What's New in 19R3

Pre-Release Date: November 4, 2019 | Release Date: November 22 & December 6, 2019

---

We are pleased to bring you Vault 19R3. Read about the new features below. You can find information on enabling new features in 19R3 Release Impact Assessment. Information on developer features (API, VQL, etc.) is in the Developer Portal.

Working with Documents

Collaborative Authoring with Microsoft Office

Collaborative Authoring with Microsoft Office allows document editors to easily check out and check in Microsoft Word documents to Office 365, where users can collaboratively author documents using co-authoring capabilities provided by Microsoft Word. This feature requires customers to configure the Vault integration in their own Office 365 tenant. Learn more about Collaborative Authoring with Microsoft Office.

Create Anchors

This feature enables users to create anchors on documents directly, via a new Create Anchors tool on the annotate toolbar. Once created, anchors are available for selection in the Select Anchors dialog.

Additionally, Vault now restricts the ability to create anchors. Users must have the new document lifecycle state permission Create Anchors to use the Create Anchor tool or create anchors via reference linking. Vault grants this new permission to all roles with View Content permission in existing Vaults. Admins can choose to revoke the new permission from any document lifecycle role as desired. Learn more about Using Link Annotations & Document Links.

Improved Handling for Multiple Action Bookmarks

This feature improves Vault’s handling of multi-action bookmarks in PDF source documents. Previously, Vault only inspected the first action of a multi-action bookmark, and the application did not support that action, Vault did not display the bookmark. Now, Vault inspects all actions on the bookmark and enables navigation for the first supported action. Additionally, Vault displays all bookmarks, including those with no supported actions, and maintains the correct nested structure in keeping with the structure of bookmarks in the source PDF.

Download Notes to CSV

This feature allows users to download annotations from Vault documents as a CSV file. This option is available as Download Notes in the document Actions menu, as well as via a new public API. The action is available to users with View Content permission whenever the document has a viewable rendition and one or more annotations. Learn more about downloading notes to CSV.

Global ID & Link Fields for Documents/Versions

Users can now reference every document and every document version through an ID that is unique across all Vaults and never changes. This ID helps identify the exact document or document version in integrations between Vaults or other external systems.

Additionally, we have introduced two new text fields, Link and Version Link, that reference the global ID of another Vault document or document version.

Global ID fields cannot be used as merge field tokens. Learn more about Global ID & Link Fields for Documents / Versions.

Download List of Records Blocking Document Deletion

Some objects contain document reference fields that point to a document or document version in the Library. In order to preserve the object record’s information, Vault will not allow a user to delete a document or version that is referenced by an object record. Prior to this release, when a user attempted to delete a document that is referenced by an object record, it was not clear which object record was blocking the deletion. A new download link now appears in the error message. The user can click the link to download a CSV file of all related records.

Disable Enhanced Checkout for All Vaults

The Enhanced Checkout Java applet is no longer available and will be disabled completely. See Enhanced Checkout FAQ for details. Please reach out to your Customer Success Manager if you would like to learn more.

Vault File Manager was released in 18R2. We encourage you to begin using this Windows desktop application. Vault File Manager has a number of advantages over the Enhanced Checkout feature, including the ability to bulk check out and bulk check in. Learn more in Vault File Manager FAQ.

Correct Currency Format in Merge Fields & Formatted Output

Vault now displays currency values within merge and formatted output documents in the format specified by the selected local currency. This is to ensure that Vault displays currency values with the correct formatting when using formatted output. Learn more about Managing Formatted Output Templates.

Relabel Doc Info Page Edit Button

The Edit button on the Doc Info page is now labeled Edit Fields. This change supports the addition of a new Edit button used for Collaborative Authoring with Microsoft Office.

Vault File Manager

Improved File Transfer for Vault File Manager

Vault File Manager now displays a progress bar for each file being checked out or checked in. It is also now able to download and upload multiple files at once and allows you to skip files, placing them at the bottom of the upload or download queue. The improved file transfer functionality is more capable of uploading and downloading files over 100MB, up to the 4GB limit that Vault allows today for source files.

Document Rendering

Optimizations for Merge Fields

This release introduces new optimizations for Merge Fields to allow for improved performance and ease of use:

• VQL ‘WHERE’ clause syntax can make use of namespaces when referencing fields in Merge Field tokens.
• Merge Field tokens now retrieve a maximum of 1,000 values, allowing for improved performance.

Learn more about Merge Fields.

Remove Deprecated Re-Render Options

With this release, we have removed some re-render options for MS Word, HTML, and email formats. These options, which relied on a secondary rendition engine, were previously visible in the Re-render Document dialog that appears after choosing to re-render. Other options that control rendition settings remain available. Learn more about Troubleshooting Renditions.

Vault Objects

Relate Multiple Records: Complex Join Related Sections

A many-to-many relationship lets Admins create dependencies between multiple records on two different objects, using a third, relational object with two parent objects. This relational object, called a join object, can be simple, meaning it only has the standard fields (Label, etc.) and parent object fields. Relational objects can also be complex, meaning they have additional custom fields.

In previous releases, users could quickly relate object records through a simple join from a Related Object section on a parent object page, but could only relate records through a complex join individually. In this release, we’ve introduced that ability for objects that are related through a complex join. When relating records, Vault creates the complex join records in the background. Learn more about object relationships.

An Admin must allow this functionality for specific join objects by enabling the Relate Multiple Records setting. The page layout for each parent object must also include a Related Object section.

Global ID & Link Fields for Object Records

Users can now reference every object record by an ID that is unique across all Vaults. This ID helps identify the exact record in integrations between Vaults or with other external systems.

We have also introduced another new text field, Link, that can be used to reference Vault global record IDs or external system IDs to connect them in integrations. We are adding both of these fields to every object. While the global ID is non-editable, Admins can control the Link field’s edit permission like existing text fields. Learn more about Global ID & Link Fields for Object Records.

Update EDL Item Tracking Fields When Batch Update Is No/Blank

Vault tracks the progress and completeness of EDL Item records based on matched documents using the following read-only fields: Completeness, Expected Steady State Document Count, All Document Count, and Steady State Document Count. In past releases, Vault would only update these fields via the continuous EDL matching job when the Batch Update field was set to Yes. This resulted in users seeing incorrect EDL Item progress.

Starting with this release, users can see the accurate progress for new EDL Item records even when the Batch Update field is set to No or left blank, as long as the EDL matching job is active and has run at least once.

This new functionality is auto-on, but Vault will not update tracking fields on existing records where Batch Update is set to No or left blank unless a user updates the EDL Item record or the matched document, triggering continuous matching. To update existing all existing records, contact Veeva Support. Learn more about continuous matching.

Simple Join Objects Include Lifecycle State Fields

When users add a lifecycle to a simple join object, the object will now remain a simple join object. This grants users the ability to relate multiple records and show parent records in a simple join related object section for join objects that have a lifecycle. Learn more about Configuring Object Lifecycles.

Download List of Unrelated Parent Records

From simple join related object sections, users can now click a link to download a CSV file containing a list of parent records that Vault could not relate to the current record.

Update Label to PHI or PII Field

In order to provide more clarity to customers, the Encrypt Field Value setting on object fields will be relabeled as Contains Protected Health Information (PHI) or Personally Identifiable Information (PII). Because all data in Vault is encrypted, this label change better reflects the intended usage for the setting. Learn more in Configuring Vault Objects.

Uniqueness Update

For every object, there are some fields where each record must have a unique field value (like Name or External ID) and others that do not need to be unique (like Therapeutic Area or Product). Supported object fields include a Values must be unique setting to control this. Starting with this release, the system will apply changes to this setting asynchronously, meaning that there may be a delay before the change takes effect, particularly when the associated object has a lot of records. While the system is processing these changes, Vault will block certain actions on the affected field, including deleting the field and modifying the Maximum Length setting.

UI Changes in Object Page Layout Editor

When editing an object page layout, Admins will see the following changes:

• The Create Section button is now labeled Add Section.
• Two options under Add Section (Single Column Detail Form and Two Column Detail Form) have been consolidated into a single item (Detail Form).
• When Admins select Add Section > Detail Form, the dialog includes a Section Layout field where they can choose to create a section with one or two columns.

Block Use of System-Managed Name in Validation Rule

Vault prevents Admins from using a system-managed Name field when defining an object record validation rule. Existing validation rules will continue to work in 19R3, but Admins will not be able to update them without removing the Name field. This change will support a future fix for an issue wherein system-managed names show non-sequential auto-numbering when validation rules fail.

Reporting

Pareto Charts

Vault dashboards currently support six types of charts: Gauge, Number, Column, Bar, Line and Pie. This feature will add a seventh option, Pareto. Pareto charts are like standard column charts except that the groups are always ordered from largest to smallest. Additionally, they provide a cumulative percentage line. These charts highlight factors that are especially important for quality control processes.

Multi-Pass Reporting Enhancements

This feature provides a number of important enhancements to Multi-Pass Reporting. Key enhancements include the ability to create report views from workflow reports, add groups to report views, and join report views by text fields. Other improvements include the ability to define conditional fields in both report views and multi-pass reports, to select inner join when joining report views, and to filter on aggregate fields defined in report views. Learn more about Multi-Pass Reporting.

Display Object Reference Fields as Links in Reports

With this release, all object reference fields in a report will display as clickable links. Users with access to the record can quickly jump to the object record detail page. In past releases, object record names were only clickable for reporting objects in the report type.

Both single value object reference fields and multi-value object reference fields (available only on documents) will appear as links in reports.

Task Instructions in Reports

This feature allows users to include Task Instructions in Workflow with Document reports. This enables users to view task instructions anytime after initiating a document workflow, providing context to later steps, actions, and decisions. Learn more about the fields available on the Workflow with Document and Workflow with Object report types.

Prevent Report Re-Execution On Export

Previous to this release, Vault re-executed a report every time a user exported it. Now when a user views a report and then exports it, the export does not require the report to re-execute. Exports directly from the Reports tab are unaffected.

This will provide a better user experience when exporting reports, saving users from having to wait for a report to execute twice. Learn more about exporting reports.

Lifecycles & Workflows

Object State Types

Prior to this release, object lifecycles had only two static state types, Initial and Complete. With this release, Admins can create custom object state types. State types are useful for actions and interactions that span different lifecycles or even different Vaults. For example, the system state type Initial State identifies the starting lifecycle state for every record.

Admins can create or modify object state types from Admin > Configuration > Object State Types. They can associate state types to specific lifecycle states in a new State Types section for each object lifecycle configuration.

Due to this feature, Vault Compare and Vault Configuration Report may show that state type lifecycle components have changed, even though there is no functional difference. Learn more about managing object state types.

Multi-Document Workflow: Start Multi-Document Workflow on a Single Document

This feature allows users to use a multi-document workflow configuration with both multiple document and single document use cases. Workflow initiators can start the multi-document workflow for multiple documents or for a single document. This change lowers maintenance costs and ensures consistency between multi-document and single document use cases because Admins only need to configure a single workflow. To enable this capability, the Admin must configure a multi-document workflow for a specific lifecycle and set up a document lifecycle state user action to support the single document usage.

Multi-Document Workflow: Constrain Multi-Document Workflow Based on Document Status & Field Values

This feature ensures that only qualified documents can be included in a multi-document workflow based on document status and field values. Admins can configure a multi-document workflow for a specific lifecycle and configure it as a user action for a specific lifecycle state with conditions. Documents are checked for these conditions when a workflow initiator starts a workflow with multiple documents. For example, if a workflow has been configured as a user action on the “Draft” state available only if the field Training Required equals “Yes,” then only documents that meet those criteria can be added to the workflow.

Multi-Document Workflow: Remove Documents from Envelope

This release introduces a widely-requested enhancement to allow a workflow initiator to remove one or more documents from an envelope after a multi-document workflow has started. In the envelope document list, the initiator can remove a document by clicking the X icon.

For example, in a review workflow involving multiple documents, it is common for the majority of documents to be ready for approval while a few documents require revision. To accomplish this, the workflow initiator can remove documents that require revisions from the workflow. Learn more about Using Multi-Document Workflows.

Multi-Document Workflow: Verdict-Based Prompt for Comments and Reasons

This feature enables Admins to configure Multi-Document Workflow tasks to prompt for comments or reasons when task owners select a specific verdict. For example, in an approval workflow, if the approval task owner selects the Reject verdict for a document, he could be required to provide a Rejection Justification. The document owner can then reference the comment when revising the document for the next round of approval.

Multi-Document Workflow: Updated Envelope Viewer

To support the ability to capture additional information beyond the verdict when completing a task, the Multi-Document Workflow Envelope Viewer has been updated to open a dialog to prompt for required inputs. Prior to this release, task owners selected verdicts for each document directly from the viewer. Now, they need to click the Document Task link to provide required information in the task dialog.

Document Workflow: Add Participants to Unselected Optional Tasks

In previous releases, the Add Participants action did not allow workflow initiators to add users to an optional task participant group if the optional task was not assigned at the start of the workflow. Participant groups associated with the optional task were hidden in the Add Workflow Participants dialog.

With this release, participant groups for optional tasks appear in the Add Workflow Participants dialog, even if the associated optional task was not assigned when starting the workflow. Workflow initiators are able to add to these optional task participant groups, thereby re- including the associated optional task in the workflow.

For example, in a medical, legal, and regulatory review and approval workflow: If the workflow initiator selects medical and regulatory reviewers at the start of the workflow, but later decides that legal also needs to be involved, the workflow initiator can now use the Add Participant action to add legal reviewers. Learn more about optional document workflow tasks.

Restrict Adding Users to Active Workflows with SDK-Managed Participants

When an object workflow configuration includes the option to use custom actions (create using Vault Java SDK) to define participants, the participant group is no longer available in the Add Participants dialog. This restriction prevents users from manually changing the membership for participant groups defined by custom Vault Java SDK code.

Vault Formulas

Link Formula Fields

Formula fields on objects allow Admins to calculate various values and display them alongside other object record field values. With this feature, Admins have a new return type for formula fields: Link. These formula fields will display a clickable link in object record pages.

In organizations with Vault to Vault Integrations, clickable links help users navigate from records in one Vault to related records in another. Organizations can also use link formula fields to navigate to an external, non-Vault URL. Learn more about using the Hyperlink function.

Increase Formula Field Limit for Objects

In past releases, each object could include up to five (5) formula fields. In this release, we’ve increased the limit to ten (10) formula fields. This increase will allow customers to create more formula fields, including fields used to display icons or clickable links. Learn more about configuring formula fields on objects.

Checklists

Three Levels of Dependent Questions for Checklists

Checklists previously supported only up to two levels of dependent questions for multiple choice controlling questions. This feature changes the limit from a maximum of two levels of dependent questions to three levels, allowing Admins to configure an additional layer of dependency without having to create another section for dependent questions. For example, previously you could only configure dependent questions such that Q1 controls Q1.1 which controls Q1.1.1. With this feature, Admins can now configure multiple choice questions so that Q1.1.1 controls Q1.1.1.1. There are no changes to the way dependent questions are configured for a multiple question design record.

Synchronize Checklist Design & Related Records

This feature allows a checklist design and all of its related records to synchronize to the same lifecycle states with a simple configuration and scalable approach. Admins can configure a new user action called Sync Checklist Design Lifecycle States which will change the lifecycle states of the Checklist Design record and all of its related sections, questions, answers, and dependencies. Previously, a change state user action and many entry actions were needed to keep the lifecycle states in sync for all of the checklist’s related records. This new user action also helps to address a platform limitation when more than 1,000 state changes are made based on the number of sections, questions, answers, and dependencies when using a state change user action and entry actions.

For example, if an Admin creates a new impact assessment checklist for use by the Chicago manufacturing site, the Admin would expect to see that all of the records for the checklist are in the same lifecycle state after approval. With this new user action, all of the lifecycle states will be set so they are synchronized when a checklist is approved for use, made inactive, or reverted to the draft state. Learn more about Sync Checklist Design Lifecycle States.

Optional Checklist Category in User & Entry Actions

This feature simplifies how the Start Checklist user action and entry action are configured. Currently, Vault instantiates Checklist Design records based on one or more matching fields defined by Admins for the Checklist Type (Admin > Configuration > Checklist Types) as well as a drop-down value selected from the Checklist Type picklist. This feature now allows all matching fields to be configured in a single location from the Checklist Type definition. If an Admin would also like to use the Checklist Type picklist as another matching field, this field can be added to the Checklist Type definition of matching field values rather than being defined in the user or entry action. In this scenario, the Admin would configure the Start Checklist user or entry action with a Checklist Type picklist value of Not Applicable. When Not Applicable is selected, this directs Vault to use only the matching fields defined in the Checklist Type.

For example, if an Admin does not want to use the Checklist Type picklist as a matching field value when determining which Checklist Design record to instantiate and only wants to use Facility as a matching field, the Start Checklist user action can be configured so that Checklist Type is set to Not Applicable and the matching field Facility is added when the Checklist Type is configured.

Administration

Enhanced Business Admin Navigation

With this release, Vault has updated Admin > Business Admin to leverage many of the search capabilities that users enjoy in custom object tabs. When working with object records in Business Admin, Admins can now use additional search options, apply filters, and save views. Using Advanced Search, Admins can search within object record attachments. These enhancements make it easier to work with objects that have many records but that do not have a dedicated custom object tab, for example, User Role Setup and Users. As part of these changes, Admins will now use a dropdown selector to open an object list page, picklist management page, or template page. Because the average Vault has at least 50 objects visible in Business Admin, we’ve made it easier to jump to a specific page. In the new selector, Admins can look up items by name. This enhancement also removes the Admin > Configuration > Business Admin Menu page that Admins previously used to determine object sort order in the Business Admin menu.

Learn more about navigating within Business Admin.

Self-Serve Pre-Release Vaults

This feature will allow customers to create, refresh and manage their pre-release Vaults within the pre-release window for each release. This will provide greater control to Vault Admins over their pre- release environments. 19R3 is the first General Release for which Admins can create a pre-release Vault.

Limited Release Sandbox

With the release of this feature, customers will now be able to create a sandbox on Limited Release from a Vault on General Release. This will allow customers the ability to manage their own Limited Release sandbox to proactively assess new functionality ahead of each General Release. Customers are entitled to three (3) configuration sandbox Vaults for every production Vault, including both General Release sandbox Vaults and Limited Release sandbox Vaults. Learn more about sandbox release versions.

Organizations must contact Veeva Support to request access to the Limited Release Sandbox feature.

User Pending State

This feature adds a new Pending state to the Vault Membership lifecycle on the User object. Users in a Pending state cannot log in to a Vault, but Admins can use their User records in the configuration. This allows Admins to assign new users to groups and sharing settings, or reference users from documents and objects prior to granting those users access to a Vault.

When adding a user via the User object, the new Activation Date field can be set to a future date. Adding an activation date sets the user’s initial state to Pending. A new job will run daily to make any pending users active, according to their activation date. The new Inactivation Date field will display the date a user becomes inactive. This field is read-only and updates automatically. Admins also have the option to defer or disable the welcome email for new users. This option was only previously available from the legacy user creation page.

Admins must add new fields to the User object page layout in order to set these fields when creating a new user.

API Usage Logs to Include Request Duration

This feature adds a Duration column to the API Usage Logs. The column shows the time it takes an API request to execute in Vault, measured in milliseconds. Note the duration does not include transport times between Vault and the client.

Auditing

Object & Document Audit History Filter Enhancements

This feature enables customers to more easily track specific activity in the object and document audit histories by providing more filtering options:

• Users will no longer be forced to select an event filter prior to adding a user filter in the document audit history.
• Users can filter the object record audit history by event, user, and object.

Learn more about Viewing Admin Logs.

System Objects Supported in Related Record Audit Trails

In past releases, when viewing the object record audit trail for a system object such as User, Vault did not allow users to view related object record audit entries. This feature adds support for system objects, such as User, in related record audit trails. Audit trails for non-system object records now allow users to show entries for related system records. For example, users could choose to include audit entries for related User records when viewing audit entries for the custom Marketing Campaign object. Likewise, audit trails for system records allow users to show entries from related objects. For example, the audit trail for a User record could also show audit entries from the associated Location records. Learn more about object record audit trails.

Record ID & Object Label Column in Object Audit Exports

Object record audit exports now include a Record ID field, and exports to CSV and Text will contain the Object Label field.

• The Record ID column provides a way to uniquely identify the related record.
• The Object Label column makes performing analysis easier for users, alleviating the need to parse this information from the Item column. Additionally, the new fields make object record audit exports more consistent across the API and the user interface, as API exports already include these fields. Learn more about audit trail exports.

Add Vault ID Field to Login Audit History UI

This feature exposes the Vault ID field in Admin > Logs > Login Audit History. With this field, Admins can quickly understand which Vault an audit entry reflects. Since Login Audit History shows information at the domain level, this detail is necessary to provide context for each entry. Previously, this field was only exposed in exports. Learn more about using audit logs.

Include Seconds in Audit Trail Export Timestamp Column

Previously, although the Admin > Logs page shows seconds when hovering over the Timestamp column, audit trail and audit history exports from the user interface only included the date, hour, and minute. This feature adds seconds to audit entry Timestamp columns, which are available when exporting from an individual audit trail or Admin > Logs. This feature makes audit exports from the user interface consistent with audit exports from the API, which already included seconds. Learn more about audit trail exports.

Authentication & Security

Enhanced Delegate Access Experience

This feature improves the experience for delegate users. Once logged in to the delegated Vault, users can return to the My Vaults page through the link in the banner. Additionally, the My Vaults page link in the Vault selector will no longer be present while the user is logged in to the delegated Vault and the list of Vaults in the Vault selector will contain all Vaults the user is able to access as the delegated user.

For added security, Vault will log all audit entries for the delegate user as: “{Delegate} on behalf of {Delegator}”. Learn more about Delegated Access.

Delegate Access: Restrict Delegate Selection

Restrict Delegate Selection provides more control over which delegates are available when delegating access to a user account. With this feature, organizations can define groups of users who can delegate access only among themselves.

For example, a user in the US Medical group can delegate access only to users who are members of the same group. A user in the US Regulatory group can delegate only to members of that group. Users who are members of multiple groups can delegate to members of all their groups.

Vault enforces this restriction in any UI where users can delegate access. Learn more about Using Delegated Access.

Vault Java SDK

Spark Integration Management

This feature enhances Spark Integrations by allowing administrators to define groupings (Integrations) of business processes (Integration Points) that work together to achieve the integration goals. Developers can leverage the Integrations and Integration Points along with Integration Rules to create specific business processing rules and to route any user exception messages to the appropriate personnel for resolution.

Learn more about integration management.

Spark User Exceptions

This feature is geared towards developers building Spark Integrations. It allows them to track, route, and resolve any exceptions that requires the attention of a Business Admin. You can view Spark user exceptions currently in your Vault from Admin > Connections > User Exceptions.

Learn more about Spark User Exceptions.

Job Processors

With this feature, Admins will see a new Job Processors section in Admin > Configuration > Vault Java SDK. Admins will also see SDK Job as an available Type when creating jobs in Admin > Operations > Job Definitions.

Spark Message Processor Label Clarification

We’ve changed the label “Message Processor” to “Spark Message Processor.” This UI enhancement will help distinguish Spark message processors from other types of messages within Vault. This label appears in Admin > Configuration > Vault Java SDK, as well as Admin > Configuration > Queues.

Java SDK Message Catalog: Admin UI

Vault Admins now have the option to add and manage Vault Java SDK custom messages through the Message Catalog UI. From Admin > Configuration > Message Catalog, Admins add the message group and default message. Once added, developers can use the message in their Vault Java SDK extensions. Admins then coordinate message translation into any Vault supported language using the Bulk Translation tool. Learn more about Using the Message Catalog.

Platform Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Platform data model. Although data model updates are automatically included in Vaults, Admins must make configuration changes to make them available.

• Added State Type (state_type__sys) attribute to object lifecycle states
• Added the following fields to all new and existing objects:
  • Global ID (global_id__sys)
  • Link (link__sys)
• Added the following fields to the User object:
  • Activation Date (activation_date__sys)
  • Inactivation Date (inactivation_date__sys)
  • Send Welcome Email (send_welcome_email__sys)
• Replaced document field checkout_flavor__v with checkout_type__sys (picklist field); this change supports additional document checkout types. The previous field was hidden and not visible to users in the UI, but was queryable via VQL. Customers must update integrations which use VQL queries on the checkout_flavor__v field.

Document Field checkout_flavor__v replaced with checkout_type__sys

To support additional document checkout types, the standard document text field checkout_flavor__v has been deprecated and replaced with a new system picklist field checkout_type__sys. The checkout_flavor_v field was hidden and not visible to users in the UI, but it was queryable using VQL. Customers must update integrations which queried checkout_flavor__v with VQL.

Clinical Operations

Person & Organization Migration

This feature introduces a series of changes to your Vault Clinical application objects. These changes serve to streamline the process of creating Person, Study Person, and Study Organization object records. Additionally, these updates serve as the foundation for future Vault Clinical Operations functionality and automation. Contact your Veeva CSM or Managed Services teams to learn more about this feature and its enablement.

We delivered the Person & Organization Migration feature in 19R2.0 as an opt-in feature that was enabled by contacting Veeva Support. In 19R3.0, the Person & Organization Migration feature will be auto-on for all customers. Learn more about Person & Organization Migration.

Subject Recruitment Planning Enhancements

This feature enhances the 19R2 Subject Recruitment Planning feature. Users will now be able to display their planned Metrics Over Time on the CTMS homepage’s Enrollment Status Graph. Additionally, the Metrics Over Time breakdown can now be done by week or by month. Lastly, users can now track Metrics and Metrics Over Time down to the Study Arm level in addition to the aggregate for the entire study. Learn more about Subject Recruitment Planning.

Veeva Clinical Network Enhancements

This feature enhances Veeva Clinical Network by allowing Vault to transfer more complex actions between connected Vaults. For example, if a user reclassifies a networked document, Vault will reclassify the document in the cooperating Vault as well. Similarly, if a user deletes a networked document, Vault will move it to the Deleted lifecycle state in the cooperating Vault.

Additionally, Veeva Clinical Network now generates an Issue record to speed up resolution if a transfer fails. Learn more about Veeva Clinical Network.

Multi-Product Studies

This feature introduces a new complex join object, Study Product, that allows users to relate multiple products to a single study. Additionally, Vault leverages a new Study Product Role object with which users can specify the role of a product within a study. For example, the Cholecap product might have the role “Lead Agent”.

The Study Product related object section replaces the Product field on the Study object and functions as the new source for the Product field value on documents. Vault will automatically create Study Product records for values currently in use in the Product field of the Study object, ensuring that existing integrations are maintained. Learn more about Managing Studies.

Promote Person to User

We have introduced a new user action available on person records that streamlines the creation of a corresponding user record. Previously, if users wanted to create a user record for a person in a Vault, they would need to manually create the user record and configure the person/user relationship. Now, Vault automatically links the newly created user to the person record via the User reference field.

Admin must configure the Promote Person to User action on an active lifecycle state on the Person object and add the Source Person field to the User object page layout. Learn more about Managing the Person & Organization objects.

TMF Viewer Document Hovercard

The new TMF Viewer released in 19R2 now also supports the same document hovercard and pop-out viewer seen in the Library. Learn more about Using the TMF Viewer (eTMF).

Date-Based Monitored Subjects & Enrollment Status Logs

The Date-Based value in the Metric Calculation field now applies to both monitored metrics on Monitoring Events and the creation of Enrollment Status Logs, which are used to populate the Enrollment Status Graph on CTMS Homepages. This enhancement only impacts customers using date-based metric calculation. Learn more about Subject & Enrollment Metrics.

Standard Monitoring Event Approval Complete Date

This enhancement adds the Approval Complete Date field to the Monitoring Event object. Vault will set the Approval Complete Date once a Monitoring Event moves to the Final lifecycle state. Learn more about monitoring events in Trip Report Administration (CTMS).

Quality Issue Reassignment

This feature will allow customers to more easily re-assign quality issues to other users. Vault now automatically populates the Assigned To field and Assigned To role on the quality issue with the re- assigned user. This brings quality issues more in line with platform Vault functionality for auto- starting workflows. Learn more about Quality Issues.

Surfacing Monitoring Reviewer Comments Resolved By

With this enhancement, Vault tracks the user who resolves a comment and then displays that user’s name in the Reviewer Comment modal. This allows users to check the status of comments without navigating to the Review Summary section. Learn more about reviewer comments in Working with Trip Reports (CTMS).

Vault Payments

CTMS customers are often burdened with tracking and managing payment requests across multiple spreadsheets, a process that is time-consuming and error prone. With Vault Payments, users can track payable items within a single application.

Vault creates Payable Items records based on Admin-defined fees, which users can group under one Payment Request record to identify payee information and the sum of related Payable Items. Additionally, users can route Payment Request record information for processing and eventual payment with their organization’s Accounts Payable system.

Reimbursement Rules Today within Vault Payments, financial specialists enter the fees negotiated with a site. Vault uses these fees to generate payable items. This feature allows for defining rules that limit the number of payable items generated for a site. Payment specialists can limit payable items to a maximum count or based on an enrollment metric.

For example, a payment specialist can limit a site to reimburse for a maximum of 10 screen failures. Additionally, they could limit based on the number of subjects that have been enrolled. For example, for every 4 subjects enrolled, the site is eligible for reimbursement of a screen failure.

Bulk Payment Requests This feature allows payment specialists to generate payment requests in bulk for all sites within a study or study country. This helps to streamline the reimbursement process and reduce the need for manual entry.

Payee Overrides With this feature, payment specialists can override the payees and amounts for individual fees. This is useful when there are multiple payees defined for a given fee (split fee). When the criteria for generating a payment are met, Vault generates separate payable items for each payee in the amount defined by the payee override. Additionally, payment specialists can define primary payees that Vault will default to when creating payable items.

Clinical Operations Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality. See 19R3 Data Model Changes: Clinical Operations for details.

SiteVault

Application Name/Logo & Data Model Changes

SiteDocs is now SiteVault Enterprise! You’ll notice an updated logo in the top left corner of the screen. Also, we have added new Institution object fields and changed some existing object fields to be more configurable. Learn more about SiteDocs / SiteVault.

Commercial & MedComms

Automated Claims Linking

This feature automates the generation of reference links on claim statements in promotional materials. Claims and associated references are configured and approved in Vault and applied to documents with the Suggest Links action. When PromoMats finds matches, it automatically creates suggested link annotations, which users can quickly review and accept. Learn more about Automated Claims Linking.

PromoMats Standard Metrics

Standard Metrics is a new capability that will allow brand and MLR teams to unlock key metrics about their content and MLR process. With Standard Metrics, Veeva is defining a Life Sciences-specific data set to help answer common questions, such as:

• What types of material have been developed?
• What is the average approval time for a piece of material?
• How many review cycles does it take for content to be approved? What is the average time content spends in review?
• What is the approximate cost to create content across various content types?

With Standard Metrics, customers can now associate their material with a standard content type and provide an approximate content creation cost. Once these fields have been populated, PromoMats will automatically calculate key performance metrics, such as time to enter review, time spent in review, number of review cycles, and total time to approval. Learn more about PromoMats Standard Metrics.

Medical Inquiry CRM Data Sharing: Inquiry Pull & Push

Inquiry Pull & Push adds two new functions to the integration between Veeva CRM and Vault MedComms that was introduced in 19R2.3:

• MedComms can pull Medical Inquiry data that originates in CRM into MedComms Case objects. Once the initial pull is completed, new and modified cases are automatically pulled into MedComms on a daily basis.
• MedComms can push status updates to Medical Inquiry Cases to Veeva CRM where the case is aligned to a Veeva CRM Account. This update is also performed on a daily basis.

Learn more about Medical Inquiry CRM Data Sharing.

Medical Inquiry CRM Data Sharing: Account Pull

This feature introduces an integration between Veeva CRM and Vault MedComms to pull account data from Veeva CRM as Case Contacts in MedComms. Customers will be able to perform an initial load of Accounts from Veeva CRM. Once the initial load is completed, new and modified accounts will be automatically loaded into MedComms on a daily basis. Learn more about Medical Inquiry CRM Data Sharing: Account Pull.

Automated Image Rendition Support for Adobe® Illustrator® & Photoshop®

With Automated Image Renditions, Admins in PromoMats and MedComms Vaults can define specific rendition types for image files and apply them to any necessary document types, subtypes, or classifications. When a user uploads a file of that type and classifies the document, Vault creates an image rendition that meets defined parameters automatically.

This release extends the Automated Image Renditions feature to support Adobe® Photoshop® (PSD) and Illustrator® (AI/EPS) files as viable source file formats. In previous releases, Vault could not render PSD or AI source files to create an Automated Image Rendition.

Allow Field Dependencies for the Multichannel Event Type Field

The Event Type (crm_event_type v) field used in Multichannel CRM is now available for use in field dependencies. This change makes it easier for multichannel content creators to select the correct values from very long picklists.

MedComms Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality. See 19R3 Data Model Changes: MedComms for details.

Station Manager

Station Manager is available for Quality and QualityOne application families.

Station Manager for iOS

With the 19R3 release, Vault Station Manager is now available as a native iOS application for use with Apple iPad™ devices on the manufacturing floor. Station Manager for iOS retains the functionality of our Android Station Manager application, while incorporating the native iOS user interface design.

Station Manager allows workers in manufacturing facilities to view content from QualityDocs on shared devices on the shop floor. Station Manager provides a completely mobile, encrypted experience for viewing QualityDocs content, with fast, offline access 24 x 7.

Additional Supporting Documents Relationship

In previous Station Manager releases, users could only see supporting documents in Vaults using supporting_documents_vs relationships. With this release, users can now see supporting documents in Vaults using the supporting_documents c relationship.

Upgrading Android Station Manager

Upgrading to Vault Station Manager 19R3 is only supported for tablets running Vault Station Manager 19R2. If you are running an earlier version of Vault Station Manager, you must first upgrade to Vault Station Manager 19R2 before upgrading to Vault Station Manager 19R3.

Safety

Safety features are targeted for tentative availability on November 22, 2012 & December 9, 2019.

Auto-Expectedness

To increase case processing efficiency, Vault Safety can now automatically determine whether a Case is unexpected using Product Datasheets.

For each Product, you can create Local Datasheets (USPI or SmPC for example), which are specific to a Product Registration, and a Core Datasheet (CCDS), which is the central datasheet for a Product. Local Datasheets list expected adverse events, and can optionally inherit additional events from the Core Datasheet.

If an Adverse Event is not listed on a Local Datasheet for a suspect product, the system marks the Case as unexpected. If a serious Case is determined to be unexpected, the system marks the Case as expedited.

Manage Product Datasheets provides more information.

Auto-Calculations

For efficiency and accuracy during case processing, Vault Safety now auto-calculates a number of E2B(R3) submittable fields when sufficient information is entered on a Case.

Vault Safety can auto-calculate the following fields:

• Case Product > Cumulative Dose
• Case Product Dosage > Duration
• Case Assessment > First Dose Latency
• Case Assessment > Last Dose Latency
• Case Adverse Event > Duration

When required, you can manually override an auto-calculated value.

MedDRA Auto-Code During E2B Import

Vault Safety now supports the automatic coding of medical terms from the MedDRA Dictionary during an E2B import. The system automatically assigns MedDRA codes when the E2B file contains reported event text but no MedDRA code.

Code MedDRA Terms provides more information.

WHODrug Search Criteria Auto-Fill

Finding a product with the WHODrug browser is now faster than ever with automatic searching.

When you open the WHODrug Search window, Vault Safety automatically populates and runs the search query with the reported product name and country entered on the External Product or Drug History record.

WHODrug UI Enhancements

This release includes the following enhancements for the WHODrug Dictionary:

• The WHODrug dictionary user interface has been updated to comply with WHODrug certification requirements.
• Sections that support WHODrug coding are better organized in this release, hiding the read-only WHODrug information fields until you code a product.

Case Information Ranking

Vault Safety now supports ranking Case Adverse Events, Products, Reporters, and Assessments during case processing. Ranked information is listed in ascending order on the Case page and in generated MedWatch 3500A reports.

Create Follow-Up Case From Potential Match

When you promote an Adverse Event Report that contains follow-up information for an existing Case, you can now create a Follow-Up Case from the Potential Matches page.

Designated Medical Events

Customers with a product registered in the European Union (EU) will benefit from the new Designated Medical Events (DME) feature.

The official DME watch list will be available by default in all Vault Safety vaults. When a Case Adverse Event MedDRA Preferred Term (PT) matches an entry in the watchlist, Vault Safety automatically marks the Case as a DME and expedites the reporting due date.

To avoid non-compliance during an EMA inspection, users can subscribe to alerts about non-serious DME Cases with a Flash Report. Administrators can also configure the Case Processing workflow to require the entry of seriousness criteria for DME Cases.

Common Terminology Criteria for Adverse Events Grades

A new field is available on the Case Adverse Event object to select the Common Terminology Criteria for Adverse Events (CTCAE) grade for cancer patients.

PADER Aggregate Reports

Vault Safety now supports generating and authoring Periodic Adverse Drug Experience Reports (PADER). Vault Safety can generate the following PADER tabulations using Cases entered in the system:

• Overall Summary of Adverse Drug Reactions
• 15-Day Alerts
• Non-15 Day Alerts
• Individual Line Listings

To enable this feature on existing vaults, contact Veeva Services to request configuration upgrades.

Generate PADER Aggregate Reports provides more information.

Device on FDA MedWatch 3500A

When generating a MedWatch 3500A report, Vault Safety now supports Section D: Suspect Medical Device. To support this section, you can now enter medical device product information on a Case.

Also, Vault Safety can now repeat Section C: Suspect Products on additional pages to include all suspect products. In previous releases, Section C was limited to two suspect products.

Case Export Data Mapping provides more information on the updated MedWatch 3500A capabilities.

Configurable AS2 Gateway

Vault Safety now supports AS2 (system-to-system) communication to exchange E2B ICSRs with custom gateway endpoints.

Configure Custom AS2 Gateways provides more information.

EMA Gateway Submissions

Vault Safety now supports Individual Case Safety Report (ICSR) submissions to the European Medicine Agency (EMA) EudraVigilance Gateway, including support for importing and exporting ICSRs in the EMA E2B (R3) ICSR format.

Cases that include Studies or Products registered in a country in the European Union follow standard EMA-compliant reporting rules.

Configure EMA Gateway provides mofe information.

FDA Submission Rules

Cases that include Studies or Products registered in the United States follow standard FDA-complaint reporting rules.

Custom Agency Submission Rules

Administrators can assign custom Agency Organizations a Submission Rule to automatically generate regulatory Submissions.

Set Up Regulatory Agency Reporting Rules provides more information on configuring regulatory submission rules.

Partner Distribution Rules

Administrators can set up partner distributions to automatically generate Distributions to trading partners.

The following pages provide more information on configuring partner distributions:

• Set Up Partner Distribution Rules
• Set Up Reporting Obligations

E2B Case Migration

You can now migrate a Case directly from a source E2B file, bypassing the Adverse Event Report intake stage. This feature is useful to migrate external cases into Vault Safety.

Like standard Case migration, the system disables all case processing features on Imported E2B Cases. However, you can create and process a Follow-Up Case from the Imported Case.

Migrate External Cases provides more information.

Receive and Acknowledge E2B Transmissions

After receiving and importing an E2B(R3) file from another organization, Vault Safety now generates an ICH E2B(R3)-compliant acknowledgments.

Once an E2B import is complete, you can view the acknowledgment on the Inbound Transmission record. For E2B transmissions received from AS2 Gateway, Vault Safety automatically sends the acknowledgment to the origin Gateway.

Receive a Gateway Transmission provides more information.

Merge PDF Action

Vault Safety and SafetyDocs can now merge multiple PDFs, contained in a binder, into a single PDF. Administrators can configure a new action on binders to start the merge PDF process. Once generated, users can download the PDF. Only documents with a viewable rendition will be merged to the PDF.

Merge a Binder to PDF provides more information.

Vault Safety API

Vault Safety now integrates with the Vault API to introduce a publicly accessible endpoint for exchanging E2B(R3) files with trusted partners in Vault Safety.

Partners can send an E2B file using the Receive E2B endpoint, which automatically imports the ICSR into an Adverse Event Report. After a successful operation, you can retrieve an E2B(R3) compliant ACK.

The Vault Developer Portal provides more information on the Receive E2B API endpoint.

Data Model Changes

See: 19R3 Data Model Changes: Safety.

QualityOne

5 Whys Analysis

This feature helps QualityOne users to quickly identify the root cause of a problem. This feature allows users to create a visual representation of their root cause analysis which they can use to perform their investigation by asking and answering “Why?” until the root cause is identified. Learn more about 5 Whys Analysis for QualityOne.

Extensible Controlled Copy for QualityOne

Extensible Controlled Copy (previously available only for the Quality application family) is now available for QualityOne. This feature introduces a new and improved way to manage controlled copies which must be tagged for tracking before leaving Vault. Extensible Controlled Copy allows Admins to configure Vault to perform the same functions as the legacy Controlled Copy feature, while also providing for:

• Configurable capture forms: Admins can specify which fields to capture when users request different types of controlled copies.
• Separated security: Admins can now define which teams can download controlled copies, reconcile controlled copies, or both.
• Lifecycle and workflow for Controlled Copy Trace records: Object records that represent your controlled copies in the field can now be configured with a lifecycle, enabling configurable reconciliation processes complete with notifications and automation-ready access to via Vault Jobs.

To access Extensible Controlled Copy in your Vault, please contact Veeva Support. We recommend Support enablement because these features are a fundamental replacement of legacy Controlled Copy functions, and as such will require some configuration before they are fully functional. The Extensible Controlled Copy feature set will supersede all legacy functionality, and enabling it will disable all configurations and actions of the older feature.

Migration will consist of working with Veeva Product Management to discuss the pros and cons of migrating data and configurations from the old model to the new, as well as guidance on how best to adopt Extensible Controlled Copies within your organization. For users of the legacy Controlled Copy functionality, we strongly encourage you to begin discussions with your Product Advisor to understand how to most effectively incorporate the new Extensible Controlled Copy feature in your Vault. Learn more about Extensible Controlled Copies for QualityOne.

Data Model Changes

See: 19R3 Data Model Changes: QualityOne.

RegulatoryOne

Formula Compliance by Internal & Regulatory Agency Standards

Regulatory agency standards prohibit and restrict ingredient concentrations for products sold in their respective countries or regions, and companies also impose their own internal standards to ensure a product does not exceed allowable concentrations, in order to maintain compliance.

This feature provides an automated way for RegulatoryOne users to check that a submission’s product ingredients and their concentrations are compliant with regulated concentrations for the product type, the ingredient’s function within the product, and market location for the submission. Admins can create and maintain a list of regulatory restrictions which is checked when users enter ingredient concentrations for a submission, flagging any active substance that exceed the restrictions. Learn more about Formula Compliance by Internal & Regulatory Agency Standards for RegulatoryOne.

Data Model Changes

See: 19R3 Data Model Changes: RegulatoryOne.

Veeva Claims

Lightweight Project Management

Brand managers in the consumer goods industry typically work on initiatives such as new product development, product line extensions, or packaging refresh. Proposing, substantiating, reviewing and approving product marketing claims is a sub-activity of these initiatives. The Veeva Claims Project Management capability enables brand managers to initiate a project and group claims pertaining to a particular initiative in this project so that key R&D, regulatory, and legal stakeholders can track and work on the related claims as a group. Learn more about Project Management for Veeva Claims.

Comments on Projects

Working on projects is a collaborative process. Within Veeva Claims, this typically involves input from marketing, legal, R&D, and regulatory stakeholders. Capturing discussions and key decisions around projects is a natural need. This feature allows multiple stakeholders to collaborate on project records. Users can notify other users via @mentions, fostering engagement and helping to create a consolidated space within the Veeva Claims application to capture feedback. Learn more about Comments on Projects.

Comments on Claims

Crafting product marketing claims (such as iterating on the language of claim statements, and assessing risk) is a collaborative process which typically involves input from marketing, legal, R&D, and regulatory stakeholders. Providing feedback on claim statements and associated information is a natural requirement. This feature allows multiple stakeholders to collaborate on claim records using comments. Users can notify other users via @mentions in the comments, creating engagement and helping to create a consolidated space within Veeva Claims application to capture feedback. Learn more about Comments on Claims.

Data Model Changes

See: 19R3 Data Model Changes: Veeva Claims.

Quality

Multi-Document Training Requirements

This release introduces a major set of enhancements the core of the Vault Training application’s Vault Document Training Requirement type in order to support multiple documents as part of a single training assignment and to facilitate informed assessment of the impact of any changes to documents within that group of documents.

Selecting Multiple Documents in a Training Requirement For example, a training administrator may ask a user to Read & Understand both an SOP and its related form, then pass one quiz to indicate competency with both of those documents as a unit. Such training assignments present the Learner with a unified set of documents to read through in order to satisfy the assigned training.

These types of Vault Document Training Requirements are intended to solicit a single R&U or quiz response for the entire set of content, and are designed to support “All or nothing” modeling of competency against a Training Requirement.

Training administrators can configure which document versions to include as part of a Training Requirement, the order in which those documents will be presented to the learner, and can even define whether or not to force the Learner to read the documents assigned to them in a specific order. This release introduces a new administration UI for defining which documents a Training Requirement uses. This specialized UI streamlines the Training Requirement authoring flow and helps trainers select the right document versions and their ordering. It also helps enforce best practices by prohibiting modification of training documents on Training Requirements in the Retired or Available lifecycle states. Learn more about Configuring Vault Training Requirements.

Assessing the Impact of Document Changes within a Training Requirement In the event of a document change, the Vault Training application’s features are designed to support informed decision-making when assessing the impacts of that change against Training Requirements. If a Document Training Requirement consists of only a single document and no quizzes, customers can expect document metadata and document lifecycle configuration to update the respective Training Requirement upon triggering the Issue Training Assignments entry action of the document lifecycle. If the Training Requirement affected by the document change has more than one document, or has a quiz, then Vault is capable of starting a Training Requirement Impact Assessment process to ensure that trainers make informed decisions about updating training based on document changes.

Training Impact Assessors (a role selected on the document which copies to the Training Requirement Impact Assessment record) will receive a task with a Vault record which describes the Training Requirement impacted, the document versions, and the quiz currently in use by the Training Requirement, and a suggested set of new document versions to update the Training Requirement to use. By editing the Training Requirement Impact Assessment’s fields and related documents or quiz sections, and providing a verdict indicating how to update the Training Requirement, Training Impact Assessors can indicate the new documents to use for the Training Requirement, a new quiz if desired, and can indicate whether or not to cancel existing Training Assignments as well as whether or not to re-issue completed Training against that requirement. The types of verdicts supported for Training Requirement Impact Assessments in this release are:

• Update the Training Requirement with the information described on the Training Requirement Impact Assessment’s fields. This will run immediately, or as soon as possible, based on whether your organization uses the “Trainable States” feature.
• Retire the Training Requirement as a result of this document change.
• Wait for additional documents before updating this Training Requirement. In some cases, a Training Requirement may include an SOP which may become Approved before the Form has been approved. This verdict indicates a postponement of the impact analysis until the remaining documents have been changed.
• No Impact: This verdict will cause the Training Requirement to not be updated with the new document version, and will not change the Training Requirement in any way, the impact assessment process will end here.

The language of these verdicts is completely configurable. Learn more about Training Requirement Impact Assessments.

Enhancing the Vault Training Data Model

This release comes with data model updates to all existing Vault Training production Vaults in order to support this transition, and introduces changes to existing Vault Training entry action behaviors to support the new model. Vault will migrate all existing Training Requirements and Training Assignments to the new data model automatically, with no action required by the customer. Data model changes are listed in 19R3 Data Model Changes: Quality.

Instructor-Led Training

In previous releases of Vault Training, Learners could complete Read & Understand on documents based on the training matrix defined by an organization and absorb the content at their own pace. However, certain content and topics (for example, annual GxP training or Quality Event SOPs) are often taught and delivered by an instructor in a group setting.

To support this type of training, this release introduces Instructor-led Training as a new Training Requirement type. The feature enables an organization to define and manage aspects of instructor-led and classroom training, such as:

• Publishing a schedule of classes
• Defining location and time of classroom training
• Materials taught in the class
• Building a roster of Learners
• Tracking Learner attendance
• Issuing a quiz during the class

Learn more about Configuring Classroom Training.

Learner Task Page for Document Training Assignments

To support many of the new features introduced to Vault Training in this release, we have enhanced the user interface and experience for Learners completing document training in Vault. Our focus here is to meet several long-standing enhancement requests around Read & Understand document training within Vault. This release introduces a new Learner task page experience with the following features:

• Support for multi-document training, providing a list of documents included as part of the Training Assignment, including visual indications to help learners keep track of which documents they have read
• Visual indications for Learners who have been assigned training on content that they are unable to see because of security settings
• Configurable ordered-reading lists to guide learners to read the documents in a Training Assignment in a specific order
• The ability for Learners to toggle between reading the document’s content and viewing the document metadata or version history while completing document training
• Introduction of a task information bar at the top of the Learner’s task page, including task descriptions and due date color treatments
• Hovering over a training item listed in the Document Selector of the Learner’s Task page displays a hovercard, which Learners can use to open two documents within the same assignment for side- by-side learning.
• The Complete Training or Take Quiz button is unavailable until the Learner has at least opened every document assigned to them as part of the assignment

These changes are immediately visible in all Vaults using Document Training Assignments within the Vault Training application, and do not require configuration to enable. These changes do not affect Vaults using the platform R&U workflow functionalities. Learn more about Completing Vault Training Assignments.

QMS Spark Connection: Change Control & Variation Management

This feature leverages the Vault Spark framework to connect QMS Vaults to Registrations Vaults, streamlining the variation process for manufacturing change controls. When enabled, this feature automatically creates Event records in the RIM Registrations Vault when a new Quality Event record is sent for regulatory impact assessment in the QMS Vault. Once the regulatory assessment is complete, QMS users will receive live updates of country approval status based on the Activity records in the Registrations Vault.

The key integration points between the two systems include:

• QMS triggering the creation of a Regulatory Event
• QMS receiving a message of a completed Regulatory Impact Assessment
• QMS sending a message of the Change Control being Approved for execution
• Receiving status updates from the associated RIM Event Activities.

Learn more about the QMS to Registrations connection.

Training Requirement Recurrence Enhancement

A new Vault Training recurrence option, Absolute, is now available for Vault document and classroom Training Requirements. The Absolute recurrence option issues training tasks to Learners on a fixed date, such as “August of every year”. Learn more about Configuring Vault Training Requirements.

Job Logging

This Vault Training feature enhances the log file for the Update Training Assignments job to provide additional detail about what the job did during its run. The enhanced log lists a count of changes that were flagged for processing, changes that were processed, and count of changes. The log also lists any errors that occurred during the job run, and details about such errors. Learn more about Vault Training Automation.

Quality Teams: Cancel Role-Assigned Task When User is Removed from Role

This feature helps streamline Quality Team member reassignment. Feedback we received on the initial design stated that reassignment and role removal were too complicated. Before this release, if a user was assigned a task through being a member of a Quality Team Role, and that user was removed from that Quality Team Role before they could complete the task, the task would remain assigned to them. This would occur even if they were unable to complete the task, now that they were off the team.

Now, Vault will intelligently issue and cancel tasks for Quality Team Role member changes when a workflow has a task issued to all members of a specific team role. This makes team role reassignment feel more natural, and eliminates manual steps during reassignment which were necessary before this release. This change also supports the Team Role Membership cascade configurations.

Veeva will automatically enable this feature for all customers using Vault Quality’s Quality Teams feature set. This enhancement does not affect task issuance or reassignment for Vaults or processes which do not leverage Quality Teams. Learn more about Working with Quality Teams.

Copy Custom Fields

This Vault Training feature allows custom field data value copying from Training Requirements to Training Assignments. This can aid in giving access to Training Assignment records beyond Learners. The feature works by copying custom field values with identical names from a Training Requirement to the Training Assignment record. Custom sharing or matching rules can be configured against those custom field values to determine who can have record access. Learn more about Configuring Vault Training.

Vault Quality Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality. See 19R3 Data Model Changes: Quality for details.

Regulatory

Hierarchy Viewer Enhancements for Regulatory

This release includes enhancements to the Hierarchy Viewer to improve the appearance and usability of the grid pane and the tree pane in RIM Vaults.

In the grid pane, the Name column is now frozen when scrolling horizontally so users can always see which records they’re editing. The horizontal scroll bar is also always visible at the bottom of the grid. This lets users scroll horizontally without having to scroll to the bottom of the grid to locate the horizontal scroll bar.

In the tree pane, users can access the Actions menu for each record in the tree. Text is also wrapped so that it is no longer cut off in the pane.

See the Hierarchy Viewer Enhancements in 19R3 video to see how these new features work.

Open Record Details in the Pop-Out Viewer from the Hierarchy Viewer

Users can now open object record detail pages in a pop-out viewer directly from the Hierarchy Viewer grid pane. Within the pop-out viewer, users can traverse through the record details pages for the records currently displayed in the Hierarchy Viewer. This makes it easier to access relevant information and perform actions on the current record and related records without losing the context of the content plan structure.

Regulatory Buttons & Breadcrumbs

This release provides additional navigation options in various RIM applications. These new navigation aids allow users to easily traverse content plans, the Hierarchy Viewer, the Submissions Archive Viewer, and Application and Submission records:

• The content plan Hierarchy Viewer contains breadcrumbs that allow for quick navigation to the primary Application, Submission, or root Content Plan record.
• The Submissions Archive Viewer contains links to object record detail pages for the Application or, when filtered, Submissions.
• Application records that have one or more imported or published dossiers include a button to navigate to the Submissions Archive Viewer.
• Submission records that have a related content plan include a button to navigate to the Hierarchy Viewer.
• Submissions with an imported or published dossier include a button to navigate to the Submissions Archive Viewer from the Submission record or the Hierarchy Viewer.

Canada XSD 2.2 & Validation

With this release, RIM Submissions Publishing Vaults support the CA HC v2.2 (XSD 2.2) specification. Users can now create content plans and generate submissions that are compliant with CA HC v2.2 specifications. Vault validates these submissions based on the corresponding CA HC v4.4 Validation Profile. Learn more about working with CA regulatory submissions.

Canada Submission Gateway Support

Canada Submission Gateway Support provides the ability to use the Vault FDA gateway profile to send submissions to the Health Canada (HC) Center directly from a Submission record. Vault captures and loads acknowledgments sent from the FDA into the applicable Submission record within Vault. Learn more about configuring gateway profiles and sending submissions through the FDA Electronic Submissions Gateway (ESG).

EU EMA ESUB Gateway Integration

This feature provides the ability for Vault Admins to set up an EMA gateway profile within Vault. Users can then send submissions to the EMA Electronic Submissions (eSUB) Gateway directly from a Submission record. Vault captures and loads acknowledgment responses sent from the EMA into the applicable Submission record within Vault. Learn more about configuring gateway profiles and sending submissions through the EMA eSUB Gateway.

Bundle Regulatory Objectives

This feature expands on the ability to group planned regulatory changes into a single submission by allowing users to start the bundling process at the Regulatory Objective record level rather than the Activity record level. The wizard guides users through a process of bundling regulatory objectives while updating associated reference relationships. Learn more about bundling regulatory objectives.

Registrations Spark Connection: Change Control & Variation Management

This feature leverages the Vault Spark framework to connect QMS Vaults to Registrations Vaults, streamlining the variation process for manufacturing change controls. When enabled, this feature automatically creates Event records in the RIM Registrations Vault when a new Quality Event record is sent for regulatory impact assessment in the QMS Vault. Once the regulatory assessment is complete, QMS users receive live updates of country approval status based on the Activity records in the Registrations Vault.

The key integration points driving the connection include:

• Vault sending a Spark Message to Registrations upon creation of a change control with regulatory impact in QMS
• Vault sending a Spark Message to QMS upon creation of an Event record in Registrations
• Vault sending a Spark Message to QMS after an impact assessment is completed in Registrations
• Vault sending a Spark Message to Registrations when the change control is approved in QMS
• Vault sending a Spark Message to QMS each time a country’s Activity record is updated in Registrations
• Vault sending a Spark Message to Registrations when a change control is closed in QMS

Learn more about the QMS to Registrations Spark Connection for change control and variation management.

Enhancements to Create Registrations Wizard

This release provides several enhancements to the bulk creation process for registrations to improve the user experience and better support customers with different registration types, such as drug products or medical devices:

• Admins can configure different registration scopes for the same country depending on the registration type.
• Admins can optionally configure the object type with which the bulk create wizard creates registered details based on the registration type the user selects.
• The bulk create wizard now copies custom field values from submission join records to the corresponding registered detail records as long as custom fields with matching names and field types are configured on both objects.
• Vault now automatically relates the Regulatory Objective selected in the bulk create wizard to the newly-created Registration records.
• Labels in the bulk create wizard UI now use object and field labels instead of static text to better match customers’ Vault configurations.

Learn more about bulk creating registrations and investigational registrations.

Dynamic Labels in Impact Assessment Report Prompt

In the Impact Assessment Report start dialog, the options in the Impact Report Type and Report Scope drop-downs now display Admin-defined object labels and object field labels to represent customers’ Vault configurations. Learn more about Impact Assessment Reports.

XEVMPD Gateway Submission

This feature allows Vault Admins to set up an EMA gateway profile within Vault. Users can then submit Vault-generated XEVPRM messages to the EMA directly from a Product Data Submission or Product Data Message record. This feature also allows Vault to capture acknowledgement responses throughout the EMA review process. Learn more about submitting to the EMA XEVMPD gateway.

Merge Published Documents into a Single PDF

Vault can now merge published PDF documents into a single PDF file as part of report level publishing. Allowing users to create documents separately and merge them later speeds the authoring process. The merging process checks whether the files are valid PDF files and converts relative path links and bookmarks to internal document links. Vault then places the merged PDF in the Submission Ready binder along with any unmerged documents. Learn more about merging published documents into a PDF.

The following limits apply to merged PDFs:

• Maximum page limit: 20,000
• Maximum file size limit: 2 GB
• Maximum hyperlinks: 5,000

Validation Results Archiving

This release introduces a new standard job that allows Vault to archive validation results from previous publishing activities, allowing users to reference validation results without cluttering their Vaults with unnecessary records. The job creates an archive package ZIP file containing validation results, adds the ZIP file as an attachment on the Submission record in RIM Submissions Publishing Vaults or the Report Level Content Plan record in RIM Submissions Vaults, and deletes the archived Submission Validation Results records. Learn more about validation results archiving for published submissions and report level content plans.

This feature is automatically available on all RIM Submissions and RIM Submissions Publishing Vaults but only impacts Vaults currently using the Inline Validation Results feature. Contact Veeva Support to enable Inline Validation Results on your Vault.

Dynamic Linking for Publishing

This feature extends Dynamic Linking functionality to RIM Submissions Publishing Vaults. Users authoring submission content can now create cross-document links targeting bookmarks and destinations within Vault in any file that Vault can render. When users create these predefined links in MS Word™ documents, the links remain valid and target updated content, even as the document content changes throughout the authoring process. Learn more about using Dynamic Linking.

This feature is automatically available on Vaults with Dynamic Linking configured for report level content plans. If your organization hasn’t enabled Dynamic Linking in this past, your Admin must configure your Vault to use it.

Dossier Import to Multiple Submissions

When the same dossier files are applicable for multiple submissions across applications, users can now import the dossier to all submissions using a single bulk action.

From a list of Submission records or a report using Submission as the primary object, users can initiate a bulk action to import dossier files from an uploaded ZIP file or a location on the FTP. When complete, Vault queues the selected dossier for import into each of the selected submissions. Learn more about importing a dossier to multiple submissions.

Dossier Review Mode

When users open documents from the Submissions Archive Viewer tab, the dossier’s outline now displays in a left panel on the Doc Info page. From within the panel, users can navigate through the dossier outline to open additional content without needing to return to the Viewer tab. Vault enforces the filters applied in the Viewer within the dossier review panel to display the same content. Learn more about dossier review mode.

Simplified Navigation to the Submission Ready Binder

A new icon allows users to navigate to a published report level content plan’s Submission Ready binder directly from the Hierarchy Viewer. Users can also access the icon and View Submission Ready Binder action directly from Content Plan and Report Level Content Plan object records.

Create Inactive Records Using Content Plan Template Constraints

This feature extends existing Content Plan Template Constraint functionality by allowing users to create inactive Content Plan records in addition to excluding irrelevant records from content plan creation. Creating inactive records provides users with an easy option to update the content plan if a section that was excluded originally needs to be included in the content plan later. Learn more about content plan filtering.

Updates to On-Demand Publishing & Hyperlink Handling

When users run on-demand publishing, Vault now publishes and runs validation on all documents that contain links to the published document. This allows Vault to keep all document links current throughout the on-demand publishing process.

Vault runs the publishing job on the related documents regardless of the values in the Continuous Publishing and Continuous Validation fields on the Content Plan Item or the Ready for Publishing field on the document. Learn more about on-demand publishing.

Allow Multi-Select on Standard Document Fields

With this feature, Admins can configure the following document fields to be multi-select:

• Drug Substance (drug_substance__v)
• Clinical Study (clinical_study__v)
• Excipient (excipient__v)
• Manufacturer (manufacturer__v)
• Nonclinical Study (nonclinical_study__v)
• Product (drug_product__v)
• Product Variant (product_detail__v)
• Country (country__v)
• Therapeutic Indication (therapeutic_indication__v)

You must contact Support to enable this feature. Once this feature is enabled, Admins can configure these fields to be multi-select.

Regulatory Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality. See 19R3 Data Model Changes: Regulatory for details.