What’s New in 18R1 | Vault Release Notes

Pre-Release Date: March 19, 2018 | Release Date: April 13 & April 20, 2018

We are pleased to bring you Vault 18R1. Read about the new features below. You can find information on enabling new features in 18R1 Release Impact Assessment. Information on developer features (API, VQL, etc.) is in the Developer Portal.

Authentication

With this release, we’re allowing our customers to enable and test Vault’s upcoming beta login features for select users. Admins can enable the beta login features by navigating to Admin > Users & Groups > Domain Users, choosing a user, and selecting the Enable enhanced login experience checkbox in the Settings section. Please reach out to your Veeva representative to learn more about these beta login features.

Working with Documents

Controlled Document Templates

This feature provides users with a way to create and manage document templates without requiring Admin involvement. Users can now create templates as regular Vault documents. To make a Vault document a template, a user selects a Template Document Type during field editing. The template document becomes available to use as a template when the document reaches its Steady state. By creating templates as regular documents, organizations can now leverage versioning, document relationships, lifecycle role permissions, lifecycle management, and other document functionality.

Any documents derived from a controlled document template inherit a Based On relationship to the document version used by the controlled template. Users can see this relationship in the Doc Info page, the Audit Trail, and the Where Used view. Users can also search and report on this relationship, providing critical visibility into a template’s adoption and efficacy. Controlled document templates do not replace existing “Basic” templates (those using uploaded files); rather, they are additive. Admins can also create controlled templates and convert existing basic document templates to controlled document templates from the Document & Binder Templates page. Learn more about Controlled Document Templates.

Export All Files from Individual Document

This feature introduces a new Export All Files document user action, which lets users export all files associated with a document in a single ZIP file. This can be useful for submission or litigation purposes. This action exports the source file, all renditions, a PDF with Annotations, attachments, a CSV of document fields, and a CSV of the audit trail, as well as the source files of all related documents. Vault exports Linked Documents as PDF files rather than source files, showing only the anchors that are specific to the exported document.

Admins must select the Allow Export All Files checkbox to enable this action. Only users with Download Source permission will see this option in the document Actions menu. Note that this feature is is automatically enabled in PromoMats and MedComms vaults. Learn more about the Export All Files action.

Vault File Manager

Vault File Manager provides a more efficient way to check out, edit, and check in Vault documents. Users can check documents out to the Vault File Manager client from the document Actions menu or by using a bulk document action. Vault File Manager downloads checked out documents automatically, and users can open files to edit them directly from the client. To check documents in, users can choose individual documents or select all. Users can also switch between vaults within the client to view documents checked out for each vault.

Vault File Manager supports Windows™ version 7 or later. Once enabled, users can download the Vault File Manager installer directly from Vault or distributed by a customer’s IT department. Only users with the Check Out to File Manager permission can use Vault File Manager. Please contact Veeva Support to enable Vault File Manager. Learn more about Vault File Manager.

New 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-supported languages are:

Armenian
Assamese
Azerbaijani
Nepali
Sinhalese
Kazakh
Quechua
Welsh

See a list of all supported languages.

Vault Objects

User & Person Object

The new User object allows customers to conveniently interact with user data throughout Vault. The User object contains records of all existing Vault users, enabling customers to report on user data, create custom fields, and reference users from documents or objects with lookup fields and reference constraints.

To immediately leverage the full flexibility of Vault objects, we’ve converted existing user reference fields to User object reference fields. For example, the Assigned To field on the Activity object makes this object available as a related list on the User record detail page.

Note that the Created By and Last Modified By fields were not converted to User object reference fields, nor were other document references to user like Checked Out By.

The Person object allows both Vault users and non-users to be contained in a single object. When referencing a user from a Person record, Vault synchronizes the standard fields from both records. For example, updating the mobile phone number in a Person record automatically updates the User record.

Vault also synchronizes domain-level attributes on User like username and email across all vaults to which that user is a member. This includes cross-domain vaults. Learn more about Managing the Person & User Objects.

The the new User object feature includes the following behavioral changes:

Document User Select Lookup: Prior to the migration of user reference fields, user selection fields could look up users by Name, User Name, or Alias by typing any of those strings in the text box. Because these fields now reference the User object, Vault will use the standard object lookup field for user selection and will only search by name. Customers can still search by Name, User Name, or Alias by clicking the binoculars icon to open Advanced Search.
Faceted Search for Migrated User References: Prior to 18R1, all references to users had a single select dropdown UI as seen in the left image below. After 18R1, all migrated user reference fields will appear as facets like any other object reference as seen in the image on the right.
Refreshing & Cloning Vaults: When cloning or refreshing a vault, any user references will be replaced with an ID of ‘1’. To support that process, the User object will include a System user record with the assigned ID of ‘1’. Additionally, refreshing a vault will not retain any custom fields created on the User object at this time.

eSignature Management for Objects

Vault now stores eSignatures captured by workflows on object records as related, system-managed object records. With this change, eSignatures display as a related list on a record detail page. This change also allows users to report on eSignatures related to object records.

Note that all existing eSignatures captured through object workflows will automatically migrate to signature objects.

With this enhancement, we’ve also introduced a new object lifecycle state entry action that enables Admins to set current eSignatures to obsolete: Make signature records obsolete. This functionality is useful when a record returns to an earlier state, for example, when a record is rejected and its previously captured signatures no longer apply. Learn more about eSignature Management for Objects.

Formula Fields

With formula fields for objects, Admins can automatically populate an object field value based on information already available in their vault. Admins can create new object fields with the Formula field type, select a Return Type for the data, and enter an expression to calculate the field value. Admins can choose Icon, Date, Boolean, Number, or Text as the Return Type. Admins can use date, number, text, yes/no, and picklist fields as the source tokens for a formula field expression. Formula fields on the object record are read-only to all users, regardless of security profile. Vault calculates the formula field’s value at run-time, and so formula fields are not available for searching or filtering. Learn more about configuring formula fields.

For example, an Admin can create a formula field of with a date return type called Audit End Date, and define it using an existing Audit Start Date field with the expression, dateAdd({audit_start_date__c}, days (7)). Vault calculates an Audit End Date that is seven (7) days after the Audit Start Date.

Formula field expressions use the standard grammar for formulas in Vault. With this feature, we added support for picklist fields, the DateTime data type (for formula fields and field defaults only), and the dateTimeDiff and dateTimeAdd functions in the standard grammar for Formula Fields.

Record Favorites

Users can now favorite object records to view them together easily and quickly, similar to document favorites. To favorite an object record, users can click on the Star icon next to the record in an object record list or detail view to mark a record as a favorite. Users can click the Star icon again on a favorited record to remove it from favorites. All favorited records for an object will show in a new view called Favorites. Favorites are specific to an object and a user.

Jobs on Objects

This feature expands the existing Job Scheduler functionality to support jobs on object records. Admins can schedule jobs for any object that uses a lifecycle. Based on object date fields, Vault can trigger actions to change the lifecycle state of an object record or to send a notification. This expansion provides better feature parity between documents and objects. Learn more about defining jobs.

Record Icons

Icons in object records can easily signify a record status. An Admin may configure a record icon as a type of badge. Admins can configure a Formula-type object field, selecting Icon for the Return Type, to display icons in object records. Admins can write the formula expression so that Vault displays certain icons based on different conditions. Admins can use any of the large set of icons provided in the Expression Editor. Admins can also assign the icon a color using a hex color code. Vault displays the icon on the object record list and detail pages. An Admin can also configure the icon so that it displays in the object record detail page header. Because icons use formula-type fields, they are read-only. Learn more about record icons.

With Update Sharing Settings workflow steps, Admins can now configure Vault to add participants to a specific application role or remove participants from a role. With this enhancement, Admins can grant and revoke permissions for an object record within the workflow sequence. For example, the workflow could assign a participant to a specific role immediately before assigning a task, and then revoke that access once the task is completed. Learn more about defining the update sharing settings step in object workflows.

Sharing settings updates through this workflow step type do not affect assignments granted through Dynamic Access Control.

Constrain Workflow Participants by Role

This release introduces a new option when configuring object workflows: the Constrain participants by role setting. This setting is available on object workflows that allow the workflow initiator to select participants. With this setting, Admins can choose to constrain users based on their object record role assignments at the time when the workflow initiator starts the workflow. When the Participant control is constrained like this, the workflow initiator can only select valid users. Learn more about defining the update sharing settings step in object workflows.

Select All for Object Reference Fields

Select All functionality allows users to select and unselect all object records using a single click, rather than manually selecting each record. This feature is available in all multi-select object reference fields. For example, a user editing a document to select related products could select all Product records.

Yes/No as Checkbox

Admins can configure a Yes/No (boolean) object field to display as a checkbox. While the Yes/No radio button can have a blank value, checkboxes always have a value (Yes/No). Learn more about configuring the Yes/No object field.

Upload Files when Adding Document Relationships

This feature provides a streamlined way to upload new files when creating document relationships. This is useful in examples like PromoMats when users are reviewing a composite piece, and need to upload and create links to multiple new assets.

When adding a document relationship, users can use the new Upload button to upload one or more new files. Like the existing document upload, users can classify the new documents, enter metadata, and perform a duplicate check on the uploaded files. Once created, Vault automatically creates a relationship between the original document and the new documents. Learn more about adding document relationships.

Object Lifecycles & Workflows

Add Participants to Active Object Workflows

Users can now add participants to active object workflows, enabling these users to participate in current tasks and future tasks on the active workflow. If the workflow configuration constrains participants based on roles, only users currently in those roles will be available to participate in the workflow. Any user with a security profile that includes the Add Participant permission can add users to active workflows. Learn more about adding participants to object workflows.

The object lifecycle Change State of Related Records entry action and Verify State of Related Records entry criteria currently support direct relationships such as parent-child and reference relationships. In this release, these features now support join relationships as well, both simple and complex joins. Learn about actions on related records.

Document Lifecycles & Workflows

Scheduled Jobs provide a way to automatically change the state of documents that meet specific criteria. In this release, jobs can change the state of documents found by the job query based on their relationships to other documents. For example, a job could expire any promotional pieces related to an Expired asset, or simply send a notification to users assigned roles on the promotional pieces. This automation is a cornerstone of digital asset management and promotional material compliance. Learn more about configuring jobs.

Enablement Change: Advanced Workflow Role Configuration

With Advanced Workflow Role Configuration, Admins can define a set of business rules that determine which roles should be required, optional, or hidden on the workflow start dialog. Previously, Admins could enable and disable this feature via a checkbox in Admin > Settings. In this release, once Admins enable this feature, it cannot be disabled.

Learn more about Advanced Workflow Role Configuration.

Reporting

Enhanced Reports Tab

This feature updates the Reports tab to provide customers with the tools they need to organize their reports in Vault and find specific reports faster. Report users will have access to search, a sortable tabular view, filters, and custom views. In addition, reports will have a field for custom tags that users can utilize to easily group reports together in views. Learn more about reporting capabilities.

Document Relationship Reports for Source Version-Specific Relationships

Vault introduced document relationship reports in V14, allowing customers to report on common relationships such as Supporting Documents, Reference Documents, and Based On (representing document copies). This feature expands the list to support all relationships except CrossLinks. Newly supported relationships include Linked Documents and Related Original Documents. Learn more about document relationship reports.

Configuration & Deployment

Locked Objects and Tabs

For customers that use application families (for example, RIM vaults) but don’t use all applications within the family, Vault will lock standard objects and tabs provided by an application that is not licensed. Vault will also lock certain system objects when the feature the object belongs to is not enabled. Locked objects and tabs are hidden from most users, but visible to users with access to the Admin area.

API Usage Logs

This feature adds a new log with information around usage of Vault APIs. Users with the new Admin > Logs > API Usage permission can access these logs via the UI and API. The logs include daily API usage information, including the time, username, sessionId, endpoint, and daily usage limits for every call to the Vault API that day. Logs are available for download in CSV or Logfile format. Learn more about the daily API Usage Logs.

Support OAuth 2.0/OIDC

The OAuth 2.0 / OpenID Connect Profiles are now available for configuration in all Vaults. The OAuth 2.0 / OpenID Connect support is now certified with Okta, in addition to PingFederate.

New Supported Component Types

The following component types are now supported for Configuration Migration Packages, Vault Compare, and Vault Configuration Report:

Saved View (Savedview)
Overlay Template (Overlaytemplate)
Signature Page Template (Signaturepage)
User Account Emails (message templates used for welcome emails, password resets, etc.)

Users can use these component types to compare configurations between vaults, export definitions to a package, and import and deploy packages to a vault.

System Admins use the Configuration > Tabs page to create and edit different tabs. In previous releases, the UI referred to one type as Sub-tab Container. In this release, we’ve renamed this tab to Menu in order to better describe its purpose and behavior. Learn more about configuring custom tabs.

Permissions & Access Control

Edit Relationships Permission

You can now give a document lifecycle role the ability to add/edit/remove document relationships without having to also give them Edit Fields permission, providing greater flexibility during your review process.

There is a new Edit Relationships document lifecycle state permission, and it is auto-on for roles that today have Edit Fields permission. Note that this permission also controls attachments.

Object Create Permission Grants Edit Permission

In past releases, Vault permission sets could include the Create permission for an object without granting the Edit permission for that object. In vaults using Field-Level Security for objects, this configuration was not effective. As of this release, the Edit permission will be granted for any permission sets that include the Create permission. This change affects both existing permission sets and future configurations.

Require View Content Permission to Send as Link to Non-Vault User

With this enhancement, users without View Content permission will no longer be able to use Send As Link to share with non-Vault users. This change does not affect a user’s ability to Send as Link to other Vault users.

“Upload Unclassified” Permission Renamed to “Always Allow Unclassified”

With this release, we relabeled the Upload Unclassified permission to Always Allow Unclassified to clarify what the permission controls. If a user cannot create documents of any type, the Always Allow Unclassified permission allows that user to upload unclassified documents. This permission does not affect the permissions of users who are able to create documents of at least one type.

Vault Users

Increased Delegated Access Limits

In previous releases, users could not have delegated access on more than 10 vaults at one time. In this release, we’re increasing the limit to 25 delegated vaults per user.

Vault Java SDK

Admin UI for Vault Java SDK

Admins can view lists of custom code deployed to a vault, such as Record Triggers, Actions, and User-Defined Classes. Organizations can develop custom code using the Vault Java SDK. Admins can download the source code file from Admin > Configuration > Vault Java SDK. Learn more about managing Vault Java SDK code in Vault. The list pages are view-only. To inquire about Vault Java SDK solutions, contact Veeva Services.

Data Model

Data Model Harmonization

Starting with this release, Veeva will provide a standard data model for Vault Platform and for each application family. Prior, standard data model elements (objects, fields, picklists, lifecycles, etc.) could be provided through a specific application, or as part of feature enablement. A vault’s standard data model elements could also vary based on when the vault was first created.

In the new approach, all vaults will include the Vault Platform data model, and the full data model for their application family. For example, a vault that includes only the RIM Registrations application would have all standard objects for RIM Submissions and RIM SubmissionsArchive, as well as all standard objects for Vault Platform.

Deploying the full data model will simplify the addition of new features and applications, as well as ensuring that customers have access to the latest functionality with every release.

Data Model Changes

As releases introduce new functionality, Veeva will automatically make changes to standard data model elements to support that functionality, even if you choose not to enable a new feature. See details in 18R1 Vault Platform Data Model Changes.

In most cases, new data model items will not affect end users and will only be visible in the Admin area. Data model items related to features with feature flags, e.g., Legal Hold, will be locked so that Admins cannot use those items.

Best Practices for Standard Elements

Going forward, Veeva will automatically update standard data model elements as needed during releases. Standard elements use the __v suffix. As a best practice, your organization should copy standard to create customizations. Custom elements use the __c suffix.

Locked Elements for Unlicensed Applications

If your vault does not include all applications within its application family, Admins won’t be able to enable certain data model elements that belong to an unlicensed application:

Objects
Document Types
Tabs

Commercial & Medical

Vault document lifecycles now allow Admins to configure a Create Related Document user action or lifecycle state entry action. With this action, Vault both creates the new document (or binder) and creates a relationship to it. These actions only support custom relationship types, for example, supporting_documents__c. Learn more about configuring user and entry actions.

Note that your organization may have worked with Veeva Services to create additional custom relationship types for your vault.

Standard Rights Management Fields

With this release, we are introducing standard fields for rights management. This feature allows customers to store rights management information without creating and managing custom document fields. The standard fields are set up as shared fields. To configure, Admins can associate the fields with specific document types based on their business needs.

New Brand Portal Widgets

This feature introduces three new automatically populated Brand Portal widgets. The Coming Soon widget enables Brand Portal users to see upcoming materials, increasing opportunities for reuse of existing materials. This widget displays documents that are associated with the Portal but that are not yet in Steady state (documents are in system starting state or system in-review state) and orders them by workflow due date.

Vault automatically populates two additional widgets based on data from the Document Usage object. The Most Active widget displays the Steady state documents that have the most activity in the Vault where the Portal exists, including views, downloads, rendition downloads, and copies. The Most Viewed widget displays the Steady state documents that are most viewed in the Vault where the Portal exists. In order for these widgets to populate, document usage metrics must be enabled.

Learn more about new Brand Portal widgets.

Launch Brand Portal from Portal Selector

In this release, we introduced an icon that enables PromoMats and MedComms users to open a Brand Portal in a new tab from the Portal Selector page, as opposed to opening the Portal in the same browser tab. Users can hover over the Portal logo on the Portal Selector page to see this icon. Clicking this icon allows users to directly launch a Portal in Portal-only mode, simplifying user experience.

Update to Brand Portal Document Fields

In the initial release of Brand Portal, the Portal (portal__v) and Portal Widget (portal_widget__v) document fields were standard fields associated with the Base Document type. In 18R1, these fields are now shared fields associated with the Base Document type, allowing customers to choose the document types available for use with Brand Portal.

Data Model Harmonization for Commercial

All vaults within the Commercial application family (PromoMats) now include all standard data model elements (objects, fields, picklists, lifecycles, etc.) for the Commercial application family, regardless of application. Elements related to an unlicensed application are locked to prevent use.

See full data model changes.

Data Model Harmonization for Medical

All vaults within the Medical application family (MedComms) now include all standard data model elements (objects, fields, picklists, lifecycles, etc.) for the Medical application family, regardless of application. Elements related to an unlicensed application are locked to prevent use.

See full data model changes.

Multichannel

CRM Vault Metadata Sync

This feature allows CRM to manage the CRM Product Library, Directories, Surveys, and Content Types in Vault. Through additional integration from CRM, which will push CRM metadata to Vault, customers will have access to new objects, fields, and dynamic reference constraints. This solves existing challenges such as an overloaded Vault Product object, difficulty in choosing the correct product, and integration failures from mismatched external ID’s. This feature requires configuration in both Vault and CRM. Learn more about CRM Vault Metadata Sync.

Approved Email: Update Litmus™ Preview for iPhone X

The Litmus integration within Vault allows content creators to preview their Email Template documents in Vault before making them available in CRM. This enhancement adds the iPhone X to the list of supported email clients, allowing users to preview how emails will appear on an iPhone X.

Single Document Multichannel Publishing: Support for MS Word™ Documents

Medical content typically includes PowerPoint presentations, PDFs, and MS Word™ documents. Currently, Multichannel only allows Vault to send MS Word™ documents to CRM through Create Presentation, which converts documents to PDF or image files for multiple slides. Single Document Multichannel Publishing, introduced in 17R2, streamlines the process of getting these documents into CRM. With this enhancement, the feature supports MS Word™ documents. Learn more about using single document multichannel publishing.

Target Specific Presentation When Copying to Another Vault

Prior to this release, storyboards in customer Vaults went through MLR approval without any link between the storyboard and the actual uploaded document. Admins can use the Create Related Document lifecycle user or entry action to link the storyboard to a blank presentation placeholder. When an agency creates content, they can now copy all slides from a source presentation into a related placeholder presentation.

This enhancement allows the agency or content creator to select a specific presentation during the vault to vault copy process, and copy created content directly to a specific Multichannel Presentation that is already related to the storyboard. Learn more about the vault to vault copy process.

Clinical

Site Users in Clinical Vaults

This feature enables easier collaboration with site users in Clinical vaults. Users with the Site User license type can see an optimized Home tab that minimizes the navigation needed to complete assigned tasks. On the Branding Settings page, Sponsors and CROs can also customize the Vault Header Logo that appears in the header of all Vault pages for Site Users.

In addition, in eTMF vaults where an Admin hasn’t uploaded a custom logo file, users with the Portal User license type now see a Vault Clinical logo instead of Vault Investigator Portal. Learn more about site user capabilities.

Link Clinical User Tasks to Milestones

As an enhancement to Clinical User Tasks and Template Tasks, users can now link Clinical User Tasks to a milestone, in addition to linking to a study, study country, and study site. Linking a user task to a milestone allows users to review and complete their tasks in the context of milestones, which define important time points during the study management process. This change also allows users to manage milestone status based on the completion of associated Clinical User Tasks, along with expected documents, matched documents, and previous milestones.

Both manually-created and template-created Clinical User Tasks can be linked to a milestone. To incorporate Clinical User Tasks with a milestone template, an Admin creates a Template Task, associates it with a Template Milestone Set, and selects a Template Milestone within the Template Milestone set. Learn more about creating Clinical User Tasks linked to Milestones.

This clinical-only feature improves the user experience when using EDLs. We added harvey balls as a visual indicator to an Expected Document record’s Completeness Status. Users can also view information about any matched documents by hovering over the harvey balls. This feature provides a seamless experience, allowing users to quickly identify what Expected Documents they should focus on.

EDL Hierarchical View

With the new EDL hierarchical view, users can click to view all expected documents associated with a given Milestone. EDL hierarchical view displays expected documents in a tree-like structure based on document type. This feature eases access to a Milestone record’s expected documents, and shows those expected documents in a familiar and easy to navigate presentation. Users can simply apply filters on this page, and then use drag and drop to upload files directly to EDL Items. EDL hierarchical view is accessible via the View Expected Documents user action on the Milestone object lifecycle. Learn more about viewing a Milestone record’s expected documents.

Multi-Site Document Distribution

This feature enables Sponsors and CROs to distribute important documents, such as protocol amendments, revised informed consent form templates, and safety information documents to many study sites at once. Only one member of the site staff for a given study needs to acknowledge the document. Sponsors and CROs can also track the delivery and acknowledgment of these documents by study, country, site, and study site staff member. Learn more about multi-site document distribution.

Clinical FTP Loader

With this feature, users can import data using file transfer protocol (FTP). While the primary use case for this feature is the ingestion of data for trip reports, users can leverage this feature for any objects in a Clinical application vault. Learn more about creating and updating records via FTP.

A user can transfer either a single CSV or ZIP file containing multiple CSV files. The name of the CSV file must correspond to the object for which the data will be ingested (subject__clin.csv). Users can specify the ordering of multiple CSV files within a ZIP using an order.txt file. When there is no order.txt file in the ZIP file, Vault imports the CSVs in alphabetical order.

Additionally, users can specify a unique field on an object within the .csv file name, for example, subject__clin.external_id__v.csv. When specifying the unique field in the file name, users no longer need to query Vault for the internal ID when issuing an update. The FTP loader updates existing records or inserts new records (upsert), based on the unique field specified.

Data Model Harmonization for Clinical Operations

All vaults within the Clinical Operations application family now include all standard data model elements (objects, fields, picklists, lifecycles, etc.) for the Clinical Operations application family, regardless of application. Elements related to an unlicensed application are locked to prevent use. See details in See 18R1 Clinical Operations Data Model Changes.

Sort Documents in TMF Viewer

Prior to this enhancement, Vault displayed documents in the TMF Viewer based on Creation Date. The feature adds a Sort by drop-down list to allow users to sort documents by Creation Date, Document Date, and Document Name, enabling users to view documents in a dated order and ensuring compliance with regulatory expectations.

Note that the Document Date sort option references Vault’s standard document date field (document_date__v), not custom document date fields. If no value exists in the Document Date field, Vault sorts by the document’s Created Date instead. Learn more about sorting documents in the TMF Viewer.

Default Monitoring Event Participants & Activities

With this release, Vault CTMS automatically adds site personnel as participants when a CRA creates a Monitoring Event. Vault adds site personnel with the Site Monitor or Principal Investigator roles as invited Monitoring Event Participants by default. Vault also automatically adds Monitoring Activities to the visit, based on the standard monitoring activities for the selected visit type (object types for the Monitoring Event object). This feature saves CRAs time as they plan monitoring visits. It also limits opportunities for errors during the planning process. Learn more about defaulting Monitoring Event Participants and Monitoring Activities.

Monitoring Visit Confirmation & Follow Up Letters

Users can now generate confirmation and follow up letters from a Monitoring Visit record with a single click. Previously, site monitors manually create documents from template and populate all of the related document fields. This feature further streamlines trial management and speeds trial execution. Learn more about generating monitoring visit letters.

With this feature, we added a new system action for Clinical applications. The Create Related Document from Template system action allows admins to create workflows where they can pre-select the document type/subtype/classification, template, lifecycle, and specify which object reference fields will auto-populate. This system action gives users a one-click experience to create content from template, without worrying about document type selection or data entry errors. Learn more about the Create Related Document from Template system action.

Configure Trip Report Sections via UI

This feature introduces a new Trip Report Questions Section Type for object page layouts. Admins can associate trip report questions to different trip report Sections. When an Admin adds a Trip Report Questions-type section to their Monitoring Event object page layout, Vault automatically adds the associated Questions to that section. With this enhancement, configuring the Monitoring Event object is far more efficient. Learn more about configuring Trip Report Sections.

Quality

Check Sibling Records as Entry Action Condition

Sibling Check is an entry action that Admins can add to lifecycle states in the QMS application. The purpose of this entry action is to allow Vault to automatically update a parent record when all of its children reach a “closed” state. The system action checks the states of the siblings of the record in which the action was triggered. If all of the siblings are in a given state, then Vault updates the state for the related record.

Data Model Harmonization for Quality

All vaults within the Quality application family (QualityDocs, QMS) now include all standard data model elements (objects, fields, picklists, lifecycles, etc.) for the Quality application family, regardless of application. Elements related to an unlicensed application are locked to prevent use. See details in 18R1 Quality Data Model Changes.

Data Model Harmonization for QualityOne

All vaults within the QualityOne application family now include all standard data model elements (objects, fields, picklists, lifecycles, etc.) for the QualityOne application family, regardless of application. Elements related to an unlicensed application are locked to prevent use.

RIM

MedDRA® Dictionary Loader

Users can now import MedDRA indication terminology (specifically Lower Level Terms, LLTs, and their associated Preferred Terms, PTs) to their vault within the Coded Indications object. Users access the loader via the RIM Maintenance tab and import dictionary data at their discretion, using their MedDRA credentials. Similarly, when MedDRA releases a new dictionary, users can perform a sequential update to update their terms, codes, and currency. Learn more about importing MedDRA terminology.

Enable Object Types on Standard User Role Setup Object

When securing documents with Dynamic Access Control, Admins can configure the standard User Role Setup object to include up to five (5) custom fields for use in matching sharing rules. In RIM application vaults, Admins can now enable object types on the standard User Role Setup object, in order to allow more than five custom fields. Using object types on the User Role Setup object allows for more nuanced use of matching sharing rules in an organization. This feature is available only for RIM applications.

Admins can create up to two (2) active object types on the standard User Role Setup object, and then configure up to five custom fields for each type. This increases the total number of fields available to use with matching sharing rules to ten (10) custom fields. When creating Application Roles, an Admin can select a User Role Setup object type. Then, when configuring matching rules for a role, Vault only displays the fields relevant to that object type. Learn more about object types on the User Role Setup object.

Support for Investigational Licenses

This feature enables regulatory customers to track ongoing clinical trials across the globe. Users can now leverage the existing data entities and wizards to generate and update investigational licenses, including study and site status and clinical hold details. Learn more about creating Investigational Registrations.

Cascade Document Version Locking for Content Plans

With a single user action, users can now change version locking on all matched documents to Content Plan Items contained within a Content Plan section. Users can remove version locking on all documents, lock all unlocked documents to the most recent steady state, or override lock all documents to the most recent steady state.

Locking documents to a Content Plan Item prevents the locked version of the documents from being dissociated from the Content Plan Item, such as when the document is complete. Unlocking documents from Content Plan Items can be used when making amendments or new drafts of documents. Override lock can be used when a new steady state version of a document is available.

Administrators can configure the Set Version Locking on Matched Documents user action on lifecycles associated with either the Content Plan or Content Plan Item object. Administrators can configure any or all of the three available functionalities of the action. Learn more about document version locking for content plans.

Submissions Archive AU v3.1 DTD Import

Submissions Archive users are now able to import submissions using the new Australia (AU) 3.1 DTD for eCTD submissions in addition to all previously supported DTDs. The AU 3.1 DTD will become mandatory by the Therapeutic Goods Administration on January 1, 2018.

Data Model Changes: xEVMPD Support

To further the vision of end-to-end registration management and ultimately support product data reporting and messaging, we added new fields and entities to our RIM data model specific to the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) data elements and their controlled vocabularies. See details in 18R1 RIM Data Model Changes.

Veeva Snap

Veeva Snap Enablement Permissions

With this feature, uploading to Vault from Veeva Snap can be enabled or disabled in individual vaults via two new Application permissions.

The Veeva Snap > Enable permission grants the ability to upload documents to a given vault from Veeva Snap. Users without this permission will see an error when attempting to upload a document to that vault from the application. The Veeva Snap > Enable App Store Configuration permission works in conjunction with Enterprise Mobile Management Support. Users with this permission can upload to Vault from the public version of the Veeva Snap application, available from the Apple® App Store®. Organizations using EMM software can remove this permission to ensure that their Veeva Snap users can only upload to Vault from an EMM-provisioned version of the application. By default, both of these permissions are enabled for all users.

Enterprise Mobile Management Support

This feature provides customers the ability to use Enterprise Mobile Management (EMM) software, such as MobileIron™ or AirWatch™, to manage Veeva Snap. With this feature, customers can provision and govern Veeva Snap using the EMM software, while also controlling certain aspects of the application by providing a profile to set default values. Customers can use this feature to control the usage of biometrics authentication (Touch-ID / Face-ID), enforce that users perform Copy Certification before uploading a document to Vault, and more.

Certified Copy

This feature enables Veeva Snap users to perform copy certification on scanned documents to validate that they are certified copies before uploading them to Vault.

Users can enable this feature within the application, and can choose whether or not to perform Copy Certification before uploading documents to Vault. On the Copy Certification page, users answer a series of verification questions about the scanned images. Users can also review the entire document and zoom in on pages to answer each question. Once Copy Certification is complete, the uploaded document has a new Certified Copy field set in Vault.

Organizations using Enterprise Mobile Management (EMM) software can also set the Copy Certification feature to be mandatory for their Veeva Snap users to ensure that documents are certified before they are uploaded to Vault.

Support Up-versioning of Documents

Admins can configure an email message template to include a link to Veeva Snap so that users can open the application from the Vault notification email. When a user launches Veeva Snap from this link, they can upload a captured document into the document placeholder identified in the email template instead of uploading it as an unclassified document into the Document Inbox. This feature allows users to launch Veeva Snap from this link to upload a document as a new version of an existing Vault document.

Performance Metrics for Veeva Snap

This feature adds two fields to the Performance Statistics object to capture information about documents uploaded via Veeva Snap. The Snap Document Count field captures the number of documents uploaded to Vault from Veeva Snap for a given day. The Snap Document Total field captures the total number of documents uploaded to that vault from Veeva Snap.

Log Capture

This feature makes it easier to diagnose errors in the Veeva Snap application. In past versions of Veeva Snap, users needed to manually email the log file from the application to Veeva Support. In this release, the Veeva Snap application automatically collects log files and uploads them to the Vault server.

EDC

See What’s New in 18R1 (EDC) for details about new Vault EDC features.