What’s New in 18R3

Pre-Release Date: October 29, 2018 | Release Date: November 16 & November 30, 2018

We are pleased to bring you Vault 18R3. Read about the new features below. You can find information on enabling new features in 18R3 Release Impact Assessment. Information on developer features (API, VQL, etc.) is in the Developer Portal.

We are pleased to bring you Vault 18R3. Read about the new features below. You can find information on enabling new features in the Release Impact Assessment.

Vault Java SDK

The Vault Java SDK is a powerful tool to apply custom business logic by programming solutions in Java. It provides complete development and deployment lifecycle support from coding and debugging in an IDE to migrating code from sandbox to production vaults.

Documentation and sample code are available in the Developer Portal. The Developer Community can provide additional details.  

Record Triggers

This feature allows customers to apply custom business logic before and/or after records are created, edited, or deleted. Organizations can use record triggers to improve data quality by performing complex data validations and field value defaults. Record triggers can also automate business processes by starting workflows, changing lifecycle states, or creating related records. Record triggers are written in Java programming language.

Record and Document Actions

Record and document actions allow customers to provide custom logic that users invoke from a record or a document. These actions can also be developed as document lifecycle entry actions. Record and document actions are written in Java programming language.

Interactive Debugger

This feature allows developers to develop code in their own familiar IDE and debug their code locally by stepping through to troubleshoot issues. The debugger allows developers to easily test their code before deploying it to Vault for others to test or use. Separately, a Debug Log is available to troubleshoot issues with deployed code running in production.   

Code Deployment

With his functionality, developers can deploy code from their local file system or source control build automation tools to Vault. Code is easy to upload and deploy using Vault’s Configuration Migration Tool. Admins can also migrate code from sandbox to production vaults using this tool.

Admin UI

This feature allows developers and Admins to view lists of code deployed in a vault. Admins can also use this UI to download the source code and perform other actions.

Vault Objects

Currency Data Type

This feature allows customers to configure currency fields on a Vault object. Currency fields are useful for payments tracking or any expense-related functionality. Customers can:

  • Use predefined currencies in Vault or add their own currency types.
  • Configure the list of currencies and their rates.
  • Allow users to select a currency type when entering values in a currency-type field.

In addition to primary currency, we support a single corporate currency in Vault that is useful for accounting and reporting. Learn more about setting up currency fields.

Parent Field Default

In past releases, we did not allow customers to default the value of a Parent Object-type field. This release expands field defaulting, allowing administrators to configure a default value for a Parent Object field. Default values must be tokens for fields that reference the same object as the Parent Object field. Learn about setting object fields defaults.

“No Operation” Action on Object Jobs

Scheduled jobs on Vault objects can now use No Operation as their primary action. This configuration allows Admins to create jobs that send notifications prior to the trigger date without taking any actions on the records that meet the job criteria, which allows notifications to alert users that an important date is approaching. Learn more about job scheduling.

Pagination for Object Record Bulk Actions

When users initiate a bulk action on more than 25 object records, they will see pagination for the records. Each page displays up to 25 object records. Note that the select all checkbox in the grid heading will select records on all pages and users can navigate between the pages without losing their selections.

Object Workflows

Exclude Workflow Participant by Role

This feature adds additional levels of control for who can be a participant on an object workflow. In addition to defining which roles can complete a task, Admins can now specify which roles are not allowed.

For example, a workflow may require that a member of the QA team provide final approval on an object record. However, the business process requires that final approval come from someone other than the record owner. To set this up, the organization would restrict the workflow participant group to members of the QA team, but also define that the user in the record’s Owner role cannot be assigned. Learn more about configuring object workflows.

With this release, Vault introduces an object workflow step that can verify if any member of the workflow participant group lacks access to the object record’s related documents. For this, Vault uses application roles and mapping to document lifecycle roles. When executing the new Check Participant Access to Related Documents step, Vault verifies that members of the workflow participant group also belong to at least one specified application role on all related documents. Workflow creators can configure granular checks on documents linked to the object record through specific relationships and check membership against a set of document lifecycle roles. When the workflow runs, Vault populates a workflow variable or a workflow component where Vault captures workflow data at runtime which an Admin can later reference to define decision steps, if any user lacks membership to the specified roles for one or more documents.

There are two ways that Admins can configure a workflow to take advantage of this feature:

  • A decision step in the workflow can verify whether the variable “is blank” or “is not blank.” If not blank, at least one workflow participant does not have the necessary access on at least one document. In this case, an Admin can then include a Workflow Task step to assign all users appropriate document permissions before continuing the workflow.
  • A notification step can alert the workflow initiator or other users that there are problems with participant access to documents. Using the variable in the notification gives the user the detail needed to address the access issue.

This feature is available for configuration in all object workflows. Learn more about configuring the Check participant access to related documents system action.

Add Participant Action for Workflow with “Use Roles as Participants”

Currently, for object workflows configured with the Use roles as participants control in the start step, the only way to assign active tasks to new participants in a role is by adding the participant directly to the designated role via manual assignment in Sharing Settings. In this release, users can now assign active tasks to new participants using the Add Participant action in the workflow Actions menu. The Add Participant action may be useful for assigning tasks to any new users who’ve been added to the role through sharing rules. Learn more about adding participants to active object workflows.

Working with Documents

Vault Digital Publishing

We released Vault Digital Publishing (previously called Vault CDN Support) in 18R2 as an early adopter feature. Vault Digital Publishing is now available for all customers to enable through an Admin Checkbox. Learn about Vault Digital Publishing.

Vault Digital Publishing Tracking

Vault Digital Publishing Tracking allows customers to pull aggregated CloudFront usage data back into Vault for reporting and analytics purposes. Once this usage data is in Vault, customers can utilize existing report and dashboard capabilities to gain greater operational and analytic insight into how content published through Vault Digital Publishing is being utilized. Learn about Vault Digital Publishing.

Automatic EDL Item Locking

This feature adds an EDL-level option to automatically lock matched document versions to an EDL Item once the document enters Steady state. Once locked, Vault no longer tries to match new document versions to the EDL Item through continuous matching or the match job.

Setting the Lock Matched Documents on Steady State field to Yes will prevent the Completeness field on EDL Items from changing from Complete to Not Started or In Progress when a matched Steady state document is up-versioned to a non- Steady state. Learn more about automatic document version locking for EDL Items.

This feature is auto-on in vaults with Custom EDL Item to Document Matching enabled. Contact Veeva Support to enable Custom EDL Item to Document Matching to use this feature in other vaults.

Anchor Management

We are introducing a new permission, Manage Anchors, that provides more control and efficiency with anchor annotations, a critical component of reference linking and reference management in Vault.

This new permission, once granted, allows users to perform certain key functions, including the ability to move (re-position in the document) and delete any other users’ anchor annotations, so long as the anchors are not in use (no inbound references). In-use anchors cannot be moved or deleted.

Users can also now move their own empty anchor annotations, even without the Manage Anchors permission. Users already have the ability to delete their own empty anchor annotations.

Bring Forward Anchors

This enhancement allows users with the Manage Anchors permission to copy anchor annotations to the latest version of a document. This ability provides greater consistency and efficiency in the reference linking process. Anchors are brought forward “empty,” meaning that they have no inbound references, and become available in the Select Anchors dialog. All existing references to anchors in the source version remain unchanged.

Brought forward anchors can be auto-placed (if enabled) or created at the page level, depending on configuration and the original annotation selection type.

Users can delete empty anchors brought forward from a prior version using the Remove brought forward annotations action. Users with Remove Annotations permission can also remove anchors brought forward by other users unless those anchors are in use.

For organizations that do not wish to use this feature, Admins can disable this functionality in Admin > Settings > General Settings by clearing the Anchors option under Allow users to bring forward annotations. Learn more about bringing forward annotations.

Bulk Action Document Archiving

The Document Archive feature supports organizations with large archives of documents that are no longer relevant in day-to-day operations. In past releases, users could only archive a document by setting a document field via the API. In this release, users can move documents in and out of the archive by performing a bulk document action in the Vault UI.

This new action is automatically available on any vaults with the Document Archive feature enabled, to any users with the Manage Archives permission. Learn more about Document Archive.

Merge Fields: Record Filtering within Traversed Records

Today, when merging data into a document via Merge Fields, Vault merges all values related to a document field specified in the token. This results in excess data within the document. This feature extends existing Merge Fields capabilities, allowing for filtering on the related object values rendered in a Microsoft Word™ (DOCX) document. Vault can filter records when an Admin includes a VQL WHERE clause and operators as part of the Merge Fields token. The ability to filter is especially important if only specific data is needed from related objects. Learn more about filtering with merge fields.

Version Description & Version History Enhancements

This release includes a number of UI enhancements that make it easier for users to track and understand a document’s version history:

  • The Description labels that appear when checking in or versioning a document are now labeled Version Description to provide better clarity.
  • When checking in from Office Online or creating a new draft, users can now add a Version Description.
  • In the Doc Info page, the Version History panel now shows a comment bubble when a version has a description.
  • Both the Doc Info page Version History panel and the pop-out Version History window display an icon indicating the MIME type for each version, so users can quickly access the versions they need.
  • The Version History pop-out window offers the standard Edit Columns functionality and allows users to modify the metadata that displays. This improvement enables users to see how metadata changes between versions, for example, tracking changes to the page count or number of annotations.
  • With the Doc Info page Version History panel and the pop-out Version History window, the Compare Versions and Delete Version actions are now located within an Actions menu.

Render Native-Resolution Images for Raster & Vector Images in Word Files

Two new Vault-wide rendition options are available for Word™ documents (DOCX files). To enable these settings, customers must contact Veeva Support:

  • Vault down-samples raster images to 220ppi by default in the viewable rendition. The first setting, Render native-resolution images for raster images in Word files, preserves the native resolution. This functionality supports PNG, JPEG, and TIFF image formats. Note that users must also enable the “Do not compress images in the file” setting in each Word™ source file.
  • Render native-resolution rasterized images for vector images in Word files renders native-resolution rasterized images for vector images (EMF and WMF formats). This avoids issues with vector images where some characters or lines may not get properly rendered. Note that this makes text in images non-searchable in the viewable rendition.

Bulk Create Document Relationships Update

In past releases, the bulk document action for creating document relationships only supported certain custom relationship types: those with the __c suffix in the relationship name. In this release, users can also bulk create document relationships for any relationship type that uses the __vs suffix.

Only vaults created before 2015 (or cloned from pre-2015 vaults) include relationship types with the __vs suffix.

In order to provide performance enhancements for Legal Hold, Vault will now only populate the Document Name and Document Version fields on Legal Hold items if a document is deleted from the vault. Previously, Vault populated these fields when the Legal Hold was lifted from the documents.

Document Lifecycles & Workflows

Multi-Document Workflow

This significant workflow feature enables Admins to configure workflows to send a set of documents in a single workflow instance. Users can send up to 100 documents from the Library, Cart, Binder Section, or Reports for review and/or approval. Workflow task recipients view the set of documents and provide verdicts on individual documents in the new multi-document workflow viewer. Multi-document workflow supports the ability to prompt for verdicts on each document and determine independent outcomes for each document based on those verdicts. Learn about configuring and using multi-document workflows. 

Document Lifecycle Field Dependency

This release introduces a new way to restrict the visibility or editability of individual document fields: the Controlled by document lifecycle option for field dependencies. With this feature, Admins can modify behavior for individual document fields based on the document lifecycle, document lifecycle state, and the user’s document lifecycle role.

For example, an organization may want to generally lock down fields for documents in the Approved state, but allow users in the Approver role to edit just a few fields. To accomplish this, that organization would configure security settings on the Approved state to remove Edit Fields permission on all roles except Approver. The organization could then use the new Controlled by document lifecycle field dependencies to set specific fields as Visible and the remaining fields as Read-only for users with the Approver role.

Learn more about document field dependencies.

Auto-Calculate Task Due Date

Admins can now configure document workflow tasks with calculated task due dates based on offsets from Workflow Start Date, Task Creation Date, or any date control configured on the workflow start step. If the task due date is based on the Workflow Start Date or Task Creation Date, the workflow initiator will not need to provide any information for the task due date when starting the workflow. Learn more about configuring document workflow tasks.

Document Lifecycle State Entry Action to Set DateTime Fields Using a Formula

Admins can now configure document lifecycle entry actions to set DateTime fields using a formula. For example, when a document enters the Approved state, the entry action could set the Approval Date to the current date and time. Prior to this feature, the Set field using formula entry action did not support DateTime fields.

Synonyms

The Synonyms feature allows Admins to import a custom thesaurus into Vault for use in a search. This can help users find more relevant search results by automatically searching other words that have the same meaning as the terms they entered in the search box.

Once a thesaurus is added, Vault looks up each term in a user’s text search against entries in the thesaurus. If any entries are found, the search expands to find matches for the synonyms of that entry, as well as the user’s original search term.

You can use synonyms to expand searches in several ways:

  • Drugs (Brand/Generic): Advil > Ibuprofen
  • Symptoms: Pain > Discomfort
  • Diseases: ALS > Lou Gehrig’s disease
  • Acronyms: NYC > New York City

You can upload a thesaurus in any Vault supported language so synonym expansion is specific to the user’s preferred language.

Search with Filters

This feature brings enhancements to search functionality across all Vault applications. Vault now allows users to search with filters applied. When a user adds or modifies a search term, all previously selected filters will remain applied to the results, allowing the user to filter first and search after. This functionality works with any view, meaning that users can search within saved views as well.

Reporting

Line Charts

This feature allows users to configure Line Charts on their dashboards. Currently, Vault dashboards support Gauge, Number, Column, Bar. and Pie charts. Line charts show data similar to column and bar charts, but better showcase many data points with a continuous x-axis, such as a time series. Vault supports both single line and multi-line charts. Learn more about creating line charts.

Flash Report Refresh

This feature provides customers with the option to refresh their flash reports on demand. Flash reports provide significant data speed and distribution benefits to customers. However, users cannot see data in real time. Some users address this issue by creating two versions of the same report: a flash report to review data in the morning, and a standard report that they can refresh throughout the day. The ability to refresh a flash report prevents customers from having to create and maintain two separate reports. Learn more about refreshing flash reports.

Reporting on Groups

Reporting on Groups enables customers to quickly understand which users are members of which groups and which groups are associated with which users. Admins in particular are assisted with general group and user management including regular audits and reconciling with external systems. Learn more about Creating and Managing Groups.

Group Date Fields on Reports by Day or Year

This feature allows customers to group Date and DateTime fields on reports by Day or Year. Currently, users can group by Week, Month, and Quarter.

Documents Reportable from Objects

This feature allows customers to build reports that include both objects and a document when a document reference field is defined on the object. Currently, reports can only show the document name and version. This enhancement allows users to include all attributes from the document. Learn more about reporting on document fields.

Formulas

Today() Supports User Parameter

When creating formulas, the today() function allows Vault to insert the current date. In past releases, today() always used the current date in the Vault timezone. This enhancement adds the “user” parameter, which allows Vault to insert the date in the current user’s timezone.

Include Decimals for DateDiff Calculation with DateTimes

When Admins define document formula fields that calculate the difference between two DateTimes, Vault can now display decimal places in reports that reference these fields, providing more accurate calculations.

DateTime Grouping Based on Local Time

When users define a report group based on a DateTime field and period, the Vault calculation now groups the DateTime values based on the user’s local time instead of UTC. This change ensures consistency between a record’s displayed DateTime and the group it is included in.

Vault Administration

Configurable Tab Status

Vault tabs will support a new status property that can be set to Active or Inactive by an Admin. Inactive tabs are not visible in the UI. This feature provides Admins with the ability to make tabs available in their vaults when they deem it appropriate. Learn more about configuring custom tabs.

System Audit History for Vault Loader

With this enhancement, the System Audit History now includes entries for each event in Vault Loader, both uploads and extracts.

As in previous releases, changes initiated through Vault Loader will also show entries in the Document Audit History and Object Record Audit History.

Permission Sets Included in Vault Configuration Report

This release enhances the Vault Configuration Report by including permission sets in the export. With this update, customers can better document the complete configuration of their vaults.

Component Modified Date for Configuration & Compare Reports

With this release, we’ve enhanced the Vault Configuration Report and Vault Compare Report to include the Modified Date for all components.

Configuration Migration Support for Report Share Settings

Now, when Admins migrate their reports using Configuration Migration, the report will include the Share Settings.

Configuration Migration Support for Vault Java SDK

Admins can create an outbound Configuration Migration package containing Vault Java SDK code and then import and deploy it to another vault. They can also extract and compare summary information about Vault Java SDK code via Vault Configuration Report and Vault Compare.

Admin UI for Vault Java SDK Document Actions

Admins can now view lists of custom Document Action code deployed to their vault. The list pages are view-only. Organizations can develop custom code using the Vault Java SDK. To inquire about Vault Java SDK solutions, contact Veeva Services.

Visibility for Workflow Configuration Version

Each time an Admin modifies a document workflow and re-activates it, Vault creates a new workflow “version.” Admins can now see a workflow configuration’s current version from the workflow details page. In the document audit trail, users will also see the workflow version with each entry for starting a workflow.

Authentication & Security

User Security

When users from different organizations are accessing the same vault, the hosting company may want to restrict user visibility based on a user’s organization, or other business rules. For instance, an organization could restrict visibility so that partner users see only users from their own organization.

In 18R3, customers can configure DAC (Dynamic Access Control) on the User object. Although user security shares some common capabilities with the Hide User Information feature, configuring DAC on the User object provides a more granular and powerful way to secure access to User records. Vault enforces user security in the UI and API.

In addition to the standard DAC behavior, this feature allows Vault to mask user information on object records, workflow tasks, and documents that reference non-visible users in the following ways:

  • A non-visible user is referenced as ‘Vault User’
  • The profile image of a non-visible user is hidden

Learn more configuring DAC on the User object.

Vault Context in Login Audit History

Certain logins occur at the domain level. When such login events occur, their login audit records are visible across all vaults in the domain. Admins in multi-vault domains need to know the specific vaults where a user logged in. This feature exposes the Vault ID for individual login events when the Login Audit History is downloaded as CSV or PDF. Vault-specific login events will have the Vault ID logged, while the login events which are domain-level will not. This information does not appear in the UI. Learn more about login audit history.

Hide Locked Components in Permission Sets

“Locked” objects and tabs are those which Vault has provisioned, but which are not available to use through the UI or API. Typically, objects and tabs are locked because they belong to an application that your organization has not licensed or a feature that has not been enabled.

We’ve added a new Show locked / Hide locked toggle on the Objects and Tabs permission pages within permission sets. This toggle is set to Show locked by default. Hiding locked objects and tabs allows Admins to focus only on the items that are relevant to their organization.

OAuth 2.0 / OpenID Connect Profile Enhancements to Support ADFS

With this feature, Vault is able to support ADFS as the Authorization Server for client applications which integrate with Vault using OAuth 2.0 / OpenID Connect protocol, such as Vault File Manager. This feature will allow configuring the Authorization Server Type and will improve the AS Metadata validation rules based on the selected Authorization Server Type. Learn more about configuring OAuth 2.0 /OpenID Connect profiles.

Disable TLS v1.0, TLSv1.1, and Weak Ciphers for HTTPS

Veeva Vault will no longer support HTTPS connections using TLS 1.0 and 1.1 and will require a TLS 1.2 or higher in order to align with industry best practices for security and data integrity. Web browsers and Vault API integrations using TLS 1.0 or 1.1 will be unable to access Veeva Vault. Find more information in the Developer Portal.

Vault File Manager

Vault File Manager: ADFS Support

This feature extends Vault File Manager OAuth support by adding ADFS as a supported identity provider in addition to Ping Identity. Users whose accounts are configured to utilize ADFS can now authenticate in Vault File Manager. Learn more about ADFS support for Vault File Manager.

Quality & QualityOne

Vault Training

Vault Training is the newest addition to the Quality Suite of applications. Veeva Vault Training manages role-based qualification and training to support job and audit readiness and demonstrate compliance. It gives companies the tools necessary to deliver the right content to the right learners. As part of the Veeva Vault Quality Suite, content development, changes and delivery, and role readiness become a seamless, continuous lifecycle. The application automates the dissemination of Training Assignment records to users based on changes to the Learner Roles, Curricula, and Training Requirements object records. Additionally, document revisions managed in QualityDocs can automatically trigger Training Assignment records, tying critical document workflows to training actions.

Training Manager Home Page

Vault Training applications come with a preconfigured dashboard for training administrators that highlights key metrics related to Training Assignment records. These metrics allow an organization to monitor the health and progress of their training programs.

The metrics on the dashboard include the number of overdue assignments, users with the most overdue assignments, and total hours remaining for assignments. The dashboard also supports drilling down to the source reports that define each metric, as well as filters that apply to the dashboard charts directly.

Extensible Controlled Copy

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 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 new Extensible Controlled Copy feature set will supersede all legacy functionality, and enabling it will disable all configurations and actions of the older feature.

For a limited time, Veeva will support configuration migration from the old Controlled Copy model to the new Extensible Controlled Copy configuration. Migration will consist of working with a Veeva team 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 Enhanced Controlled Copies within your organization. We strongly encourage every QualityDocs customer to begin discussions with your Customer Success Manager or Project Team to understand how to most effectively incorporate the new Extensible Controlled Copy feature set in your vault. Learn more about downloading Extensible Controlled Copies.

Checklist Design Preview

With Checklist Preview, Business Admins who are building checklist designs can verify that the questions, answers, and dependencies are working correctly without making the checklist design available. The Preview Checklist Template action is available through the Checklist Design record’s Actions menu on Draft, Approved, and Inactive lifecycle states.

When users preview, they can interact with a functional response UI in order to see how all the elements will work once the design is approved. Learn more about previewing design checklists.

Checklist Question Library

Many times, individual checklist designs share identical or very similar questions. With the Question Library, organizations can set up template questions to streamline the checklist design process. When Admins build a checklist design, they can select Library Question records to default all the values for a question and, when applicable for multiple choice questions, the available answers. The defaulted values are editable, so users can modify a question if needed, but still benefit from the streamlined process. Learn more about checklist question libraries.

Checklist Scoring

This release introduces scoring and weighting capabilities for the Checklist feature. Using Checklist Scoring, a Business Admin can assign score values to individual answer choices on multiple choice questions, allowing Vault to calculate a total checklist score when the checklist is completed. If needed, an Admin can also weight each section of the checklist differently, placing more importance on one section than another. Learn more about question scoring.

Checklist Scoring provides a way for your business to assess performance, make comparisons over time, or compare two entities. For example, Checklist Scoring could enable an organization to assess risk associated with an impact assessment for a change control or conduct supplier assessments using Vault.

Checklist Cascade Delete for Checklist Designs

With this enhancement, Admins can delete a checklist design and all related records (section designs, question designs, available answer designs, and dependency designs) in a single step. This update allows Admins to more easily maintain checklist designs.

This action is only available on designs that are currently in Draft or Inactive lifecycle state. It is not available on any checklist designs that have already been used to create a checklist. Learn more about enabling and configuring checklists.

Checklist Multi-Select Multiple Choice Question

A new multiple choice question answer type has been added called Checkbox that will allow a user to select one or more answers when completing a checklist. Multiple choice questions with the Checkbox answer type must be configured when adding a multiple choice question to a checklist design in order to be used. The different options for multiple choice question answer types now include radio button, drop-down list, and checkbox. Learn more about Configuring Checklists.

Data Model Updates

This release includes various data model changes to support the Extensible Controlled Copy feature and Vault Station Manager application. See Quality & QualityOne Data Model Updates in 18R3.

Regulatory

Bundling & Splitting Records for Submission

With this release, Vault supports the bundling of multiple Activity records into a single submission, as well as the splitting of planned regulatory changes into multiple submissions. Both aspects of this feature are relevant for the management of planned variations at the country level. Users frequently need to group several planned changes together (bundle) according to local regulations. The wizard guides users through a process of bundling activities into a new submission and regulatory objective while updating associated data.

Conversely, if a planned change is only partially approved, country-level users may choose to split objectives into smaller components and again update the data that HQ reports on to ensure it is accurate. The splitting wizard guides you through a process of breaking up regulatory objectives and activities into a new submission.

Learn about configuring your vault for bundling and splitting.

Generate Document from a Template for Content Plan Items

With this feature, users can generate documents from a document template through a Content Plan Item user action. When initiating this action, Vault automatically matches the new document to the corresponding Content Plan Item. Vault creates a new document each time a user triggers this action. Learn about generating documents from a template for Content Plan Items.

Configure Table of Contents for Content Plans

With this feature, users can create a Table of Contents (TOC) document, using DOCX format only, for a Content Plan. Vault generates the TOC list based on the Content Plan hierarchy, matched documents, and when specified, bookmarks from matched documents.

Additionally, Admins can configure document templates with special tokens that render Table of Contents (TOC) for a Content Plan. Learn about configuring a table of contents for Content Plans.

Dynamic Linking

This feature provides users authoring submissions content in MS Word™ the ability to create cross-document links targeting bookmarks and destinations within Vault. Although submissions content may change throughout the authoring process, these predefined links remain valid and target the updated content. When enabled, Vault also converts links targeting Named Destinations to links targeting a page and coordinates. This feature is only available for early adopters.

This enhancement permits users to copy durable, versionless full-path URLs to the target of bookmarks and named destinations in Vault documents, in support of RIM Dynamic Linking. Once enabled, Vault utilizes a Permalinks object type to generate permalink URLs and displays the Copy Link function on Bookmarks and Destinations in the Doc Info page. This feature is only available for early adopters of Dynamic Linking and must be enabled by Support.

FDA Gateway Integration

This feature adds support for the transmission of US eCTD submissions within Vault to the FDA Electronic Submissions Gateway (ESG) to the CDER and CBER divisions. Vault captures and loads acknowledgments sent from the FDA into the applicable Submission record within Vault.

Submissions Archive: Secure Remove Action

With this feature, Submissions Archive users can configure Atomic Security on the Remove action. This ability allows Admins to control if the Remove action is hidden, viewable, or executable for object records by lifecycle state and role.

Submission Report Type for Bulk Export

With this feature, users with the Bulk Export permission can export multiple Submissions Archive submissions based on the submissions record report. This functionality extends the ability to quickly extract submissions to facilitate product divestiture, product collaboration, and outsourcing to publishing services. Learn more about bulk submission export.

xEVMPD Support: Data View

xEVMPD Data View allows customers to generate a snapshot of registration data at a specific point in time to prepare for submission to the EMA in support of Article 57. This feature includes new lifecycle actions to trigger the data initiation and subsequently view it in a hierarchical UI for both high level and detailed reviews. Users will be able to use the data generated in this view to generate xEVPRM files in an upcoming release.

Support for US Validation Criteria v3.7

This feature adds support for the US FDA Validation Criteria update to v3.7, enabling users to validate submission output against the v3.7 validation criteria.

US FDA Grouped Submission Support

This feature adds support for US FDA Grouped Submissions, in accordance with US FDA eCTD Specification v3.3. Users can define and group submissions to send to the FDA as a single submission, and publish the submission in accordance with the specification. Learn about grouped submissions support.

Data Model Updates

This release includes various data model changes to support the xEVMPD Support feature. See RIM Data Model Updates in 18R3.

Clinical Operations

Default Document Field Value Based on User Attribute

Vault can now automatically populate document field values based on the user creating or updating content. This is available on two document fields: the Content (blinding__v) field and the Contributor’s Organization (contributor_organization__v) field.

Admins can define whether a user can create blinded (unrestricted) or unblinded (restricted) content at the User Role Setup or User object level. Vault then sets the Content document field value when that user creates, classifies, or reclassifies a document, or when they update the Study, Study Country, or Site document fields. This minimizes the risk of users accidentally setting the wrong field value, helping organizations to better manage restricted content in Vault. Learn more about document field defaulting on the Content field.

Admins can also define the organization a user belongs to at the User object level. Vault then populates Contributor’s Organization document field when that user creates a new document. This document field allows users to report on documents by organization or start different workflows for each organization. Admins can also use the Contributor’s Organization field in Dynamic Access Control setup. Learn more about document field defaulting on the Contributor’s Organization field.

Standard Quality Issues Object

This feature allows for tracking quality issues on documents using the Quality Issue object, which has its own workflow and lifecycle. Users can now log multiple issues individually and send each issue to users in a way that promotes issue resolution and enables robust reporting. Learn more about quality issues.

Study Startup Specialist Homepage

This feature adds a standard tab and sub-tab to Study Startup vaults that display a role-specific homepage containing actionable tasks, milestones, and data related to overdue and high priority items. Designed with Startup Specialists in mind, this page allows users to specify a Study, Study Country, or Site and then review data for that context in a series of widgets, including:

  • A list of Sites and related data for the selected context
  • Summary charts of upcoming Submission Milestones and Site Greenlight Milestones, including detailed hover cards
  • Summary counts of tasks that are Unassigned, Overdue, and Due Today, which toggle to list views
  • A list of all upcoming Milestones
  • Running totals of Site Greenlight Milestones by Baseline Finish Date, Planned Finish Date, and Actual Finish Date

The Study Startup Specialist Homepage is automatically available in all Study Startup vaults, but Admins must grant users additional permissions to see it. Learn more about working in the Study Startup Specialist Homepage.

Seeding Subject Visits on Monitoring Events

This feature allows CTMS users to populate a Monitoring Event with subject visits by copying the data to a Monitored Subject Visit section on the Monitoring Event record. Vault will pull Subject Visits with an SDV Complete Date between the previous Monitoring Event’s Actual Visit End Date plus one (1) day and the current Monitoring Event’s Actual Visit End Date into the Monitoring Event record. If no previous Monitoring Event exists, Vault will pull all Subject Visits for that Site into the Monitoring Event record. Learn more about seeding Subject Visits.

Subject Visits

This feature provides the ability to define a standard set of Subject Visits at the Study level and create Subject Visit records for individual Subjects. Users can leverage Subject Visit information within trip reports and general study management reporting. Learn more about creating Subject Visits.

Display Archived Study at TMF Viewer

Prior to this release, users could only select Study, Study Country, or Site records in the Active lifecycle state from the TMF Viewer drop-down. With this release, users can also select Study, Study Country, or Site records in the Archived state, allowing users to view documents in the TMF Viewer for both Active and Archived studies.

Data Model Updates

This release includes various data model changes to support the 18R3 feature set. See Clinical Operations Data Model Updates in 18R3.

Commercial

Quick Look Enhancements

Users can now preview documents, play video files, and listen to audio files directly from the Portal Quick Look viewer on the Portal Homepage or Portal Library. In addition, users can view documents and videos in full screen mode. These Quick Look viewer enhancements help users to more quickly determine if specific content is relevant for their current requirements. Learn more about using the Quick Look viewer.

Single Document Publishing: Support Slide Titles

The Create Presentation feature has a field that allows Vault to Use PPTX page title as “Name” and “Title” for each slide document. This automatically populates the Name or Title field on the Multichannel Slides generated via Create Presentation for PowerPoint™ source documents. However, because Single Document Publishing is an automatic process, there is currently no option for Vault to use the PowerPoint™ page title to populate field values. This feature adds a Use PPTX page title field on the CRM Rendition Settings object, allowing users to use PowerPoint™ slides titles as the Title or Description fields in CRM.

Event Material Document Type for Events Management

For Engage Webinar, the ability to record webinar sessions is an essential capability. The recordings provide customers with valuable content to use for on-demand training and events. The recordings also serve as an auditing tool for reviewing the performance of external speakers and ensuring the sessions meet compliance guidelines. Engage Webinar now stores webinar recordings as a new document type, Event Material (event_material__v).

SiteDocs

Document Reuse Across Studies

Customers often reuse Person-, Organization-, and Product-related documents, such as CVs and Lab Certifications, across many studies. Manually updating the Study document field each time a new document version is created is a time-consuming process. Vault SiteDocs can now automatically associate studies to all relevant document versions so that users no longer need to manually update the Study document field. Learn more about document reuse across studies.

Mobile Applications

Veeva Snap: Improve Scan Filters

This feature improves the built-in filters for Veeva Snap to better remove shadows and clean up scanned images.