What’s New in 19R1

Pre-Release Date: March 18, 2019 | Release Date: April 12 & April 19, 2019

We are pleased to bring you Vault 19R1. Read about the new features below. You can find information on enabling new features in 19R1 Release Impact Assessment. Information on developer features (API, VQL, etc.) is in the Developer Portal.

We are pleased to bring you Vault 19R1. Read about the new features below. You can find information on enabling new features in 19R1 Release Impact Assessment.

Vault Java SDK

Spark Messaging

Spark Messaging enables near real-time integration between vaults and with external systems. Vault developers can use the Vault Java SDK to send message notifications as events occur in a vault. Spark messages are lightweight, signed messages sent via HTTPS. Outbound messages are processed by a queuing system to provide reliable delivery. Inbound messages received from another vault are processed by custom Java SDK code. Learn more about Spark Messaging in the Developer Portal.

HTTP Callout

Vault developers can use HttpService in the Vault Java SDK to send requests to an endpoint, including the Vault REST API and external application APIs. Requests sent to another vault are made through a trusted connection to allow data access control. Requests sent to external applications support basic username and password authentication. Builder and reader utilities for JSON and CSV data are provided to work with the request and response body content. This feature enables real-time integration with another vault or external applications. Learn more about HTTP Callout in the Developer Portal.

Vault Objects

Layout Rules

Layout Rules use Boolean expressions to streamline the data entry process by dynamically hiding irrelevant fields and sections on a page based on business needs. For example, a veterinary clinic could hide all fields and sections related to feline medicine on the patient record page if the patient is a dog.

  • Layout Rules use Vault’s standard expression grammar and return true or false. Vault hides fields and sections when expressions return true.
  • One rule can hide multiple fields and sections.
  • Object type layouts can have rules that are independent of the base object.
  • Vault executes Layout Rules in the order in which they appear on the Layout Rules List page. Admins can easily change this order.
  • Layout Rules can only use fields from the current object or object type. They cannot use related object fields, however, they can use lookup fields from related objects.

Learn more about Layout Rules.

Lookup Value Update in Edit Mode

Object Lookup field values are now updated whenever a user changes the Lookup relationship during record editing. Previously, Lookup values only updated after saving a record. Learn more about Lookup Fields.

Save Button Enabled on Change

With this release, when editing a record from the object record details page, the Save button is only clickable after users update a field value. If users decide not to edit any fields, they can click Cancel to exit edit mode. Learn more about managing object records.

In previous releases, the related record audit trail was only available through Veeva Support. In this release, it’s automatically enabled in all vaults. Contact Veeva Support to disable this feature.

With the related record audit trail, users can select objects in the Included Objects drop-down to include related records when retrieving the audit trail for a given object record, making it easier to track audit history across related objects. Vault returns audit events for these related records in the audit history. Users can add any object that has an inbound relationship to the audited object as an included object. Note that related record audit trail requests covering a period of four (4) or more months may take longer to process. Learn more about using the related record audit trail.

Working with Documents

Conditional Overlays

Conditional Overlays allow Admins to apply different overlays based on the document status, document type, and other document field values. Admins can set up conditional overlays from the document lifecycle configuration page using a rule builder that supports multiple rules. Learn more about Conditional Overlays.

Rendition Profiles

Rendition Profiles allow Admins to specify a set of rendition settings for a document. When user uploads a document Vault, Vault generates the PDF rendition that is created for the document based on the Rendition Profile specified for the document, rather than the Vault-wide rendition settings. Rendition Profiles provide flexibility to render documents differently based on users’ exact needs. Learn more about Rendition Profiles.

Copy Link to Document and Page

In the document Actions menu, users can now click Copy Link to create a permalink to the document and copy the link to their clipboard. This makes it easy to share a document link with someone else, or embed it in another location, without worrying about changes to the URL over time.

Vault creates the link for the page that the user is on at the time, or for the document as a whole if it is a video, placeholder, or other document that does not have a viewable rendition (such as a binder). If a new version of the document is created after the permalink is created, the link leads to the latest version of the document to which the user has access.

Convert Orphan Annotations to Page Level

Whenever re-render events result in a reduced page count without also creating a new version, any existing annotations on lost pages become “orphaned” – not visible to users. This can occur when editing fields on a document with Merge Fields enabled, and when editing Word Rendition Settings or PowerPoint Rendition Settings without also deselecting Preserve my annotations.

In those situations, Vault now presents an alert message to the user within the Edit Fields view or the Rendition Settings dialog. To maintain visibility on those annotations after re-render, Vault converts those annotations to page-level on the last page of the document. Learn more about re-rendering documents.

Previously, when a user navigated a Vault document in View mode, embedded links opened in a new tab or browser window, while annotation links opened in a mini-browser window.

With this feature, embedded links and annotation links now open in a single mini-browser window when the document is in View mode, improving the document review experience. Clicking another link in the document refreshes the current mini-browser window to display the new target. The updated mini-browser window can also display external web links and Vault documents that lack a viewable rendition, such as video files, binders, and MIME type files that don’t support rendition generation. This feature doesn’t affect other link navigation or mini-browsers within Vault. Learn more about embedded link navigation.

To improve the document loading performance in the Document Viewer, Vault now renders all values in object reference fields (such as Country or Product) as a blue link. If users click on a record to which they do not have access, users stay on the page and see a hovercard message over the record stating that they do not have permission to view that record.

Lookup Fields on Documents Support Multi-Value Picklists

When creating a Lookup-type document field, users can now reference a multi-value picklist field on the related object. In past releases, only single-select picklists were supported. In configurations where the object reference field is also multi-select, the Lookup field gathers the picklist values from all related object records, but does not display each picklist value more than once. Learn more about Lookup fields.

Enable Asynchronous Binder Export

The design of Asynchronous Binder Export, which was introduced in V13, provides greater usability and no longer relies on a Java applet. With this enhanced binder export functionality, which most vaults already use today, Vault walks users through the process of selecting documents to export; selecting which artifacts to export for the selected documents, including the ability to export custom rendition types; and verifying the export size. Vault then starts the export, asynchronously creating the export file and notifying the user upon completion. The user who initiated the export receives an email and Vault notification, which includes a link to the downloadable ZIP file containing the export contents.

Lifecycles & Workflows

Lifecycle Stages

This feature is postponed to a later release.

Auto-Start Object Workflow

With this feature, Admins can configure Vault to initiate a workflow when an object record is created or enters a specific lifecycle state. This configuration supports process automation in a variety of different use cases.

For example, when a Product record enters the In Approval state, a configured workflow could notify a set of users, update Approval Start Date on the record, and open a task for the record owner to acknowledge the change.

Learn more about object workflow configuration.

Event Actions on Object Lifecycles

Event actions are configurable actions that take place automatically when a user or the system creates a new object record. In this release, we’ve introduced event actions for object lifecycles. For object lifecycles, Admins can configure Update Record Field and Start Workflow actions. An organization could use event actions to automatically begin a review workflow on a record after record creation. Learn more about event actions.

Short-Circuit Object Workflow Tasks

With this enhancement to object workflow, Admins can identify verdicts that will short-circuit the review and approval process by canceling related open tasks. Learn more about configuring object workflows.

Event Actions on Document Lifecycles

Event actions are configurable actions that take place automatically when a user creates a new document, creates a new draft of an existing document, or creates a copy of an existing document. In the current release, event actions support custom actions coded through Vault Java SDK as well as the Update Document Field action.

Learn more about event actions.

Allow Short Circuit in Document Workflow for Non-Cancellable Tasks

In document workflows, the short-circuit option allows Admins to identify verdicts that will short-circuit the review and approval process. For example, with “Reject” as a short-circuit verdict, any approver who submits a “Reject” verdict could automatically cancel the uncompleted parallel approval tasks and proceed to the decision step without having to wait for all other approvers to submit their own verdicts.

In the original release of this functionality, a workflow could only short-circuit tasks if those tasks had the Allow cancel task setting enabled. With this enhancement, Vault no longer enforces this requirement.

Workflow Configuration Version History in Document Workflow Admin

Each time an Admin edits a workflow configuration and makes that configuration active, Vault “versions” the workflow. The initial configuration would be version 1. The next edit would create version 2. With this enhancement, Admins can review past workflow configurations from the workflow details page. Accessing past versions can help with troubleshooting workflow configuration problems. Learn more about workflow configuration versions.

Multi-Document Workflow: Constrain Participants

Multi-Document Workflow enables users to send a set of documents for review and approval. With this release, Admins can limit workflow participation for users and groups based on roles on the content documents. For example, in an Approval workflow, only users in the Approver role on the documents are allowed to receive an approval task. Learn more about configuring multi-document workflows.

Active Workflow Performance Improvements

Users can view a list of document workflow tasks from the Active Workflow panel within the Doc Info page and from Home > Active Workflows. In past releases, some vaults automatically displayed every task in the workflow. Now, users only see the first 10 tasks in Doc Info and the first 25 tasks in the Home tab. To see the full task list, they can run the Workflow History Report on the document. This change helps ensure better performance.

Limit Active Workflows Page

In past releases, the Home > Active Workflows page showed all in-progress workflows that the user could access. To improve performance on this page, we have limited the page to 200 workflows. To see the full list of active workflows, users can create a report using the Workflow with Document report type.

Checklists

Checklists for Vault Platform

Checklists are a data entry method that allows a user to input information in a question and answer format in the context of an object record, for example, a Product record. In addition to introducing a special, survey-like UI for responding to checklists, this release includes capabilities to define and manage templates called Checklist Designs. When a business process requires a checklist, Vault automatically selects the appropriate checklist design and creates an instance based on business context and matching rules.

In 18R2, the Checklists feature was introduced for Vault Quality and Vault QualityOne application families. In this release, we’ve extended checklist functionality, allowing organizations to configure checklists for system, standard, and custom objects in any Vault application. Vault creates necessary checklist-related objects through the creation of a checklist type component record from Admin > Configuration > Checklist Types.

Learn more about Configuring Checklists and Designing Checklists.

Checklist Design Loader Retrofitting for Scoring & Weighting

With this feature, users can upload weight and score values on available answer design records using the Checklist Design Loader. Users can access the new CSV template and example file from Vault Help. Learn more about checklist design loading.

Checklist Design Export to Flattened CSV

This feature allows Admins to configure a user action on a checklist design lifecycle state that exports a checklist design and its related records to a flattened CSV. Related records include sections, questions, answers, and dependencies. Users can upload this file to a vault using the Checklist Design Loader.

Improvements to Introduction Sections in Checklists

To help users better understand the differences between an Introduction section and a Question section, Vault now prevents users from adding questions to Introduction section design records, both through the Vault UI and through the Checklist Design Loader. Likewise, users cannot add weights to Introduction sections because they cannot include questions. Learn more about configuring checklists.

Advanced Mode for Hierarchy Filters

We have extended the advanced filtering option to allow search filters that represent a hierarchy such as Document Type > Subtype > Classification and Study > Study Country > Study Site. Users can select more than one value at any level of the hierarchy. Users can also exclude values at any level. For Example, documents can be filtered to show document types A and B, then exclude certain subtypes. Learn more about searching and filtering.

Reporting

Flash Reports Support Expanded Groups in Email

In past releases, Vault delivered flash reports that used grouping to organize records with those groups collapsed in emails, meaning that users could not see record-level details. In this release, we’ve introduced the option to expand groups, exposing both group* and record-level detail within the flash report email. Learn more about creating flash reports.

Formulas

Enhanced Vault Formulas

This feature improves Vault formula capabilities, usability, and performance. By utilizing new operators, new functions, and the User system variable, customers can streamline formulas and perform new calculations. The new formula engine also provides significant improvements to performance when Vault executes formulas.

These formula changes apply to Formula-type fields on objects, field defaulting for object fields, object record validation rules, lifecycle and workflows, and reporting date function filters. The changes do not apply to Formula-type fields on documents (also called reporting metrics). See documentation for a detailed explanation of where each operator and function is available.

Learn more about Vault formulas.

Updated Functions & Operators

This release includes the following changes to functions and operators:

  • = and != can now compare Text, Number, Picklist, Date and DateTime values.
  • + can now add time intervals to Date and DateTime values.
  • - can now calculate the difference between Date and DateTime values.
  • >, <, >= and <= can now compare Date and DateTime values.
  • The Time() function allows users to construct DateTimes.
  • The Text() function now supports DateTime and Picklist values, as well as supporting additional formatting options.
  • The IsBlank() function can now evaluate both blank and null values.
  • The new Abs() function returns the absolute value of a number.
  • The Case() function can now accept a Picklist as the first parameter.
  • The Hour(), Minute() and Second() functions now accept DateTime values as a parameter and return the current hour, minute, and second, respectively.

User System Variable

With the User system variable (@User), formulas can reference details about the active user. For example, when defaulting a Contact Info field on an object record, Vault could read the details from the user’s profile and provide the user’s email address.

Other Changes

  • Users can return a null value in formulas, which will allow a formula to set a field value to blank.
  • The Object. prefix is no longer required for object references.
  • Both single and double quotes are supported when defining string literals.
  • Certain functions including TextEquals, NumberEquals, PicklistEquals, DateAdd have been deprecated. These functions will continue to work as before but will not appear in the UI selector.

Formulas Support Multi-Value Picklists

Formulas may now compare multi-value picklists to single value picklists, text fields, and string literals using the Includes() function. Includes() uses the specified name values of picklist items for comparison. For example, Includes(color__c, ‘red__c’) would return true if the color__c picklist field includes the value Red (red__c).

Admins can also access a multi-value picklist’s labels using the Text() function. This function will return a string that contains the comma-separated labels of the selected values. For example, color__c would return red__c, yellow__c, but Text(color__c) would return Red, Yellow.

Formula Support for Picklist Field Default

In past releases, Admins could only set defaults for picklist fields on objects using static values. In this release, Admins can leverage Vault formula functionality when setting default values for picklists. With this enhancement, Vault better supports automation of data entry. For example, with Vault formulas, an organization could set different default picklist values for different object types.

Note that this enhancement only supports single-value picklist fields. Multi-value picklists must use static value defaults. Learn more about setting object field defaults.

Persist Formula Formatting

When Admins define formulas, Vault now preserves spacing and new lines created for formatting purposes. This enhancement improves the user experience when writing, debugging, and reading complex formula expressions. Learn more about Vault formulas.

Vault File Manager

Okta Support for Vault File Manager

Vault File Manager now supports users who log in to Vault using Okta as their Single Sign-On (SSO) identity provider. We’ve also added support for corporate networks that use network proxies, and implemented a custom URI schema for redirects. See details about Okta support for Vault File Manager.

Enhancements for Vault File Manager

With this release, we’ve made the following enhancements supporting Vault File Manager:

  • If a document has been checked out to Vault File Manager and a user clicks Check In from the Vault document Actions menu, Vault prompts the user to check the document in from the client.
  • When users hover over the Checked Out padlock icon, Vault displays specific information about who checked the document out, when it was checked out, and whether it was checked out using Vault File Manager, Office Online™, or a standard Vault checkout.
  • The Vault File Manager Actions menu now contains a Help option linking to Vault Help, as well as a Give Feedback option that allows users to provide feedback and suggestions on the Veeva Support page.
  • The Vault File Manager login page now automatically places the cursor in the User Name and Password fields instead of requiring users to click into those fields.
  • The Vault File Manager client now displays a File Extension column, allowing users to choose a program with which to open the file.
  • Vault File Manager only applies prefixes to duplicate file names in the same directory rather than every file checked out to the client.
  • When no documents are checked out to Vault File Manager, users now see table headers and a message stating that no files are checked out.
  • Users can click a new button in Vault File Manager to easily refresh the client and see newly checked out documents.
  • When a user launches Vault File Manager, it now automatically checks the public host for updates and, if updates are available, prompts the user to restart the application to complete updates.

Vault Administration

Sandbox Vault Header

Sandbox vaults now have a blue header to provide a clear distinction between sandbox and production vaults. The blue header makes it clear to users that they are logged into a sandbox vault. Users can remove the sandbox styling with a button next to the Vault logo. Learn about administering sandbox vaults.

Application Role Support for Custom Sharing Rules

Admins typically use Custom Sharing Rules on objects to provide access (Read, Edit, or Delete permissions) to all object records for one or more groups of users. For example, an Admin can grant Read access to all records of a Quality Event object in certain a state to all Internal users, while giving Edit access on specific records by using DAC or manual assignment.

Vault previously limited Custom Sharing Rule role assignment to the standard Viewer, Editor, and Owner roles. With this release, Admins can assign any application role when configuring a Custom Sharing Rule. This provides a consistent role naming convention and reduces duplication of the role permission settings. Admins can use the same role in any assignment method, whether it is Custom Sharing Rules, Matching Sharing Rules (DAC), or manual assignments.

Vault Configuration Report Enhancements

In this release, we’ve enhanced Vault Configuration Reports to include the following components and settings:

  • Document & Binder Templates
  • Default Rule & Override Rules
  • Vault Settings

In addition to new supported components and settings, we’ve also included the following updates:

  • Readability: The Vault Configuration Report provides user-friendly readability of Document Lifecycle State and Role Security Options as well as Object Lifecycle State Entry Criteria, Entry Action, and User Action.
  • Formatting: We’ve added a new formatting macro that allows users to format Vault Configuration Report tabs into a more logical layout. This includes hiding empty columns, auto-fitting column width and height with wrap text enabled, as well as page setup and print areas.
  • Table of Contents: We’ve added a Table of Contents tab which includes all reported components and settings along with a count of the number of components and their last modified date.

Learn more about Vault Configuration Reports.

Formatted Output Report Execution on Closed/Locked Records

Users can now generate formatted outputs without Edit permission on a record and its Attachment section when they are downloading or printing the output. This allows users to generate a printout on closed records, without requiring the Attachment section of the record to be editable. The existing behavior for generating a formatted output and attaching the file back to the record has not changed and still requires Edit permission. Learn more about formatted outputs.

Formatted Output Tokens for User & Timestamp

Admins can now configure formatted outputs to display additional tokens on the output that represent the vault user that requested the output. The tokens display the full name, last name, and/or first name of the user. An additional token can display the timestamp for the output generation. Learn more about formatted outputs.

Activate & Inactivate Picklist Values

When Admins delete a picklist value in a document or object record today, Vault inactivates the value and hides it from Admin. In this release, Admins are able to expose those inactivated values in the Admin UI, allowing them to edit or reactivate those values as needed. We have added a number of other small UI enhancements to help with the administration of picklists in Business Admin. Learn about managing picklists.

Limit for Picklist Items

Starting in this release, Vault prevents Admins from adding more than 1,500 items to a single picklist. Vault will not modify picklists that already have over 1,500 items. However, Admins will only be able to edit and save existing picklists if the total number of items is 1,500 or fewer. Learn about managing picklists.

Document Type Admin Displays Name

In previous releases, Vault showed only the label value for Document Types, Subtypes, and Classifications in the Admin > Configuration > Document Types screen. In this release, the UI shows the label value alongside the name, for example, “Promotional (promotional__c)”. The name value is not editable, but it can help when distinguishing between two similarly named document types or mapping the original document label to a new label. Learn about configuring document types.

Vault Loader

Vault Loader Load Usability Enhancements

Vault Loader introduces a new column mapping utility that allows users to map the columns of a CSV file to the available fields of the selected object type. We’ve also enhanced the Loader UI to support the specification of a key field that can be used as the lookup key for an upsert, update, and delete operation.

Vault Loader now automatically formats valid boolean values to Vault standard format before submitting the load job. Additionally, Vault Loader looks up the picklist value key based on the label before submitting the load job. Learn more about Column Mapping.

Vault Loader Support for 50k VQL Limit

Prior to 19R1, Vault Loader (UI and CLI) supported a total VQL query limit of 10,000 characters including a Where Clause limit of 2,000. With this release, we raised the total VQL query limit to 50,000 characters and removed the 2,000 character Where Clause limit in favor of the total limit of 50,000 characters. Learn more about Vault Loader.

Vault Loader Support for Creating Records in Any State

Vault Loader allows users with the Vault Owner Actions: Record Migration permission to create records in any lifecycle state.

Create Object Records in Non-Initial State

With this release, organizations can use the Vault REST API v19.1 to create object records in a state other than the starting state. To create a record in a non-initial state, specify X-VaultAPI-MigrationMode=true in as an API header and provide a valid lifecycle state (state__v) field value in the API body. This functionality is helpful for organizations migrating records into Vault from another system of record.

Authentication

OAuth 2.0 / OpenID Connect Audience and Client ID Validation

With this feature, Vault validates that the token issued by an Authorization Server and presented by the client application is intended for a specific OAuth 2.0 / OpenID Connect Profile. Token validation only passes if Vault is the intended recipient of the token.

This feature adds the Perform strict Audience Restriction validation checkbox on all existing OAuth 2.0 / OpenID Connect profiles. This checkbox is disabled by default. When Admins keep this checkbox disabled, the profile does not perform any audience restriction validation, helping to prevent changes that would break existing integrations.

Although Admins can choose not to enable audience restriction validation, the checkbox will be enabled by default on all new profiles created after 19R1. Learn more about Audience and Client ID Validation.

OAuth 2.0 / OpenID Connect Client ID Mapping

With this release, OAuth 2.0 / OpenID Connect Profiles support managing mapping between the client IDs defined by the Authorization Servers and the client IDs defined in the client applications. This allows integrating with Authorization Servers where client IDs must be uniquely generated per each app and does not allow configuration with the static client IDs built into native applications such as Vault File Manager or Veeva Snap.

OAuth 2.0 / OpenID Connect Support PingFederate Remote Keys for access_token Validation

With this feature, Domain Admins can select “PingFederate” from a list of available Authorization Server Providers on the OAuth 2.0 / OpenID Connect profile page. By selecting the “PingFederate” authorization server, Admins see a PingFederate-specific configuration option called “Access Token JWKS Endpoint”. Use this option to specify an additional JWKS endpoint containing the validation keys used to validate signatures for JWT access_tokens. This enables Vault to validate the signatures of JWT access_tokens issued by PingFederate AS locally instead of using a remote callout, thus improving the stability and performance. Learn more about PingFederate support.

OAuth 2.0 / OpenID Configurable Identity Claim

With this release, Vault supports configuring the claim from id_tokens or access_tokens that would be used as the claim containing the identity information. Vault uses the “sub” identity claim by default, but Admins can configure any other claim as an alternative.

OAuth 2.0 / OpenID Connect Authentication Event Logging

With this feature, Domain Admins can capture the detailed log of OAuth 2.0 / OpenID Connect authentication events. This helps Admins troubleshoot any potential configuration or authentication issues. Each capture action logs events for up to 10 authentication requests. Additionally, Admins can filter the captured events by the specified user and client application. Learn more about Authentication Event Logging.

Salesforce Delegated Auth Supports URLs Without Salesforce Instance Names

In the Spring ’18 release, Salesforce announced a critical update of removal of instance names from URLs for Visualforce. With this release, Vault now fully supports the changes detailed in Salesforce’s critical update. Vault customers who have integrations using Salesforce Delegated authentication will not be affected by this update.

Minor Enhancements

Localize Vault to Thai

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

Vaults created before the 19R1 release should contact Veeva Support to obtain the new Thai translation file. Learn more about supported languages and localization settings.

Additional Languages for Multilingual Document Handling

In this release, we added more options to the Language picklist, enabling users to more accurately set the language of their documents. For these languages, users must make a manual selection. The newly-added language options are:

  • Basque
  • Creole
  • Yiddish
  • Tongan
  • Tswana
  • Kinyarwanda
  • Other

See a list of all supported languages.

Quality

Quality Teams

The Quality Teams feature set allows users to make individual work assignments to individual Change Controls, Audits, CAPAs, or other Quality event related processes. Users define these assignments directly from the record detail page by selecting individual user assignments from a list of users authorized to perform that role on that record. Quality Teams integrates deeply with Vault’s Sharing Settings & Security platform, allowing for a simple experience for business users without sacrificing critical compliance tools.

Team Role Constraining

Admins can constrain the selection of users for Quality Team roles on a given record. This ensures that only the right people are assigned to the right team roles.

Team Role Cascading

Admins can configure team roles so that Vault defaults the same team members for each related process record created from a team-enabled record.

Team Validation & Completeness

When a team is either missing required team members or contains assignments which are not valid based on an organization’s process, Vault alerts users to take corrective action. When Admins provide the minimum required users for each team role in a quality team, the team-enabled record can automatically enter the next state of its lifecycle, triggering any configured entry actions. Quality Teams is intentionally designed for use in automating the assignment and issuance of tasks in a QMS. The Auto-Start Object Workflow feature allows organizations to get the most out of Quality Teams.

Team Member Reporting

Users can report on team role assignments. This allows for change review boards and other QMS operations teams to make sure they’re distributing workload appropriately across members of the organization.

The Quality Teams feature set is intended for early adopters in this release. If your organization is interested in participating in the early adopter phase of Quality Teams, contact Veeva Support. Learn more about Quality Teams.

Vault Training: Direct Assignments

With Direct Assignments, authorized users can issue Training Assignment workflow tasks on an ad-hoc basis. For example, a manager may decide that a user requires re-training on a document. The manager fills out a Direct Assignment Request form, accessible from a Training Requirement record, that includes the learner, training requirement, due date, and justification. Vault then creates a Training Assignment record and assigns a workflow task to the learner.

Organizations can integrate the Direct Assignment feature with QMS processes. A CAPA Action or an Audit Finding can identify the list of individuals that need to be re-trained. Once the QMS process is ready for execution, Vault Training will issue Training Assignment workflow tasks to users identified in the QMS process. Learn more about Direct Assignments.

Vault Training: Import Training Assignments

This feature allows Admins to import legacy or historical Training Assignment records from other systems into their vault. This allows an organization to have all training completion data in one system for reporting. Learn more about importing Training Assignments.

Vault Quality Station Manager Enhancements

This feature provides enhancements to the Station Device object. New fields collect additional Station Device information, such as the user logged into the device, the time the device last successfully synced, the approval date, and the removal date. A new action also moves a Station Device record from the Approved state to the Removed state.

Vault Quality Station Manager Client Permissions

This feature introduces a new set of client application permissions for Vault Station Manager. Users have the Application: Station Manager: Enable permission to use the Station Manager mobile application with their vault. Users also need the Application: Station Manager: Enable App Store Configuration permission to use the version of Station Manager available from the public app store.

Record-Level Locking for Quality

We’ve introduced record-level locking and the External ID (external_id__v) field for the following objects:

  • Organization (qms_organization__qdm)
  • Audit (audit__qdm)
  • Audit Team (qms_audit_team__qdm)
  • Related Audit (related_audit__qdm)
  • CAPA Action (capa_action__qdm)
  • Quality Event (quality_event__qdm)
  • Related Quality Event (related_quality_event__qdm)
  • CAPA-Quality Event (capaquality_event__qdm)
  • Context (context__qdm)
  • Product-Quality Event (product_quality_event__qdm)
  • Context-Organization (context_organization__qdm)
  • Context-Quality Event (contextquality_event__qdm)
  • Change Action (change_action__qdm)
  • Effectiveness Check (effectiveness_check__qdm)
  • Investigation (investigation__qdm)
  • Extension Request (extension_request__qdm)
  • Investigation Team (investigation_team__qdm)
  • Root Cause (root_cause__qdm)

Record-level locking prevents users from editing the same record simultaneously and saving over each other’s updates. This functionality blocks a second user from saving changes if another user already made and saved changes to the record.

Quality Data Model Updates

See 19R1 Quality Data Model Updates for data model changes in Quality vaults.

QualityOne

Risk Management

This feature allows risk managers to create and manage enterprise and operational Risk Registers using one or more Risk Matrices (for example, operational risk matrix, quality risk matrix, safety risk matrix, financial risk matrix, etc). Admins can create qualitative or quantitative risk matrices that are based on Severity and Occurrence values and color-coded Risk Levels. Risk levels allow risk managers to identify which risks to prioritize so that users can take actions to mitigate them. Additionally, risk managers can add potential risk events or opportunities to a risk register while simultaneously going through the standard steps of risk assessment including risk identification, analysis, evaluation, treatment, closure, and residual risk.

Learn more about Risk Management.

Regulatory

Submission Administrative Information Management

This feature allows users to view and manage the Submission Administrative Information that becomes part of the Regional XML when publishing a submission. Users can manage the eCTD Submission Administrative Information from the Submission record or Submission Country join record for EU submissions.

Additionally, users can view the Submission Administrative Information contained within the XML from the Submission Country join record for imported or published US and EU submissions. Learn more about managing Submission Administrative Information.

xEVMPD Support: Data Review Enhancements

This extension of xEVMPD functionality supports several critical use cases, including tracking EV Codes for the same medicinal product at the packaging level, better handling for multilingual markets such as Belgium, and centralized procedure. Additionally, users can now generate xEVMPD for both complex and simple drug products, as well as those that are mixed or modified before administration. Learn more about Data Review.

xEVMPD Support: Message Generation

This feature introduces xEVPRM XML generation for xEVMPD data. Vault now generates full messages, including the xEVPRM XML, attachments, and ZIP file, and supports technical validation in accordance with Article 57 guidelines.

Users can generate the XML from the Product Data Submission record, triggering Vault to create a new Product Data Message record for each EV Code or Local Number related to the medicinal product through the Medicinal Product Registration record. Vault notifies users of results and XML validation findings when the job completes. This feature includes new objects to store the message ZIP file and resulting validation findings. Learn more about xEVPRM XML generation.

xEVMPD Support: Validation

The initial release of xEVMPD validation support delivers the validation framework and a subset of business rule checks, including the existence of EV Codes and checks related to presentation name and indications. Vault runs validation checks while generating the Product Report structure and sends a notification when complete. This feature includes new objects to track validation results for each Product Data Submission. Learn more about xEVMPD Product Report validation.

In a future release, Vault will support remaining validation criteria checks.

In previous releases, the RIM Registrations Create Related Records wizard created one Activity record per application. Now, when creating Activities in bulk, users can choose to create one Activity record per application per country by selecting an Activity Scope Level in the wizard. Country-level Activities are particularly useful for European applications, for example, those using the Mutual Recognition Procedure, in which one Member State may require local approval for an item in addition to the Lead Market approval. Learn more about creating related records.

Copy Matching Custom Fields When Adding New Registered Details

When users add new registered details in RIM Registrations vaults, the Manage Registered Details wizard now copies custom field values from Regulatory Objective or Submission join records to the corresponding Registered Details records as long as custom fields with matching names and field types are configured on both objects. For example, Vault could populate a custom Manufacturer Type field on a Registered Drug Product record using the matching field value from a Submission Drug Product record. Vault supports copying custom fields for Picklist, Object, Date, DateTime, Yes/No, Text, and Number field types. See details about copying custom field values when adding new registered details.

When bulk creating related Submissions and Regulatory Objectives from an Event record or an Impact Assessment Report, RIM Registrations users can now choose specific relationships to copy from the Event details to the new Submissions and Regulatory Objectives. For example, when an Event has multiple impacted Active Substances, a user could choose to copy only a specific subset of those Active Substances to the resulting Submissions and Regulatory Objectives records. Learn more about bulk creating Submissions and Regulatory Objectives.

Split Content Plan Item

With this feature, users can split a Content Plan Item when the number of matched documents exceeds the expected number of documents. The new Split Content Plan Item user action creates additional Content Plan Item records and matches the extra documents from the source Content Plan Item to the new records based on the Expected Steady State Count.

This feature also introduces two new tokens that resolve based on the matched document’s Name and Title fields. Vault can resolve these tokens in the Content Plan Item record’s Name, Title, or Published Output Location fields. Users can also combine these tokens with other supported content plan tokens.

Additionally, if Vault can’t resolve a token, for example, if the matched document’s Title field is blank, users can update the unresolved tokens using a second new user action, Update Tokens in Fields.

Learn more about splitting Content Plan Items.

Preserve Inactive Records on Cascade State Change

When a user updates a Content Plan record, for example, when moving it from Baselined to Locked state, Vault also moves all Inactive related records associated with that Content Plan to the Locked state. Users then have to set those records back to Inactive state manually.

With this feature, Admins can now configure a new entry action on lifecycles associated with the Content Plan or Submission objects. The Change active related object lifecycle state entry action updates lifecycle states for related objects that are in an Active status. Vault skips Inactive records and all of their child records, keeping them in the Inactive status. Learn more about configuring object lifecycles to change active related object lifecycle states.

Preserve Inactive Records When Copying a Content Plan

When defining a master content plan, users sometimes set Content Plan or Content Plan Item records to Inactive if those sections are not needed. Currently, when a user copies a content plan, for example, to distribute the master content plan to different regions, Vault copies all records in the starting lifecycle state, including Inactive records.

Now, when a user selects the Copy from Content Plan action, Vault copies records that are in an Inactive lifecycle state in the source content plan and creates them in an Inactive lifecycle state in the newly-created content plan. Vault continues to copy records that are in Active status in the starting lifecycle state. Learn more about copying content plans.

EU EMA v3.0.3 (DTD 3.0.1) Specification Support

With this release, RIM Publishing vaults support the EU EMA v3.0.3 (DTD 3.0.1) specification. Users can now create Content Plans and generate submissions that are compliant with EU EMA v3.0.3 specifications. Vault validates these submissions based on the corresponding EU EMA v7.1 Validation Criteria Version. Learn more about working with EU regulatory submissions.

Exclude Correspondence from Bulk Export

When the Show Correspondence in Viewer setting is enabled, Admins can now choose whether to include or exclude correspondence documents during bulk submission exports from the Admin > Settings > Application Settings page.

Bulk Submission Export Job Enhancements

With this release, Vault groups each bulk submission export request by Export ID within the requesting user’s FTP folder. Vault automatically deletes these from the FTP after 15 days.

Dynamic Linking in Admin Settings

In a previous release, we introduced Dynamic Linking, which provides the ability for users authoring submissions content in MS Word™ to create cross-document links targeting bookmarks and destinations within Vault. Previously, this was only available through Veeva Support. In this release, Admins can enable it from Admin > Settings > Application Settings. Learn more about Dynamic Linking.

Support for US Validation Criteria v3.8

This feature adds support for the US FDA Validation Criteria update to version 3.8, enabling users to validate submission output against the version 3.8 validation criteria.

Jordan (JO) 1.0 DTD Support

Submissions Archive users are now able to import submissions using the new Jordan (JO) 1.0 DTD for eCTD submissions. The JO 1.0 DTD pilot phase began on 1 December 2018 and runs through 1 March 2019, with an eCTD mandatory date of 1 March 2019. See more information about the Jordan 1.0 DTD.

Swiss (CH) 1.4 DTD Support

Submissions Archive users are now able to import submissions using the new Swiss (CH) 1.4 DTD for eCTD submissions in addition to all previously supported DTDs. The CH 1.4 DTD began acceptance on 1 January 2019, and the transition period for accepting prior versions ends on 30 June 2019. See more information about the Swiss 1.4 DTD.

Record-Level Locking for RIM

We’ve introduced record-level locking for the following objects:

  • Application (application__v)
  • Submission (submission__v)
  • Regulatory Objective (regulatory_objective__rim)

Record-level locking prevents users from editing the same record simultaneously and saving over each other’s updates. This functionality blocks a second user from saving changes if another user already made and saved changes to the record.

19R1 Additional RIM Data Model Updates

With this release, we’ve added the following components to the RIM data model. These data model updates are automatically available on all RIM vaults. Admins must perform additional configuration to make them available for users.

  • Added the Product (product__v) field to the following objects:
    • Application
    • Content Plan
    • Report Level Content Plan
    • Drug Product
    • Active Substance
    • Clinical Study
    • Nonclinical Study
  • Added a Product (product__v) lookup field to the Content Plan object on the Content Plan Item object
  • Added the following fields to the Report Level Content Plan object:
    • Primary Clinical Study (primary_clinical_study__v)
    • Primary Nonclinical Study (primary_nonclinical_study__v)
  • Added the following values to the Controlled Vocabulary Type picklist:
    • Dossier Format (dossier_format__v)
    • Storage Conditions (storage_conditions__v)
  • Added a new Constraint Scope (constraint_scope__v) field on the Constraint object

In vaults created after the 19R1 release, the following objects will be relabeled to better support medical devices:

  • Relabeled the Product (product__v) object to Product Family
  • Relabeled the Product Detail (product_detail__v) object to Product Variant
  • Relabeled the Drug Product (drug_product__v) object to Product

In existing vaults, Admins can make these changes manually. Learn more about customizing standard Vault objects.

See 19R1 RIM Data Model Updates for all data model changes in RIM vaults.

Clinical Operations

eTMF Homepage

The eTMF Homepage provides users with key metrics relating to their TMF health. Users can check their homepage for actionable insights into the timeliness, quality, and completeness of documents being filed in their TMF. Learn more about the eTMF Homepage.

Monitoring Reviewer Comments

This feature enhances the reviewing capability on Monitoring Event records for CTMS customers. Once configured, users can navigate to a comment modal by clicking the icon next to related records or trip report questions on a Monitoring Event record. Users can post, review, and resolve comments from the modal. In addition to the modal, a new section called Review Summary allows users to easily navigate and review all comments logged on a particular Monitoring Event. Learn more about Working with Trip Reports.

Homepage Enrollment Status Graph Enhancements

The Enrollment Status Graph on both the CRA and Study Manager homepages now shows data even if First Subject In, Last Subject In, or Last Subject Out dates are unavailable. Lines on the graph, such as the black solid line and purple dotted line, do not show if the appropriate data associated with them is unavailable. An icon on the widget shows what data the selected Study, Study Country, or Study Site is missing in a hovercard. In addition, the Enrollment Status Graph now utilizes Milestone Planned Finish Date values instead of Baseline Finish Date values. Learn more about the Study Manager Homepage.

Person & Organization Migration

This feature is postponed to a later release.

Milestone/EDL Creation Job Runs as System

This feature enhances the milestone and EDL creation job by running it as System instead of as the user initiating the action. This supports use cases where a user has permissions to activate a site, but should not have access to view the milestones and EDLs created from the site activation.

Vault Payments Data Model Updates

We have updated all Clinical Operations vaults to include new objects and object lifecycles to support Vault Payments. New objects are in a locked state and are inaccessible to Admins unless Veeva Support enables Vault Payments in your vault. Admins can see new lifecycles from Admin > Configuration > Object Lifecycles, but these lifecycles do not work while their related objects are locked.

  • Objects:
    • Fee (fee__v)
    • Fee Schedule (fee_schedule__v)
    • Payment Request (payment__v)
    • Payment Request Detail (payment_detail__v)
    • Payable Item (payable_item__v)
    • Procedure (procedure__v)
    • Procedure Definition (procedure_def__v)
    • Site Fee (site_fee__v)
    • Site Fee Definition (site_fee_def__v)
  • Object Lifecycles:
    • Fee Lifecycle (fee_lifecycles__v)
    • Fee Schedule Lifecycle (fee_schedule_lifecycle__v)
    • Payment Request Lifecycle (payment_lifecycle__v)
    • Payment Request Details Lifecycle (payment_detail_lifecycle__v)
    • Payable Item Lifecycle (payable_item_lifecycle__v)
    • Procedure Lifecycle (procedure_lifecycle__v)
    • Procedure Definition Lifecycle (procedure_def_lifecycle__v)
    • Site Fee Definition Lifecycle (site_fee_def_lifecycle__v)
    • Site Fee Lifecycle (site_fee_lifecycle__v)

Commercial

Medical Inquiry

Medical Inquiry is a new capability in Vault MedComms that allows users, such as call center agents, to capture, manage, and fulfill medical inquiries directly from MedComms. Prior to this feature, customers often relied on legacy applications or complex integrations to capture and respond to a medical inquiry.

With Vault MedComms’ medical inquiry capability, customers can manage cases and case contacts, define priority-based service level agreements (SLAs), automatically generate standard response cover letters, assemble electronic response packages, and directly fulfill inquiries via email.

Medical Inquiry introduces the following new objects to MedComms:

  • The Case object holds all of the information about an individual request for information and is the parent object to the Case Requests and Case Content User Tasks objects.
  • The Case Contact is a subtype of the Person object used to hold information about the person making the inquiry. Using the Case Contact subtype requires that Object Types be enabled on the Person object.
  • The Case Request object holds the individual pieces of information requested in the case.
  • The Case Response object holds all attributes of the response to the inquiry, including the Cover Letter and Fulfillment Docs.
  • The Case SLA determines the deadline for responding to a request.
  • The Person Address object holds contact information for a Case Contact.

Learn more about Medical Inquiry.

Additional User-Editable Portal Widgets

With this enhancement, Portal managers can create additional manually-curated widgets for Brand and Medical Portals. These new widgets (Additional Content 1-4) perform like the existing Featured Items widget.

For existing portals, these new widgets are inactive by default. Admins can activate them as part of the portal editing process. Customers should rename the new widgets to reflect their own curation options.

Learn more about managing portals.

Automated Image Renditions

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. For example, an Admin could define an Automated Image Rendition type to convert a TIFF file into a JPEG format and resize the image.

This feature adds the following components to Rendition Types to support Automated Image Renditions:

  • Automated Image Rendition field
  • Format field
  • Resize field
  • Quality field
  • Colorspace field
  • Density field
  • Resample field

Learn more about creating Automated Image Renditions.

The Consent Check picklist in PromoMats and MedComms vaults provides Admins another level of granularity to determine how consent is applied to email templates. Admins can configure any email template, including Engage Meeting invites, to only allow an email to be sent if valid consent has been captured. Learn More about the Consent Check picklist.

SiteDocs

Study eBinder

This feature allows a SiteDocs user to view a study’s documents organized into a binder-like structure. This view is intended to be used by casual SiteDocs users, auditors, and inspectors to quickly find study documents of interest.

SiteDocs Data Model Changes

We have updated the SiteDocs data model to enable basic tracking of expected documents (EDLs) and replaced the current Role field on the Study Person, Study Organization, and Study Product objects.

We’ve also included an Institution (institution__v) object with an associated field on the Study object.

Mobile Applications

Veeva Snap: Additional OAuth Support

Veeva Snap now supports Microsoft ADFS, Okta, and Exostar identity providers in addition to PingFederate. Admins can configure Vault so that users can login via these identity providers.

Android Station Manager Enhancements

This release introduces several enhancements to the Android Station Manager mobile application:

  • When setting the previous_document_number__c metadata field for a document available on Station Manager, it now syncs to the device and displays on the Document Information page. The application also supports document searching using all non-date fields available on the Document Information page. This enables users to view and search for documents by the previous document number.
  • Vault now stores the login user and the time of the last successful sync on the Station Device record for each device using Station Manager. This enables Vault Admins to track and report on login users and successful sync times for Station Device records.
  • Supporting Documents now display as links on the Document Information page. These only display when the supporting document is also synced to Station Manager and when the relationship is not version specific. This feature supports vaults using the Supporting Documents document relationship.
  • Station Manager for Android now supports localization.