is configured with this rendition type.

In past releases, the Large Size Asset rendition type was assigned to the Base document type on all Vaults, but was not available for selection in the UI because Large Size Asset renditions could only be added via the FTP Inbox. To ensure it does not appear for all users, we have removed this rendition type from the Base document type for all Vaults other than PromoMats in this release.

To upload Large Size Asset renditions using Vault File Manager, Admins can assign this rendition type to their document types. Note that this is currently the only rendition type supported for 100 GB uploads using Vault File Manager.

PDF/A Document Rendition

In addition to standard PDF viewable document renditions, Vault now supports PDF/A viewable renditions to comply with widely-adopted ISO standards. The PDF/A format is an ISO-standardized (190005) PDF specialized for the archiving of electronic documents. This document format provides a reviewable standard and is common in regulatory submissions. Learn more about PDF/A renditions.

Video Playback Speed Controller

With this feature, users can modify the playback speed of videos in Vault by clicking on a minus (–) icon to slow down, or a plus (+) icon to speed up, within a set of defined speeds:

0.25x
0.5x
0.75x
1x (default)
1.25x
1.5x
2x

Vault displays the selected speed next to the control.

Note that speed control is not supported for Android devices, and is not available on audio-only source files.

Learn more about video playback controls.

Video Review: Bring Forward Annotations

With this release, users can bring forward annotations on video documents. Users can also enter Move mode to edit the time signature of annotations. Note that annotations between video and non-video renditions, such as a storyboard PDF, cannot be brought forward. Learn more about annotating videos.

Annotate Filters: Enhancements

This enhancement provides updates to annotation filters, including:

Moving annotation filters to a sidebar
Reorganizing some filter options
Adding two new filters: Author and Tag

Document Owner Can Undo Checkout for All Check Out Types

In past releases, the only user who could cancel or undo a checkout session was the user who checked out the document. This feature extends this capability to the Document Owner, as long as they have a document role with the Edit Document permission. This change makes the ability to cancel checkouts more consistent across all checkout types.

Enabled Field for Document Type Detail Object

This feature introduces the Enabled field on the Document Type Detail object, which reflects the active or inactive status of its associated document type, subtype, or classification. When configuring controlled document templates, Admins can now create a reference constraint on the Template Document Type field using the Enabled field to display only active document types. Learn more about controlled document templates.

Document Auto-Naming: Excluded Characters

With this feature, Vault excludes curly bracket characters when auto-naming documents as these can cause issues when resolving document field tokens.

Admin Field Layout Matches Doc Info

With this release, the order of sections that users see on the Doc Info page always matches the section order on the Field Layout page. Previously, the order of these sections may not have matched if an Admin imported new sections to the Vault using a Configuration Migration Package, or if Veeva provisioned a new section as part of a new release.

Template Search Enhancements

When creating documents from templates, the field where users select a template is now a type-ahead field. This allows users to find templates in Vaults where there are a large number of templates available for the selected document type.

Increase to Maximum Source File Size for Videos

With this release, the maximum source file size for video files is 4GB. Files up to this size will also be rendered, allowing users to review and annotate them in Vault.

Show Document Number in Cart

Vault now displays the document number for each document in your Cart, which helps to differentiate between documents with similar names. If you start a multi-document workflow from the Cart and there is an issue adding documents to the workflow, the warning dialog presents the document numbers that are causing issues.

Vault Objects

Rich Text Fields for Vault Objects

Users can now format the content of field values with Rich Text fields. Vault supports most common formatting options such as font size, font family, text alignment, text decorations, lists, and scientific notation. Admins can configure Rich Text fields in most places that support text fields, including object list pages, object detail pages, reporting, workflows, VQL, Vault Loader, exports, and APIs.

This feature is especially useful for customers with business needs to capture information in a specific format, for example, if certain types of information must conform to standardized formatting for audit and compliance purposes. Learn more about configuring Rich Text fields.

This feature allows Admins to configure Criteria VQL filters on Related Document sections in object page layouts to restrict the documents that users can add, similar to dynamic reference constraints on object reference fields. Admins can use fields on the related document and on the current record to construct query conditions and filter the list of documents shown in the related document section.

For example, if the filtered list of documents should belong to the same product as the current object record, an Admin could write a condition that matches the Product field on the document to the Product field in the Criteria VQL of the Related Document section. Learn more about Related Document Section Filters.

With this feature, Admins now have the ability to control whether users can add new related documents directly in the Related Document section of the object page layout.

Web Sections for Object Page Layouts

With this release, Admins and users will see any web sections added to object page layouts through MDL. Web sections are similar to web tabs and can be used to specify the URL of external web content. For example, to display an address’s map location on an Organization record.

We have renamed the Show in Library link in related document sections of object records to Show in Tab. Clicking on the link opens the list of related documents in a dynamically-generated list of related documents. Previously, the link opened the Library tab. This change resolves an issue where users who did not have access to the Library tab were redirected to the Home tab instead.

Lifecycle & Workflow

Enablement Change: Atomic Security for Document Lifecycles

In past releases, Atomic Security for document lifecycles was only available to customers who requested it from Veeva Support. In this release, Atomic Security for document lifecycles is available for all Vaults.

With Atomic Security, Admins have more granular control, based on lifecycle state and role, over who can perform specific lifecycle user actions in the Atomic Security tab, such as changing a document’s state and starting a workflow, and active workflow actions, such as Cancel Workflow and Add Participant. Each action is individually listed in the Atomic Security tab, allowing fine control over access. Workflow Initiators and users in the Coordinator role will continue to have automatic access to active workflow actions.

Learn more about Atomic Security for Document Lifecycles and the impact of this enablement change.

Object Lifecycle & Workflow: Long Text & Rich Text Fields

Admins can now configure Rich Text and Long Text fields on object lifecycle and workflow components. Vault can update Rich Text and Long Text fields via:

Entry actions, such as Update Record Field and Update Related Record Field
Event actions, such as Update Record Field
Workflow steps, such as Update Record Field and Update Related Record Field

Both Rich Text and Long Text fields are available in field prompts for workflow Task steps. Rich Text fields are also available in action conditions. Learn more about configuring object and multi-document workflows.

Object & Multi-Document Workflow: Replace Workflow Owner

Users with the appropriate permissions can now change the owner of an active or in-progress workflow using a new Replace Workflow Owner action. Workflow ownership can be changed through a workflow action in the Vault UI or by using the API. The new owner must have the permission to start the workflow. When a user replaces the workflow owner, Vault automatically assigns all current and future incomplete tasks from the previous to the new owner.

Access to this action is controlled at the user profile level by a new Replace Workflow Owner permission. By default, this permission is available only to Vault Owners, System Admins, and Business Admins.

The Replace Workflow Owner action is also available in Bulk APIs. Learn more about using object and multi-document workflows.

Object & Multi-Document Workflow: Timeline View & Task Bar Enhancements

This feature includes several enhancements to the Timeline View and Task Bar:

Users can now see verdict details in the Timeline View of a multi-document workflow, including the verdict, comments, reason, and capacity. In a multi-verdict scenario, the verdict for each document is visible in the multi-document viewer’s Timeline View.
Vault now shows Task Instructions provided by the Workflow Initiator in the Task Bar for both object and multi-document workflows.
Multi-document workflows now show pending tasks in the Lifecycle Stage Chevron panel.

Learn more about the Timeline View.

Object & Multi-Document Workflow: Capacity Without Requiring eSignature

This feature allows Admins to configure capacity in an object or multi-document workflow verdict without configuring an eSignature. Capacity is now available outside the eSignature section of a verdict in a workflow task.

Existing verdicts continue to require a capacity. However, Admins can make them optional or remove them. There can be only one capacity value for each task completion. Learn more about configuring object and multi-document workflows.

Object & Multi-Document Workflow: Send Notification Based on Roles

Vault can now send notifications based on roles in an object or multi-document workflow. Workflow Admins can select one role per notification step.

In multi-document workflows, Vault sends the notification to users who are in that role on every document in that workflow. For object workflows, Vault sends the notification to users who are in that role in the object record’s sharing settings. Learn more about configuring notification steps for object and multi-document workflows.

Object & Multi-Document Workflow: Conditional Controls on Start Step

This feature allows Workflow Admins to hide some controls from the workflow start dialog based on the value of a Yes/No (boolean) expression configured at the start step of a workflow. Conditional start step controls are available for both object and multi-document workflows. Controls that can be hidden include Participant, Date, or Field controls. Learn more about configuring start steps for object and multi-document workflows.

Admins can now configure a new Task Event called Task Reassignment From in the Update Sharing Settings section of an object or multi-document workflow Task step. This event allows Admins to add a user to or remove a user from a role on document or object sharing settings when the task is reassigned from that user. Learn more about configuring object and multi-document workflows.

Multi-Document Workflow: Short Circuit Tasks

With this feature, Admins can advance multi-document workflows without waiting for every task to be completed by automatically canceling workflow tasks with matching tags. Vault cancels all tasks with any matching tag, including parallel tasks, when a short circuit verdict is provided.

Admins can configure short circuit verdicts on both single-verdict and multi-verdict tasks and on both Any Lifecycle and Specific Lifecycle multi-document workflows. Learn more about short-circuiting tasks in multi-document workflows.

Multi-Document Workflow: Use Role as Participants

Multi-document workflows now support user roles as participant groups. For example, a participant group can consist of users in the Approver role. This automatically adds all users who have the Approver role on every document in the workflow as participants in the workflow. Admins can only select one role per participant group to include. Vault does not currently support exclusion-based roles. Learn more about configuring object and multi-document workflows.

Multi-Document Workflow: Optional eSignature Manifesting on Documents

This feature allows Admins to configure whether eSignatures will be manifested on documents in a multi-document workflow. By default, Vault continues to manifest eSignatures for all applicable verdicts. Learn more about configuring multi-document workflows.

Multi-Document Workflow: Edit Document Fields

This feature allows users with appropriate permissions to edit document fields within the multi-document workflow viewer. Users no longer need to open individual documents to edit fields. The Edit Fields button is available in both Field View and Mixed View.

Some functionalities, like access to workflow timeline, document actions, and task completion, are not available while in the field-editing mode. Learn more about using multi-document workflows.

Object Lifecycle & Workflow Expression Enhancement

With this feature, expressions in object workflow configuration and lifecycle configuration support additional fields, functions, and operators. These items were already available in other expression-based features in Vault object configuration. The additional items are supported in expressions within Event Actions and Entry Actions in lifecycles, and within Update Record Field and Update Related Record Field steps of workflows.

For example, these areas now support functions such as If and Case, and operators such as >= (greater than or equal to) and <= (less than or equal to).

Learn more about expression support across Vault in the Vault Formula Reference Guide.

Inactivate Roles Used in Multi-Document Workflows

Admins can now make document lifecycle roles used in multi-document workflow Start, Notification, and Sharing Settings steps inactive.

Admins cannot select inactive roles in new participant groups as a constraining role, in role-based Participants controls, as notification recipients, or as participants when updating sharing settings. Existing workflow steps with inactive roles continue to work as before. Learn more about configuring object and multi-document workflows.

Reporting

Multi-Pass Reports Support Binders & Document Relationships

With this release, Admins can define binder reports and document relationship reports as report views. Admins may now join binder reports and document relationship reports to other report types, including object, document, and workflow reports. Learn more about Multi-Pass reports.

Enhanced Support for Rich Text & Long Text in Reports

This feature allows users to export the full text of Rich Text and Long Text fields from reports. For Rich Text fields, users can choose to export either formatted or unformatted text. Additionally, users can now view the full text within the context of the report.

Formula Fields in Document Reports

This feature allows users to define formula fields directly in their document reports. Users have access to a rich set of functions and operators to analyze and format their document data without making changes to their data model. In addition, users can define formula fields in Expected Document reports and use formula fields in conditional fields.

Column Sorting in Reports is Consistent with Library

With this release, column sorting in Vault reports is consistent with what users see in the Library and other lists within Vault. Sorting is now case insensitive, which means that text beginning with the same characters appear next to each other regardless of capitalization. In addition, blank cells no longer appear at the top when users select ascending and instead appear below cells with values for both ascending and descending.

Increase Maximum Number of Objects for Standard Report Type

This feature increases the default maximum number of objects that can be included in a standard report type to ten (10).

Object Formula Field Enhancements for Reports

This feature allows Admins to define report formula fields on objects directly in a Report View. In addition, users can now include Picklist field types when defining formula fields in reports.

Improved Handling of Hyperlinks in Excel Exports

With this release, report exports to Microsoft Excel™ support more than 65,000 links.

Additional Functions in Report Date Filters

This feature adds support for the If() function and several logical operators, including = and !=, to report date filters.

Exports of Icon Fields in Reports Return Alternative Text

This feature makes exports of Icon-type Formula fields from reports consistent with exports from object list views. Exports now display alternative text instead of the full formula.

Auditing

Document ID in Document Audit Exports

With this release, document audit exports to CSV contain a Document ID column.

Search

Expanded Search

This feature allows Admins to create collections of objects that users can search together. Once an Admin creates a collection of objects, users can expand their search from a single object in a custom tab to all of the objects in the collection. Users can filter and sort the search results for each of the objects independently to build a refined view of records across the collection. Learn more about Expanded Search.

Contains Operator for Advanced Filtering

This feature adds a new contains operator to the advanced filtering options for Picklist and Object Reference field types. This operator returns any documents or object records that match any portion of the search string.

For example, when users filter on the Country field using the contains operator and enter the term United, Vault returns all search results with United States, United Kingdom, or United Arab Emirates in the Country field. Learn more about advanced filtering.

In past releases, when related object filters were configured on object tabs, they were only available in the Advanced Search dialog. Now, users can add these related object filters in the Filters section of the tab sidebar. For example, users can add a Country Decision Detail filter within the Regulatory Objective object tab on RIM Vaults. Learn more about applying related object filters.

Checklists

Checklist: Ad Hoc Questions

Admins can configure Checklists to allow respondents to add questions to checklist instances on an ad hoc basis. Learn more about ad hoc questions.

This enhancement updates the confirmation banner that alerts users when a checklist starts to include more detailed text. Additionally, Vault now sends a notification to confirm when a checklist is being created.

Auto Claims Linking

Note: Auto Claims Linking is only available in Commercial Content Vaults at this time. These features are currently unavailable in other Vaults.

Auto Claims Linking: Display Match Text Variation in Info Card

With this release, Vault displays the Match Text Variation record ID next to the Claim ID in the footer of Suggested, Approved, and Auto Link annotation info cards when a Match Text Variation is used to match a Claim record to a document. Users can hover over the ID to view a hover card, or click the ID to open the record detail page in a mini-browser window.

Auto Claims Linking: Configurable Columns in Select Claims Dialog

With this release, any Claim object field configured to appear in the Claim hover card now also appears as a column in the Select Claim dialog when users are selecting records to manually create Claim Links on documents. Learn more about Auto Claims Linking.

Auto Claims Linking: Prevent Duplicate Records

This enhancement prevents users from saving new and updated Claim records if doing so would create an exact duplicate of an existing record. Duplicates are defined as Claims with identical Match Text and matching field values. Note that, for the purpose of duplicate validation, Vault treats wildcards as plain text, and ignores excluded characters, trailing periods, and trailing exclamation points.

Auto Claims Linking: Preview & Create Anchor from Claims

With this feature, users with the appropriate permissions can preview, select, and create anchor annotations while defining references on Claim records.

Learn more about previewing and creating anchors.

Vault File Manager

Upload Large Size Asset Renditions Using Vault File Manager

With this release, users with the Check Out to File Manager and File Staging: Access permissions will see a link when adding renditions to documents and selecting the Large Size Asset rendition type. This link allows users to select and upload their Large Size Asset rendition via the Vault File Manager desktop application. We recommend using Vault File Manager to upload files larger than 1GB.

To support this feature, we have also updated the UI for the Add Rendition modal in Vault and made it possible to select the Large Size Asset rendition type if it is included on the document type. Before this release, users could only upload Large Size Asset renditions via the FTP Inbox. Learn more about Large Size Asset renditions.

Track User, Machine & Vault File Manager Version

With this release, Admins can track which users are using Vault File Manager and which version of the application they are using. When users log in to the Vault File Manager desktop application or switch Vaults within the application, the events are recorded in a new object in the Vault to which the user connected. Note that Vault File Manager is only available on Windows™. Learn more about Vault File Manager.

Administration

Enhancements to Document Name Inheritance

Admins can configure a document type’s Document Name Format and select whether the document name regenerates whenever the document is saved. With this release, it is easier for users to determine in the Edit Document Type dialog if the Document Name Format or Document Name Regeneration settings are inherited from a parent document type.

Templates: Hide Inactive Document Types

With this release, templates for inactive document types are no longer displayed by default on the Document & Binder Templates page in Business Admin. To display inactive document type templates, Admins can click the Show Inactive button.

Rendition Status

This feature introduces the Rendition Status page, which provides Admins with the ability to view the status of a rendition and troubleshoot rendering issues with source documents. The Rendition Status page provides Admins with clear and actionable information on specific rendering failures and errors.

From the Rendition Status page, Admins can apply filters to find specific renditions statuses.

Web Tab URL Tokens

Web tabs allow external applications to display inside a tab in Vault. With this release, Admins can use a token in the web tab URL definition to specify passing a query string parameter or the entire query string from a web tab request to the embedded external application.

Enhancements to API Limits

As of 21R1, the Vault API no longer enforces daily limits and no longer returns the daily limit HTTP headers in responses for calls made using v21.1 of the API and higher. The daily limit also no longer appears in Admin > Settings > General Settings and will not be returned in the API Usage log. Previous versions of the API will return static values for the daily limit headers:

X-VaultAPI-DailyLimitRemaining: 999,999
X-VaultAPI-DailyLimit: 999,999

Additionally, the burst limit has been raised to 2,000 calls in a five-minute fixed period. When the burst limit is exceeded, Vault automatically delays all API calls for 500ms and no longer returns an error. Users who exceed the burst limit are logged in the System Audit log and can also be viewed in the API Usage log. Users no longer receive notifications when burst limits are exceeded.

Learn more about API Limits.

Job API Enhancements

To make the UI and API consistent, the Instance ID label has been updated to Job ID on the Admin > Job Status page.

Access Control

Enhanced User Profile Page

With this release, the User Profile page has been updated with a new layout and has added customizability. The new User Profile page is based on the User object. Admins can now configure the User Profile page to show or hide User fields.

For example, by adding the Tasks field, Admins can allow their users to set notification preferences for workflow tasks by choosing whether to receive a notification every time a workflow task is assigned to them or to get a daily summary notification. Previously, these preferences could only be set by Admins.

As part of this feature, Vault now has a new application permission for users: View User Profile. By default, all users have this permission to maintain existing behavior. Admins now have the ability to remove this permission and hide the User Profile page, if needed. Learn more about the User Profile page.

Flexible DAC Field Mapping

In previous releases, Admins had to use similar field names when matching a document or object field with a User Role Setup field in a Dynamic Access Control (DAC) matching rule. This feature provides more flexibility in DAC rule configurations as needed while maintaining the previous default behavior of matching fields with similar names.

When creating a DAC matching rule, Admins can now match an Object– or Picklist-type field to a User Role Setup field as long as both fields reference the same object or picklist. This applies to DAC matching rules securing documents and objects.

Role Permissions

To simplify complex security profile configurations, Admins can now grant individual permission sets to users outside of security profiles by assigning User Roles.

Role Permissions allow you to differ access between users with the same high-level job, as defined by their Security Profile. Access can differ based on specific application role assignment, which, for example, might be determined by additional responsibilities or training level.

Authentication & Security

Maximum Session Duration of 48 Hours

As part of the continuous security enhancements, the maximum session duration of an active Vault session is now 48 hours. Previously, active sessions had no maximum duration.

A session is considered active as long as some activity happens within 48 hours in the UI or via the API. After 48 hours of activity, a session is no longer valid, and the user must obtain a new session. This is in addition to sessions which become inactive from inactivity or major security changes such as password changes.

Note: This feature will be available with the 21R1-B release on April 16.

Additional Session Duration Options

Vault Session Duration has additional duration options ranging from ten (10) minutes to eight (8) hours. Session duration controls the amount of time users can be idle or “inactive” before Vault automatically ends the session and logs them out. These options are configurable at the domain level.

Note: This feature will be available with the 21R1-B release on April 16.

Configuration Migration

Enhance Compare & Configuration Report to Provide Warnings

This feature enhances the Vault Compare and Configuration Reports to provide a list of potential component and configuration issues in a separate error log for easier troubleshooting.

Vault Loader

File Staging for Vault Loader CLI

With this feature, Vault Loader users with File Staging permissions to manage files and folders on Vault’s staging area. Users can view, create, move, rename, delete as well as upload and download to and from the file staging area using the Vault Loader Command Line tool (CLI). Learn more about file staging for Vault Loader CLI.

Vault Loader Where Clause Validation

This feature adds a new Validate button to the Vault Loader Extract page, which allows users to check the syntax of the Where Clause prior to submitting the Vault Loader export job. Learn more about extracting data with Vault Loader.

Vault Loader Export Usability Enhancements

This feature enhances column selection filtering and Where Clause token help for Vault Loader Document, Document Relationship, Document Version, Object, and Legacy User extractions. Learn more about extracting metadata and files with Vault Loader.

Vault Loader Bulk Document Attachment Enhancements

Vault Loader now supports the creation and deletion of document attachments. In addition, this feature adds support for the extraction of document attachment relationships. Learn more about managing document attachments with Vault Loader.

Vault Loader Bulk Object Attachments Support

Vault Loader now supports the creation and deletion of object attachments. Learn more about managing object attachments with Vault Loader.

Vault Java SDK

SDK Job Queues

Admins can now create custom SDK job queues for use with Vault Java SDK integrations from Admin > Operations > SDK Job Queues. Prior to this release, it was not possible to create custom job queues and only the default System queues were available. This feature also completes the SDK Jobs UI Enhancement in the last release by separating the SDK Job Queues from the Spark queues.

Learn more about SDK Job Queues.

Move Spark Queues to the Connection Tab

Admins can now access Spark Queues under the Connection tab alongside the other Spark components. This enhancement streamlines UI navigation when creating Spark integrations, and separates Spark Queues from SDK Job Queues.

Spark Integration Rule Support for Object Relationships

Spark Integration Rules, which fetch and map data in Vault to Vault integrations, now support object relationships from the source Vault. This allows the Spark integration to retrieve data based on the configured relationship from the source Vault.

For example, there is a Spark integration which needs to retrieve a Product’s Manufacturer’s Incident Phone Number, where Manufacturer is represented as an object relationship field on the Product object. With this feature, integration rules can map the relationship between Product and Manufacturer. For example, the Vaccine product has a Manufacturer field with the value VeePharm, where VeePharm is a Manufacturer object record which has a text field labeled Incident Phone Number. Given the Vaccine product, this Spark integration can quickly grab the Incident Phone Number on the related VeePharm record.

Learn more about the primary query object, which enables object relationships for your integration rules.

Separate Job Queue & Spark Queue Permissions

SDK job queues and Spark queues serve different purposes and are often managed by different administrative users. These queues are now managed independently from each other and are controlled with separate permissions.

Instead of one Queues permission, the queues are now controlled by the Spark Queues and SDK Job Queues permissions. Users who previously had the Queues permission and access to both queue types will automatically have both the Spark Queues and SDK Job Queues permissions.

Any MDL or VPKs generated prior to this change which include permission sets must be regenerated to accurately reflect permissions.

Spark Integration Rules: Allow Modification of Standard Integration Rules

Standard integration rules can now be delivered as inactive, enabling Admins to turn them on or off as needed. Additionally, Admins can now edit field defaults for standard field rules.

Spark Integration Rules: Field Default Prompts

With this feature, Admins can easily configure field rule defaults for their Spark integrations with prompts specific to the target field. For example, if the target field is a Yes/No (boolean) field, Vault prompt for a value of True or False. If the target field is a Date field, a date selector calendar UI appears. Previously, these values were entered manually which may have left room for error.

Spark Integration Rules: Query Filter Clause Change

In this release, we’ve modified the Criteria VQL available for a query object’s Filter Clause. Filter clauses now only support the WHERE clause. The following clauses are no longer supported:

ORDER BY
PAGESIZE
PAGEOFFSET

Additionally, users no longer need to enter the keyword WHERE in their filter clauses. For example, in previous releases users would enter a filter clause as WHERE status__v = ‘active__v’, but now users only need to enter status__v = ‘active__v’.

Any existing filter clauses which still have WHERE, ORDER BY, PAGESIZE, or PAGEOFFSET in them after this release must have these keywords removed for the integration to continue to work. We encourage users to make the appropriate changes as soon as 21R1 is released.

Vault Java SDK Service Account

A new Java SDK Service Account user appears in the Users & Groups tab. This system-managed, read-only user will support future Vault functionality. Vault does not include this user in license counts.

Minor Enhancements

Additional Signature Token

With this release, the Signee Federated ID (signee_federated_id__v) token is available for signatures.

Platform Data Model

Platform Data Model Changes

See 21R1 Data Model Changes: Platform.

Clinical Operations

RBSM: Automated Risk Mitigation Actions

This extension of our Risk Based Study Management (RBSM) capabilities includes the ability to define standard Risk Mitigations for potential Risks. Generating a Risk Assessment will automatically pull these mitigations into a Study Risk Assessment. This feature also provides the ability to automatically generate mitigation tasks for users in selected roles to perform for each Study, Study Country, or Study Site. These actions are tracked with Vault’s enhanced issue management capabilities. Learn more about Automated Risk Mitigation Actions.

Issue Management Enhancements

This CTMS feature extends our current Protocol Deviations object to include full Issue Management capabilities. To fully utilize this feature, we recommend that all organizations relabel their Protocol Deviations object to “Issues.” To track preliminary observations and findings in Vault, we have introduced an Observations issue type that users can utilize in conjunction with the Change Issue Type action. Additionally, Admins now have greater flexibility when configuring the requiredness of fields on the Issues (formerly Protocol Deviations) object, such as Category, Sub-Category, and Severity. Learn more about Issue Management.

Change Issue Type Action

The Change Issue Type action allows Admins on CTMS Vaults to configure user actions that change the object type of an Issue (formerly Protocol Deviation) record. This allows users to promote and demote Issue records to other Issue types. For example, users can promote an Observation to a Protocol Deviation.

Seeding Issues on Monitoring Events

This feature allows users to seed open Issues (formerly Protocol Deviations) and Issues closed since the last Monitoring Event within the current Monitoring Event. Additionally, Admins can specify which Issue types seed into Monitoring Events. This action works similarly to the Seed Follow Up Items action.

This feature enhances the CRA Homepage to display all active Issues (formerly Protocol Deviations) object types in the Protocol Deviations and Other Issues graph. This feature also updates widget labels to reflect configured names and introduces the ability to filter based on Issue status.

Create Document from Template Up-Versioning

This feature enhances the existing Create Related Document from Template action to up-version the document instead of replacing the current version, allowing users to track previous versions created using this action.

This action is primarily utilized in CTMS Vaults for monitoring follow up letters and confirmation letters and in Vaults that have Vault Payments enabled to generate payment letters. It is also possible to use this action for a protocol deviation log and study communication log. Learn more about the Create Related Document from Template system action.

Safety Distribution Email Support

This enhancement to Veeva Site Connect’s Safety Distribution feature allows users to email Safety Distribution documents to Study Sites not using SiteVault. Safety Documents are bundled into a deduplicated daily digest email and sent to designated Safety Distribution study team members. Vault also provides tracking for email delivery and whether or not recipients have viewed documents. Learn more about Safety Distribution Email Support.

Additional Study Sites Visible While Sending Safety Distributions

With the Safety Distribution Email Support feature, Veeva Site Connect users now see all relevant Study Sites in the Distribute to Sites dialog. Previously, Vault only displayed Study Sites with active Site Connect Agreements.

Comments for Document Exchange

With this feature, Veeva Site Connect customers can send and receive comments when exchanging documents and document requests with SiteVault.

USN Picker

With this feature, users on Clinical Operations Vaults can search for a site’s Universal Site Number (USN) from within their Vault and assign it to an Organization record in their Global Directory. Additionally, users can now easily identify “connected” Organizations and Study Sites via a new visible icon on the object records.

Site Connect Enhancements

This feature provides a number of enhancements to the Veeva Site Connect application, including: support for transferring additional Vault Clinical Docs artifacts; a new standard Site Rendition rendition type; and hiding the Send Document via Clinical Network action when a document is not related to a Study with an active Site Connect Agreement. Learn more about Veeva Site Connect.

Site Connect: Additional Vault Clinical Docs Support

With this release comes support for transferring additional document types via Veeva Site Connect. Document types mapped to the following Vault Clinical Docs artifacts can now be exchanged between Clinical Operations Vaults and SiteVault Vaults:

Data Privacy Agreement
Investigators Agreement (Device)
Investigator Newsletter
Investigator Regulatory Agreement
Note to File
Other Financial Agreement
Other Site Staff Medical License
Site Signature Sheet
Visit Log

Optional State Change for the Send Document via Clinical Network Action

This feature allows Admins to configure an optional state change on Veeva Site Connect’s Send Document via Clinical Network action. For example, a document can be moved from an In Progress lifecycle state to an At Site lifecycle state automatically once Vault successfully delivers it to a Study Site.

Veeva Site Connect Notifications Send After Transfer Completion

With this enhancement, Veeva Site Connect users receive notifications related to sending documents and document requests to SiteVault after the transfer is complete. Previously, Vault sent notifications prior to transfer completion.

Atomic Security for Documents & Clinical Operations

The enablement change of the Atomic Security for Document Lifecycles feature to auto-on in this release removes the Start Workflow permission from the document lifecycle state security matrix, which Vault previously checked when determining which users can perform the Send Document Package action on Study Site records. Users are now required to have a permission set with the Start Workflow permission to perform these actions.

CDMS & Clinical Operations Vault Connection: Procedures

With this release, a new integration is available in the CDMS & Clinical Operations Vault Connection. This feature allows users using both Vault EDC and Vault CTMS to transfer Procedures. An Admin must enable the new standard Procedure Status picklist values and activate the Procedures integration to utilize this feature. Learn more about the CDMS & Clinical Operations Vault Connection.

CDMS & Clinical Operations Vault Connection: SDV Requiredness

This feature allows Admins to configure the CDMS and Clinical Operations Vault Connection to transfer the SDV (Source Data Verification) requiredness status from EDC Vaults to CTMS Vaults. When SDV is required on an Event in EDC, the connection transfers the required status for Subject Visits connected to CTMS Vaults. Learn more about the CDMS & Clinical Operations Vault Connection.

CDMS & Clinical Operations Vault Connection: Repeating Visits

This feature supports repeating visits in CTMS Vaults. Additional fields now exist to support scenarios where multiple visits in EDC are mapped to the same Visit Definition.

The CDMS and Clinical Operations Vault Connection now transfers the event label override for Events from EDC Vaults as well as the eligible Event Definitions. CDMS & Clinical Operations Vault Connection.

TMF Viewer for TMF Transfer

This feature allows users who have received documents via TMF Transfer to view those documents in a meaningful hierarchical manner using the TMF Viewer. When users select the RM 2.0, RM 3.0, or Vault Clinical Docs display model of the TMF Viewer, Vault displays documents classified as TMF Document document type based on the Artifact record in its Source Hierarchy field. Learn more about the TMF Viewer.

TMF Transfer Archived Documents

This feature expands TMF Transfer so it can transfer archived documents from a source Vault. When users select a study to transfer that contains archived documents, Vault creates those documents as archived documents in the target Vault. Additionally, users can now transfer archived Study Sites and Study Countries. Learn more about TMF Transfer.

Clinical Operations & RIM Vault Connection Document Versioning

This feature improves the Clinical Operations & RIM Vault Connection by introducing new versioning behavior for CrossLink documents to keep multiple versions of the same document. When a document reaches Steady state in the source Vault, the target Vault will create a new CrossLink if one does not already exist or version the existing CrossLink if a prior version CrossLink exists. Learn more about the Clinical Operations & RIM Vault Connection.

Clinical Operations & RIM Vault Connection CrossLink Metadata Sync

This feature improves the Clinical Operations & RIM Vault Connection by introducing metadata syncing capabilities across CrossLinked documents. When the fields on a source document for a CrossLink are modified, that document’s fields are updated in the target Vault to reflect the updates. Learn more about the Clinical Operations & RIM Vault Connection.

Rule Set-Level Field Defaults

This feature allows Admins to create field defaults at the Rule Set-level for Veeva Site Connect and Simple TMF Transfer. Field Defaults no longer need to be created for every Connection.

User Profile Accessible for Existing Site Users

With Platform’s Enhanced User Profile Page feature, Site Users can now access their User Profiles in Clinical Operations Vaults. If necessary, Admins can disable access via the new View User Profile permission flag in the appropriate permission sets.

Site User Deprecation

This feature removes the Site User License Type and associated legacy collaboration features from Vaults not currently utilizing them. This includes the legacy Send Document Package action from the Study Site object and the Multi-Site Document Distribution document lifecycle user action. For customers using this legacy functionality, there will be no change to existing behavior.

Yuzu: CTN Enhancements

With this release, we’ve made various enhancements to Yuzu Clinical Trial Notifications, including:

Auto-populate the Study Site field on Study Organization and Study Person types of CTN Data records
Populate the Site field for Study Organization and Study Person CTN Data
CTN generation error dialog now includes a link to the record with error
Various Change Log enhancements
Trial Applicant / 治験届出者 and Applicant Representative / 治験届出担当者 handling enhancements
Validation check for CRO/SMO service area
Option to keep old organization- and person-related information for the designated Study Organization and Study Person identified on CTNs
Track changes made to CTN Remarks records

Learn more about Yuzu Clinical Trial Notifications.

Clinical Operations Data Model Changes

See 21R1 Data Model Changes: Clinical Operations.

Commercial

Capture Adverse Events

Medical Inquiries are a frequent source of Adverse Events. With this release, a standard object in MedComms Vaults allows users to capture additional data related to Adverse Events as part of Medical Inquiries. This additional data can then be shared to Pharmacovigilance.

Export Adverse Events to E2B(R3) Compatible Case Safety Report

This feature is used in conjunction with the standard data model for capturing Adverse Event data as part of a Medical Inquiry and allows users to export the standard Adverse Event data in an XML format using the E2B(R3) standard. The exported data can subsequently be transferred to a Pharmacovigilance/Safety system. Learn more about configuring Medical Inquiry.

Modular Content: Create & Approve Modules

With this release, users can create and approve content modules that can be reused in multiple material pieces. This feature allows users to relate Claims Library items, image documents, and data assets from within Vault and add text elements and business rulesets, including rules for placement, inclusion, and exclusions. Learn more about Content Modules.

eCTD Compliance Package: Generate Correspondence Letter

This feature adds the ability to automatically create a Correspondence Letter when generating a Pre-Clearance Compliance Package in Vaults with eCTD Compliance Package Generation enabled. The Correspondence Letter contains information that must be submitted to the FDA, preventing users from manually creating the letter. Learn more about eCTD Compliance Packages.

eCTD Compliance Package: Relative PDF Links Work in PromoMats

In the 20R3 release, we added the eCTD Compliance Package feature, which automatically creates the compliance package, generates submission-ready copies of documents, and converts Vault link annotations to relative PDF links for both Post Marketing and Pre Clearance Compliance Packages. Previously, users would need to export the compliance package and open the ZIP file to check the relative PDF links.

With this release, relative PDF links open in PromoMats, and users no longer need to export the compliance package to open the links. Note that relative PDF links can still be opened after exporting the compliance package.

Commercial Data Model Changes

See 21R1 Data Model Changes: Commercial.

Mobile

Warning Mode

With this feature, customers can configure a time of day after which the Station Manager mobile app must successfully sync with Vault. If the app does not sync by the configured time, mobile app users see configurable warning messages that documents may be out-of-date. This feature is available on both platforms:

Warning Mode on iOS

Warning Mode on Android

Record Based Categorization

With this feature, customers manage categories for Station Manager using object records and use Vault’s access controls to restrict which users can manage categories and the assignment of categories to Station Documents. Object-based categories are flexible and allowing scoping (e.g. by Facility) to allow each site to manage their own list of categories. Once the categories have been defined and assigned in Vault, they are displayed in the mobile app for selection by manufacturing end-users. This feature is available on both platforms:

Record Based Categorization on Android

Record Based Categorization on iOS

Settings Access Enhancements

This feature streamlines the user experience for the Station Manager mobile apps to prevent manufacturing end-users from unnecessarily attempting to access the settings menu.

This feature is available on both platforms:

Settings Access Enhancements on iOS

Settings Access Enhancements on Android

Display Document Version in Viewer

With this feature, the document version is visible when viewing the contents of a document or video in Station Manager, providing manufacturing end-users with additional context. This feature is available on both platforms:

Display Document Version in Viewer on iOS

Display Document Version in Viewer on Android

Display Page Numbers on iOS

Station Manager for iOS now displays page numbers within the document viewer to provide manufacturing end-users with additional context.

Veeva Snap: Improved Edge Detection

This feature improves Veeva Snap to better and more consistently detect document edges against varied background contrast and at various angles.

Quality

Process Navigator

The goal of the Process Navigator is to provide a way for customers to define process hierarchies and their supporting documents directly in Vault QualityDocs using a standard data model.

Documents that support a process can be associated with one or many processes and can be viewed as a user browses their process hierarchy relevant to their role. A purpose-built user interface allows casual end-users an experience that allows them to view process information along with their supporting documents in an intuitive, visually guided way. Learn more about setting up a Process Navigator page.

Quality Teams: Team Role Restrictions & Enhancements

With this feature, Quality Teams can now be made to enforce business logic rules such as: For a given Deviation, the same person cannot be both Owner and Approver. Quality teams now support the declaration of team roles as exclusive, meaning a given user, if they’re a member of an exclusive team role, cannot also be a member of any other role for that record.

For customers with existing team-enabled Vault configurations, this feature can be enabled individually on a team-by-team, team role-by-team role basis. Once the feature is enabled, Vault flags affected records as requiring new Team assignments from that point forward. Vault allows reassignment of such invalid assignments, allowing users to select new assignees from the pool of potential assignees for each role impacted by an exclusive assignment, and allowing for the preservation of any assignments to non-exclusive roles.

In addition to making these Quality Team Role assignment changes, Quality Teams can now be employed on a wider variety of processes and objects, like the QRM Risk Event. Quality Teams now supports objects which are modeled as Child Objects in the Vault, with some exceptions based on the depth of such relationships. Learn more about working with Quality Teams.

Quality to RIM Vault Connection Update & Resync Enhancements

This feature extends the QMS to Registrations Spark Connection to allow updates to data in both the QMS Vault and the Registrations Vault after the initial regulatory Event has been created. These enhancements support the following scenarios:

Users can resend updates to the impacted product scope in the QMS Vault to the Registrations Vault manually, which updates the Event record with additional impacted product information.
If the initial impact scope changes and new impacted countries are added in the Registrations Vault, users can send these to the QMS Vault.
New Activity lifecycle state types represent when the filing has been submitted and when the filing type indicates an implicit approval, for example, when a change is able to be implemented immediately in a given market. Learn more about configuring and using the QMS to Registrations Spark Connection.

QMS: Product & Supplier Data Model

With this release, new data model changes are included to improve both our Product hierarchy and our Supplier Quality Management components. For the Product Hierarchy, we introduced additional related objects to optionally support three levels starting at the Product Family level.

For Supplier Quality Management, we are introducing several data model changes. This includes new Organization object types to distinguish between site locations, a new SCAR object to support Supplier Corrective Action Requests, and a Qualification object that can manage what a given supplier or site is approved and qualified to provide.

Quality Teams: Team Role Attribute Label Change

To support future functionality, the Quality Teams Team Role attribute Constraining Role label has been updated to Constraining Application Role.

Prerequisite Training

This Vault Training feature allows a customer to require that certain training, which is a prerequisite, is completed first before the next set of training, which has a prerequisite, can be completed by a Learner.

In this release, a Training Admin can configure a single prerequisite Training Requirement for another Training Requirement. On the Learner Homepage or the Learner Task Page, the system indicates whether the Training Assignment has an incomplete prerequisite and will not allow the Learner to complete training until the prerequisite Training Assignment is completed first. Learn more about setting up prerequisite training requirements.

Maximum Attempts for Quizzes

With this Vault Training feature, learners can retry a training assignment’s quiz a specified number of times. Once a learner exceeds the maximum attempts for a quiz, Vault locks the quiz and notifies training admins or managers. While the quiz is locked, the training assignment is still accessible so that the learner can continue to review material within the assignment.

Once locked, quizzes can be unlocked by training admins or managers. If configured with a lockout period, the quiz will be auto-unlocked after a preset period of time. Learn more about creating quizzes for training assignments.

Self-Registration for Classroom Training

With this feature, Training Administrators can specify whether classroom training requirements allow Learner self-registration. If their classroom training assignment allows self-registration, Learners can then view available classes and register for the one that best fits their schedule.

This allows Vault Training customers to configure a self-service model where Learners can self-register without the involvement of an Administrator or Instructor.

Use Document Date Field as Due Date

With this feature, Vault Training can use document Date fields, such as Proposed Effective Date, as a Training Assignment’s due date when it is assigned due to document revisions. The Training Admin can choose which document Date field to use as the Training Assignment’s due date. The system automatically uses the configured document due date as the Training Assignment’s due date when creating the Training Assignment. Learn more about document revision impact.

Flexible Vault Training Job Scheduling

This feature allows Admins to modify the time and frequency of Vault Training’s Update Training Assignments job on the Job Definitions page in the Admin interface. The job is set to daily frequency by default and can be set to hourly, daily, weekly, or monthly.

Learner Homepage: Resources Section

Training Admins can now add and configure a Resources section for the Learner Homepage. The Resources section allows the Learner to view key information about Training and can contain configurable FAQ information, descriptions, and links to internal or external sites. Learn more about the Learner homepage.

Learner Homepage: Mobile Web Support

This feature allows a Learner to view the Learner Homepage from a mobile browser. The Homepage is optimized for mobile devices and allows the Learner to quickly see open Training Assignments, grouped by due date. The Learner can then view and complete Training Assignments from the mobile browser. Learn more about the Learner homepage.

E-Learning Content Mobile Web Support

This feature allows a Learner to view and complete e-learning courses, such as SCORM or AICC, from a mobile browser. E-Learning Training Assignment is mobile-optimized and allows the Learner to launch, play, and complete training on the e-learning course. Learn more about completing Vault Training assignments.

External Training Type Mobile Web Support

This feature allows a Learner to view and complete External Training Assignments from a mobile browser. The External Training Assignment is mobile-optimized and allows the Learner to view information about the Training, upload attachments, and complete training. Learn more about completing Vault Training assignments.

Classroom Training Type Mobile Web Support

This feature allows a Learner to view Classroom Training Assignments from a mobile browser. The Classroom Training Assignment is mobile-optimized and allows the Learner to view key classroom training information, such as when and where class is, as well as view class materials. Learn more about completing Vault Training assignments.

Update Training Assignment Due Date Without Sending Task Cancellation Email

With this release, when a Training Assignment’s Due Date is updated, a task cancellation email will no longer be sent. The workflow task due date will still be updated. However, if the Training Assignment’s Due Date is before the current date, the workflow task due date will not be updated. The Due Date value can only be the current date or a future date.

Updates to Cloning Rules for Vault Training Objects

With this release, when a Vault is cloned, the following Vault Training objects are not cloned:

Learner Role (learner_role__v)
Curriculum (curriculum__v)
Training Requirement (training_requirement__v)
Curriculum-Learner Role (curriculum_learner_role__v)
Training Requirement-Curriculum (training_requirement_curriculum__v)

Users can use Vault Loader to move data from these objects to a target Vault.

EU MIR: PDF Generation

This feature adds the ability to generate formatted PDF output of the EU MIR form. Customers can use this feature to submit the PDF file manually to the appropriate health authorities within the EU, or to share the information within their organization.

EU MIR: XML Generation

This feature enables support for generation of EU MIR XML payloads. Users can manually submit the XML payload to the health authorities via email. The generated XML payload adheres to validation criteria provided by EU health authorities.

US FDA eMDR: PDF Generation

With this release, VPS users are able to generate a formatted PDF output of the eMDR 3500A Medwatch form. This PDF form allows users to view the data included in the Adverse Event Report in a more readable format, suitable for sharing within their organization.

US FDA eMDR Enhancements

This release includes significant enhancements to the US FDA eMDR generation and submission feature:

One-Click Submit to Gateway: Customers no longer have to create a Transmission record before submitting to FDA gateway. Instead, a user action VPS: Submit to Gateway is now available on the Reportable Event.
Transmission Message Enhancement: Messages from FDA are now more readable on the Transmission Message object.
Notification enhancements: Notifications upon a failure to generate the XML/PDF file are more readable and show all the validation errors.

Learn more about Vault Product Surveillance.

eMDR: Attachment Support for XML Payload

Customers can now submit any additional information to the FDA in the form of attachments on the XML payload.

EU MIR Data Model Updates

With these data model updates, customers are able to leverage Vault Product Surveillance to triage a complaint that is determined to be a reportable adverse event to a country within the EU utilizing a standard output for an EU Manufacturer Incident Report (EU MIR). This is an extension of Adverse Event Reporting to the US FDA. Learn more about Vault Product Surveillance.

Station Manager: Record Based Categorization

This feature allows customers to manage categories for Station Manager using object records and use Vault’s access controls to restrict which users can manage categories and the assignment of categories to Station Documents. Object-based categories are flexible and enable scoping, by Facility for example, to allow each site to manage their own list of categories. Learn more about setting up document categorization.

Quality Data Model Changes

See 21R1 Data Model Changes: Quality.

Regulatory

Create Records in Content Plan Hierarchy Viewer

Admins can now configure two new record actions for the Content Plan and Content Plan Item objects: Create Sibling and Create Child. These actions allow users to create Content Plan or Content Plan Item records as children or siblings of a record in the Content Plan Hierarchy Viewer. When users select either of these actions from a Content Plan or Content Plan Item record, Vault automatically populates some fields in the record creation dialog based on the source record to streamline record creation. Learn more about creating sibling and child records.

Asynchronous Content Plan State Change

This feature allows Admins to configure a new Content Plan Hierarchy State Change system action on a Content Plan object lifecycle or in a workflow. Once configured, initiating this action changes the state of the Content Plan record and all of its descendant Content Plan and Content Plan Item records to the configured next lifecycle state. Rather than needing to remain on the page until the state change completes, Vault now queues and processes the state change asynchronously. The user who initiated the action receives a notification and a downloadable results log once the state change is complete. Learn more about configuring and using asynchronous content plan state changes.

Publishing Progress Indicator

A new Publishing Status field displays the current state of submissions publishing and report level publishing, providing a visual indicator to let users know if Vault is still processing publishing jobs. When configured, users can view Publishing Status on Submission, Report Level Content Plan, Content Plan, and Content Plan Item object records. Learn more about viewing publishing progress.

Auto-Create Product Family & Submission Language Joins

This release introduces new settings on the Application Settings page that enable Vault to create join object records automatically when users create or update certain records. When enabled, Vault can:

Create appropriate join records when users populate the Primary Product Family field while creating or updating Application, Clinical Study, Active Substance, Nonclinical Study, and Product object records
Create Submission Language join records when users create new Submission Country records, based on the languages associated with that country

Learn more about automatic record creation in RIM Vaults.

Sequence ID Automation

With this release, Admins can choose to allow Vault to automatically set the XML Sequence ID to the next available number within the application. Learn more about Sequence ID automation.

Retain Expansion Levels & Scroll Position in Content Plan Hierarchy Viewer

Prior to this release, every time a user opened the Content Plan Hierarchy Viewer, Vault collapsed the Content Plan and Content Plan Item rows and reset the scroll position to the top of the page. Now, Vault remembers which Content Plan and Content Plan Item rows are expanded and keeps them expanded after users complete actions within the viewer, refresh the page, or navigate to another page and back to the same content plan in the viewer within the current browser tab. Additionally, Vault attempts to scroll back to your previous location in the content plan if the page reloads in the same browser tab. Note that Vault does not retain expanded matched document rows in the viewer.

Split Content Plan Item Order Update

This release enhances the Split Content Plan Item action. Vault now places newly-created Content Plan Item records directly after the Content Plan Item record that was split, rather than below all of the other records in the same level of the hierarchy. This prevents users from needing to manually reorder split Content Plan Item records to move them to the correct location. Learn more about splitting content plan items.

Documents Matched to Inactive Content Plan Items

In the Content Plan Hierarchy Viewer, documents matched to inactive Content Plan Item records now display struck through document icons. This icon allows users to differentiate these from documents matched to active Content Plan Item records when filtering matched documents in the viewer.

Content Plan Tokens Create Sections Alphabetically

When Content Plan Template hierarchies include Content Plan section tokens, Vault now creates new repeating sections in alphabetical name order. This change aligns with the default display order of Submission relationship records.

Cross-Application & Cross-Reference Leaf Creation

Users can now create a cross-reference leaf to a leaf that resides in another application or submission. During publishing, Vault will create the leaf correctly within the resulting XML. Learn more about how to create a reference leaf.

Continuous Non-eCTD Structure & TOC Publishing

With this release, RIM Submissions Publishing Vaults can continuously publish non-eCTD structures, as well as continuously generate and publish a Table of Contents (TOC) as part of a submission. Learn more about configuring and using TOC publishing.

Continuous Publishing Prioritization

With this release, Vault automatically prioritizes continuous publishing jobs based on the value in the Planned Submission Date (planned_submission_date__rim) field on the Submission record. Continuous publishing jobs where the Planned Submission Date is in the next two (2) days will receive the highest priority.

Detect Source from Content Plan

RIM Submissions Archive Vaults now leverage the matched documents within a submission content plan to identify the source document of imported content. If an active Content Plan Item record in the submission content plan has a Published Output Location that corresponds to a file location in the current import, Vault uses the matched document as the source for the Submissions Archive-type document as well.

Allow Imports to Proceed with Invalid XML

A new setting on the Admin > Settings > Application Settings page allows users to import eCTD dossiers that are invalid according to the DTD or XSD. Vault will display a warning but won’t block the submission import. The dossier must contain util-related files and folders for the import to proceed. Learn more about enabling submission imports with invalid XMLs.

Save Import Results as Attachments

With this release, if attachments are enabled on the Submission object, Vault automatically saves the import results as an attachment on the Submission record if an error or warning occurs during import. Vault up-versions the attachment with subsequent imports to the same Submission record. Learn more about accessing submission import results.

Create & Update Dossier Details

With this release, Vault automatically creates and updates Dossier Detail records at submission import with the import status, the number of files in the imported dossier, and the imported dossier size. To leverage this feature, the Dossier Details and Dossier Status fields must be assigned to the Submission record’s object type.

Dynamic Sorting in Submissions Archive Viewer

With this release, Admins can choose to order documents and sections in the Submissions Archive Viewer dynamically. When enabled, Vault reorders submissions within the Viewer based on the Actual Submissions Date on the Submission record, even if the date is populated after an import has already taken place. If no date is available, Vault defaults to the Ordering Date Time field on the Submission Metadata object record. This enhancement also corrects the order of sections that were not placed in the correct order at the time of import. Learn more about dynamic sorting.

Update CrossLink Document Fields & Version CrossLinks

This feature enhances the Clinical Operations & RIM Vault Connection to version CrossLink documents and update document fields. When a source document reaches its Steady state in the Clinical Operations Vault, the RIM Vault checks to see if a CrossLink document already exists for a prior version of the source document. If the connection already created a CrossLink document for a prior version, Vault will version the existing CrossLink document instead of creating a new one.

In addition, when users update document fields in the Clinical Operations Vault, the RIM Vault updates the connection’s related document fields as well. For example, if a user adds a study to an Investigator’s CV in the Clinical Operations Vault, Vault updates the CrossLink document’s Clinical Study field in the RIM Vault to include the additional study. Learn more about the Clinical Operations & RIM Vault Connection.

Submissions Archive: South Korea 1.0

With this release, RIM Submissions Archive Vaults support importing and viewing eCTD submissions based on the South Korea v1.0 DTD.

Display Sequence ID

Vault now uses the Sequence ID (xml_submission_id__v) field to display a leaf’s operation lifecycle within the Submissions Archive Viewer, Historical Leaf Lifecycle dialog, Cumulative View dialog, and within the Dossier Panel. If the field is not populated on the Submission record, Vault will continue to display the Submission record’s Name field.

Japan eCTD Section Label Update

This feature updates the Japan eCTD Module 1 to include section numbers as part of the section name.

API Job ID in Audit Trail

When a user initiates a submission import via the Vault API, Vault now includes the Job ID assigned to the import in the Submission record’s audit trail.

Content Plan Hierarchy Viewer Enablement & Permissions Update

With this release, the legacy Hierarchy Viewer for content plans has been deprecated. We will only introduce new functionality and fix defects for the Content Plan Hierarchy Viewer, which is the newest iteration. In addition, the Enable tree grid checkbox on the Application Settings page is now one-way, meaning that an Admin cannot revert to the legacy Hierarchy Viewer once they enable the updated Content Plan Hierarchy Viewer. We recommend that all customers who are actively using content planning enable the Content Plan Hierarchy Viewer if they have not done so already.

To make it easier for customers to enable the Content Plan Hierarchy Viewer, this release also automatically grants Read permission for the Hierarchy Path and Hierarchy Level fields on the Content Plan and Content Plan Item objects for permission sets that include Read access to these objects. Admins no longer need to configure permissions for these fields when enabling the viewer.

Worksharing Improvements

This feature updates the bundling and splitting wizards to better support cross-application regulatory objective handling. Vault now correctly updates Country Decision Detail records for cross-application regulatory objectives based on related applications. In addition, this feature includes several UI improvements to the record grid pages in the wizards:

Bundling grids now display 50 records per page, increased from 10 records per page, to better accommodate customers with large datasets
Searching or applying filters in the grids no longer clears any previously-selected records
Every grid page now includes a clear indicator displaying the total number of selected records selected for any given step of the bundling or splitting process, regardless of the filters or search settings applied

Pull Objective Data for Medical Devices & Manufacturing Sites

The Pull Objective Data user action now supports pulling additional medical device- and manufacturing site-related data from a Regulatory Objective record’s details into a Submission record’s details. Additionally, this action now supports object type mappings to create Submission details with the appropriate object types for drug submissions or medical device submissions. Learn more about configuring and using the Pull Objective Data user action.

Update Country Decision Detail Count Upon Record Deletion

This feature updates the behavior of the Country Decision Detail Count field on Regulatory Objective object records. When a user deletes a Country Decision Detail record, Vault now updates the Country Decision Detail Count field accordingly to reflect the actual number of related Country Decision Detail records.

New settings on the Application Settings page allow Admins to configure the default naming patterns for Regulatory Objective and Submission records that Vault creates through the Create Related Records wizard. Admins can reference any field on the Event object to define the naming pattern.

Another setting on the Application Settings page allows Admins to set a default Activity Scope Level in the wizard according to their organization’s business processes. In past releases, Vault automatically selected the first value in the list. Learn more about configuring the Create Related Records wizard.

Configurable Impact Assessment Report Updates

In past releases, users needed to have a security profile that included the Object: Report: Create permission in order to use configurable impact assessment reports. This feature removes that requirement, making it easier for users to access these reports. With this feature, Vault also saves any values that users enter in the Impact Report Options dialog as report filters when running the report to store a true snapshot of the data input. Learn more about using configurable impact assessment reports.

Configure Affiliate Home Page Components

This feature allows Admins to choose which actions and chart panes appear on the Affiliate Home tab. These customization options let customers hide the actions or charts that may not be relevant to their affiliate users. Vault automatically adjusts the Affiliate Home tab based on the Admin’s selections. Learn more about configuring the Affiliate Home tab.

Quality to RIM Vault Connection Update & Resync Enhancements

Users can resend updates to the impacted product scope in the QMS Vault to the Registrations Vault manually, which updates the Event record with additional impacted product information.
If the initial impact scope changes and new impacted countries are added in the Registrations Vault, users can send these to the QMS Vault.
New Activity lifecycle state types represent when the filing has been submitted and when the filing type indicates an implicit approval, for example, when a change is able to be implemented immediately in a given market.

Learn more about configuring and using the QMS to Registrations Spark Connection.

The Create Related Records wizard can now populate new objects and fields introduced in 20R3 to support IDMP compliance. This update includes mapping data from Event Shelf Life and Storage and Event Site Role records to the corresponding relationships on Regulatory Objective and Submission records. Learn more about creating related records.

Include New IDMP Relationships in Manage Registered Details Wizard

This feature updates the scope of the Manage Registered Details wizard to support new registered detail objects added for IDMP functionality. Users can now:

Create and update additional Registered Indication fields
Create and update Registered Shelf Life and Storage and Registered Site Role records
Update includes Registered Packaged Medicinal Product records

All new records are subject to verification workflows and registration history reporting based on your Vault’s settings.

Include New IDMP Relationships in Create Registrations Wizard

Include New IDMP Relationships in Pull Objective Data Action

This feature enhances the Pull Objective Data action to support pulling data from the Regulatory Objective record relationships to the Submission record relationships for the Submission Shelf Life and Storage object. An Admin must make the Submission Shelf Life and Storage object available to users in order for Vault to populate data. Learn more about pulling Regulatory Objective data to Submissions.

IDMP: Integration with RMS

This feature integrates Vault RIM with the EMA’s Referentials Management System (RMS) using the EMA’s public REST-based API. The structured data from RMS will populate values of the Controlled Vocabulary records relevant to IDMP, for example, route of administration, dosage form, and units of measurement. Learn more about configuring the EMA RMS integration.

IDMP Accelerators: Generate Registered Details & Medicinal Product Details

This feature adds new settings on the Admin > Settings > Application Settings page that allow Vault to automatically create related records when users create new records for certain objects that support IDMP. Automatic record creation helps streamline the data entry process for users while ensuring that data is more accurate. When enabled, Vault can automatically create the following object records:

Registered Packaged Medicinal Product
Registered Site Role
Medicinal Product
Medicinal Product Registration

IDMP Accelerators: Registered Detail Mapping

As part of the 21R1 release, Vault will map existing values from registered details into new object records to support IDMP functionality. Vault will map data as follows:

Vault creates one (1) new Registered Shelf Life and Storage record for each unique combination of Packaging and Shelf Life on existing Registered Packaging records.
Vault creates one (1) new Registered Site Role record for each unique combination of Finished Product Manufacturer and Manufacturing Site Role on existing Registered Packaging, Registered Product, Registered Active Substance, and Registered Inactive Ingredient records.

Vault will use these new records as a source for IDMP record generation. See Data Mapping for IDMP Accelerators & Worksharing Improvements in 21R1 for details.

XEVMPD Enhancements

This feature improves the overall XEVMPD submission process by providing targeted updates to validation results and acknowledgment handling. Additionally, this feature updates submission document handling to accommodate multiple languages and introduces tracking for traffic through the EMA gateway. Learn more about XEVMPD gateway submission.

XEVMPD Denominator

This feature updates validation to include the Unit of Presentation controlled vocabulary in XEVMPD denominator units, in alignment with Article 57 guidance. This update allows users to select both Unit of Measure and Unit of Presentation controlled vocabularies for denominator units in XEVMPD data.

Worksharing Improvements: Data Model Update

This feature adds the Application Regulatory Objective object to the RIM data model. The Application Regulatory Objective object provides a many-to-many relationship between the Regulatory Objective and Application objects to better support complex worksharing and cross-application grouping scenarios.

As part of the 21R1 release, we will automatically populate this object with data for all RIM Vaults. See Data Mapping for IDMP Accelerators & Worksharing Improvements in 21R1 for details.

21R1 Regulatory Data Model Updates

See 21R1 Data Model Changes: Regulatory.

Safety

Safety features are targeted for tentative availability on April 15, 2021 & April 23, 2021.

E2B R2 ACK for Inbound Transmission

The system now supports the generation and transmission of Acknowledgment Message (ACK) in the E2B(R2) format for inbound single-case or multi-case E2B(R2) transmissions.

Note: This feature is available automatically with no additional action required.

Learn More: Receive an E2B Transmission

Multiple Case E2B Import

Vault Safety now supports the import of EMA E2B(R3) files that contain multiple cases. When an Inbound Transmission’s Origin field is EMA, the system skips the auto-generation of Submissions with Destination to the EMA during the evaluation of case reporting obligations.

Note: This feature is available automatically with no additional action required.

Multi-Case E2B Import via API/AS2

Vault Safety now supports the ability to import multi-case XML files in E2B(R2) and (R3) format via AS2 Gateway or API. Additionally, multi-case E2B(R2) files can be imported manually through the UI.

Note: This feature will be available automatically in a future release for vaults with AS2 Gateway or API Transmissions already configured. In 21R1, contact Veeva Managed Services to request this feature.

Learn More:

Receive an E2B Transmission

Duplicate Detection Using External System UID

Vault Safety will now use the External System UID for duplication detection. It will return potential matches for cases that only have this field matching the Inbox Item or AER.

Note: This feature is available automatically with no additional action required. However, an administrator must configure the External System UID field to capture this data on AER and Case page layouts if it was not already added in 20R3.

Learn More: Duplicate Case Detection

Promote to Case Follow-up: Set Follow-up Receipt Date to Initial Receipt Date

With this release, when an AER is promoted to a Follow-Up Case, the receipt date on the Follow-Up defaults to the Initial Receipt Date. This change in behavior resolves an issue where the New Information Date (C.1.5 in E2B R3) was possibly earlier than the Receipt Date (C.1.4 in E2B R3) if the Receipt Date was incorrectly entered on the AER.

Note: This feature is available automatically with no additional action required. This new default behavior takes effect for new cases when they are created from an AER. This feature does not update existing cases.

Learn More: Enter Case Data

Support VAERS Reason Omitted “Other”

With this feature, customers can select “Other” as a reason omitted value for the Race (FDA.D.11) and Vaccination Facility (FDA.G.k.4.r.14.8) fields. Nullflavor “OTH” is also mapped to reason omitted “Other” as part of the FDA VAERS E2B R3 export.

Note: This feature is available automatically with no additional action required.

Learn More:

Japan (PMDA) Local Fields

With this release, Japanese local data elements required by PMDA (Japan regulatory authority) become available for data entry.

Note: An administrator must configure the new regional fields to make them available for data entry.

Learn More:

Korea (MFDS) Local Fields

With this release, Korean local data elements required by MFDS (Korean regulatory authority) become available for data entry.

Note: An administrator must configure the new regional fields to make them available for data entry.

Learn More: Prepare a Localized Case: Enter Regional Data on Localized Cases

Pregnancy and Parent-Child Case Data Collection Enhancements

Pregnancy and Parent-Child cases have been enhanced for the collection of child information with the introduction of the new Child Information object type for cases. This allows non-submittable pregnancy cases to be more easily tracked.

To improve data entry for follow-ups to collect pregnancy outcomes, Child Information records will automatically generate test result placeholders for APGAR scores (1, 5, and 10-minute), Birth Outcome, and Head Circumference.

In the event that the pregnancy outcome results in an adverse event in the neonate, the information is captured as a regular Case with a reference to the Parental (Pregnancy) Information.

Note: An administrator must perform configuration to make this feature available. See Enable Pregnancy and Parent-Child Case Data Collection for instructions

Learn More: Add a Pregnancy Case

Case Version and Transmission Sequence Numbers

Vault Safety will now stamp every new case and transmission with an internal sequence number. The sequence number can be used in conjunction with Vault platform reporting capabilities to create custom multi-pass reports to retrieve the latest version of a Case or Transmission for a given reporting period.

Note: This feature is available automatically. However, this will not stamp previously created cases or transmissions. A buffer of 10,000 unused numbers has been provided for previously created cases; however, this is not automatically applied. Contact Veeva Services to apply this buffer to existing Cases and Transmissions.

Learn More: Use Case or Transmission Unique Numbers in Reporting

Recode Badge for MedDRA Terms

Users are now made aware with a visible indicator when a coded term’s MedDRA Version is not in sync with the Case MedDRA Version.

Note: This feature is available automatically with no additional action required.

Learn More: Recode a MedDRA Term

PADER Transmission Date Filter

Vault Safety now filters PADER reports based on Transmission Date by default, which allows a firm cutoff date for including cases in the report. Cases with multiple versions for initial, follow-up or amendment reasons within the same reporting period are counted as initial in the PADER. In the 15 Day Summary Reports, the system considers additional criteria to identify fatal cases.

Note: This feature is available automatically with no additional action required for customers who have configured PADER aggregate reports. This feature will not impact previously generated reports. Reports must be re-generated to take effect.

Learn More: Create PADER Aggregate Reports

Postmarket Studies and Literature Enhancements for PADER, PBRER, PSUR, CIOMS and 3500A

PADER, PBRER, PSUR, CIOMS I, and 3500A have been enhanced to leverage Study Type to account for Post Market studies. To improve the data entry experience, administrators can now configure Study Type on Studies so that new study cases can automatically default the Study Type.

A new literature flag has been added to Report Type to classify literature. This will be automatically turned on for our standard Literature Report type and can be configured on custom report types to drive literature classification in PADER, PBRER, PSUR, CIOMS I, and 3500A.

Note: This feature is available automatically for customers who are using PADER, PBRER, PSUR, CIOMS I, or 3500A. However, there is some page layout configuration for the Study Type field. See Enable Postmarket Studies for instructions. This feature will not impact previously generated reports. Reports must be re-generated to take effect.

Learn More:

PADER Subtotal/Grand Total and New Appendices

PADER now includes two new appendices: Non-Primary Suspect Product Report, and List of Death Cases. Additionally, Subtotals and Grand totals are now displayed in the Summary Tabulation of ADRs.

Note: While this enhancement is introduced automatically, an Administrator must upload the templates for the new appendices and replace the existing PADER Summary Tabulation of ADRs template before generating PADER reports after the 21R1 release. Also, to generate appendices, the Documents to Generate field must be added to the Aggregate Report Page Layout to allow users to generate the new appendices. See Enable PADER Authoring and Table Generation for instructions.

Learn More: Create PADER Aggregate Reports

PBRER, PSUR, DSUR Case Approval Date Filter

Vault Safety now provides the option to filter PBRER, PSUR, and DSUR reports by Case Approval Date, this allows a firm cutoff date for including cases in the report. The system will continue to use the Case Receipt Date / New Info Date by default.

Note: This feature is available automatically in vaults with the Filter Cases By field. If this field is not on the Aggregate Report Page Layout, it must be added to the page layout for users be able to specify the Case Approval Date. Enable Filter Cases by Approval Date in Aggregate Reports provides instructions. Reports must be re-generated for this feature to take effect.

Learn More:

PBRER, PSUR, DSUR, PADER Timezone Awareness and Enhancements

PBRER, PSUR, DSUR and PADER report filters have been enhanced to recognize timezones for more precise case inclusion. In addition, the ability to run PADER reports based on the Case Receipt Date / New Info Date has been replaced by running the reports solely based on Transmission Date. Also, the Non-Primary Suspect Product Report will now be generated by default. Lastly, the PBRER Cumulative ADRs from Postmarketing “Interval” column has been enhanced to respect the Case Approval Date when that option is selected in the PBRER “Filter Case By” field.

Note: This feature is available automatically with no additional action required for customers who have configured the corresponding aggregate report (PBRER, PSUR, DSUR, and PADER). This will not impact previously generated reports. Reports must be re-generated to take effect.

Learn More:

PSUR Time to Onset and Group by PT

PSUR reports have been updated to use MedDRA Preferred Terms (PT) for grouping adverse events. This replaces the previous verbatim term grouping mechanic. Additionally, the PSUR Line Listing now includes Time to Onset information.

Note: While this feature is auto-on, we recommend that you upload the new 21R1 PSUR report templates, which have updated labels. See Enable PSUR Cumulative Tabulations and CIOMS II Line Listings for instructions. This feature will not impact previously generated reports. Reports must be re-generated to take effect.

Learn More:

EMA E2B R3 Submission Validation

This feature introduces full EMA E2B R3 conformance rules, extending the ICH E2B R3 validation capabilities delivered in 20R3. Validation is automatic when the EMA E2B R3 file format is generated or regenerated for a reporting destination. Validation Result records are created based on each evaluated Validation Criteria and can have an outcome of Pass, Fail, or Warning.

Note: MHRA uses the EMA E2B R3 format and will be validated for EMA E2B R3 conformance.

Note: This feature is Auto-On. However, if ICH Submission Validation was not previously enabled in the 20R3 release, this feature requires configuration on the Transmission (Submission and Distribution) to add the Validation Results section to the Page Layout.

Learn More: Case and Submission Validation

FDA E2B R2 - Support “FDA Safety Report Type” (A.1.FDA.16) Field

Vault Safety now supports adding the FDA Safety Report Type (A.1.FDA.16) element to FDA E2B(R2) Transmissions.

This feature only impacts the Transmission file format FDA E2B(R2). Only the FDA Safety Report Type tag is being added to support postmarket submissions (E2B Code=3). Other IND Safety Report tags are not yet supported.

Note: This feature won’t take effect until the FDA E2B (R2) mandated date requiring the new regional data element A.1.FDA.16 (FDA Safety Report Type). After this date, FDA E2B (R2) files generated from Vault Safety will include this field automatically.

Local Expedited, Downgrade, and Postmarket Study Submissions

Vault Safety is extending its agency submission and distribution capabilities to configure rules-driven local expedited criteria, downgrades (one last time rule), and non-interventional postmarket studies. These updates have been reflected in the EMA and FDA rulesets. In addition, the FDA and EMA rule names have been refreshed to be more business-friendly names.

Note: This feature is available automatically with no additional action required for customers who have enabled the Evaluate Reporting Obligations action, which was introduced in 19R3 as part of the EMA Submissions feature.

Learn More:

Configurable Back Reporting

Vault Safety now supports configurable back reporting for agencies, licensed partners and other reporting destinations. Back reporting means that a report will be sent back to the original sender. By default, back reporting will be turned off (i.e. prevented) for all reporting destinations, except Health Canada. Enabling back reporting for specific destinations can be done via Transmission Profiles. For an example, after importing an E2B downloaded from EVWEB, if that case is further processed and approved, a submission to the EMA isn’t generated (unless back reporting is enabled for EMA).

Note: Contact Veeva Support to request this feature be enabled.

Learn More: Configure Back Reporting

VAERS Certification Enhancements

Vault Safety has enhanced collection, verification, and generation of data as part of VAERS E2B (R3) Guidance-Compliant Testing. Scenarios include, postmarket study cases with combination products, support for similar devices, support for VAERS specific units of measurement, display of VAERS related dosage fields for external vaccines, support for patient as non-primary reporter, fixes for malfunction-only cases, and fixes for transmission of blinded study flag.

Note: This feature will be available automatically in a future release for vaults with Vaccines and VAERS Submissions enabled. In 21R1, contact Veeva Managed Services to request this feature. To display VAERS related dosage fields for external vaccines, the External Product Type field must be added to the External Case Product Page Layout.

Learn More:

VAERS E2B R3 Submission Validation

This feature introduces full VAERS E2B R3 conformance rules, extending the ICH E2B R3 validation capabilities delivered in 20R3. Validation is automatic when the VAERS E2B R3 file format is generated or regenerated for a reporting destination. Validation Result records are created based on each evaluated Validation Criteria and can have an outcome of Pass, Fail, or Warning. Additionally, at the case level, an extra safeguard has been added for Vaccines to display a warning if the most severe adverse event is not set as the primary.

Learn More: Case and Submission Validation

Tracking Non-Submittable Cases (Suppress Submission)

When enabled this feature prevents automatic ICSR submission record generation for cases designated as non-submittable (i.e. Invalid, Pregnancy cases, etc). These cases will also be excluded in aggregate reports.

Note: An administrator must configure the Suppress Submissions field to make this feature available. See Enable Suppress Submissions for instructions.

Learn More: Suppress Case Submissions

Use Adverse Event PT on CIOMS and MedWatch 3500A

Vault Safety now supports the option to display adverse events using the MedDRA Preferred Term (PT) on CIOMS I and MedWatch 3500A forms.

Note: Contact Veeva Support to request this feature be enabled. Once enabled, all new CIOMS I and MedWatch 3500A forms will use the MedDRA PT for adverse events. This will not impact previously generated reports, they must be re-rendered to take effect.

Learn More:

Show Assessment Results on CIOMS I

This feature reintroduces Case Assessment Results on the CIOMS I form, replacing the system-generated identifiers for Product names with readable names. As always, this section respects study masking and will show the blinded name on blinded forms.

Note: This feature is available automatically with no additional action required. This feature will take effect for any newly generated CIOMS I form. This will not impact previously generated reports. Reports must be re-generated to take effect.

Learn More: CIOMS I Generation Data Mapping

Inbox Item PHI/PII Encryption

This feature adds an extra layer of protection for standard personal identifiable Information (PII) on the Inbox Item. This prevents Veeva from viewing encrypted fields unless they are assigned Delegate Access for 20+ Inbox Item fields and 20+ Case fields when received via API pass-through.

Note: This feature is available automatically with no additional action required.

Learn More: Manage Field Encryption: PHI and PII Field Encryption

Inbox Item Manual Data Entry Enhancements

Manual Inbox Item intake has been enhanced for better usability. When a user manually creates an Inbox Item, the record will now have sections for the Primary Reporter, Suspect Product, and Adverse Event by default. When a user creates additional Case Contacts, Products, or Medical Events, the new section will be opened at creation. Additionally, when viewing a section with multiple products, events, or contacts, the first item will be expanded by default.

Note: This feature is available automatically with no additional action required.

Learn More: Create an Inbox Item Manually

Inbox Item Manual Study Intake

Users are now able to select the Study and Study Arm on the Inbox Item to perform manual study case intake. On case promotion, Study and Study Arm information will be downloaded from the Vault Safety Library, including the Study Registration and Study Products, to reduce data entry effort. This enhancement supports open and blinded Studies with Arms.

Note: Study intake capabilities are available automatically. However, an administrator must update the case validity criteria in the Inbox Item Lifecycle and the Case page layout to show Study information.

Automatic PDF Form Intake

Safety.AI will automate intake from PDF forms using Artificial Intelligence and Machine Learning. A new User Action on Vault library documents will allow users to start the extraction process from the document text.

Upon successful completion, an Inbox Item will be created with the extracted case information for the Reporter, Patient, Adverse Events, and Products and prioritized (P1 to P3) based on the detected seriousness.

Dosage Extraction

Safety.AI will now automatically extract the dose and administration dates from unstructured text and PDF forms, and link them to their associated Case Products. The dosage information will be populated with a confidence icon and the source text will show in the Source Data pane to facilitate human verification.

Note: This feature is available automatically with no additional action required.

MedDRA Auto-Coding For Intake API and PDF Forms

When an Inbox Item is created from data received through the Intake API or extracted from a PDF form, Safety.AI initiates MedDRA auto-coding. MedDRA auto-coding extends to all MedDRA fields on an Inbox Item with corresponding verbatim (“as reported”) fields. Auto-coding is based on an exact match (case insensitive) search across all MedDRA PTs/LLTs.

Note: This feature is available automatically with no additional action required. Your vault must have an active MedDRA dictionary to use this feature.

Learn More:

Multiple Candidates for Date and Country Fields

Safety.AI will now show up to 4 candidates for Date and Country fields supported for extraction from text. Safety.AI will show the confidence level icon for each value and populate the one with the highest confidence score.

Note: This feature is available automatically with no additional action required.

Checkboxes and Fields Recognition and Verification from PDF Forms

Safety.AI will automatically extract and map Seriousness checkboxes from a source PDF document to suggest the Inbox Item Priority. The Source Data pane will show this information to facilitate human verification. Also, Safety.AI will now extract document field labels for values found in the document text and will show them the Source Data pane along with the source text.

Drug/Biologic/Vaccine-Led Combination Product Intake

Safety.AI supports intake for Drug, Biologic, and Vaccine Combination Products on the Inbox Item. On case promotion the combo product information will be mapped to the product constituents and product constituents’ information will be downloaded from the library.

Note: This feature is available automatically with no additional action required.

Learn More: Manage Combination Products

SiteVault

Document Delete With Audit Trail Access

This feature allows SiteVault users with appropriate permissions to delete documents that are in a steady state (such as Current or Final). Users who delete steady-state documents are required to enter a reason for deletion with optional comments. In addition, Admins can more easily access and download audit trails of deleted documents.

With this feature, Profile objects (organizations, products, and patients) can be defined as research organization-wide, which makes them available for use across all sites (such as Sponsor records) or specific to one site (such as local IRBs).

End Date Defaulting From File Names

On the bulk source upload page, any dates specified in uploaded file names now default to the End Date field (rather than the Start Date field).

Research Organization Defaulting for Documents & Objects

This new standard behavior allows customers to meet information security requirements with less manual work. Vault automatically populates the Research Organization field on new documents and object records. If the user creating the document or record is assigned to a Site, Vault also populates the Research Site field.

When an existing document or object is updated, the Research Organization field is defaulted in the same manner as it was defaulted on record creation. This behavior is part of a series of updates introducing the Research Organization object.

SiteVault: Comments for Document Exchange

With this feature, SiteVault users can send and receive comments when exchanging documents with sponsors or CROs on Connected Studies. Comments are displayed in the Documents to Return, Other Received Documents, and Returned Documents sections of Regulatory Document Requests.

Connected Studies Icon

With this feature, a Connected Study icon is displayed on the header of the Study page layout whenever an active Veeva Site Connect Agreement is in place. This icon indicates users can use SiteVault to exchange documents and data directly to and from the sponsor or CRO’s Vault for the study.

New Exchangeable Document Types on Connected Studies

This feature adds support to transfer the following new document types through Veeva Site Connect:

Data Privacy
Delegation of Authority
Monitoring Visit Log
Note to File
Subject Screening Log

SiteVault & MyVeeva for Patients: eConsent

This feature allows site users to consent study participants electronically using Veeva eConsent and MyVeeva for Patients:

Site users can create new study eConsent documents either from a template or by copying an existing study eConsent document. The user can then edit the document in their browser using the Edit eConsent action and the Veeva eConsent editor.
Site users can select and send one or more steady-state eConsent documents to the participant. The participant receives the forms in MyVeeva for Patients, where they can review and sign electronically. When the participant signs the forms, the forms are automatically uploaded to SiteVault and routed to the site user for countersignature.
Site users can cancel eConsent documents that have already been sent to a participant. This enables site users to correct sent eConsent documents and resend for approval.
When a participant signs a new version of an eConsent document, the newly signed document becomes the steady-state version and the previous steady-state version, if present, is superseded.

Data Model Updates

See 21R1 Data Model Changes: SiteVault.

QualityOne

Inspection Sampling & Evaluation

This feature allows users to define sample and success criteria using a fixed number or percentage of the total method for incoming, in-process, and outgoing inspection types. Users run an action to generate the sample records with inspection test results based on the sample size and method. The success criteria analyzes the status of every sample and provides an immediate inspection result, saving time and improving efficiency. Learn more about using Inspection Sampling and Evaluation.

Incident Management Standard Object Enhancements

This feature provisions additional fields for the incident management object model. The improved object model allows organizations to better report, track, and manage safety, environmental, vehicle, and property damage incidents. The improvement simplifies implementation and represents health and safety processes best.

Note: This feature is currently available only to early adopters. Contact your Customer Success Manager for more information.

QualityOne Mobile for iOS – Incident Management

Note that this feature is targeted for tentative availability on April 27th. This feature introduces Incident Management as an extension to the QualityOne Mobile for iOS application. In addition to logging nonconformances, users can now log HSE Incidents on the spot and attach photos. This application operates in environments where cellular data or WiFi connectivity is available.

Note: This feature is currently available only to early adopters. Contact your Customer Success Manager for more information.

QualityOne: Root Cause Analysis support on NCR and HSE Event

This feature offers users the ability to perform 5Whys Analysis from the NCR and HSE Event object. For every parent of the Root Cause Analysis object, the system automatically creates the related 5Whys Root Cause record for each corresponding Why record identified as a root cause. Learn more about Root Cause Analysis.

Comments on Objects with User Mentions

Once configured on an object, this feature allows an internal user to collaborate with other internal users or external users (suppliers, etc.) on various QualityOne processes. Admins can configure the Comments object for both custom and standard objects. Users creating the Comment record can mention other users using the @/+ signs. Mentioned users are notified via an email and an in-app notification each time they are mentioned in a comment. Learn more about configuring and using comments for QualityOne objects.

Support for Multiple Findings on Audit Checklist Responses

This feature allows users to create one or more audit finding records from a checklist respondent UI when the checklist target object is Audit. Previously, users were able to flag a question with only one Finding? each, creating a single Finding record when the checklist is completed. Learn more about Audit Findings.

Audit Checklist Enhancements for QualityOne Mobile for iPadOS

Note that this feature is targeted for tentative availability on April 27th. This feature allows users of QualityOne Mobile for iPadOS to create one or more audit findings for each checklist response when completing an Audit Checklist.

COA Header Ingestion Enhancements

This feature improves the accuracy of ingested header information after users upload a COA document by introducing the ability for Admins to configure additional matching rules, reducing manual intervention to process a COA Inspection record.

Note: This feature is currently available only to early adopters. Contact your Customer Success Manager for more information.

COA Characteristic Matching Variant Enhancements (Synonyms Management)

This feature allows Admins to define and manage synonyms for each characteristic by configuring the Characteristic Matching Variant rule that is specific to a Product, Product Version, Supplier, and Supplier Location.

Note: This feature is currently available only to early adopters. Contact your Customer Success Manager for more information.

Data Model Changes

See 21R1 Data Model Changes: QualityOne.

RegulatoryOne

Obsolete Features

Note that this feature applies to customers who adopted RegulatoryOne up to, and including, 20R3.

The following RegulatoryOne features will no longer be available:

Formula Insights by Internal & Regulatory Agency Standards
Ingredient Lists
Generate Submission Ingredients
Product Raw Material Ingredient Rollup

Obsolete Raw Material Token feature

Note that this feature applies to customers who adopted RegulatoryOne up to, and including, 20R3.

The Submission Content Plan token ${submission_raw_material__v} is no longer supported. Admins can no longer reference the Submission Raw Materials token in cosmetic Content Plan Templates and will not generate Content Plan sections for each Submission Raw Material Variant record.

Obsolete RegulatoryOne Data Model

Note that this feature applies to customers who adopted RegulatoryOne up to, and including, 20R3.

The following standard objects will no longer be available:

Substance Restriction
Submission Substance Restriction
Ingredient List
Ingredient List Product Variant
Ingredient List Active Substance
Submission Ingredient List
Raw Material
Raw Material Variant
Product Variant Raw Material
Raw Material Variant Active Substance
Submission Raw Material
Formula Ingredient Function

Users can view existing records in these objects but cannot create or edit existing records. Users cannot select a reference to an existing record in these objects from a related object but can view existing references to existing records in these objects from related objects.

Registration & Dossier Management Data Model

Note that this feature applies to customers who adopt RegulatoryOne for 21R1. Note that this feature is targeted for tentative availability on April 27th.

This feature provisions a standard object model for Registration & Dossier Management as a first step towards allowing organizations to create events that require regulatory work to be completed, as well as related requests, registrations, and requirements.

Product Hierarchy Data Model

Note that this feature applies to customers who adopt RegulatoryOne for 21R1. Note that this feature is targeted for tentative availability on April 27th.

Consumer and chemical products and their associated formulations can form multilevel hierarchical relationships. With this release, we are introducing a shared standard product hierarchy data model that can be leveraged to store complex hierarchical products to reduce reliance on customization.

These data model changes are automatically included in RegulatoryOne, but Admins must make configuration changes to make them available.

Note that this feature is also available for Veeva Claims.

Data Model Changes

See 21R1 Data Model Changes: RegulatoryOne.

Veeva Claims

Note that Veeva Claims features are targeted for tentative availability on April 27th.

Auto-Populate Local Pack Copy

Pack Copy is a specification document that brand marketers create in order to deliver the packaging specifications of a product to artwork and creative teams. In order to service multilingual and global markets, Marketers need to localize Global Pack copy specifications to specify and translate locale-specific Pack Copy elements.

The auto-populate pack copy capability enables users to create a new local pack copy with already-translated or to-be translated localized elements. This feature allows translators to add the missing translations for a single country in multiple languages in a single view. Learn more about configuring auto-populate local pack copy.

Pack Copy Hierarchy Viewer Enhancement

This enhancement ensures consistent performance for the Pack Copy Hierarchy Viewer. If a hierarchy contains more than 10 Pack Levels or more than 500 Panels, the section displays a message to users instead of all records. Learn more about the Pack Copy Hierarchy Viewer.

Self-Referencing Statement Records

This feature allows users to store statement translations in the statement library. The translated statement records are tied to the global statement record. Learn more about self-referencing statements.

Claim Creation Uniqueness Check

This feature prevents duplicate Claim record creation when users create records manually or by copying records. Vault checks if a Claim record already exists with the same claim Statement and Product combination, and avoids duplicate record creation. This uniqueness check increases the efficiency and accuracy of the Claims approval process.

Product Hierarchy Data Model

See: feature description.

Data Model Changes

See 21R1 Data Model Changes: Veeva Claims.

Working with Documents

Link Annotations to Permalinks

Audio & Video Renditions for CrossLinks

Document Inbox Enhancements

Document Inbox Drag & Drop

Always Display the Document Inbox

Document Inbox Improvements

Updated UI for Add Renditions

PDF/A Document Rendition

Video Playback Speed Controller

Video Review: Bring Forward Annotations

Annotate Filters: Enhancements

Document Owner Can Undo Checkout for All Check Out Types

Enabled Field for Document Type Detail Object

Document Auto-Naming: Excluded Characters

Admin Field Layout Matches Doc Info

Template Search Enhancements

Increase to Maximum Source File Size for Videos

Show Document Number in Cart

Vault Objects

Rich Text Fields for Vault Objects

Related Document Section Filters

Prevent Document Add in Related Document Section

Web Sections for Object Page Layouts

Show in Tab for Related Document Section

Lifecycle & Workflow

Enablement Change: Atomic Security for Document Lifecycles

Object Lifecycle & Workflow: Long Text & Rich Text Fields

Object & Multi-Document Workflow: Replace Workflow Owner

Object & Multi-Document Workflow: Timeline View & Task Bar Enhancements

Object & Multi-Document Workflow: Capacity Without Requiring eSignature

Object & Multi-Document Workflow: Send Notification Based on Roles

Object & Multi-Document Workflow: Conditional Controls on Start Step

Object & Multi-Document Workflow: Reassignment Task Event in Update Sharing Settings

Multi-Document Workflow: Short Circuit Tasks

Multi-Document Workflow: Use Role as Participants

Multi-Document Workflow: Optional eSignature Manifesting on Documents

Multi-Document Workflow: Edit Document Fields

Object Lifecycle & Workflow Expression Enhancement

Inactivate Roles Used in Multi-Document Workflows

Reporting

Multi-Pass Reports Support Binders & Document Relationships

Enhanced Support for Rich Text & Long Text in Reports

Formula Fields in Document Reports

Column Sorting in Reports is Consistent with Library

Increase Maximum Number of Objects for Standard Report Type

Object Formula Field Enhancements for Reports

Improved Handling of Hyperlinks in Excel Exports

Additional Functions in Report Date Filters

Exports of Icon Fields in Reports Return Alternative Text

Auditing

Document ID in Document Audit Exports

Search

Expanded Search

Contains Operator for Advanced Filtering

Related Object Filter Updates

Checklists

Checklist: Ad Hoc Questions

Checklists: Updated Confirmation Banner & Send Confirmation Notification After Starting a Checklist

Auto Claims Linking

Auto Claims Linking: Display Match Text Variation in Info Card

Auto Claims Linking: Configurable Columns in Select Claims Dialog

Auto Claims Linking: Prevent Duplicate Records

Auto Claims Linking: Preview & Create Anchor from Claims

Vault File Manager

Upload Large Size Asset Renditions Using Vault File Manager

Track User, Machine & Vault File Manager Version

Administration

Enhancements to Document Name Inheritance

Templates: Hide Inactive Document Types

Rendition Status

Web Tab URL Tokens

Enhancements to API Limits

Job API Enhancements

Access Control

Enhanced User Profile Page

Flexible DAC Field Mapping

Role Permissions

Authentication & Security

Maximum Session Duration of 48 Hours