What's New in 20R2

Pre-Release Date: July 13, 2020 | Release Date: July 31 & August 7, 2020

We are pleased to bring you Vault 20R2. Read about the new features below. You can find information on enabling new features in 20R2 Release Impact Assessment. Information on developer features (API, VQL, etc.) is in the Developer Portal.

Working with Documents

Archived Document Security Enhancements

This release introduces big changes to the Archived Documents functionality. These changes ensure your documents are not edited in any way once archived.

New permissions for viewing archived documents

As of this release, users need a security profile with the new View Archive permission in order to see archived documents. Like before, users will also need to be in a document role that includes the View Document permission. To view the Archive tab, users must have the Tab: Archive and View Archive permissions. Users with the Manage Archive permission automatically have the View Archive permission.

Archived documents are not editable

Once documents enter the archive, Vault now prevents users from taking the following actions:

  • Editing fields
  • Adding or removing relationships
  • Adding or removing attachments
  • Adding or removing renditions
  • Deleting the document (without Power Delete permission)
  • Deleting document versions (without Power Delete permission)
  • Checking out
  • Starting a workflow
  • Executing a user action

Note that when Vaults are in document migration mode, Vault allows certain edits.

New user action to move documents in and out of the archive

Users with a security profile that grants the Manage Archive permission can now move documents into and out of the archive from an action in the document Actions menu.

Auto-Place Brought Forward Image Annotations

With this release, brought forward annotations on images and text can be automatically placed based on the page and coordinates in the source version. If the coordinates or page do not exist in the new version, Vault places the annotations at the page level.

Indicate When Annotations Hidden by Filters

When a user views a document with annotations that are hidden by Annotate filter settings or by the Hide button on the Info Card, Vault now displays an alert message to the user.

This message includes a count of the currently hidden annotations. This count is limited to 99, and updates whenever annotations are created, hidden, un-hidden or deleted. Learn more about Annotating Documents.

Shared Lookup Fields for Documents

Admins can now create Lookup type document fields as shared fields. It is also possible to convert existing lookup fields into shared fields. In order to share a lookup field with a document type, an Admin must ensure the Lookup Object Field is on the same document type or inherited from a parent document type.

XML Rendering

This feature provides the ability to generate a viewable rendition for XML files. XML files are rendered in text format and can be reviewed and annotated within Vault.

Document Migration Mode API Header

This feature introduces a new Document Migration permission. Users with a security profile that grants this permission can include a new document migration mode header in bulk API calls that would normally require enabling Migration Mode for the entire Vault, which can disrupt auto-matching processes such as EDL and Legal Hold.

Learn more about the Document Migration Mode API Header in the Vault Developer Portal release notes.

Move Merge Anchors to Create Anchor Tool

The Merge Anchors action now appears when users select the Create Anchor tool. With this change, we have also modified the required permissions. Users must now have:

  • Security Profile permission: Merge Anchors
  • Document Role permission: Annotate
  • Document Role permission: Create Anchors

In previous releases, Merge Anchors appeared when users selected the Link tool. To perform the action, users previously needed a document role that included Edit Relationships permission, but not Create Anchors permission.

Learn more about Merging Document Link Anchors.

Restore Resizing to Annotation Comments Field

The ability to manually resize the Comment field in Create Annotation and Edit Annotation dialogs was removed in a prior release. This feature restores that ability and makes minor improvements. Now, users can resize the Comment field vertically to make it taller or shorter. Users cannot resize the field to make it wider. When users resize the field, the entire dialog increases to accommodate the new field size. This allows the author to view significantly more entered text at once.

Unified Navigation Behavior when Clicking Object References in Document Fields

In previous releases, clicking on an object record in a document field would take the user to a custom tab, the business admin page, or to a standalone object details page, depending on the user’s access. This feature makes the behavior more consistent. With this release, Vault always takes the user to a standalone object detail page for the object record, even if the user has access to a custom tab or the Business Admin page.

Collaborative Authoring

Save Version to Vault Without Ending Collaboration Session

Users participating in a collaborative authoring session can now save the latest “Edit Version” to Vault without ending the collaborative authoring session for themselves or other users. The same file remains checked out to Microsoft Office 365, allowing collaborative editing to continue.

With this release, all users who are part of a collaborative authoring session now see Save to Vault as their primary button. In addition, the Check Out User, the document Owner, and Vault Owners can access a dropdown menu in the button, where they can either Save to Vault or Check In. Check In ends the collaboration session for all users. The Save to Vault and Check In actions are also available in the document action menu. Learn more about collaborative authoring.

Collaborative Authoring: Alert Box for Documents Being Edited

When a user views a document that is being edited by another user via Collaborative Authoring, Vault displays a message in the document viewer to indicate that what is displayed may not be the latest content. This message is dismissed when the user clicks within the viewer area.

Learn more about Using Collaborative Authoring with Microsoft Office.

Lifecycle & Workflow

Atomic Security for Documents: Lifecycle User Actions

With this release, Admins have more granular control, based on lifecycle state and role, over who can perform specific lifecycle user actions like changing document state and starting a workflow. For example, the Editor role may be able to start the Review workflow, but not the Expedited Approval workflow. Previously, access to start workflows or change a state was all or nothing: roles either had access to all workflows or all state changes, or had access to none.

Immediately upon enabling Atomic Security for Documents: Lifecycle User Actions, Vault performs the following migration actions:

  • For all configured user actions (previously controlled by Start Workflow and Change State permissions), Vault will set the State Behavior to Execute.
  • Vault will apply overrides to hide these actions for any role that did not include the controlling permission before enablement.
  • Vault will grant access to the new Multi-channel Actions permission for any roles which included Start Workflow permission.

Multi-Channel Actions Permission

In previous releases, access to certain Multichannel functionality was controlled by the Start Workflow permission. This feature introduces the new Multi-Channel Actions permission to control these actions:

  • Create Presentation
  • Send to CLM
  • Preview CLM

Atomic Security for Documents: Active Workflow Actions

With this release, Admins have more granular control over who can perform actions like Cancel Workflow, Add Participant, Reassign Task, and Cancel Task on an active workflow. Previously, access to these actions was granted at the permission set level and the Workflow Initiator had automatic access. Admins can now define access to each of these actions by document lifecycle state and document lifecycle role. For example, users in the Editor role may only be able to Cancel Task while a document is in certain lifecycle states.

When enabled, the Workflow Initiator / Workflow Owner no longer receives automatic access to these actions. Admins will need to ensure that users who start workflows are also in document lifecycle roles with access to manage their active workflows if this is needed.

Variables for Multi-Document & Object Workflows

This feature supports the creation of workflows with more branching options. Admins can define a variable (text, picklist, or yes/no) when configuring a workflow and then use the variable value as the basis for a decision step. For example, a workflow could prompt at the start for whether training is required. Based on the Workflow Initiator’s response, the workflow could follow a branch that includes a training task. Learn more in Configuring Multi-Document Workflows and Configuring Object Workflows.

Multi-Document Workflow: Execute Entry Action & Entry Criteria When Canceling Workflows or Removing Documents

When users cancel a multi-document workflow, Vault moves the content documents to the configured Cancel Workflow State. Your organization can configure this to be either the “state in which the workflow started”, a specific state in the document’s lifecycle, or no state change.

With this enhancement, Vault also executes entry actions and entry criteria for the cancel state. This change will help customers who would like to capture information like workflow cancellation date or reset values that were set during the workflow process.

Auto-Number Envelope Record for Multi-Document Workflow

With this feature, Admins can configure a multi-document workflow where Vault automatically generates a name for the Envelope record. The auto-naming can use any string and a token that generates a unique number, for example, Document Review – [######] would generate names like “Document Review – 000001” and “Document Review – 000002”.

When the workflow initiator starts the workflow, the system-generated envelope name will display in the start dialog as a read-only value.

Object & Multi-Document Workflows: Invoke Record Action via a System Action Step

This feature enables Admins to configure a System Action workflow step that invokes a Vault Java SDK Record Action as part of an Object Workflow or a Multi-document Workflow. When the workflow reaches the System Action step, Vault executes the custom Record Action logic. Learn more about using Record Actions in a System Action Step.

Additional Operators for Document Lifecycle State Entry Actions, User Actions & Entry Criteria

This feature adds new operators to help Admins configure conditional state entry actions, user actions, and entry criteria in document lifecycles. These operators are available for conditions based on Document Type, Subtype, or Classification:

  • The new is not equal to operator is available for conditions based on Document Type, Subtype, or Classification.
  • The new does not include operator is available for conditions based on Document Type, Subtype, or Classification, as well as all object reference fields.

Previously, with support for only is equal to and includes operators, Admins needed to list all Document Type, Subtype, or Classification rather than just the exceptions.

Vault File Manager

Configure Auto-Open Safelist for Vault File Manager

In past releases, when users checked out a document’s file to Vault File Manager, the file opened automatically when the download completed. Now, organizations can configure which file extensions will automatically open when download is complete by adding VFM File Security Policy object records. If there is not an object record for a file extension, instead of the file opening automatically, the Vault File Manager client displays to the user when the file download is complete.

Learn more about Configuring the Auto-Open Safelist for Vault File Manager.

Vault File Manager: Check In & Check Out Enhancements

With this release, Vault no longer opens new browser tabs when checking out to and in from Vault File Manager.

Vault Objects

Sharing Settings UI Enhancements for Objects

In this release, we’ve streamlined the object Sharing Settings UI.

Role assignments are now displayed in one single table, rather than multiple tables. This table includes an Access column which indicates how the role is assigned, such as custom sharing rules, matching sharing rules, or manual assignment.

In the updated page, users can search for role assignments assigned to a specific user or group. The results include both directly assigned roles and implicit assignments, such as group membership.

LongText Field Enhancements

In this release, we’ve enhanced LongText fields to provide a better Admin and user experience:

  • Vault Admins can now create LongText fields from the Objects > {Object} > Fields > Create Field page.
  • Users can edit LongText fields in a pop-up dialog on the object record details page, which provides them a larger area to edit large content.
  • Users can now export the entire content of LongText fields in an object tab.

Audit Captures Source Record ID in Copy

In past releases, Vault used the same Event Description in the audit trail when users created a new object record or copied an object record. Now, Vault uses separate descriptions for these actions. When users select the Copy Record action, the Event Description in the new record’s audit trail includes the source record’s name. Learn more about copying object records.

This feature allows users to change the object type of related object records using the Actions menu within related record sections on an object record details page.

This feature allows users to copy a related object record directly from the Actions menu within related record sections on an object record details page. Copy Record is available for all types of related lists except simple many-to-many related lists.

Full EDL Job Match

In this release, the Match EDL Items to Documents job is optimized to run more efficiently. As a result, the first time that Vault runs the Match EDL Items to Documents job after the release, every document in a customer’s Vault will be evaluated for matches against all active EDL Item records. It is possible that Vault will match or unmatch older EDL Items and documents because the Match EDL Items to Documents job has only been doing incremental updates prior to this release. After the job runs fully once, it will return to incremental updates. Learn more about the Match EDL Items to Documents job.

EDL Item Upload Visibility Update

In previous releases, there were some cases where a user only needed Read or Viewer permission on the EDL Item object to access the Upload action. With this release, Vault requires users to have Edit permission on the EDL Item object to access the Upload action on EDL Item records. The user must also be in an Editor role when sharing settings are enabled.

Link (link__sys) is a system field on all objects that is used for integrations, including Spark Messaging integrations. In past releases, this field allowed up to 1,500 characters. This release reduces the maximum field length to 255 characters.

Reporting

Or Filter Logic

This feature allows users to determine whether AND or OR logic should apply between two filters or prompts in reports. Users can also add parentheses to group certain filters together. To delete or modify filters, users must first remove the advanced logic.

Support Priority Multi-Document Workflow Fields in Reports

This feature adds support for the Task Verdict Comment and Task Verdict Reason fields for multi-document workflows in Workflow with Document reports. Additionally, Task Verdict Comments has been added as a default field to the Workflow History Report. Learn more about workflow fields.

Include Prompts with Filters in Report Builder

This feature adds prompts to the filter section of the report builder. Users can decide whether a filter should be determined at runtime by selecting a checkbox.

Searching & Filtering

Enhanced Document Number & ID Search

This feature enhances searching for documents by document number in two ways:

  • Partial document number searches: Searching for the beginning, middle, or end of a document number now gets a match. The search engine will detect document number patterns in a search automatically to find that document with more precision than before. For example, if a user is looking for VV-123-DEF, they can search VV-123-DEF, VV123DEF, VV123, 123DEF, or 123-DEF to find that document. If a user searches with the incorrect punctuation, such as 123_DEF, they will also find a match.
  • Multiple document numbers in Advanced Search: In Advanced Search, the Document Number field now supports multiple document numbers, making it easier to search for more than one specific document.

Learn more about Enhanced Document Number & ID Search.

Minimum Match Logic: Strict Matching

When searching documents or records with multiple search terms, strict matching will require most search terms to match. Results that only have one matching term will not be considered relevant. This will return a more precise set of search results and often reduce the number of results as the number of search terms increases. This feature is Auto-on but can be turned off with an Admin checkbox in Search Settings.

Learn more about Strict Matching.

Default Search Context

When users log in for the first time or navigate to a tab that is not searchable, such as Home or Dashboards, the search box context defaults to search All Documents. Admins can now specify any document or object tab as the default search.

Learn more about Configuring the Default Search Tab.

With this feature, Vault constrains object reference field values in filter value searches on object tabs. These filters now only return values that are included in a user’s search results for both document and object tabs.

This feature offers a CJK Optimized setting on Vaults with Chinese, Japanese, or Korean text in object record fields. When this setting is enabled by Veeva Product Support, Vault will split all CJK phrases into words on object record text fields when users search so that field values are easier to find.

Vault Formulas

Updates to Object Workflow & Lifecycle Formula UI

This feature updates the formula editor for object lifecycles and workflows. The formula editor is now consistent with the editor available when configuring objects.

Usability & UI Updates

Localize Vault to Hungarian

The Veeva Vault UI now supports Hungarian. Users can update the language Vault displays for them by changing the language settings on the User Profile page. Vault also supports setting Hungarian translations for labels in user-configurable data such as document types, fields, picklist values, and lifecycle names. Learn more about supported languages and localization settings.

Enablement Change: Localize Vault to Dutch

In past releases, the Veeva Vault UI supported Dutch for customers that requested it through Veeva Support. Now, Dutch is available automatically. Users can update the language Vault displays for them by changing the language settings on the User Profile page. Vault also supports setting Dutch translations for labels in user-configurable data such as document types, fields, picklist values, and lifecycle names. Learn more about supported languages and localization settings.

Administration

Inbound Component Dependency Validation

This feature enhances the Review & Deploy process for Configuration Migration packages by showing information regarding component relationships. In addition to component comparison information, Vault now provides component dependencies, identifying whether they are required and whether they exist in the inbound package or the target Vault. In case any steps are not ordered correctly for deployment, users will be able to reorder them prior to deployment. Learn more about Inbound Component Dependency Validation.

Document Migration Mode for Vault Loader

In Vault Loader, the Object Type Create action for Document Renditions, Document Versions, and Documents, Versions, Roles can now be used without placing the entire Vault in Migration Mode. In order to use this feature, the user must have the new Document Migration permission and enable the Document Migration Mode checkbox in the Vault Loader UI or use the -documentmigrationmode parameter in the Vault Loader Command Line tool. Learn more about Document Migration Mode.

Notification Preferences

With this release, notification preferences can be configured to help users manage emails coming from Vault. Admins can configure the following notification types:

  • Task Notifications
  • User Mentions
  • Send as Link
  • Shared Views

By default, Vault sends an email notification for every occurrence of user tasks, user mentions, and send as link, and does not send notifications for shared views. If a notification type is set to Summary, messages of this type will be held until the next scheduled email. Vault will collate summary notifications together and send them as a single email. Vault sends Shared View-type notifications when a user shares a search view. Learn more about email & messages.

Spark Integration Rules UI

With this release, Admins can now configure Spark Messaging integration rules in the Vault UI. Previously, integration rule configuration was only available through MDL. With this feature, Admins can configure integrations much more quickly and easily.

Re-establish Vault to Vault Connections

Spark Vault to Vault Connections require two Vaults with configured and approved connections. If one or both of these Vaults are a sandbox Vault and you refresh the sandbox, the connection will break. Prior to 20R1.2, reconnecting a broken connection is only possible by completely reconfiguring the connections from scratch, including all integration-related components such as Integrations, Integration Points, and Integration Rules.

This feature allows you to break the connections by setting one of the connections to Pending using the new Make Connection Pending user action on the connection. From there, you can download a new connection file to reconnect and approve the connection without needing to recreate any interaction-related components.

This feature is available for both custom and standard connections.

Improvements for Long Running Jobs

Vault now clears out jobs that are stuck and do not make progress for three (3) days. Prior to this release, job instances would remain stalled in a Running state for 14 days before getting cleared out.

Custom Job Processors with the Vault Java SDK

In this release, the Vault Java SDK now provides the ability to create custom job processors. After creating a custom job processor and deploying it to your Vault, SDK Job will appear as a selectable Type when creating a new job definition from Admin > Operations > Job Definitions. In addition, Vault extensions such as triggers or actions can execute job processors without a job definition.

VPK Deployment Order Dependency & Validation

This feature introduces a new Validate feature at the Inbound Package level that allows the Admin to determine if an Inbound Package has any dependencies that are blocking the deployment of the package. The Admin will be able to download a validation log that contains all component dependency information, including whether they are required and whether they exist in the package or in the target Vault.

Domain Users: Add Vaults in CSV Export

When a Domain Admin filters on All Users or Current Domain on the Domain Users page and exports the list of users to CSV, the exported file now includes a list of Vaults to which each user is assigned. Learn more about the Domain Users page.

State Change Job Improvements

State change jobs on documents are enhanced to handle cases where there is an active workflow on the latest version of a document, and a prior Steady State document needs to change state. For example, expiring an Effective document when a newer draft is In Review. With this change, the workflow can continue on the newer version after the state change is executed on the prior version.

Default Profile Image for System User

System-owned Users such as System and Application Owner now appear with the Veeva “V” logo as a user image throughout Vault. This image will also appear in notification summary emails where a notification was sent from a System-owned User.

Rename Permission for Mobile Applications

With this release, the Enable App Store Configuration permission is relabeled to Enable Direct Installation. The new label and associated help text better reflect the behavior of this permission for Vault mobile applications. Learn more about permission sets.

Authentication & Security

Separate SAML SSO Configuration for Login & eSignature

Vault now supports a new type of SAML profile, eSignature Profile, specifically for electronically signing documents and object records via SAML. As part of this feature, we also renamed SAML Profiles to Single Sign-on Profiles. Using eSignature Profile is optional: if not configured, Single Sign-on Profile is used for both SSO login and eSignatures. One Single Sign-on Profile and one eSignature Profile can be associated with a Security Policy. Learn more about Configuring SAML Profiles.

Allow Inclusion of KeyInfo in SAML Requests

With this feature, SAML Profiles allow inclusion of the KeyInfo element in SAML Requests. Inclusion of KeyInfo will be required when the Vault certificate is rolled over later this year. This feature provides for testing time to ensure the customers’ Identity Provider solutions are properly configured to support the new certificate when it is released.

Auditing

Individual Audit Filters

In previous releases, individual audit trails only supported filtering by date, while admin audits supported filtering by date, event and user. With this release, users can now apply event and user filters to individual document and object audit trails. This feature allows users to more easily find specific activity of interest within individual audit trails. Learn more about filtering on individual audit trails.

Display Page X of Y & Datetime in PDF Audit Exports

This feature improves audit exports to PDF by including the total page count on each page and adding the audit name as well as the Vault name to each page. Additionally, the date currently provided on each page of a document audit trail export is now a datetime to provide more detail. These changes to PDF audit exports make them more consistent with PDF report exports. Learn more about audit exports.

Platform Data Model Changes

See 20R2 Data Model Changes: Platform.

Clinical Operations

Archive TMF

Archive TMF User Action & Snapshot

This feature introduces a user action to archive a study, its documents, and its related records in a single automated job. The Initiate Study Archival action moves study documents into the Vault platform archive, moves the study, its countries, and its sites into the Archived lifecycle state, and inactivates related records such as EDLs, Milestones, and CTMS objects. For documents used across multiple studies, the action creates a study-specific copy, or snapshot, of the document and archives that copy. Learn more about archiving studies with lifecycles.

This feature ensures that CrossLink documents are protected from further changes when a study is archived. At the moment of archival, the system automatically creates snapshots of all CrossLink documents to ensure their immutability, while allowing the original CrossLink documents to live on for future use.

Archive TMF Security

This feature enables study team assignments and new document upload for archived studies. Access to the newly available capabilities for archived studies is controlled by the Manage Archive permission. Learn more about managing archived studies.

RBSM: Clinical Risk Assessments

This feature allows users to curate a library of selectable risks, create re-usable risk assessment templates, and generate study-specific risk assessments. By tracking impact, probability, and detectability on study-specific risks, along with an overall risk score on the study-specific risk assessment, users can understand specific areas of risk and how this study compares to the risk of other studies. Learn more about Risk Based Study Management.

Site Connect: Site Packages

With this feature, Site Connect users can create custom regulatory document packages to be sent to Study Sites using SiteVault. SiteVault users will receive documents and document requests. Learn more about Vault Site Connect.

Simple TMF Transfer

Simple Transfer provides users with the ability to transfer a set of study documents from the CRO to the Sponsor without requiring an extensive mapping operation. After establishing a connection between the two Vaults, the CRO can elect a study for transfer and send the approved TMF Reference Model 3.0 documents, the Study Country records, and the Study Site records to the Sponsor. Vault creates the documents as TMF Documents, a special new document type that decreases the amount of mapping required. Study Country and Study Site records are created without normal requirements. Learn more about Simple TMF Transfer.

EDL Automation for Study Personnel, Organizations & Products

This feature allows users to apply EDL Item Templates to specific roles for a Study Person, Study Organization, and Study Product in a given study. Vault automatically creates EDL Items that match on a Person, Organization, or Product when those are added to a study, and it links the new EDL Items to open milestones based on template configuration. This feature is available for configuration in Vaults with the Clinical EDL Template Refactor and Person & Organization Migration features enabled. Learn more about working with EDLs.

Investigator Initiated Studies in Vault Clinical Operations

This feature allows users to track the internal processes of Investigator Initiated Studies, including proposal review and approval, study planning and execution, publication tracking, and document tracking. Learn more about Investigator Initiated Studies.

Milestone Evolution & Standard Metrics

With this feature, Veeva has defined industry-standard Global Milestone Types, and Global Milestone Offsets to measure key cycle times between milestones. Users can map custom milestone types to these standards and Vault calculates Cycle Times between completed milestones on a daily basis and recalculates Cycle Times to support historical data. This feature is available for Admin configuration in Study Startup Vaults. Learn more about Global Milestone Types and Cycle Times.

Payments: Generate Payable Items User Action

In previous releases, Vault only generated payable items when Subject Visits, Procedures, or Site Fees were updated. Vault now allows users to generate payable items for activities performed before a fee schedule was approved. Your organization’s Admins can configure this user action for the Study, Study Country, and Study Site objects or include it in workflows. Learn more about manually generating Payable Items.

Pre-Save Field Defaulting

This feature improves defaulting behavior for document metadata field values populated by Vault based on values in other fields. Previously, the controlled field did not update until after saving. Now, the controlled field values update dynamically to reflect changes to the controlling field in real-time while the user is editing.

Rule Set Override

Rule Set Overrides allow users to constrain the set of documents transferred when an Agreement is made active. For example, the CRO may want to only send documents to the sponsor where the QA Check Completed field is set to Yes. Rule Overrides can be used to apply these constraints to any documents and records sent to the receiving Vault. Learn more about Rule Overrides.

Yuzu: CTN Enhancements

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

  • CTN Site IP Name is now selectable from a list on Study Country records
  • Improved error handling for XML validation
  • User action to trigger the Change Log job immediately
  • JIS Level 1 and 2 character sets validation for CTN data
  • Format improvements for generated documents

Learn more about Clinical Trial Notifications.

Organization Document Reuse Update

This feature updates the document reuse functionality for Organization Profile documents to leverage the Organization document field rather than the Contributor’s Organization document field.

Vault Clinical Docs Update

This feature adds new artifact records to the Vault Clinical Docs Model so that users can map certain document types with more granularity.

Clinical Data Model Changes

See 20R2 Data Model Changes: Clinical Operations.

Commercial

Standard Metrics Fields Now Required

Standard Metrics was turned on for all PromoMats Vaults in 20R1 with three user input fields: Global Content Type, Content Creation Currency, and Content Creation Cost. With the 20R2 release, these fields are now required on all documents. Four new currencies have been added to the Content Creation Currency field: Swiss Franc, Canadian Dollars, Chinese Yuan, and Australian Dollars. Standard Metrics fields cannot be hidden, but can be configured with default values.

For more information, visit the Vault PromoMats Standard Metrics resource center.

Unified Medical Inquiry Case Intake Form

This feature introduces a single, unified form for the intake of medical inquiries in MedComms. This allows the user to enter details of the Case, Case Request and, if required, Case Response in one place, simplifying the data entry process and reducing the time it takes to create a medical inquiry. Learn more about the Case Intake Form.

When a user performs the Suggest Links action, and a Claim or Match Text Variation matches the content exactly (without wildcards), Vault bypasses the Review & Approve step and creates a pre-approved link annotation known as an Auto Link. By comparison, when a user manually Accepts a Suggested Link, the result is known as an Approved Link. Once created, Auto Links can be removed in bulk by the Remove Suggested Links button, which removes both Suggested Links and Auto Links (but not Approved Links). Users can also delete their own Auto Links manually.

To opt out of Auto Linking, contact Veeva Support. Learn more about Auto Links.

Auto Claims Linking: Manually Target Claims

When enabled, this feature allows users to select an Approved Claim when manually creating link annotations on documents with non-text content if the Suggest Links action is enabled for the document type. Selecting a Claim record results in a Claim Link: a manually created link annotation with non-editable links to the references defined in the selected Claim.

After selecting the link tool, users with permission see a link type selector in the toolbar. When the user selects Claims, then selects image or text content, Vault opens the record picker dialog containing all Approved Claims that match the document’s matching field values that the user has permission to view.

This enhancement allows users to leverage the approved Claims Library when manually referencing content, including creating links to approved references on images and pseudo-text, which cannot be linked by the Suggest Links action. Claim links are not available in Video Annotations. Learn more about manually adding claim links.

This feature provides greater focus and efficiency when reviewing references by allowing users to control the visibility of manual and auto links on a document. Manual Links include standard, manually created link annotations, as well as Claim Links. Auto Links include both Approved Links and Auto Links (if enabled). The new Manual Links and Auto Links filters replace the existing Links filter, and do not impact the visibility of pending Suggested Links, which are filtered separately. Manual Links, Auto Links and Suggested Links filters are only visible in Vaults with Suggest Links enabled. Learn more about filtering by link type.

Auto Claims Linking: Display Claims in Document Fields

With this feature, Vault now displays a list of Claim records in the Document Fields panel of the Doc Info page to indicate which Claims have been used to generate Suggested Links and Approved Links on a document. This new field appears on document versions where Suggested Links or Approved Links exist. Each Claim is also a clickable link to the Claim record. A Claim is removed from the list if all Suggested Links and Approved Links created from that Claim have been rejected, removed, or deleted.

This field helps users to better discover relationships between Claims and documents and enables reporting on documents with references created from specific Claim records.

Vault now displays a link to the related Claim record in the Annotation Info card for Suggested Links and Link Annotations created by accepting a Suggested Link. This provides valuable context to reviewers and helps users when troubleshooting results of the Suggest Links action.

This feature allows users with permission to preview and remove references from the References component by granting Preview: Execute and Remove: Execute permissions on Link Target: Object Action Permissions for all Standard Admin permission sets, including Business Administrator Actions, System Administrator Actions and Vault Owner Actions.

When the Suggest Links action is initiated, Vault displays a Generating suggested links… message. Vault now updates this message to notify the user when the action is completed successfully, or fails, or when the Suggest Links action takes longer than three (3) minutes. This timeout period was incorrectly identified as 60 seconds in a previous version of these release notes.

China CDN Replication Support

With this feature, Admins can configure which CRM Engage and CLM content for Chinese customers will be replicated to a China-hosted CDN, improving load times and overall performance. This Vault configuration will be used by a future CRM release.

Vault Digital Publishing Security Update

This feature enhances Vault Digital Publishing configuration to prevent inappropriate configurations and provide configuration validation. When configuring digital publishing, an additional step is required to ensure appropriate access to the S3 buckets that are in use. The feature is on automatically, and existing Vaults with Digital Publishing in a working state do not need to make configuration changes unless any of the CloudFront or S3 configuration is changed. Learn more about configuring Vault Digital Publishing.

Commercial Data Model Changes

See 20R2 Data Model Changes: Commercial.

Quality

E-Learning Technology Standards Support

Many organizations include e-learning content in their training implementations. This format of training content can be dynamic, engaging, and easier for learners to absorb than other formats.

With this Vault Training release, we have introduced support for the e-learning technology standards AICC and SCORM. Content published in AICC or SCORM can be uploaded into a Vault, just like any other document. Once uploaded into the Vault, training admins can associate the content to a Training Requirement as part of a training matrix.

As the Learner, a user can interact with the course while Vault captures course data to facilitate completion of the associated Training Assignment. If the Learner’s interactions with the e-learning material meets the AICC or SCORM completion criteria, the Learner can then complete the Training Assignment. Learn more about setting up e-learning content support.

Substitute Training

This feature enables Vault Training to assign an alternative, or substitute, Training Assignment to a Learner in place of a required Training Assignment using Training Admin-defined substitution rules. For example, suppose a Learner that speaks a locale-specific language is required to fulfill a Code of Conduct training requirement. A Training Admin can define a substitution rule such that the Learner is automatically assigned a substitute Training Assignment based on the Learner’s locale, Department, or Facility. When the Learner completes the substitute Training Assignment, the Learner automatically gets completion credit for the required Training Assignment.

The feature allows for the following:

  • Training Admins can mark a Training Requirement as a substitute. A Training Requirement marked in this way cannot be added to a Curriculum or have other attributes configured.
  • Training Admins can define Substitute Rules for a Training Requirement. Rules include duration, as in how long the rule is valid for, and conditions, which are based on Person, Learner Role, or Curriculum fields.
  • The Vault Training application will determine, via the nightly job and on the fly evaluation, the appropriate Training Assignment for the Learner based on the Training Requirement and its Substitute Rule definitions.

Learn more about Substitute Training Requirements.

Facilitated Training

This feature enables a Training Admin, or a user with proper access, to give completion credit for Training Assignments on behalf of Learners. This allows completion of Training Assignments for Learners that may not have access to Vault. For example, in some organizations, users could be contractors, external employees, temporary employees, or otherwise outside the primary organization.

The Facilitated Training feature allows organizations to have Learners that do not reference a user account. Vault Training automation still issues Training Assignments, but does not assign a workflow task. After training is held, a Training Admin can create a Facilitated Training Request record and select the Training Assignments for which to give completion credit. After completing the Facilitated Training Request process, the linked Training Assignments are moved to the Completed state. Learn more about Facilitated Training.

Training Nightly Job Performance & Robustness Improvements

This feature improves the performance and robustness of the Update Training Assignments job which drives Vault Training automation. In addition to internal improvements, the job can now more gracefully handle issues encountered while processing Training Assignments. In previous releases, the job would stop upon encountering an issue on one training path. With this release, the job now continues to issue Training Assignment records even if an issue is encountered, skipping paths which have issues. Learn more about Vault Training automation.

Power Delete Action for the Training Assignment Object

During Vault Training configuration and testing you may need to delete a Training Assignment record and all of its related records, such as Class Schedules, Quizzes, and others. By default, you must delete each record individually.

With this release, we have introduced the Power Delete Training Assignment Records record action, which completely deletes a Training Assignment record and its related records. Learn more about Vault Training configuration.

Assignment Details Lifecycle State No Longer Updated

To improve accurate reporting and searching, the Assignment Details lifecycle state is no longer updated. In previous releases, the Assignment Details lifecycle state changed when the Training Assignment entered the Assigned, Completed, or Cancelled states.

With this release, there is now a lookup field on Assignment Details records that references the parent Training Assignment record’s lifecycle state. This provides a real-time indication of the Training Assignment lifecycle state. This change also improves the performance of the Update Training Assignment job by negating the need to change the Assignment Details lifecycle state.

Note that if there are reports, filters, or views that use Assignment Detail lifecycle state, customers should update those items to instead use the Training Assignment Lifecycle State lookup field. The Assignment Details lifecycle state is no longer in sync with the Training Assignment’s lifecycle state. Learn more about Training Assignments and Assignment Details.

Classroom Training: Usability Enhancements

With this release, Classroom Training Assignments now have an associated auto-start workflow called View Classroom Training Assignment that provides easy access to the Classroom Training Assignment record for Learners. Once an Admin activates the View Classroom Training Assignment workflow, it is automatically started when a Classroom Training Assignment enters the Assigned state. Other enhancements to Classroom Training include:

  • In previous releases, when a Learner opened a Classroom Training Assignment record that was not yet part of a Class Roster, the Learner would see the object details page. With this release, the Learner now sees a task page.
  • When an Instructor changes a Classroom Training Assignment record’s state to Completed, the open Training Assignment workflow is automatically canceled with a configurable entry action.

Training Assignment Lifecycle User Actions

With this release, Admins can now edit user actions on the Training Assignment Lifecycle. This feature is only intended to support the Download Formatted Output user action. Avoid configuring other actions to this lifecycle, such as the Change State to or Start Workflow user actions, as this may cause issues, such as duplicate Training Assignments or preventing the completion of active Training Assignments. Learn more about configuring Vault Training.

Updated Training Requirement Document Picker Dialog

The dialog box when selecting documents in a Training Requirement or Training Requirement Impact Assessment has been updated to match the checkbox-style document picker introduced in the 20R1 Vault release.

With this release, Admins can now configure Quality Event records or CAPA Action Item records to automate the creation and processing of Effectiveness Check records upon entering a configurable lifecycle state.

The Create Effectiveness Check record entry action is available for the Quality Event and CAPA Action Item object lifecycles. Configuration options for the action allow you to define the type of Effectiveness Check record to create (if applicable), and which field on the Effectiveness Check record to populate, linking the new record to the triggering process.

To take full advantage of this feature, you can model configurations to fully automate the business process around completing changes or actions within the QMS.

For example, you can configure the following process based on the Require Effectiveness Check field on the Quality Event or CAPA Action Item:

  • Automatically create the Effectiveness Check record.
  • Set the Effectiveness Check record’s fields based on values from the parent-process record, such as setting Effectiveness Check Due Date and Effectiveness Check Start Date based on Action Completed Date + 120/90 days, respectively.
  • Assign an automated workflow task to describe the effectiveness check details. Use Record Event Actions to prompt responsible parties to describe details of the effectiveness check to take place in the future.
  • Using Vault’s jobs framework to automate the start of the effectiveness check workflow for that change or action at the chosen time in the future.

This feature is recommended to be used with Quality Teams feature to guarantee access for the correct users on the automatically created record. It can also be configured to use security features such as Dynamic Access Control’s Matching or Sharing rules. Learn more about configuring the Create Effectiveness Check entry action.

Risk Management: Detectability Support for Qualitative & Quantitative Risk Matrices

With this release, users of Vault Quality Risk Management features can now model the likelihood of detecting a risk should it be realized, and use that likelihood to calculate both quantitative and qualitative risk levels for risk events. Admins can now opt-in to add Detectability to Risk Matrices.

The new Detectability object and its associated fields behave similarly to Severity and Occurrence. Included with the new object and matrix support, we’ve introduced new standard fields to the Risk Event object to capture Detectability before and after mitigation actions have been taken. Combined, these new components enable automatic updates to Risk Matrix Setup rows in a Risk Matrix, and interacting with Risk Level on Risk Events.

Customers with existing Quality Risk Management configurations will need to make configuration changes to take advantage of Detectability in risk related activities. Depending on your business needs, you can either update existing risk matrices to include Detectability or include it in newly created risk matrices, add the Detectability fields to Risk Event, and update risk level calculations to include Detectability scores for quantitative risk scoring models. Learn more about QMS Risk Management.

QRM: Process FMEA Assessment Methodology Support

This enhancement to Vault Quality’s Risk Management (QRM) feature suite introduces the ability to model Process FMEA (pFMEA) risk assessments within your Vault. These are separate from Risk Registers, but function similarly, so if users are already familiar with Risk Registers within QRM, the details of this new feature set will be easy to learn.

Organizations can now create pFMEA risk assessment records to model risk assessments of processes within the business. Processes require a set of steps to be identified, such that the events within a pFMEA assessment are tied to individual steps, supporting a procedural approach to risk identification, analysis and mitigation. FMEA Risk Assessments contain FMEA Risk Events which represent unique combinations of failure mode, effect, cause and control within a step of a process. Users can tag specific FMEA Risk Events with more general Risk Categories for trending and reporting. These FMEA Risk Events are scored with pre- and post-assessment fields to capture Severity, probability of Occurrence, and Detectability scores, combined in an overall Risk Priority Number for the event. FMEA Risk Assessments make use of the existing Risk Matrix, Risk Matrix Setup and Risk Level functions of Vault QRM to model the qualitative and quantitative scoring systems for your organization’s assessments. For details on the new data model elements introduced with pFMEA support, see the Quality Data Model Updates section of these release notes.

In addition to modeling your pFMEA Risk Assessments, events and process steps, this new feature set introduces the ability to duplicate a completed or in progress FMEA assessment. This action allows users to re-assess a process without changing your original assessment. This FMEA Assessment-specific action clones the Assessment, Step, Risk Event and Mitigation Action Set records and their field data into a new set of records, then restarts the lifecycles for those records. Copying the records and their field values allows for a clean re-assessment, including the removal or addition of new Risk Events in the new assessment. In this release, the copy action will not duplicate inbound relationships for any of the records copied. However, records copied in this way will maintain a reference to the record they were copied from, allowing for traceability of assessments in the system. Note that this functionality assumes the process itself has not changed between assessments. For processes which have had their steps changed, we recommend creating a new FMEA assessment to account for accurate modeling of Risk Events against process steps.

For existing QMS customers, this new feature set will require configuration by an Admin.

Lastly, based on feedback from our customers, this feature also introduces the ability for QRM Risk Matrices and their component configurations to be cloned between environments for easier deployment and sandboxing. Learn more about Process FMEA Risk Assessments.

Enablement Change: QMS to Registrations Spark Connection

Enablement of the QMS to Registrations Spark Connection for Change Control & Variation Management no longer requires a Support request to activate. Use of this feature still requires configuration. Learn more about the QMS to Registrations Spark Connection.

Synchronize MDCC & Document States

With this feature, when a Multi-Document Change Control (MDCC) moves through its lifecycle, the state of the documents to be released can be synchronized with the state of the MDCC itself. State-based document controls can then be used to ensure the appropriate permissions and controls are in place.

For example, when an MDCC is routed through an approval workflow, if document states do not change until the approval process is complete, it may result in issues like new drafts being created after the documents have been routed for approval. Configuring your Vault to synchronize document states with the MDCC can alleviate this problem, as state-based document controls can prevent actions, such as creating drafts, which could affect the documents while they are in the approval process. Learn more about configuring Multi-Document Change Control.

Include Purpose for eSignatures Cascaded from MDCCs to Documents

This feature allows adding purposes when cascading eSignatures from Document Change Controls to Documents to be made Effective and Obsolete. On the signatures page with a new token for purposes, users will now be able to differentiate between eSignatures for release and eSignatures for obsolescence. This ensures that if a user approves the release of a document, then later approves the obsolescence of that same version, this activity is recorded as two separate signatures.

Admins can set purpose values in the workflow steps for cascading eSignatures system actions, and include the signature purpose token in the eSignature template. Once the values are set, the purposes are also manifested in the document’s audit trail. If an Admin does not set purpose values in the workflow steps, all behaviors remain as-is. Learn more about cascading eSignatures.

Auto-Close Completed MDCCs

With this feature, customers can configure a new document lifecycle state entry action in their Vault to automatically transition Multi-Document Change Control (MDCC) records to a closed state when all documents in the MDCC have been released or obsolesced. This automation can lower the amount of manual work involved in monitoring and closing MDCC records. Learn more about configuring Multi-Document Change Control.

MDCC: Banner Visibility Update

When a document is governed by a Multi-Document Change Control (MDCC), Vault displays a banner stating which Document Change Control record the document is currently governed under. With this release, Vault displays the banner to users with at least one of the Edit Document, Edit Fields, Annotate, or Version permissions. The banner is no longer displayed to users with only the Change State or Start Workflow permissions and none of the other four permissions.

Quality Data Model Changes

See 20R2 Data Model Changes: Quality.

Station Manager

Custom URL & QR Code Support

With this feature, customers can generate custom Station Manager URLs for documents. When a manufacturing operator opens these custom URLs on their tablet device by scanning a QR code, for example, it opens the target document in the Station Manager mobile app. This enables customers to create shortcuts for operators to quickly navigate to the right documents for their current task. This feature is available on both platforms:

Custom URL & QR Code Support on iOS

Custom URL & QR Code Support on Android

Release to Google Play

Station Manager for Android is now available for installation from Google Play.

Enforce Client Permissions on Android

Station Manager for Android enforces specific permissions granted to a shared account used to login to the mobile app. This enables customers to tightly control the usage of the app within their organization. For example, by enforcing that a shared account cannot be used to login unless the app is installed via an Enterprise Mobility Management solution.

Customers often embed links to QualityDocs documents within the content of other QualityDocs documents. With this feature, tapping an embedded link on Station Manager opens the target document directly within the app if the target document is downloaded to the device. This feature is available on both platforms:

Regulatory

Submission Join Filters

Users now have the option to filter which submissions to display in the Submissions Archive Viewer based on the submission’s related records. For example, users can filter to see only the submissions related to one or more clinical studies based on the Submission Clinical Study records.

Admins can enable this feature on the Application Settings page. Note that enabling this feature will deactivate and remove any metadata that was mapped at the time the submission was imported. Learn more about filtering on submission join records and configuring submission join filters.

Submissions Archive Reimport

Users have a new option to reimport a submission dossier that was previously submitted. Users can select the Reimport action to remove the original dossier and import the updated dossier in a single step. Admins must grant users the correct permissions in order to see this action.

This action is only available through the Vault user interface and does not impact submission imports through the API. Learn more about reimporting submissions.

Submission Import with Vault File Manager

This feature allows users in Submissions Archive Vaults to upload and import submission dossiers directly from Vault File Manager. Uploading with Vault File Manager simplifies the submission import process by eliminating the need to stage files on FTP or prepare ZIP files for import. Vault File Manager also allows users to upload and import ZIP files larger than 4 GB.

Users with the appropriate permissions can start the import process from a Submission record in Vault and select the Vault File Manager option in the Import Submission dialog. After selecting this option, Vault File Manager opens. In Vault File Manager, the user can upload the submission folder or ZIP/TAR.GZ file and track the upload progress. After the upload is complete, Vault automatically queues the files for import to the Submission record in Vault. Learn more about importing submission content with Vault File Manager.

Submissions Archive Switzerland (CH) 1.5 Support

With this release, RIM Submissions Archive Vaults support importing and viewing Switzerland 1.5 DTD submissions.

Expand Content Plan Section to View Descendant Records in Viewer

With this release, a new Expand action is available on Content Plan records in the Content Plan Hierarchy Viewer. This action allows users to expand and view all descendant Content Plan and Content Plan Item records within a content plan section at once, up to the 2,000-record limit. Selecting this action will not expand matched documents in the Hierarchy Viewer. Users will need to expand Content Plan Item records manually to see matched documents.

The Expand action is automatically available for users whose permission sets include the All Object Actions: Execute permission on the Content Plan object. Admins will have to add the Expand: Execute object action permission on the Content Plan object to make this action available to other users.

Matched Document Version Locking Entry Criteria

A new Matched Documents are Version Locked entry criteria option is available for Admin configuration on the Content Plan Item object lifecycle. This entry criteria requires that all documents matched to a Content Plan Item record are locked to a Steady state version. Configuring this will help prevent content plans from progressing to a final state when matched documents are not version locked and ensure that content plans contain the correct document version. Learn more about managing content plans with a lifecycle.

Copy Content Plan with Constraints

With this release, Admins can choose whether or not Vault respects the target application and submission’s Content Plan Template Constraints when users copy a content plan. When configuring the Copy Content Plan system action, Admins can set the Ignore Content Plan Template Constraints checkbox to allow Vault to create a copy of a content plan without applying Content Plan Template Constraints. Admins can leave this checkbox blank to apply constraints to the new content plan.

When the Ignore Content Plan Template Constraints checkbox is set, Vault creates sections in the new content plan if the target submission contains Submission join records that don’t exist in the source submission. Learn more about configuring the Copy Content Plan system action.

Start Multi-Document Workflow from the Content Plan Hierarchy Viewer

Users can now start a multi-document workflow from the new Content Plan Hierarchy Viewer introduced in 20R1 to send matched documents for review or approval in bulk. In the Content Plan Hierarchy Viewer, users can drill down into a section and apply filters to more specifically target which documents to include in the workflow. Learn more about starting multi-document workflows from the Content Plan Hierarchy Viewer.

The Start Multi-document Workflow action is automatically available on Vaults with the 20R1 Content Plan Hierarchy Viewer enabled. Users can only see the action in Vaults that have at least one active multi-document workflow configured and that have at least one Content Plan Item record or matched document available in the Content Plan Hierarchy Viewer. Contact Veeva Support to enable the Content Plan Hierarchy Viewer in your Vault.

Additional Content Plan Hierarchy Viewer UI Enhancements

This release includes several minor improvements to the Content Plan Hierarchy Viewer UI:

  • Matched document rows now include a gray document icon (Matched Document Icon) to help users more easily differentiate them from Content Plan and Content Plan Item records.
  • When users have active content plan workflow tasks, the task banner now displays below the root Content Plan record name.
  • Users can select additional document fields to display as Matched Document columns, including standard RIM fields and custom fields.

Enablement Change: Content Plan Hierarchy Viewer

This release introduces an enablement change for the Content Plan Hierarchy Viewer. In 20R1, an organization needed to contact Veeva Support to request this feature. Now, this updated Hierarchy Viewer is available automatically on any Vaults that do not contain existing Content Plan records. On Vaults that contain Content Plan records already, an Admin can enable this feature from the Settings > Application Settings page.

Copy Content Plan Update

In past releases, when users copied a content plan, Vault incorrectly applied source Content Plan Template Constraints to the target content plan. With this release, we’ve corrected the behavior. Now, Vault does not apply the source content plan’s Content Plan Template Constraints and when copying a content plan.

Merge PDF Error Handling

This enhancement provides additional details in the Vault notification message when Vault encounters errors while merging content as part of report level content plan publishing. The CSV file in the notification message now includes a user-friendly message for each document that encounters errors. Any errors, such as encrypted files, files in XFA format, or files exceeding a page limit, cause the PDF merge to fail.

This feature also introduces a new Exclude from Post Processing on Failure checkbox field on the Publishing Validation Criteria object. Admins can choose to set this field on Publishing Validation Criteria records to prevent documents that encounter this error from merging. Learn more about merging published documents into a PDF.

This feature, when configured for a submission, allows documents to be auto-matched to Content Plan Item records of submissions within the same application. This option removes the need for users to manually match documents in cases when they need to reference previously matched documents. Learn more about configuring a submission to allow auto-matching of previously matched documents.

Archived Document Security in RIM Submissions

We made several enhancements to existing features to account for archived documents and binders:

  • When a binder that was created from a content plan is archived, Vault prevents the user from up-versioning the archived binder and sends the user a Vault notification.
  • When a Submission Ready binder that was created as part of report level content plan publishing is archived, Vault prevents the user from up-versioning the archived binder and sends the user a Vault notification.
  • If a Content Plan Item Template references an archived document and a user tries to create a document or Table of Contents from the template for a Content Plan Item record, Vault prevents document creation and sends the user a Vault notification.

GCC eCTD DTD 1.1 Publishing & Validation

With this release, RIM Submissions Publishing Vaults support the GCC v1.5 (DTD 1.1) specification. Users can now create content plans and generate submissions that are compliant with GCC v1.5 specifications. Vault validates these submissions based on the corresponding GCC v1.4 Validation Criteria. Learn more about working with GCC regulatory submissions.

South Africa eCTD DTD 2.1 Publishing & Validation

With this release, RIM Publishing Vaults support the South Africa v3.0 (DTD 2.1) specification. Users can now create content plans and generate submissions that are compliant with South Africa v3.0 specifications. Vault validates these submissions based on the corresponding South Africa v2.1 Validation Criteria. Learn more about working with South African regulatory submissions.

Switzerland eCTD DTD 1.5 Publishing & Validation

With this release, RIM Publishing Vaults support the Switzerland 1.5 (DTD 1.5) specification. Users can now create content plans and generate submissions that are compliant with Switzerland v 1.5 specifications. Vault validates these submissions based on the corresponding Switzerland v1.5 Validation Criteria. Learn more about working with Swiss regulatory submissions.

Thailand eCTD DTD 1.0 Publishing & Validation

With this release, RIM Publishing Vaults support the Thailand v1.0 (DTD 1.0) specification. Users can now create content plans and generate submissions that are compliant with Thailand v1.0 specifications. Vault validates these submissions based on the corresponding Thailand v1.0/01 Validation Criteria. Learn more about working with Thai regulatory submissions.

Registration History View

This feature allows users to extract audit trail data for registrations and registered details, grouped by the regulatory objective that originated the change. Vault exports the Registration History Report to Microsoft Excel™. Users can extract a report for a set of Registration records across a specific date range or for a single Registration’s entire history. This report supports health authority reporting requirements, such as a history of changes to registration data required for Pharmacovigilance Master File (PSMF) maintenance. Learn more about generating the Registration History Report.

Verification of Registration Data

This feature allows Admins to configure a workflow to run at the end of the update process for registration and registered detail data. This optional enhancement to the Manage Registered Details process starts a workflow to allow users to review proposed changes before Vault commits the updates to existing object records or creates new records. Vault sends data verification tasks to users in Admin-defined roles to allow for a multi-user review of any changes to the data. Once the reviewers confirm changes in accordance with the workflow, Vault updates the registration and registered detail records. Learn more about the verification workflow for registration data.

Enhancements to Manage Registered Details

This feature includes several enhancements to the user interface and navigation in the Manage Registered Details wizard. Navigating within the wizard is clearer, because users no longer see steps that they cannot take based upon the Regulatory Objective record from which the wizard started. When updating existing details, users now see details grouped by Registration in addition to Country. When adding new details, we’ve increased the size of the Add: Registered Details dialog. Learn more about managing registered details.

Manage Registered Details for Medical Devices

Customers using the Regulatory Objective object as the source of data for the Manage Registered Details wizard can now use the wizard to update and add related registration details for medical devices. Customers that have both drug and device registrations can create Object Type Mapping records to ensure that Vault adds new registered details using the appropriate object types. Learn more about managing registered details.

IDMP Phase 1: Algorithms

This feature introduces an aggregation algorithm that will recurse through RIM Registrations data to compile submission data in new IDMP objects. The full IDMP feature set will be delivered across multiple releases. Learn more about configuring and generating IDMP data.

Contact Veeva Support to enable the IDMP algorithm and the Generate IDMP Elements user action in your Vault. RIM Registrations Vaults include all IDMP objects automatically.

QMS to Registrations Spark Connection: Configurable Event Object Types

With this feature, customers can now configure the QMS to Registrations Spark connection to create regulatory Event records of different object types. This change better supports change controls for commercial products versus investigational products and the downstream processes for each change control. Learn more about configuring the QMS to Registrations Spark connection.

Enablement Change: QMS to Registrations Spark Connection

As part of the 20R2 release, customers who wish to enable the QMS to Registrations Spark Connection can do so through configuration, without contacting Vault Support to request the feature. This does not automatically enable the feature, but makes the configuration options available to Admins. Learn more about configuring the QMS to Registrations Spark connection.

Brexit: Remove UK from Centralised Countries for Create Registrations

With this feature, Vault no longer defaults the United Kingdom in the list of EU countries for Centralised Procedures in the Create Registrations wizard. This change aligns with Brexit. If needed, users can still add the UK to the scope manually.

20R2 Regulatory Data Model Updates

See 20R2 Data Model Changes: Regulatory.

Safety

Safety features are targeted for tentative availability on August 6, 2020 & August 14, 2020.

Copy Report Type and Receipt Date from AER Source Document Vault Metadata

Report Type and Receipt Date can now be captured on documents and copied over to an AER when it is created from a document.

E2B R2 Product Import Converter and Other E2B Enhancements

When importing E2B (R2) files, Vault Safety now merges drug duplicates (B.4.k section) and creates a single Case Product, including all of its dosages and substances.

A drug is considered a duplicate when the following data points match:

  • Proprietary medicinal product name (B.4.k.2.1)
  • All active substance names (B.4.k.2.2)
  • The country where the drug was obtained (B.4.k.2.3)

The system sends a warning notification if conflicting information is found under drug duplicates.

In addition, During FDA E2B(R2) generation, Vault Safety now exports non-standard frequency measurements (cyclical, as necessary, and total) to the dosage text field (B.4.k.6) and leaves the frequency value and unit blank (B.4.k.5.4 / B.4.k.5.5) to ensure a compliant FDA E2B(R2) file is generated. The system sends a notification when it maps non-standard frequency values this way during an FDA E2B (R2) export.

Learn More: E2B Case Import Data Mapping

Duplicate Detection Enhancements

Vault Safety now uses Study Arm and Site Reporter information for duplication detection. The system also returns potential matches for cases that have only one MRN field matching for Patient information. Additionally, the Potential Matches page now shows the Lifecycle state for the AER and potential matches to facilitate the review.

Learn More: How Duplicate Detection Works

Performance Optimization: Promote to Case

Vault Safety 20R2 features an updated framework to enhance Promote to Case performance speed.

Medical Review Timeline

Vault Safety now has the ability to display certain case-related events on a visual timeline to help medical reviewers view the progression of events. The system currently supports displaying Case Adverse Events, Case Products, including individual doses, Case Test Result, Case Drug History, and Case Medical History.

Users can toggle individual series on and off and adjust the zoom (amount of time shown). The timeline infers dates from other available information when full dates are not present. Inferred dates are approximate and the underlying data should always be verified before making a final determination.

Learn More: Perform Medical Review

Drug / Biologic Combination Products

Vault Safety now supports end-to-end case processing for post-marketing combination products. For combination products marketed in the US, an FDA-bound E2B (R2) Submission is generated, along with the new FDA regional E2B fields for combination products. Leverage these capabilities to remain compliant with the FDA’s PMSR requirements for combination products with or without device constituents (21 CFR Part 4), which take effect July 21, 2020.

Without Device Constituents

When a case concerning a combination product is opened, the system downloads its pre-configured constituents to the case and auto-generates Case Assessment records for them. Furthermore, Watchlists created for the Combination Product (such as AESI or IME) are applied to the case.

With Device Constituents

You can now enter additional device information during data entry, including device event problem codes, device evaluation codes, and remedial action information. The generated FDA-bound E2B (R2) Submission and the new FDA regional fields for combination products with device constituents include support for Malfunction (30-Day) and Public Health Risk (5-Day) reports.

Learn More:

Manual Case Lock

Individual users can now lock Cases and their related records, including Case Adverse Events, Products, Medical History, and Assessments, to prevent other users from editing them.

The user who locks the Case can edit the Case normally, but all other users will be prevented from saving changes to the Case. Using role-based atomic security, if necessary, administrators can grant certain users permission to unlock the Case or reassign which user the Case is locked to.

Learn More: Manually Lock and Unlock a Case

Case Locked Icon in Approved, Closed, and Superseded State

A new Case Locked icon will be automatically available with no configuration needed. The lock icon will appear by default on Cases in the Approved, Closed, Superseded, and Rejected states.

Loading Page for Create Follow-Up

When a user creates a Follow-Up Case, they will be redirected to a loading page while the Follow-Up is being created.

Case Product Drug Role: Treatment

Users can now assign the drug role of a Case Product to be a treatment of the adverse event. Case Products designated as a treatment will not be included in any standard generated reports (aggregates, E2B, CIOMS I, MedWatch 3500A, etc.). Note this feature was first introduced in 20R1 but could be enabled by Veeva Support only. In 20R2, this feature can be made available through Configuration.

Deprecated Controlled Vocabularies

Administrators can now deprecate non-system Controlled Vocabularies without impacting imports and Follow-Up Cases. Users will be unable to select Deprecated Controlled Vocabularies for new cases but will still be able to process older ones. This is particularly useful for migrated data.

Learn More: Deprecated Controlled Vocabularies

Substances

Vault Safety can now track Substances and their use in individual products. When adding a Product to a Case that is associated with a preconfigured Substance, the substance details are now be snapshotted to the Case Product.

Learn More: Add Substances

MedDRA Auto-Coding

The MedDRA auto-code feature is now automatically available. Previously, this feature required configuration. Vault Safety 20R2 automatically updates all MedDRA fields to use the auto-code control. In addition, the Case Diagnoses and Case Drug History records now support the MedDRA auto-code control.

Learn More: Code MedDRA Terms

MedDRA: Centralization

Vault Safety now hosts a centralized MedDRA dictionary that is managed and regularly updated twice a year by Veeva. This alleviates customers from their ongoing management of MedDRA. When a new dictionary version becomes available in the centralized repository, customers can choose when to transition to it.

Learn More: Manage the MedDRA Dictionary

MedDRA Browser Hierarchy Tree View

The MedDRA Browser now offers a tree view to help users navigate and find MedDRA terms. You can browse through MedDRA in the Tree View hierarchy and to refine their searches to a specific MedDRA level to find terms. The MedDRA Browser also has incorporated a number of usability enhancements for resizing and selection.

Learn More: Code MedDRA Terms

WHODrug Version Selector

While selecting the active WHODrug dictionary, administrators can now see when the list of releases in their vault is out of sync and fetch the latest WHODrug versions.

Learn More: Manage the WHODrug Dictionary

DSUR Appendices (Cumulative SAR, Death Cases) and DSUR Masked Distributions

In this release, to facilitate both DSUR submissions to health authorities and distributions to partners/committees, customers will be able to generate both masked and unmasked versions of the Cumulative Tabulation of SAEs and Interval Line Listings.

Customers will also be able to generate Appendix R1 Cumulative Tabulation of SARs, and Appendix R2 List of Subjects Who Died During the Reporting Period.

Learn More: Create DSUR Aggregate Reports

PSUR Cumulative Tabulations and CIOMS II Line Listings

Vault Safety now supports generating Periodic Safety Update Reports (PSURs) cumulative tabulations along with CIOMS II line listings. Reports can be generated based on drugs, studies, and/or active substances.

Learn More: Create PSUR and CIOMS II Line Listing Reports

XLSX Aggregate Report Templates

This release supports the use of .XLSX aggregate report table templates. This allows administrators to configure Vault Merge Fields tokens to display additional aggregate details (product family, date, etc.) on the generated Aggregate Line Listings and Cumulative reports.

Learn More: Configure Aggregate Report Templates

E2B R2 & R3 Validation

This release contains various enhancements to inform users of validation errors when entering data and submitting E2B messages.

When a Submission E2B file is created, the system validates the XML schema and reports any errors so that the user can address validation errors before attempting to submit to the Health Authority. This feature includes support to validate the XML schema for EMA E2B (R3), FDA E2B (R2), FDA Combination Products, and Health Canada E2B (R2) files.

Vault Safety also validates specific nullFlavour values during data entry, as well as Value/Unit pair controls, and displays an icon for the invalid selections.

Learn More: E2B XML Validation

Health Canada E2B R2 Export

Vault Safety now supports the ability to export ICSRs in the Health Canada compliant E2B(R2) .xml format.

Learn More: E2B Generation Data Mapping

Optimized Submissions: Local Datasheets & Primary Expectedness

This release introduces improvements to the auto-expectedness feature. First, the system now syncs the Case-level expectedness from the primary Case Assessment.

Second, Vault Safety will now generate submissions on assessment level expectedness which will be based on a product registration’s country and product. Auto-expectedness will also now calculate only the primary case assessment.

This enhancement facilitates more precise reporting, ensuring that submissions for a serious adverse event are generated with the correct due dates, based on their country-specific expectedness.

Learn More:

API Name for Transmission Profiles

API Names have been added to the Transmission Profile object. In addition, standard system-generated Transmission Profile records, such as CBER and EVHUMAN, are protected with an __v API Name, preventing their deletion.

Vault Safety System Updates for Case Promotion

The following system updates will be visible to administrators:

  • The Promoting state in the Case lifecycle
  • The Promotion Transmission object record type
  • The External Safety System Transmission Profile and Gateway Profile

Automated Intake API Integration

Vault Safety.AI integrates with Vault API to introduce a publicly accessible endpoint for high-volume case intake.

The Intake API can be used to import new cases from a JSON file. The source JSON file can contain both structured and unstructured data. After a successful operation, the system extracts the data using AI and Natural Language Processing to create an Inbox Item for verification.

Learn More: Vault Developer Portal

Intake API Limits

Safety.AI enforces limits on the Intake API input data and Inbox Item child records (for example, multiple products) to ensure the system remains stable at all times. The maximum number of records and other limits are configurable and can be adjusted by Support upon request within predefined limits.

Learn More: Vault Developer Portal

Inbox Item Priority Auto-Calculation

Safety.AI automatically suggests the priority for new Inbox Items, based on Adverse Event seriousness. You can verify the suggested priority while verifying the data in each Inbox Item. You can use priority to quickly sort and filter Inbox Items, to find and process the highest priority items first.

Product Dosage Intake

Safety.AI supports product dosage intake. The Intake API will accept dosage information in the JSON structured data that will be presented in Product sections of the Inbox Item user interface. Up to 10 dosages will be supported and users will be to verify, edit, add and delete product dosages for each product record.

Learn More: Inbox Item Field Reference: Products Section

Natural Language Processing and Data Extraction

Safety.AI uses Natural Language Processing (NLP) and rule-based algorithms to automatically extract case information from unstructured data (text) sent through the API. This information is then merged with other unstructured and structured data to create an Inbox Item. Safety.AI extracts information for patient, reporter, case products, and adverse events.

AI Suggestion Generation

When Safety.AI infers case data from indirect mentions in the source text and make suggestions for the user to consider during data verification. Safety.AI clearly identifies suggestions in the user interface, along with their confidence level and rationale to make verification easy.

The system can make suggestions for the Patient Gender, Event Country, Product Rank and Product Role fields if the data cannot be directly extracted from the intake source. For example, if the event country is not stated but the text includes the reporter’s country, the system infers the reporter’s country may be the event country and makes a suggestion based on that data.

Simple Conflict Resolution for Text Fields and Age

To make data verification easier, Safety.AI shows the confidence score for values extracted from the source text. This feature helps reduce the effort to resolve information conflicts when multiple potential values were inferred from the source text by showing the options ranked with the highest confidence score first.

Safety.AI automatically populates high confidence level predictions, while medium confidence level data is available in a drop-down menu. Veeva support can configure custom confidence thresholds.

Data Verification Interface

The user interface has been designed for Safety.AI to streamline high-volume case intake. The system seamlessly guides users through their verification and data entry tasks on the Inbox Item page, with the ability to edit multiple records at once and verify data extracted through the API while reviewing source data side-by-side.

Safety.AI guides users to review and verify information extracted from unstructured data, such as case narratives. To provide context during data verification, the system shows a snippet of the relevant unstructured data and highlights the extracted value. You can expand and collapse blocks of unstructured data for additional context.

During data verification, users can assign ranks to repeated sections (Case Adverse Event, Product, and Reporter). Sections assigned a rank are listed in descending order.

Promote Inbox Item to AER

After verifying the data of an Inbox Item, users can create an AER to proceed with case processing. This feature includes section validation to ensure field values are E2B (R3)-compliant.

Send AER to External System or Promote to Vault Safety

Safety.AI integrates seamlessly with Vault Safety. Customers with the full Vault Safety Suite can promote their AER to a Vault Safety Case and continue with case processing.

For customers using an external system for case processing, Safety.AI transmits AERs through an AS2 Gateway using the ICH-compliant E2B (R3) format.

Duplicate AER Detection

Prior to sending the AER to an external system or promoting it to a Vault Safety Case, Safety.AI runs duplicate detection on the AER. When duplicate detection runs, the system compares the current AER against all other AERs in the system. If your vault is licensed for both Vault Safety and Safety.AI, the system compares the AER to all existing Cases and AERs.

QualityOne

Automated Inspection of Certificate of Analysis

This feature allows users to upload a Certificate of Analysis file to a COA Inspection object which Vault analyzes to determine if the measurement values on the COA conform to Admin-configured specifications. The solution performs an OCR scan of the COA file and extracts characteristic parameters. The specifications show a comparison between the test result from the COA file and the inspection plan for the product. If all of the measurement results from the COA are within the specification limits, the COA is marked as passing the inspection. Users can manually adjust the results, if needed. Learn more about automated inspection of Certificate of Analysis.

Supplier Portal Phase I

This feature offers a simple and easy to use interface that empowers the supplier to effectively collaborate with the buyers when participating in the QMS processes starting with the supplier nonconformance process. Suppliers can review, update, and create nonconformance details, such as reviewing objective photo evidence and creating action items. Admins can configure the supplier portal to include instruction text and a link to sample documentation or guidelines where needed so that users have a clear indication of what is required of them. Learn more about configuring Supplier Portal.

QualityOne Station Manager Updates

With the 20R2 release, we’ve updated QualityOne Station Manager in the following ways:

  • Station Manager for iPadOS: QualityOne Station Manager is now available as a native iPadOS application for Apple™ iPad devices.
  • Additional Supporting Documents Relationship: Users can now see supporting documents in Vaults using the supported_documents__c relationship.
  • Document Categorization: Admins can now define and manage categories in Vault so that documents can be categorized by Station, allowing operators to browse documents relevant to their current task.
  • Enforced Document & Size Maximums: The application enforces maximums of 1000 documents per Station, 10gb total rendition size, 100mb per PDF rendition, and 500mb per video rendition.

Azure AD SSO Support For QualityOne Mobile for iOS

This feature allows users using Azure AD SSO login credentials to access QualityOne Mobile.

Prevent Document Record Archival for Training Management

We enhanced QualityOne Training Management to account for archived documents so that documents associated with an active Training Assignment or Training Requirement cannot be archived.

MDCC: Banner Visibility Update (QualityOne)

When a document is governed by a Multi-Document Change Control (MDCC), Vault displays a banner stating which Document Change Control record the document is currently governed under. With this release, Vault displays the banner to users with at least one of the Edit Document, Edit Fields, Annotate, or Version permissions. The banner is no longer displayed to users with only the Change State or Start Workflow permissions and none of the other four permissions.

Data Model Changes

See 20R2 Data Model Changes: QualityOne.

RegulatoryOne

Raw Materials

This update provides the objects to support raw materials for RegulatoryOne so that users can include raw material information in submissions. Users can define a list of Raw Materials, their manufacturers, their ingredients, and the formulas that use the raw materials. Users can also associate documents to a Raw Material after an Admin creates the appropriate document type. Learn more about raw materials.

Product Raw Material Ingredient Rollup

This feature provides users with an action to calculate the ingredients in a product and their concentrations based on the product variant’s raw material concentrations and the raw material’s ingredient concentrations. This capability removes the need for customers to calculate a formula’s ingredient concentration manually.

Add Submission Content Plan Token for Raw Materials

This feature adds support for a new Raw Material token that users can reference in a Content Plan Template. The new token generates Content Plan sections for each Submission Raw Material Variant record, improving efficiency for RegulatoryOne users. Learn more about the raw materials token.

This feature, when configured for a submission, allows documents to be auto-matched to Content Plan Item records of submissions within the same application. This option removes the need for users to manually match documents in cases when they need to reference previously matched documents. Learn more about configuring a submission to allow auto-matching of previously matched documents.

Data Model Changes

See 20R2 Data Model Changes: RegulatoryOne.

Veeva Claims

Note that Veeva Claims 20R2 features are scheduled for tentative availability on August 18th.

Pack Copy Management

This key module introduces the ability for brand marketers to manage all packaging label content (such as claims, ingredients, logos, manufacturer addresses, usage instructions) in a structured format. Brand marketers can create pack copies organized by packaging levels (such as primary, secondary) and panels (such as front, back, top, bottom).

Reusable Statement Library

This enhancement introduces the ability for companies to create a library of unique statements that users can utilize to create claims. This library enables the reuse of existing unique statements and improves efficiency while creating claim records. Learn more about statements.

Automated Generation of Claims & Local Adaptations from Projects

This enhancement provides an easy and efficient way for users to create claims and their local adaptations in a project. From a project, users can select multiple statements and products, and then initiate a user action to generate claim records. Users can apply scope restrictions on the statements in order to create claims only for specific product classifications (such as brand, sub brand, product). Similarly, users can also create local adaptations of those claims in a project. Learn more about configuring the automated generation of claims and local adaptations from projects.

Data Model Changes

See 20R2 Data Model Changes: Veeva Claims.

SiteVault Enterprise

Site Packages: SiteVault

This feature enables site users to receive and respond to regulatory document requests directly in SiteVault when working with Sponsors and CROs who are using Vault Site Connect.

Easy Source Upload

The new Source Upload tab dramatically reduces the effort required to upload source documents into SiteVault so that the documents can be sent for Monitor review.

Site Field is System-Managed

Users no longer need to manually update the Site field on documents in SiteVault Enterprise. Now, when an update is made to a document’s Study field, the site for any added studies is also added to the document’s Site field.