What’s New in 18R2 | Vault Release Notes

Pre-Release Date: July 9, 2018 | Release Date: August 3 & August 10, 2018

We are pleased to bring you Vault 18R2. Read about the new features below. You can find information on enabling new features in 18R2 Release Impact Assessment. Information on developer features (API, VQL, etc.) is in the Developer Portal.

We are pleased to bring you Vault 18R2. Read about the new features below. You can find information on enabling new features in 18R2 Feature Enablement Details.

User Administration

Removing Support for iMedidata

As of 18R2, Vault will no longer support iMedidata Delegated Authentication. Admins will observe that the Security Policy will no longer have an ability to activate iMediata Delegated Authentication and the User Profile will no longer have an iMedidata UUID field.

Working with Documents

Vault CDN Support

Customers often take regulated content out of Vault to use on websites and other digital channels. This poses a risk if that content is no longer compliant. Customers need a new way to push regulated content to their various distribution channels, as well as tools to withdraw superseded or obsolete content easily. Vault CDN Support changes the way that organizations push content to the web, enabling our customers to serve regulated content directly through publicly addressable URLs generated by Vault. With this revolutionary enhancement, organizations no longer need to email or move content out of their regulated system.

Vault CDN Support requires customers to purchase an Amazon Cloudfront subscription directly through Amazon. This feature is currently only available to specific early adopters. For more information, contact your Vault representative. Note: This feature is not validated in 18R2.

OCR for Scanned Documents

OCR helps users find and use scanned information by unlocking the content of scanned files (image and PDF formats) and Veeva Snap files. When rendering the source file, Vault will index text detected with a high confidence score for full-text search, in-page search, and text annotations. Additionally, admins can add two new shared fields, OCR Requested and Pages OCR’ed (%), to the base, type, subtype, and classification document levels that detail if an OCR was requested, and the percentage of pages with content extracted by OCR. This release offers optimal performance for English text but extracts Latin characters for other languages as well. Learn more about searchable scanned documents.

Configurable Copy Fields

With this feature, customers can define which field values are included when users execute the Make a Copy action on a document. When configuring fields, Admins will see the new Do not copy this field during Make a Copy option.

By better controlling which field values are copied, Vault customers can prevent unexpected behavior for copied documents, such as pieces expiring earlier than expected and incorrect metadata applying to a new document.

Users can now view and navigate to Destinations in the viewable renditions for PDF documents in Vault. When a user clicks the Show Destinations button in the upper-left corner of the document viewer, Vault displays a Destinations panel similar to the Bookmarks panel. When the user views the panel, Vault displays all existing Destinations in the order that they occur in the document. Clicking a Destination link navigates the user to the Destination’s coordinates in the document viewer.

Note that the Show Destinations button displays for all documents with a viewable rendition, whether or not Destinations exist in the document. When no Destinations exist in the document, Vault displays No destinations in the Destinations panel. Learn more about navigating Destinations.

Static Reference Constraints for Document Fields

Building on Dynamic Reference Constraints for object reference document fields, this feature allows users to filter object records by static values. Users can filter object records by object type, object lifecycle state, or other fields on the referenced object records.

Users can also combine dynamic reference constraints with static reference constraints. For example, if a user had a join between the Country and Product objects and wanted to only show Products associated with a selected Country that were also in an Approved object lifecycle state, the reference constraint would be:

id IN (SELECT id FROM countryproduct__cr WHERE country__c CONTAINS ), state __v = ‘approved_state__c’

Note that on the edit page for object reference document fields in Admin, the label of the Dynamic Reference Constraints section has been relabeled to Reference Constraints to include both constraint types. Learn more about configuring reference contraints on document fields.

Unbound Document Display Options for Binders

Today, unbound documents display as the absolute latest version of that document. This can be problematic in situations where two users need to see different versions of the same document when viewing a binder. This feature allows users to control how unbound documents are displayed for users who are viewing a binder or exporting from a binder. When editing document types, the choice to display unbound documents as the Latest Version, Latest Viewable Version, or as the Latest Steady State Version is now available. Changing this setting immediately affects all unbound documents within binders with the modified document type.

The Latest Viewable Version option is particularly useful in situations where different roles may need to see different versions of the document, similar to how documents are displayed in the Library. For example, a document author may need to see the latest version, while document consumers should only see the latest steady state version.

Please note that this new configuration is only for binder display and export purposes, and when retrieving a binder through the API. It does not apply when reporting on documents in binders or executing VQL queries for binder contents. Additionally, the Outline View search widget is only available when the document type is set to display the Latest Version. Learn more about binder display options for unbound documents.

Viewable Renditions for Hangul Word Processor (HWP) Files

Vault automatically creates viewable renditions for Hangul Word Processor (HWP) source files. Hangul Word Processor is a South Korean word processing application with specialized support for the Korean language. Vault supports font embedding, overlays, eSignatures, and full-text search for viewable renditions generated from HWP files. Learn more about working with HWP viewable renditions.

Default Values for Standard Picklist Document Fields

Prior to 18R2, users could only specify default values for custom picklist document fields. Now, this functionality is available for standard picklist document fields as well.

Note that Vault only applies default values during creation of a new document, and not during an action such as creating a draft or making a copy.

Binding Rule Label Changes for Binders

In this release, we’ve updated the labels for the Set Binding option to more clearly describe their behavior. In particular, note that the Reset to unbound option has been relabelled, and will now detail the unbound display option selected for that document type. For example, the option may now read: Always show the Latest Version.

Document Type Details Label Change for Binder Options

Due to the addition of the new Document Type configuration section Binder Display Options: Unbound Documents, we relabelled the section above (previously Binder Options) to be clearer about what it allows users to configure.

Split Artist Field into Separate Author & Artist Fields

This feature places Artist and Author document metadata into two separate fields: Author and Artist. At document upload, Vault now populates both the Author and the Artist fields to more accurately reflect the document’s metadata.

Platform Data Model Updates

With this release, we’ve introduced the following objects to support the functionality of Vault CDN:

CDN Distribution Status (cdn_distribution_status__v)

We’ve added the following field to support the separation of the Artist field into two separate fields:

Author (file_meta_author__v)

Vault Objects

Record Validation Rules

Validation Rules enhance data quality by comparing user-entered data with Admin-defined rules for an object record. This feature allows Admins to set up simple validation rules on an object from within the object configuration. For example, a user’s vault could include a validation rule where the Audit Start Date must be before the Audit End Date.

A record’s field values must pass every validation rule before a user can save the record. If one or more validation rules fail, Vault displays an Admin-configured error message for those failed rules.

This new object security feature provides customers with the ability to limit how much information and control non-admins have over the access rights of other users. We’ve disabled this security option by default, but Admins can enable it on an object.

By default, users who can see an object record can also view who else has access to the record (sharing settings). Likewise, users who can edit the record can grant or remove access to the record by adding or removing role assignments in sharing settings.

Enabling this object-level option allows Admins to secure sharing settings in a more granular way. Administrators can then secure the Sharing Settings object action at the profile level, and optionally with Atomic security for fine grain control at the state and role level. The following access options are available:

Hide: Sharing settings is hidden on the record details page.
View: Sharing settings is visible but the user cannot add or remove direct role assignments.
Execute: Sharing settings are visible, and the user can add or remove direct role assignments.

Secure Inbound Relationships

In many business processes, the relationships between object records and related object records, or documents, need to be preserved once the object record reaches a certain state.

As an example, if a Monitoring Event object record (CTMS) is in “Ready for Review” state, it should not be possible to assign a new protocol deviation record to the monitoring event record or delete a protocol deviation related to the monitoring event.

Likewise, it should not be possible to assign to the monitoring event new related documents (object to document relationship), and unassign or delete documents already assigned to the monitoring event.

The secure inbound relationship feature allows customers to control when related object records or documents can be assigned or unassigned to an object record, based on the record state and roles (in our example, the Monitoring Event object).

Admins can use Atomic security to configure relationship security on the record lifecycle state details page. This enables customers to individually configure object-to-object or object-to-document relationships based on the record state and assigned roles. Learn more about secure inbound relationships.

This feature allows users to configure an object lifecycle state entry action, or an object workflow step to automatically update a field on a related record. This feature makes it easy to keep related records in sync as they move through their business processes. Learn more about configuring object lifecycle state entry actions.

Many vault configurations have business process information spread across a variety of objects. Currently, tracking audit history for multiple related objects requires users to retrieve audit trails for each record separately. With the related record audit trail feature, users can now 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 working with the related record audit trail.

Note: Vault doesn’t enforce Dynamic Access Control or Field Level Security in the audit trail. It is possible for a user to utilize the related record audit trail to view audit events on records they do not have permission to view. We recommend only granting permission to access object record audit trails to users with the Business Administrator security profile.

Default Single Value Reference Fields

This feature allows quick and easy entry of record data by defaulting object reference, self-referencing, and parent fields when the referenced object only has one record. This feature is only available for empty, required fields.

When creating or editing an object record, these reference fields default while editing, instead of upon saving. Note that these fields do not auto-populate when inline editing object records from an object record list view.

In this release, we’ve introduced an object action that enables users to delete an object record and its related eSignature records. The Delete Record and Related Signatures action is available on objects with Enable Signatures enabled and is by inactive by default. As with other actions, Admins can configure Atomic Security on this action to control access based on role and lifecycle state.

Support for Object Lifecycle State in Expression Grammar

This feature allows Admins to use the object record lifecycle state (object.state__v) in formula-based expressions. Admins can write validation rules, formula field expressions, or field defaulting expressions based on lifecycle state.

User & Person Object Enhancements

With this release, we’ve made the following enhancements to the User & Person objects:

When Admins enable user object reference links, the Created By and Last Modified By fields link to User object records. These two fields did not previously link to a user record because they don’t have an outbound relationship to the user object. Vault now renders these fields as links like other object references for easier navigation to user records.
There is a new Vault Membership lifecycle on the User object that controls whether or not a user has access to a given vault. Users can participate in workflows and jobs via this lifecycle.
We’ve added the Security Policy, and Salesforce Username fields to the User object. This enables customers to create users with references to custom security policies and delegated authentication information.
Creating Person records has been made much simpler by only requiring First and Last name or a reference to a User.

Learn more about the User & Person Objects.

Add Participants to Active Object Workflows: Enhancements

For object workflows configured to get participants from Sharing Setting roles, users can now add participants to active workflows by adding users directly to roles through Manual Assignments. These users will be added as participants in the workflow and will receive any current active workflow tasks, as well as future tasks. Learn more about adding participants to object workflows through role-based assignment.

Vault File Manager

Vault File Manager: General Availability

In previous releases, customers could only get Vault File Manager through Veeva Support. With this release, feature enablement options for Vault File Manager become visible in Admin > Settings.

Vault File Manager: Enhancements

Vault File Manager is a Windows™ desktop application that provides a more efficient way to check out, edit, and check in Vault documents. Updates to the Vault File Manager client in this release include:

Instant deletion of local files after document check-in
Additional columns in the Vault File Manager client for Document Number and Document Type
Detailed date-time when users hover over a document’s Last Updated date

Note: These changes will appear to users working in general release vaults prior to the 18R2.0 general release. Note that these changes will not be available on pre-release vaults.

OAuth Configuration for Vault File Manager Supports Wildcard for Port Assignment

With this update, Vault File Manager supports a wildcard (*) in place of a specific port number for OAuth authentication using Ping Identity. Customers using OAuth for Vault File Manager must update their Ping Identity configuration to replace “http://127.0.0.1:65521/” with “http://127.0.0.1:*/”. This change helps to prevent port collisions.

New customers deploying Vault File Manager for the first time, and setting up authentication using OAuth and Ping Identity, must utilize this new configuration. Learn more about configuring Vault File Manager.

Note: This feature will be available to users working in general release vaults prior to the 18R2.0 general release. Note that these changes will not be available on pre-release vaults.

Improved OAuth Support in Vault File Manager on Older Windows Operating Systems

This enhancement improves Vault’s ability to support Vault File Manager authentication via OAuth for users on Windows™ 7, Windows™ 8, and Windows™ 8.1 environments. In order to take advantage of this enhancement, Admins must update their OAuth / Ping ID configurations to include an additional Redirection URI: “http://localhost:65521/”. Learn more about a configuring an OAuth profile for Vault File manager.

Configuration & Deployment

Sandbox Vaults

Admin users can now manage the sandbox vaults for their production vault using the Vault Admin UI and APIs. Sandbox vaults are used to develop and test configuration changes, data migrations, and integrations without impacting your production vault and users. Sandbox vaults are critical to an effective change control process.

When creating or refreshing a “Configuration” sandbox vault, the production vault’s configuration is copied. This ensures that the sandbox vault is an accurate replica of production, suitable for making and testing changes without exposing production data. Creating a sandbox for a new project and refreshing your sandboxes often will avoid issues and delays when deploying changes in production.

Vault Loader File Validation

Vault Loader allows users to quickly load large quantities of data using a CSV file. With this release, Vault Loader can perform the following validations on the CSV file before starting the load process:

For create operations on objects, verify that when all records in the CSV are imported, the number of records will not exceed the maximum allowed per object.
The input file contains a valid header row and at least one record.
The input file contains no empty columns.
Verify columns and display all columns that do not map to valid fields for the selected object. If the input file contains invalid columns, users can choose to proceed and ignore those columns.

Note that Vault only performs file validation when users create, update, or delete document relationships, legacy users, groups, or object records via the Vault Loader.

Dataset Support for Configuration Migration Packages

This feature allows users with Configuration Migration permissions to include data loads into an Outbound Package. This is particularly useful when migrating components that require reference data. Rather than having to perform manual data load via Vault Loader, you can now include the corresponding data load steps into an Outbound Package. Additionally, customers can use this feature to help streamline the replication of sample test data from production to sandbox or sandbox to test.

Service Availability Email

This enhancement gives customers an option to provide an email address in each of their Vaults that is used to notify an individual or distribution list within an organization about planned system maintenance or other service disruptions.

Authentication

With Enhanced Login Experience, Vault stores a customer’s user name and a profile photo (if configured) on the login page after successfully logging into Vault. This change provides an improved user experience and expedites the login process, as users are only required to provide their passwords for future logins. Additionally, Vault automatically directs SSO users to their corporate identity systems. Users who regularly utilize multiple Vault accounts can easily switch from the saved account to another by clicking the Switch user link.

If organizations want to prevent browser and password managers from saving users’ passwords, they can disable the new Allow browsers to save and autofill password field on the login form setting on password-type security policies. This setting appears on all password-type security policies

Enhanced Login Experience also improves handling of error messages. Transient errors will now display in a notification above the login form and can be dismissed by the user to easily continue with login.

Note: This will be auto-on for all customers on August 10. It will not be automatically enabled with the early POD release. Customers have the option to preview this feature by enabling it via an Admin Checkbox in Pre-Release.

Reporting

Populate Last Ran Field for All Reports

The Last Ran Date field is now populated for each report when the report is executed. This information helps customers identify reports that are no longer being used. Prior to this release, the Last Ran Date field was only populated for flash reports.

Commercial

Automated InDesignⓇ Component Linking

PromoMats and MedComms users working with AdobeⓇ InDesignⓇ packages no longer need to manually upload and link documents or images used in the package. Automated InDesignⓇ component linking takes content from the Links panel in the InDesignⓇ package and either creates Auto-Linked document relationships to existing assets in Vault or creates new documents of type InDesign Component and links them to the InDesignⓇ package source file.

Brand Portal Editor

With the Brand Portal Editor, creating and configuring Portals becomes an easier, more visual, and more intuitive process. Brand Managers with correct permissions can easily manage their Portals as they appear to end users. The Editor allows Brand Managers to easily add, reorder, and update content in Portal Widgets directly from the Portal Homepage. Other tasks, such as synchronizing the Vault-populated widgets on the Portal homepage, also become easier. The Brand Portal Editor is automatically available in PromoMats and MedComms vaults with Brand Portal enabled. Learn more about using the Brand Portal Editor to create and manage Portals.

Make a Copy from Brand Portal

Content reuse is a key component of a successful DAM implementation. To help address this, PromoMats and MedComms users with the correct permissions can now perform the Make a Copy action directly from the Portal Home Page or the Portal Library. Users can click the Copy button from a document’s hover card or the Quick Look Viewer. Learn more about making a copy from the Brand Portal Homepage.

My Portal Tasks

With this feature, document workflow tasks are now available in Brand Portal on the Portal Home Page. In the My Portal Tasks pane, PromoMats and MedComms users can now see any assigned tasks for documents in the current Portal. Users can also click a View All link to see all tasks across their vault. Users can toggle to switch between the My Portal Tasks pane and the About standard Portal widget. Learn more about using the My Portal Tasks pane in Brand Portal.

Reason Selection When Making A Copy

This feature extends the Make a Copy functionality for PromoMats and MedComms vaults to allow users to select a reason when copying documents and binders. Customers can provide their own reason codes for users to choose from. With this data, customers can better understand how they are repurposing their content, and inform best practices around reuse. Learn more about enabling reasons for copying documents.

Multichannel

Multichannel Field Updates

In this release, we’ve updated the field length for two (2) text fields used for Multichannel purposes. For Approved Email, we’ve increased the Subject (subject__v) field from 255 to 1,500 characters, and the CRM Territory (territory__v) field from 100 to 255 characters. These field updates support functionality that will be available with the CRM 18R2 release.

Clinical

Consolidate Organizations and Personnel Tabs

In this release, the Organizations tab will be renamed from organization__clin to organization__ctms, and the Personnel tab will be renamed from personnel_directory__clin to personnel_directory__ctms. This allows tab names to be consistent across all Clinical Operations vaults. This change affects Clinical Operations vaults with organization__clin and personnel_directory__clin tab names. These vaults are likely to be eTMF vaults created during 17R3 or Clinical Operations vaults created during 18R1.

Expose Global Directory and Study Personnel Tabs in eTMF

This feature exposes the following standard tabs in eTMF vaults:

Tab: Global Directory (global_directory__ctms)
- Sub-tab: Organizations (organization__ctms)
- Sub-tab: Personnel (personnel_directory__ctms)
Tab: Study Personnel & Communication (study_contacts__ctms)
- Sub-tab: Study Personnel (study_personnel__ctms)

Admins may need to update Tabs permissions in eTMF permission sets to reflect the availability of these standard tabs. Users in eTMF vaults that utilize standard Security Profiles (e.g. Document User) will have these tabs available automatically.

Manage EDL Bulk Update Options in Clinical Vaults

The Update Related EDL Items action on site-level Expected Document records allows users to bulk update records that have the same classification under either the same Study or the same Study Country. In some cases, it may be useful to hide the option to Update EDL Items for all sites in the same study to prevent users from accidentally updating all EDL Items for sites they do not manage. This feature adds a checkbox to the Admin > Settings page that allows Admins to remove this option from the Update Related EDL Items dialog. When this checkbox is set, users are only able to bulk update related EDL Item records within the Study Countries for which they are responsible. Learn more about manging EDL bulk updates in eTMF Vaults.

Standardizing Central Monitoring and Trip Report Template Admin Tabs

This feature standardizes the provisioning of the Central Monitoring tab, including the Central Monitoring Events and Site Evaluation sub-tabs, and the Trip Report Template Admin tab, including the Trip Report Admin, Question Bank, and Answer Set Bank sub-tabs. This change ensures these tabs and sub-tabs are available to all CTMS customer vaults. CTMS customer vaults with custom versions of these tabs should evaluate switching to the new, standard tabs. Admins may need to update Tabs permissions in CTMS permission sets to reflect the availability of these standard tabs. Users in CTMS vaults that utilize standard Security Profiles (e.g. Document User) will have these tabs available automatically.

Study Country Auto-naming

This feature allows Admins to set a checkbox in Application Settings that enables the Study Country Name field on a Study Country record to be system-managed. Once enabled, when a user creates a new Study Country record, they do not need to manually specify a value in the Study Country Name field. On save, Vault sets the field to the name of the selected Country. Vault also continues to check that the name is unique within the Study, ensuring that only one Study Country exists for each applicable Country. Admins can also modify the default configuration so that Vault sets the field based on the Country Abbreviation field or another value. Note that, once enabled, this feature cannot be turned off and enabling will affect integrations that interact with Study Country records. Learn more about enabling Study Country auto-naming.

Study Organization Role

The new Study Organization object allows users to assign specific roles to an organization at the Study, Study Country, or Study Site level. The Role field on this object will allow users to more readily track roles from a regulatory standpoint and pinpoint organization performance on previous studies. This feature also introduces a standard Study Organizations sub-tab under the Study Personnel & Communication tab.

This feature introduces a hover card, visible from any list of Milestone records, that displays a summary of the Milestone’s completeness. When users hover over a Milestone record, Vault displays a hover card that includes overall Milestone completeness, previous milestone dependencies, expected document completeness, and matched documents, with direct navigation to object records or a list view of records. This feature improves Milestone usability by helping users to more quickly determine whether a Milestone requires attention. This feature is available for configuration in vaults with Milestone Autocompletion enabled. Learn more about milestone hovercards.

Upload Trip Report Questions

Vault CTMS allows an Admin to define Trip Report Sections and Questions within Monitoring Events. Previously, to create a list of Trip Report Questions, an Admin had to either manually populate records or use Vault Loader to populate multiple objects in bulk. With this feature, an Admin can simply download a single template CSV file from Vault, populate data, and upload the file back to Vault to create Trip Report Questions. Learn more about uploading Trip Report Questions.

EDL Hierarchical View: Label Update

The filter buttons on the EDL hierarchical view page now use object field labels instead of static text. This enhancement ensures that filters are always in sync with a customer’s Vault configuration. For example, if a customer changed the Department field to Functional Owner, the Department filter button would change to Functional Owner as well. This feature also initially changes the All Statuses filter button to Completeness.

The Monitoring Status pane on the Study Manager Homepage in CTMS vaults now displays only the lifecycle states that Monitoring Event records are currently in, instead of displaying all possible states.

Subject Metadata & Vault CTMS/EDC Connection

This feature allows CTMS users to report on new and existing Subject Statuses and new Subject Status Dates integrated from Vault EDC. Customers can also configure the ability for users to navigate from a Subject or Monitored Subject within CTMS to the Subject‘s associated casebook within Vault EDC. For example, a CRA may want to perform Source Data Verification (SDV) on Subject data in Vault EDC while populating their Monitoring Event in Vault CTMS. Learn more about the EDC to CTMS connection.

Subject Metric Updates Based on New Subject Statuses

With the addition of the End of Treatment and Randomized statuses to the Subject Status picklist on Subject records, we’ve updated the Metrics and Monitored Metrics jobs, as well as the Study Enrollment Status graph on both the CRA Homepage and the Study Manager Homepage, to take these new statuses into account. This feature also makes the labels in the Summary Metrics pane on the CRA and Study Management Homepages dynamic based on applicable field values.

Clinical Operations Data Model Updates

As part of standardizing the configuration across all Clinical Operations applications, we’ve made the following changes to standard configuration:

Added the End of Treatment (end_of_treatment__v) and Randomized (randomized__v) statuses to the Subject Status (subject_status__clin) picklist.
Added the EDC ID (edc_id__v) field to the following objects in CTMS vaults in support of connection with EDC vaults:
- Study (study__v)
- Study Country (study_country__v)
- Study Site (site__v)
- Subject (subject__clin)
- Monitored Subject (monitored_subject__ctms)
Added the following fields to the Subject (subject__clin) object in CTMS vaults in support of connection with EDC vaults:
- Subject ID (name__v)
- Subject Status (subject_status__clin)
- Screened Date (screened_date__v)
- Screen Failed Date (screen_failed_date__v)
- Enrolled Date (enrolled_date__v)
- Randomized Date (randomized_date__v)
- Withdrawn Date (withdrawn_date__v)
- End of Treatment Date (end_of_treatment_date__v)
- End of Study Date (end_of_study_date__v)
Added the following fields to the Milestone (milestone__v) object in support of milestone hover cards:
- % Complete (complete__v)
- Completeness (completeness__v)
Added the Study Organization (study_organization__v) object
Renamed the Organizations tab from organization__clin to organization__ctms
Renamed the Personnel tab will be renamed from personnel_directory__clin to personnel_directory__ctms
Added the following standard tabs and sub-tabs in eTMF vaults:
- Global Directory (global_directory__ctms)
  - Organizations (organization__ctms)
  - Personnel (personnel_directory__ctms)
- Study Personnel & Communication (study_contacts__ctms)
  - Study Personnel (study_personnel__ctms)
Added the following standard tabs and sub-tabs in CTMS vaults:
- Central Monitoring (central_monitoring__v)
  - Central Monitoring Events (central_monitoring_events__v)
  - Site Evaluations (site_evaluations__v)
- Trip Report Template Admin (trip_report_template_admin__v)
  - Trip Report Templates (trip_report_templates__v)
  - Question Bank (question_bank__v)
  - Answer Set Bank (answer_set_bank__v)

Quality

Checklists for Quality Events

Checklists are a new data entry method that allows a user to input information in a question and answer format in the context of a Quality Event, for example, an Impact Assessment or Change Control. 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. Learn more about setting up checklists.

Checklist Design Loader

The Checklist Design Loader adds a user action, configurable on any Checklist Design lifecycle state, to load checklist designs using a template file in CSV format. Vault will process the single CSV to create all of the Section Design, Question Design, Available Answer, and Dependency Design object records needed for the checklist. Admins will need to download the template CSV file from Vault Help in order to use this feature. Learn more about setting up checklists.

In this release, users can add entry criteria logic to object record lifecycle states which allows a record’s progression to be directly linked to the statuses of related documents. Configurations will allow records to check if all, any, or at least one of the documents related to a record through a configured relationship is in a specific state type. Additionally, users can add criteria to ensure that at least one document has been related to the record, regardless of the document’s state.

These options allow for configurations such as “Don’t allow a Multi-Document Change Control to be Closed/Completed until all Documents to be Released are in the Steady State of their lifecycles”, and “Don’t allow a Multi-Document Change Control to be routed for Approval until all Documents to be Released are in the Ready for MDCC Approval state.”

Both document reference field relationships from an object to a document, and object reference field relationships from documents to objects are supported. All lifecycle state types are supported. Learn more about configuring entry criteria for state types of related documents

RIM

Regulatory Objective & Submissions Data Sync

This feature ensures data consistency for customers as we move to a different relationship between Regulatory Objective records and Submission records. While this flag is enabled, Vault will automatically copy records into the new join object so that data is complete when your organization decides to start using the new object.

Additionally, this feature allows users to reduce data entry by copying Submission data from the Regulatory Objectives associated with the Submission. Admins can configure this option on any state of the Submission record lifecycle.

Report Level Content Plans

Report Level Content Plans enable RIM Submissions customers to create and publish Clinical and Nonclinical Study Reports. Specifically, users can create a report content plan for a study and then on-demand publish documents in the report content plan. Before publishing a document, users can add Vault Link Annotations to their approved documents. The publishing process reconciles these links to become relative PDF hyperlinks. During report level publishing, Vault validates content and makes it available to users to review and correct when needed.

Users can export published content into a folder structure specified within the report content plan. Users can also view the published content in the Library within the Submission Ready Binder created for the report level content plan. Learn more about Report Level Content Plans.

Export Large Submissions to FTP

With this release, users with security profiles that include RIM Submissions Archive: Export and FTP Staging: Access permissions have the option to export submissions to the FTP when submissions exceed Vault’s file size and artifact limits for ZIP file creation. Vault places the exported submission within the Submissions Archive Export folder on FTP, where it is available for users to download locally. Learn more about exporting large submissions.

Link Publishing

With this release, Admins can enable Vault link annotations as an option on RIM Submissions vaults. When using report level content plans or Submissions Publishing in conjunction with link annotations, the publishing process will reconcile these links to become relative PDF hyperlinks. The hyperlink properties are set to comply with ICH and the respective Health Authority Requirements.

Additionally, the Link Publishing process resolves links in PDF documents that refer to documents in the same vault and Content Plan using the Vault URL. When used with Report Level Content Plan publishing, Vault converts these links to relative path PDF hyperlinks.

Regulatory Objective Data Model & Process Update

This feature is a set of enhancements to allow for more complex relationships between regulatory objectives and submissions, as well as usability updates to the RIM wizards. This includes creating submission join data based on Event records, allowing Activity records to be rolled up to an application, enabling dynamic labels of all fields across wizards and enhancing the data that can be displayed for related records.

Note: This description was updated on October 2, 2018. In the previous version, it incorrectly stated that this feature allowed Activity records to be created per country.

Use Regulatory Objective Data in Manage Registered Details Wizard

Users can leverage the superset of Regulatory Objective data rather than a group of Submission data to update registration details. Enabling this setting in Admin updates the Manage Registered Details wizard to look for data based on the Regulatory Objective rather than the Submission records, which reduces data entry for customers who do not track detailed information at the Submission level.

Usability Updates to Manage Registered Details Wizard

Based on customer feedback, we have added some simple but helpful user interface and logic enhancements to the Manage Registered Details wizard:

All data presented in grids allows hover cards to show additional details.
Lifecycle states will default whenever possible and users will be warned when they are changing the lifecycle state of multiple records.
Any changes made in the wizard will be applied to the records, regardless of lifecycle state change.
Additional help hover text has been added throughout the wizard.
The wizard will dynamically inherit labels from any customer-defined labels.

With this feature, the Create Related Records wizard creates data in Submission and Regulatory Objective join records based on the event data, both when users create records from a report and when users create records from an Event record. This change affects default auto-naming for the records created, but Vault does not override any customer configurations for auto-naming.

Please note that the user must have Read permissions on both source (Submission) join objects (including all fields) as well as the target (Regulatory Objective) join objects (including fields) to create the target join records with the full set of data.

Expand All for Single Submission

When filtered to a single submission within Submissions Archive Viewer, users are now able to expand all the child nodes within a section. This feature creates a more efficient review process by allowing for quicker and easier navigation of submissions content.

RIM Component Unification

With this release, we complete our work to ensure that all RIM customers have access to all necessary components within a RIM Vault. In 17R3, we unified objects, fields, and picklists; in this release, we deploy any standard object types, report types, notification templates, and document fields to all RIM vaults. This second and final step concludes our efforts in this area. Going forward, Vault will deploy updates to RIM components or additions of new components to all RIM vaults with every release.

RIM Data Model Changes

With each release, we introduce new changes to the application family’s data model to support new functionality and meet customer needs.

We introduced new shared document fields:

Ready for Publishing (ready_for_publishing__v)
Promotional Material Audience Type (promotional_material_audience_type__v)
Promotional Material Document Type (promotional_material_document_type__v)
Promotional Material Type (promotional_material_type__v)
Date of Actual First Use (date_of_actual_first_use__v)

We made data model changes to support Submissions Publishing:

Added dossier_detail__v object
Added health_authority_division__v object
Added publishing_validation_criteria__v object
Added publishing_validation_status__v object

Object	Object Type
Related Submission (`related_submission__rim`)	Related Application (`related_application__v`)
Constraint (`constraint__rim`)	Health Authority (`health_authority__v`)

Object	Field
Application (`application__v`)	Applicant (`applicant__v`) Application Folder Name (`folder_name__v` Expected Acknowledgements (`expected_acknowledgments__v`) Health Authority (`health_authority__v`) Health Authority Division (`health_authority_division__v`) XML Application Number (`xml_application_number__v`)
Content Plan (`edl__v`)	AdPromo Scope (`adpromo_scope__v`) XML Attribute (`xml_attribute__v`) XML Attribute Type (`xml_attribute_type__v`) XML Element ID (`xml_element_id__v`) XML Element Name (`xml_element_name__v`) XML Title (`xml_title__v`)
Content Plan Item (`edl_item__v`)	Continuous Publishing (`continuous_publishing__v`) Continuous Validation (`continuous_validation__v`) Promotional Material Audience Type (`promotional_material_audience_type__v`) Promotional Material Document Type (`promotional_material_document_type__v`) Promotional Material Type (`promotional_material_type__v`) Published Document (`published_document__v`) Published Document (`unbound`) (`published_document_unbound__v`) Published Output Location (`xml_xlinkhref__v`) Source for Published Document (`source_for_published_document__v`) XML Keywords (`xml_keywords__v`) XML Leaf Attribute (`xml_leaf_attribute__v`) XML Leaf Attribute Type (`xml_leaf_attribute_type__v`) XML Leaf ID (`xml_leaf_id__v`) XML Modified File (`xml_modifiedfile__v`) XML Node Type (`xml_node_type__v`) XML Operation (`xml_operation__v`) XML Title (`xml_title__v`)
Content Plan Template (`edl_template__v`)	AdPromo Scope (`adpromo_scope__v`) Folder Path (`folder_path__v`) Vault RIM UUID (`vault_rim_uuid__v`) XML Attribute (`xml_attribute__v`) XML Attribute Type (`xml_attribute_type__v`) XML Element ID (`xml_element_id__v`) XML Element Name (`xml_element_name__v`) XML Title (`xml_title__v`)
Content Plan Item Template (`edl_item_template__v`)	Continuous Publishing (`continuous_publishing__v`) Continuous Validation (`continuous_validation__v`) External ID (`external_id__v`) Filename (`filename__v`) Promotional Material Document Type (`promotional_material_document_type__v`) Promotional Material Type (`promotional_material_type__v`) Source for Published Document (`source_for_published_document__v`) Vault RIM UUID (`vault_rim_uuid__v`) XML Keywords (`xml_keywords__v`) XML Leaf Attribute (`xml_leaf_attribute__v`) XML Leaf Attribute Type (`xml_leaf_attribute_type__v`) XML Node Type (`xml_node_type__v`) XML Title (`xml_title__v`)
Country (`country__v`)	Primary Applicant (`primary_applicant__v`)
Constraint (`constraint__rim`)	External ID (`external_id__v`) Health Authority (`health_authority__v`) Health Authority Division (`health_authority_division__v`) Vault RIM UUID (`vault_rim_uuid__v`)
Controlled Vocabulary (`controlled_vocabulary__rim`)	Filter Vault RIM UUID (`filter_vault_rim_uuid__v`) Vault RIM UUID (`vault_rim_uuid__v`)
Content Plan Template Constraint (`content_plan_template_constraint__rim`)	External ID (`external_id__v`) Vault RIM UUID (`vault_rim_uuid__v`)
Submission (`submission__v`)	AdPromo Scope (`adpromo_scope__v`) Applicant (`applicant__v`) Create Node Extension (`create_node_extension__v`) Dossier Details (`dossier_details__v`) Dossier Status (`dossier_status__v`) Enable Continuous Publishing (`enable_continuous_publishing__v`) Pending Acknowledgements (`pending_acknowledgments__v`) Published Content Owner (`published_content_owner__v`) Submission Contains Files (`submission_contains_files__v`) Submission Format (`submission_format__v`) Validation Criteria Version (`validation_criteria_version__v`) XML ICH DTD / XSD Version (`xml_ich_dtd_xsd_version__v`) XML Regional DTD / XSD Version (`xml_reg_dtd_xsd_version__v`) XML STF DTD / XSD Version (`xml_stf_dtd_xsd_version__v`) XML Sequence ID (`xml_submission_id__v`) XML Submission Description (`xml_submission_description__v`)
Submission Active Substance (`submission_active_substance__rim`)	XML Drug Substance (`xml_drug_substance__v`) XML Drug Substance Manufacturer (`xml_drug_substance_manufacturer__v`)
Submission Clinical Study (`submission_clinical_study__rim`)	XML Clinical Study ID (`xml_clinical_study_id__v`) XML Clinical Study Title (`xml_clinical_study_title__v`) XML Type of Control (`xml_type_of_control__v`)
Submission Country (`submission_country__rim`)	XML Country Code (`xml_country_code__v`)
Submission Drug Product (`submission_pharmaceutical_product__rim`)	XML Drug Product (`xml_drug_product__v`) XML Drug Product Dosage Form (`xml_drug_product_dosageform__v`) XML Drug Product Manufacturer (`xml_drug_product_manufacturer__v`)
Submission Inactive Ingredient (`submission_inactive_ingredient__rim`)	XML Excipient (`xml_excipient__v`)
Submission Indication (`submission_indication__rim`)	XML Indication (`xml_indication__v`)
Submission Language (`submission_language__rim`)	XML Language Code (`xml_language_code__v`)
Submission Nonclinical Study (`submission_nonclinical_study__rim`)	XML Duration (`xml_duration__v`) XML Nonclinical Study ID (`xml_nonclinical_study_id__v`) XML Nonclinical Study Title (`xml_nonclinical_study_title__v`) XML Route of Administration (`xml_route_of_administration__v`) XML Species (`xml_species__v`)

We made data model updates to support the various functionality changes in Regulatory Objective Data Model & Process Update:

Added Event Nonclinical Study object (RIM Registrations only)
Added Submission Regulatory Objective object (RIM Family)
Added Regulatory Objective Active Substance object (RIM Family)
Added Regulatory Objective Clinical Study object (RIM Family)
Added Regulatory Objective Nonclinical Study object (RIM Family)
Added Regulatory Objective Drug Product object (RIM Family)
Added Regulatory Objective Inactive Ingredient object (RIM Family)
Added Regulatory Objective Packaging object (RIM Family)
Added Regulatory Objective Indication object (RIM Family)
Regulatory Objective is no longer a child object of the Application object. The Application field on Regulatory Objective is now an Object field, rather than a Parent Object field.
Any object reference relationships to Regulatory Objective that previously included Application as a controlling field now include a reference constraint based on Application. Note that this change will not modify any existing reference constraints, so users may see a behavior change in these situations. This change affects the following fields:

Object	Field
Activity (`activity__rim`)	Regulatory Objective (`regulatory_objective__rim`)
Registered Active Substance (`registered_active_ingredient__rim`)	Regulatory Objective (`regulatory_objective__rim`)
Registered Clinical Study (`registered_clinical_study__v`)	Regulatory Objective (`regulatory_objective__v`)
Registered Drug Product (`registered_drug_poduct__rim`)	Regulatory Objective (`regulatory_objective__rim`)
Registered Inactive Ingredient (`registered_inactive_ingredient__rim`)	Regulatory Objective (`regulatory_objective__rim`)
Registered Indication (`registered_indication__rim`)	Regulatory Objective (`regulatory_objective__rim`)
Registered Product Details (`registered_product_details__rim`)	Regulatory Objective (`regulatory_objective__rim`)
Registered Packaging (`registration_packaging__rim`)	Regulatory Objective (`regulatory_objective__rim`)
Registration (`registration__rim`)	Regulatory Objective (`regulatory_objective__rim`)
Submission (`submission__v`)	Regulatory Objective (`regulatory_objective__rim`)

We made the following changes to support Report Level Content Plans:

Added new many-to-many relationship objects between Regulatory Objective and the following objects: Drug Product, Active Substance, Inactive Ingredient, Packaging, Clinical Study and Nonclinical Study
Added a many-to-many relationship between Events and Nonclinical Study
Added new fields to various objects:

Object	Field
Report Level Content Plan (`report_level_content_plan__v`)	Content Plan Template (`content_plan_template__v`)
Report Level Content Plan (`report_level_content_plan__v`)	Content Plan (`content_plan__v`)
Report Level Content Plan (`report_level_content_plan__v`)	Published Content Owner (`published_content_owner__v`)
Report Level Plan Clinical Study (`report_level_plan_clinical_study__v`)	Report Level Content Plan (`report_level_content_plan__v`)
Report Level Plan Clinical Study (`report_level_plan_clinical_study__v`)	Clinical Study (`clinical_study__v`)
Report Level Plan Nonclinical Study (`report_level_plan_nonclinical_study__v`)	Report Level Content Plan (`report_level_content_plan__v`)
Report Level Plan Nonclinical Study (`report_level_plan_nonclinical_study__v`)	Nonclinical Study (`nonclinical_study__v`)
Content Plan (`edl__v`)	Report Level Content Plan (`report_level_content_plan__v`)
Content Plan (`edl__v`)	Report Level Plan Clinical Study (`report_level_plan_clinical_study__v`)
Content Plan (`edl__v`)	Report Level Plan Nonclinical Study (`report_level_plan_nonclinical_study__v`)
Content Plan Item (`edl_item__v`)	Report Level Content Plan (`report_level_content_plan__v`)
Content Plan Item (`edl_item__v`)	Report Level Plan Clinical Study (`report_level_plan_clinical_study__v`)
Content Plan Item (`edl_item__v`)	Report Level Plan Nonclinical Study (`report_level_plan_nonclinical_study__v`)
Content Plan Item (`edl_item__v`)	Published Output Location (`xml_xlinkhref__v`)
Content Plan Item (`edl_item__v`)	Source for Published Document (`source_for_published_document__v`)
Content Plan Item (`edl_item__v`)	Published Document (`published_document__v`)
Content Plan Template (`edl_template__v`)	`folder_path__v`
Content Plan Template (`edl_item_template__v`)	`filename__v`
Content Plan Template (`edl_item_template__v`)	Source for Published Document (`source_for_published_document__v`)
Publishing Validation Result (`publishing_validation_result__v`)	Application (`application__v`)
Publishing Validation Result (`publishing_validation_result__v`)	EDL (`edl__v`)
Publishing Validation Result (`publishing_validation_result__v`)	EDL Item (`edl_item__v`)
Publishing Validation Result (`publishing_validation_result__v`)	External ID (`external_id__v`)
Publishing Validation Result (`publishing_validation_result__v`)	High (`high__v`)
Publishing Validation Result (`publishing_validation_result__v`)	Low (`low__v`)
Publishing Validation Result (`publishing_validation_result__v`)	Medium (`medium__v`)
Publishing Validation Result (`publishing_validation_result__v`)	Other (`other__v`)
Publishing Validation Result (`publishing_validation_result__v`)	Publishing Validation Result Type (`object_type__v`)
Publishing Validation Result (`publishing_validation_result__v`)	Submission (`submission__v`)

All new objects are automatically added, but require configuration for users to access them.

RIM Submissions Publishing

With this release, we’ve added a new application, RIM Submissions Publishing, within the RIM Suite. This enables users to publish planned submission content, create a submission ready structure, and documents within RIM Submissions Archive. Publishing occurs continuously, ensuring any changes to source content appear in the published output. Vault continuously validates published content, enabling users to review and correct potential issues as they occur during the creation of the submission ready content.

With this release, Vault supports US FDA eCTD Module 1 DTD version 3.3, with the corresponding US FDA Validation Criteria version 3.6, Study Tagging File version 2.2, ICH DTD version 3.2.

Please note, licensing of RIM Submissions Publishing has a prerequisite of RIM Submissions and RIM Submissions Archive applications.

Vault RIM Submissions Publishing enables users to:

Leverage planned submission data within a content plan to create publish output, allowing users to publish directly from a content plan.
Automatically convert Vault link annotations within the source content to relative hyperlinks within the published output.
Continuously publish documents without the need for users to monitor changes and manually publish.
Continuously validate the published output, allowing users to resolve validation issues early.
Create, validate, and transmit AdPromo Submissions from within Vault.

Continuous Publishing

RIM Submissions Publishing includes the Continuous Publishing process. This feature improves the submission delivery process by allowing customers to continuously publish documents as they become associated with a content plan and as there are updates related to the content or metadata.

Continuous Validation

The Continuous Validation feature provides customers with the ability to verify an eCTD submission based on the Health Authority validation criteria. This process occurs during submissions assembly in Vault. This enables customers to validate and make corrections during submission assembly as content becomes available.

FDA Gateway Integration

This feature has been postponed to a later release.

Select Leaf Operation Target

This feature allows customers to use the new Set Leaf Operation action to select a leaf node from a prior submission of the same application. This occurs when the XML Operation field on a content plan item is set to Append, Replace, or Delete.

US FDA v3.3 Specification Support

Support for submissions in accordance with the US FDA v3.3 specification has been added to RIM Submissions Publishing. This feature also supports Promotional Labeling Advertising submissions. This feature allows users to create Content Plans based on the scope of a submission, and generate submissions compliant with US FDA v3.3 specifications.

Veeva Snap

Veeva Snap: Support Uploads as Attachments

Vault Admins can configure an email message template to include a link to Veeva Snap, allowing users to open the application from a Vault notification email. When users launch Veeva Snap from this link, they can upload a captured document or image as an attachment to another Vault document or to an object, depending on the link configuration.

Veeva Snap: Automatic Picture Taking

A new mode has been added that allows Veeva Snap to take photos automatically. Users simply hold their device over the page, and Veeva Snap automatically takes a picture after it detects the page edges for a certain amount of time. Automatic photo capture makes it easier and quicker to scan multi-page documents.

Veeva Snap: Support Image Uploads

Another new mode allows users to capture and upload images to Vault from Veeva Snap. Veeva Snap converts the images to PDFs before uploading to Vault. This mode turns off page edge detection in the camera and doesn’t apply the default filter or auto-crop the picture. Users can still manually crop and filter images as desired.

Veeva Snap: EMM Provisioning

This feature adds a new EMM profile attribute used to define whether or not the Veeva Snap application is provisioned via an organization’s EMM vendor. Previously, to provision Veeva Snap from an EMM vendor, an Admin had to assign the application a new ID and resign it with their own certificate. This feature allows an Admin to simply set a value for the VeevaSnapEMMProvisioned property in the EMM configuration file. This attribute will be used when an Admin does not grant the Veeva Snap: Enable App Store Configuration permission, which differentiates an EMM-provisioned version of Veeva Snap versus the version available from the Apple App Store.

Minor Enhancements

Date Functions

This feature allows users to compare a date or dateTime field to a today function, which will resolve to the current date each time the report is run. In addition to today, users will be able to define functions for now, tomorrow, and yesterday. Date functions will be available in filters and conditional fields. One important use case for date functions is enabling users to filter for late processes within flash reports, which do not support prompts.

Domain-level User Profile Images

In previous releases, users had to assign a profile image for each vault they had access to. With this release, Vault manages the user profile image at the domain level as opposed to the vault level. When a user uploads a profile image, it becomes available across all vaults to which the user has access in the home domain and cross-domains.

Note that some users may have multiple profile images within their domain. With this release, Vault selects a single profile image to use as the domain profile image. If the profile image that Vault selects is incorrect, users can easily change the profile image.

Use Names for Bulk Translation

With this feature translation files exported and imported with the Bulk Translation Tool use component names as the Object Key where possible. This makes it easier for an Admin to correlate the translation row to the component in Vault. It also allows translation files to be managed across multiple Vaults more effectively. Learn about the Bulk Translation Tool.

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 languages are:

Sesotho
Catalan
Swahili

See a list of all supported languages.

Object Record Search by ID

This feature allows users to search for object records with object record IDs.

Search Ranking Improvement

This feature updates search ranking to prioritize exact-match terms above “starts with” matches. For example, if a user searches for “promo”, Vault will always rank precise matches to the term “promo” before matches such as “promotional” or “promote”.