New in 19R3.4: Single Create Button Across All Tabs, and more…

Release Date: February 7, 2020

We are pleased to bring you the following new functionality in this week’s release. See details about feature enablement below.

Usability & Interface Improvements

Single Create Button Across All Tabs

Vault now supports a single global Create button for all tabs. Users can create object records, documents, reports, and dashboards from this unified create button and menu.

This updated component includes a button on the left to create an item based on the user’s current context and a drop-down on the right. The Create menu also shows the three (3) most recently created item types (for the current user), allowing a user to operate more quickly, even out of context, if they are frequently creating the same item types.

For example, if Teresa is on the Product tab, she can click Create to make a new product record. If she navigates to the Library tab, she can click Create to create a new document. However, if she’s been creating product records recently, she will also be able to create a new product record without leaving the Library tab from the most recent items.

As part of this change, Vault will no longer show individual inline Create buttons within each object, report, and dashboard tab. Note that the Admin interface will not change in 20R1. Learn more about the Create button.

Consolidate Document Options in the Create Menu

Vault will now have a single option for all document creation. The Document option in the Create menu allows users to upload a document, create a document from a template, create a binder, create a placeholder, or create a CrossLink document. Learn more about creating documents.

Navigation Panel Update

With this release, the navigation panel and links on the object record detail page and the Sharing Settings page now appear on the left side of the screen instead of on the right side.

Moving the navigation panel and links, also known as jumplinks, enables users to navigate to different sections on the page more easily. These links not only navigate users to those sections but also expand them automatically to easily display data.

Updated Document Picker Dialog

With this release, we have updated the user interface shown when selecting documents while adding document relationships. The new interface makes it clearer if the user can select multiple documents, or just one document.

In addition to the standard Library views, this feature adds the ability to limit the view to documents that are currently in your Cart. Learn more about document relationships.

New Tab-based UI for Vault File Manager

This release introduces several updates to the Vault File Manager UI, including tabs. Only the checked out documents tab is visible in 19R3.4. Future releases will add additional functionality in new tabs, including allowing new files to be uploaded to Vault via the Vault File Manager application. Learn more about Vault File Manager.

Working with Documents

Collaborative Authoring with Microsoft Office: PowerPoint & Excel Support

Collaborative Authoring with Microsoft Office now supports checking out and editing Microsoft PowerPoint and Microsoft Excel files. Previously this feature only supported Microsoft Word files. The feature supports files that use the Office Open XML format: .pptx or .xlsx. Learn more about Collaborative Authoring with Microsoft Office.

Collaborative Authoring with Office Usability Enhancements

The Collaborative Authoring with Microsoft Office feature has been enhanced to reduce the number of user clicks required to check out or edit a document from Vault. In addition, the Edit button has been updated to be consistent with Vault design standards.

Update Flow for Upload Document in a Record’s Related Document Section

The user experience for uploading a document from within an object record’s related document section is now consistent with uploading a document using the global Create button. The “Upload” dialog has been removed, providing unified Upload steps for users regardless of the context from which they upload a document.

Enable External Users to Bring Forward Anchor Annotations

A user with the External User license type, when granted the Annotate lifecycle permission and the Manage Anchors permission, can now bring forward anchor annotations from a previous version to the latest version of a document. Previously, external users were unable to bring forward anchors because users of that license type did not have access to Manage Anchors permission.

Document Archive Changes for Merge Fields & CrossLinks

This feature introduces changes to how Vault handles documents when users archive them:

• When archiving a document with Merge Fields, Vault automatically sets the Merge Fields document field value from Yes to No. If the field value is blank, it will stay blank.
• When archiving a CrossLink document, Vault automatically sets the version binding to version-specific to retrieve the current latest version of the source document.

Eliminate Separation on Mid-Word Changes to Font Face, Size & Style

Vault has made several minor updates to document text indexing in order to improve the efficacy of several features, including Auto Claims Linking, Bring Forward Annotations, and Find in Document. These include:

• Vault no longer separates a single word into two words when it contains a change in font face, size or style.
• Combining characters no longer split words if they overlap with the character with which they are combining.
• Vault no longer always indexes a character as a distinct word just because it is on a different y plane than the previous character. Word separation is now restricted to very significant changes to y plane alignment.
• “Bell” characters are dropped from text extraction because they’re sounds, not text.
• ETX control characters are counted as a space because they’re meant to signal the end of a block of text.

Note that Vault preserves the existing word indexing for already-indexed documents and applies the new indexing to any new, newly rendered, or re-rendered document versions. For re-rendered documents with existing annotations, Vault updates the annotation placement when annotations are preserved.

Document Rendering

Merge Fields Sorting

This feature introduces the ability to order the values being merged to a Microsoft Word™ document using an ORDER BY clause on the mapped token.

When placing a token for a Merged Field into a Microsoft Word™ document (DOCX files only), this feature allows you to apply a criteria-based sort, such as ordering by Sequence Number, Date Created, Name (alphabetically), or others. Learn more about filtering and sorting Merge Fields.

Prevent Merge Fields in Steady State

In previous releases, the Merge Field content in documents continued to update regardless of the document’s status. This feature disables automatic merging of document fields when the document is in the Steady State.

Once a document reaches the Steady State, it will no longer merge document fields or related object fields when an action that triggers fields to merge occurs. The document will not merge while in its Steady State regardless of whether the merging event is triggered by the system or due to a manually performed action. Learn more about Merge Fields.

Unmodified Source Rendition Type for Modified Vault Documents

This feature provides Vault Owners with the ability to download unmodified source files that are stored when Vault makes changes to the Source Document through features such as Merge Fields, RIM Dynamic Linking (Named Destinations) and RIM Create ToC for Content Plan Items. Vault Owners can use the Unmodified Source files for sanity-checking or restoration if needed. Learn more about the Learn more about the Unmodified Source rendition.

Vault Objects

Additional Deletion Rule for Document Reference Fields

Document reference fields now support another deletion rule: Set object field to blank in related records. This is similar to the Set to Null deletion rule available on object reference fields. When an Admin sets a document reference field’s deletion rule as Set object field to blank in related records, Vault no longer blocks deletion of the referenced document. When a user deletes the referenced document, Vault sets the field that references the deleted document to Null. Learn more about deletion rules for document reference fields.

Prevent Null Checkboxes

Prior to this release, checkbox fields defaulted to null/blank when users created new records. Starting in this release, when users create a new record and don’t provide a value in a checkbox field, the field defaults to No. When an Admin adds a new checkbox field to an object with existing records, Vault sets the checkbox field to No on every existing record.

Lifecycle & Workflow

Multi-Document Workflow: Single Verdict for All Content Documents

This enhancement allows Admins to configure a document task in a multi-document workflow to prompt for a single verdict that will apply to all content documents. For example, when sending a package of related documents for approval, it is now possible to prompt the task owner for a single approval verdict that applies to all of the documents in the workflow, rather than a verdict for each document. This is important in use cases where the entire package of documents must be either approved or rejected. Learn more about Multi-Document Workflows.

Entry Criteria: Content Must Not Be Checked Out

This enhancement to document lifecycle state entry criteria allows Admins to verify that a document is not checked out when entering a specific lifecycle state. For example, in an authoring workflow, a document may be checked out for editing. However, when a document is about to transition into the Approved state, configuring this entry criteria on the Approved state can ensure that the document does not get approved while the content is checked out. Learn more about document state entry criteria.

Multi-Document Workflow: Bound Document Versions

This enhancement supports the ability to include both bound and unbound document versions in a multi-document workflow. For example, when sending a set of related documents for review and approval, some documents may be already in Steady state and included for reference only. In these use cases, it is important that the Steady state document version is locked so that the workflow participants are always looking at the correct version even if a new draft is created.

Note that the only way to start a multi-document workflow with bound document versions currently is by starting a multi-document workflow from the Content Plan Hierarchy Viewer in a RIM Vault or through the API.

Multi-Document Workflow: Add Participant

This enhancement allows users to add participants to an active multi-document workflow. For example, in a document approval workflow, the workflow initiator may discover after the workflow has already started that additional subject matter experts are needed. The workflow initiator can now add them without restarting the workflow.

Optional Tasks for Object & Multi-Document Workflows

This enhancement allows Admins to configure a task to be optional in an object or multi-document workflow. For example, when sending a record or set of documents for approval, not all departments or subject matter experts are required in every instance. When sending a promotional piece for Medical, Legal, and Regulatory (MLR) Approval in a PromoMats Vault, one, two, or all three subject matter experts may be required. This configuration allows the workflow initiator to determine which participants should be included in the approval at the start of the workflow.

Advanced Criteria for Entry Actions on Related Records

With this feature, Admins have additional filtering criteria for object lifecycle state entry actions that execute changes for related object records. When setting up the Change related object lifecycle state entry action on an object, it’s now possible to filter the related object records that the action will affect.

For example, a Quality Event object has related Change Action records. Some Change Actions will be in Canceled state, while others are in Accepted state. By configuring a condition on the entry action, an Admin set up the state change to approve the Quality Event and related Change Actions, but leave the Canceled state Change Actions in their existing state (Canceled).

Removing Validation that Prevents State Changes in Multi-Document Workflows When a Document is Checked Out

With the release of the new document lifecycle state entry criteria, Content must not be checked out, we’ve removed the validation that prevents state changes in multi-document workflows when a document is checked out. Admins can now control this behavior by configuring the new entry criteria in selected states.

Record Workflow Action Enhancement: Display Custom Participant Group on Object Workflow Start Dialog

This enhancement allows users to implement record workflow actions that determine the participants of a workflow with the option to display those participants on the workflow start dialog. Workflow initiators can then see who the participants will be before starting the workflow. Learn more about using object workflows.

Managing Users

New Domain Admin UI

This feature, along with the User Object Admin Page feature, delivers an overhaul of user management from Admin > Users & Groups.

The updated Domain Users page allows domain administrators to perform domain-specific tasks:

• View and search domain users
• Filter by Vault and Vault status
• Export a list of domain users
• View a Vault user’s domain-level fields
• Manage Vault membership assignments across Vaults in the domain
• Assign domain users to a Vault under a certain license type and security profile
• Remove a user from current Vault memberships

The new Domain User page is read-only except for Vault membership assignments across Vaults. User attributes for users assigned to the current Vault can be edited from the Admin > Users & Groups > Vault Users page. User attributes for users not assigned to the current Vault can be edited on the Admin > Users & Groups > Vault Users page in any Vault where the user is assigned. Learn more about the new Vault Users page and managing Vault users with the User object. Learn more about managing domain users.

User Object Admin Page

With this release, we’ve updated the Admin > Users & Groups > Users administration page to leverage the User (user__sys) object. This allows Admins to manage all Vault users with the flexibility of Vault objects, including making the User object page layout customizable with field level security, layout rules, and more.

This feature adds new page sections and actions to the User object, which are available anywhere the User object is displayed. New actions available on User object records include Create Cross Domain User, Reset Password, and Resend Welcome Email. New User object page layout sections include:

• Groups: View the user’s group membership and assign the user to groups.
• Delegate Access: View active delegations and assign or edit new ones.
• Grant Support Access: Grant temporary access to Veeva Support.
• Security Overrides: View any security overrides configured for the user.

As part of the new Vault Users page, there are updates to certain permissions related to managing users. Any users with the Admin: User: Create and Admin: User: Edit permission are now automatically granted the Read and Edit permissions on all User object fields.

System Owned User Field

A new System Owned User field appears on the User object to distinguish system-managed users, such as the Application Owner User, from your authenticated Vault users. This Yes/No field is system-managed and read-only.

This feature was released in 19R3.2.

Search & Filter

Object References in Advanced Search

Admins can now configure up to five (5) object reference fields to be included as filters in the Advanced Search dialog for documents. This provides quick access to the object reference fields that are the most important to an organization and helps users locate documents easily.

These new configurable filters are interactive with existing filters, so users can choose to use them as part of a new Advanced Search or to use Advanced Search to iterate on a previously applied set of search criteria. These filters also support parent/child relationships between objects, so users are prompted to select a value in a parent filter first. Vault then constraints the values in the child filter based on the value the user selected in the parent filter. Learn more about configuring object reference fields as filters in Advanced Search.

Exclude Inactive Picklist Values from Filter Lookups

When users look up picklist values within search filters, Vault now excludes inactive values. This change impacts Advanced Mode for picklist filters as well as the lookup that appears when over 15 items display on a standard picklist filter.

Checklists

Aggregate Checklist Designs

In Vaults with Checklists enabled, this feature allows Admins to aggregate content from two or more Approved Checklist Designs (“Sub Checklists”) in a specified order so the content can be reused and easily managed with no duplication. Admins can aggregate a maximum of six non-aggregated checklist designs which belong to the same object type. Learn more about Aggregate Checklist Designs.

Checklist Design Versioning

In Vaults with Checklists enabled, this feature allows Admins to manage checklist design versions in a controlled manner so that changes can be tracked easily. At any given time, only one version of a Checklist Design record can be in each of the Draft and Approved lifecycle states. Admins can choose to configure any Checklist Type to be version controlled. This feature also introduces a new concept of Checklist Design Master where Admins can view all the versions belonging to a specific Checklist Design. Learn more about Checklist Design Versioning.

Attach Multiple Documents in Checklist Responses

In Vaults with Checklists enabled, this feature allows a user to select one or more documents as part of their response to a checklist question the same way that one or more file attachments can be included with a response. Previously, only a single document reference was possible. This is an important enhancement because in certain situations such as when conducting an audit using a checklist or conducting an impact assessment for a change control, users may need to attach multiple documents to provide supporting evidence. Learn more about configuration to Attach Multiple Documents in Checklist Responses.

Administration

Test Data Packages

This feature introduces a new type of Outbound Package called Test Data. Admins can leverage this type of package to export and load object records between Vaults. For example, Admins can create a Test Data package to export all of the transactional data into a VPK and then load and deploy the VPK accordingly once the sandbox Vault has been refreshed. Learn more about Test Data Packages.

Formatted Output: List of Attachments

With this release, Formatted Output users can now include a list of attached files from the primary record that the Formatted Output is run against. In previous releases, while users could attach files directly in the prepared zip file from Vault, this feature additionally allows Formatted Output PDFs to clearly indicate the full context of the record within the PDF itself.

For example, if a user generates a PDF rendition of a CAPA record, they can now include a field in that PDF which lists each attachment (excluding other previously generated Formatted Output PDFs) from that root CAPA record.

This specialized token, for use within the Formatted Output template, prints the name and version of each eligible attachment from the root record on separate lines within the body of a designated field in the PDF. While this feature was purpose-built for the Quality application, it is available to all Vault applications. Learn more about Formatted Output templates.

Vault ID Filter for Login Audit History

This feature introduces the ability to filter the Login Audit History by Vault ID. Admins can use the Vault ID filter to view only logins for a specific Vault. The timestamp filter options have also been updated to include the last two weeks. This allows Admins to easily see the number of successful user logins over a period of time. Learn more about viewing Admin logs.

Reporting

Excel Templates for Reports

This feature allows users to upload Microsoft Excel templates to reports and then export report data into those templates. With Microsoft Excel templates, users are able to format reports, perform calculations, apply conditional formatting, use pivot tables to group and analyze, and access more chart options for visualization. Additionally, users are able to export report metadata such as the report’s name, filters, and export date to the Excel template. Learn more about Excel report templates.

Define PDF Export Option in Reports

This feature provides users with more flexibility when exporting a report to PDF. Within the report, users may now choose whether the report is exported with all of the columns fitting onto the page or whether to use the existing formatting. This option was previously defined at the Vault level. By default, all reports will have the fit to page option selected, but this may easily be modified. Learn more about exporting reports.

Formulas

New Functions and state__v Support

This feature introduces the following new functions to Vault Formulas:

• Power()
• Sum()
• Average()
• StartOfDay()

This feature also enhances the existing Today() function to accept an optional timezone parameter.

Additionally, this feature allows Vault Formulas to access the name of a lifecycle state with state__v . Previously, formulas could only access the label with Text(state__v).

Platform Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve made the following changes to the Platform data model:

Added the Archived Date (archived_date__sys) DateTime document field to the Base document type, in the General doc info section

• This field is special because it only displays in Doc Info if the field contains a value
• This field is always assigned to Base document type
• This field is provisioned in the General display section, but can be configured in Admin
• This is a system managed field that Vault populates when a document is archived

• Added the Unmodified source (unmodified_source__sys) Rendition Type
  • The new Unmodified Source Rendition Type is created in the database (in the vcf_renditiontype table), with the public key unmodified_source__sys.
  • The Unmodified source (unmodified_source__sys) has been added to the base document type and is inherited by all document types.
  • The Unmodified Source Rendition Type cannot be modified or deleted from the base document type.
  • The Unmodified Source Rendition Type is system managed, so it cannot be manually assigned by Admins or Users to a document, nor can it be assigned via the API.
  • Unmodified Source rendition type is listed under Configuration > Document Setup > Rendition Types.

Commercial

Auto Claims Linking: Prevent Move & Edit References on Approved Links

Once a Suggested Link is accepted, users cannot Move or Add / Remove references on the resulting Link Annotation. Those functions are “locked” and the associated Move and Link buttons do not appear in the Annotation toolbar. Learn more about using Auto Claims Linking.

Auto Claims Linking: References in Audit Trail

This feature is postponed to a future release.

Auto Claims Linking: Hierarchical Copy on Claims

When making a copy of Claims records, users can now choose to also copy the References and Match Text Variations. Learn more about Copying Object Records.

Auto Claims Linking: Make Dependent on Link Annotation Enablement

When Allow creation of link annotations is disabled in Admin, Vault hides the Suggest Link button on the Doc Info page, hides any existing Suggested Links, and does not display either Suggested Link options in Admin > Configuration> Document Types. Learn more about enabling Auto Claims Linking.

Open Portal Experience from Vault

Currently, PromoMats and MedComms users can only view the Portal homepage in Vault unless they open the full Portal. With this feature, users can open the full Portal in the current browser tab. In addition, users with the correct permissions can edit the Portal directly from the Portal Selector drop-down on the Portal Homepage. Learn more about accessing Portals.

Enhanced Configurability of Standard Fields on Select Medical Inquiry Standard Objects

This feature provides greater flexibility in the Medical Inquiry data model by allowing customers to specify whether the following standard fields are required or not required:

• Case object
  • Case Contact
  • Case Priority
  • Origination Channel
• Case Request object
  • Request Category
  • Preferred Response Method
• Case Contact object
  • National Provider Identifier (NPI)
  • Specialty

Learn more about the Medical Inquiry Data Model.

Clinical Operations

Streamlined Reuse for Product/Person/Org Documents

Certain document types in a TMF (CVs, Lab Certifications, and Investigator Brochures) can be reused across multiple studies. This feature allows users to identify which of their document types are frequently reused, and maintains the Study field for those document types as Persons, Organizations, or Products are added to and removed from studies. Learn more about document reuse across studies in Clinical Operations Vaults.

Known Issues

• Customers who have set the Study, Study Country, or Study Site fields as required will not be able to create placeholders, documents from template, or binders with a document Classification that they have added to the Product Profile, Person Profile, or Organization Profile Document Type Groups.
• When Vault removes values from the Study, Study Country, or Study Site fields after a user versions a document, these changes do not appear in the audit trail.

Fee Schedule Date Effectivity

Organizations can now approve multiple fee schedules at a site for various date ranges. Fee schedules may specify their effective start and end dates. When populated, Vault Payments will generate payable items and values based on the fee schedule in effect when the payable event occurred. Learn more about Fee Schedules.

Multi-Status Fees

With this feature, Vault Payments users can define the list of fee statuses that may generate payable items during the corresponding payable event creation or update in Vault CTMS. Fees and fee templates now support multiple statuses for generating payable items. Payable items will only generate once for each fee and event combination from the allowed set of statuses. Learn more about Multi-Status Fees.

Yuzu: Japanese Clinical Trial Notification Generation

When Vault CTMS customers conduct Clinical Trials in Japan, they must submit Clinical Trial Notifications (CTN) to the Japanese Health Authority (PMDA). This feature allows users to generate and manage Japanese CTN on Vault CTMS seamlessly with other clinical trial activities. Learn more about Clinical Trial Notifications.

Clinical Operations Configuration for Object References in Advanced Search

The Object References in Advanced Search feature enables Admins to add up to five (5) object reference fields as filters in the Advanced Search dialog for documents. By default, Clinical Operations Vaults include the Study, Study Country, and Site object reference fields as filters in the Advanced Search dialog. Admins can remove or update these from the Admins > Settings > Search Settings page.

Delay & Batch Milestone Autocomplete Job

In order to ensure that users see accurate completeness calculations for milestones, Vault will no longer evaluate milestone autocomplete logic instantly. Instead, Vault will calculate completeness metrics and autocompletion after a five minute delay. This change ensures that the calculations will take newly-created tasks and other recent activity into account.

EDL Hierarchy Viewer: Behavior Change for Navigating EDLs

This change was reverted.

Clinical Operations Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality.

We added the following components to support Streamlined Reuse for Product/Person/Org Documents:

• Added the following Document Type Groups:
  • Person Profile
  • Organization Profile
  • Product Profile

We added the following components to support Fee Schedule Date Effectivity:

• Added the Procedure Date (procedure_date__v) field to the Procedure (procedure__v) object

Quality

Person Object: Remove User Restrictions When Adding a Learner Role

In previous releases, when a Learner Role was added to a Person record, Vault required an active User reference, regardless of the value of the Training Eligibility field. With this release, an active User reference is only required if Training Eligibility is set to Eligible.

Note: This change only applies if the Use Training Eligibility setting is enabled in your Vault. For most Vault Training Vaults, this setting is automatically enabled. If you are not sure, please contact Vault Support. Learn more about training eligibility.

External Training Type

With this Vault Training release, we are introducing the External Training type, which allows Learners to complete training on content or topics that occurred outside of Vault. For example, an organization may require that Learners complete a third-party online course or receive an external certification.

With the External Training feature, a Training Admin can create External Training Requirements and include them in their training matrix. Learners will receive a Training Assignment with instructions on how to complete the Training Assignment. Managers or other users in an appropriate role can verify the Training Assignment before it is set to the Completed status in Vault Training. Learn more about configuring External Training Requirements.

Direct Assignment to Multiple Learners

In previous releases, the Vault Training Direct Assignment feature could issue a Training Assignment to only one Learner at a time. With this release, Direct Assignment now supports issuing a Direct Assignment Training Assignment to multiple Learners with a single request.

To support this enhancement, we have made the following changes to the Direct Assignment User Input page layout:

• Removed the existing Learner (learner__v) field and marked it as not required
• Added the new multi-select Learners field

Learn more about Direct Assignment.

Direct Assignment to Curriculum

With this release, the Direct Assignment action can also be performed on a Curriculum. This allows users to issue Training Assignments for that Curriculum to the Learners selected. Learn more about Direct Assignment.

Complete Training Assignment Workflow Visible in Admin

Previously, the Complete Training Assignment Workflow, which is used for Vault Document Training Assignment, was hidden in Vault Admin. In this release, the workflow is now visible. This allows Notification and Task Reminders to be configured for the workflow.

Note: Modifying this workflow can cause issues delivering Training to Learners. Only certain workflow elements can be updated. Learn more about the Complete Training Assignment workflow.

Improvements to Learner Task Page

In this release, the Vault Training Learner Task Page user interface is enhanced for Training Assignments containing multiple documents. Learners will see the following changes:

• Upon clicking into a Training Assignment, Learns will arrive at a default landing page, requiring them to select a document. Previously, the first document would automatically be selected and displayed to the Learner.
• Vault now displays a green checkmark for each document a Learner views.
• Vault now always displays the Learner Task Page for completed Training Assignments, along with a link to View Quiz. Previously, a Learner clicking into a completed Training Assignment would see the record details page.
• Other minor cosmetic improvements to the Learner Task Page.

Learn more about Learn more about completing Vault Training assignments.

Training Requirement Object Type Limitation

To ensure that Vault Training continues to function as intended as we continue to add new features, the following restriction is now in place on Training Requirement records:

• A Training Requirement record’s object type cannot be changed once the record is saved.

Learn more about Learn more about Training Requirement object types.

Auto-Recall Controlled Copies

In previous releases, if a document utilizing Extensible Controlled Copy functionality was superseded or obsolesced, users would need to manually review the associated Controlled Copy Trace records to determine if a recall process was necessary for any currently-disbursed copies.

With this feature, customers using Extensible Controlled Copy can configure their Vault to find all associated controlled copies when a document version is superseded or obsolesced, and change their lifecycle state. Users can configure an auto-start workflow to issue a task to the person responsible for reconciling each issued copy. This automates the process of manually tracking and reconciling controlled copies. Learn more about automatically recalling controlled copies.

Display Mandatory Participants in Workflow Start Dialog

This feature enhances the workflow start dialog for the initiator of a Document Change Control (DCC) workflow that includes Mandatory Participants. The initiator is able to see which groups and users will receive mandatory review or approval tasks before starting the workflow. This can help them determine which users (if any) need to be manually assigned review or approval tasks for that DCC. Learn more about Mandatory Participants.

Station Manager: Additional Fields on Station Device

With this release, Station Device records now include three new fields to give Business or IT Admins additional information visibility for their tablets running Station Manager:

• Operating System: The operating system of the device, for example, iOS™ or Android™
• Application Version: The version of the mobile application currently running on the device
• Sync Details: Information about the most recent Vault sync on the mobile application

Note that these fields will be populated by future versions of the Station Manager mobile applications. Learn more about setting up Station Manager.

Quality Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve made the following changes to the Quality data model to support new features:

The following changes support the External Training Type feature:

• Updated Training Requirement (training_requirement__v) with the following fields:
  • Instructions (instructions__v)
  • Training Link (training_link__v)
• Updated Training Assignment (training_assignment__v) with the following fields:
  • Instructions (instructions__v)
  • Training Link (training_link__v)
• Updated Training Requirement (training_requirement__v) with the following object type:
  • External Training Requirement (external_training_requirement__v)
• Updated Training Assignment (training_assignment__v) with the following object type:
  • External Training Assignment (external_training_assignment__v)
• Added the following object workflows
  • Complete External Training Assignment (complete_external_training_assignment__v)
  • Verify External Training Assignment (verify_external_training_assignment__v)
  • Resubmit External Training Assignment (resubmit_external_training_assignment__v)

The following changes support the Direct Assignment to Multiple Learners feature:

• Updated Direct Assignment User Input (direct_assignment_user_input__v) with the following fields:
  • Apply to Training Requirements in (apply_to_trs_in__v)
  • Learners (learners__v)
• Updated Direct Assignment User Input (direct_assignment_user_input__v) with the following changes:
  • Learner (learner__v) is no longer a required field
• Updated Direct Assignment Request (direct_assignment_request__v) with the following fields:
  • Direct Assignment User Input (direct_assignment_user_input__v)

The following changes support the Direct Assignment to Curriculum feature:

• Direct Assignment User Input (direct_assignment_user_input__v) with the following fields:
  • Apply to Training Requirements in (apply_to_trs_in__v)
  • Learners (learners__v)
• Direct Assignment User Input (direct_assignment_user_input__v) with the following changes:
  • Learner (learner__v) is no longer a required field

We have made the following changes to support the Complete Training Assignment Workflow Visible in Admin feature:

• Added the following object workflow:
  • Complete Training Assignment (complete_training_assignment__v)

The following changes support the Auto-Recall Controlled Copies feature:

• We have added two new state types on the Controlled Copy Trace lifecycle:
  • Controlled Copy In Use: When a document version is superseded or obsolesced, the Recall Controlled Copies document entry action finds all associated Controlled Copy Trace records in this state type and transitions them to the Controlled Copy In Recall state type.
  • Controlled Copy In Recall: When a document version is superseded or obsolesced, the Recall Controlled Copies document entry action finds all associated Controlled Copy Trace records in the Controlled Copy In Use state type and transitions them to this state type.
• We have added a new field to the Controlled Copy Trace object:
  • Recall System Details: System-captured details about the automated recall process for this controlled copy. For example, if an entry criteria prevents a transition from the Controlled Copy In Use state type to the Controlled Copy In Recall state type

The following changes support the Station Manager: Additional Fields on Station Device feature. We have added three new fields to the Station Device object:

• Operating System: Captures the mobile operating system running on the device. For example, Android or iOS
• Application Version: Captures the version of the mobile application running on the device, e.g. 201.0.1-76
• Sync Details: Captures information about the most recent Vault sync for the device. For example, if the Station User does not have access to view one or more documents assigned to the Station

QualityOne

QualityOne Mobile for iOS

QualityOne introduces a configurable native iOS application for smartphones that allows users to log nonconformances against Purchase Orders, Production Orders, or Processes on the spot when discovering a nonconformance, including attaching photos. The application operates in environments where there is connectivity, either cellular data or WiFi. QualityOne Mobile for iOS allows Admins to configure the solution to best meet their needs. Learn more about QualityOne Mobile.

Regulatory

Start Multi-Document Workflow from Content Plan Viewer

This feature leverages the Multi-Document Workflow functionality to allow users to start a review and approval workflow for matched documents directly from the Content Plan Hierarchy Viewer. When a user selects the action to start the workflow, Vault retrieves up to 100 documents matched to active content plan items in the current grid view and prompts the user through steps to launch the workflow.

The document version that Vault sends on the multi-document workflow depends on matched document version locking. If a content plan item is locked to a specific document version, Vault includes that version in the workflow. If the content plan item is not locked to a specific document version, Vault includes the latest document version in the workflow.

The action to start the workflow is automatically available on all Vaults with at least one active multi-document workflow configured. We recommend that Admins configure a review and approval workflow specifically for content plan’s matched documents. Learn more about starting a multi-document workflow from the content plan Hierarchy Viewer.

Enhancements to Create Related Records Wizard

This release provides several enhancements to the bulk creation process for activities, submissions, and regulatory objectives to improve the user experience and to better support the management of medical device-related change events in addition to drug-related change events:

• Users have the flexibility to create any combination of activities, submissions, and regulatory objectives.
• Vault selects all available relationships by default.
• The bulk create wizard now supports several additional medical device fields and relationships.
• The bulk create wizard can be configured to automatically determine the appropriate object types for the records it creates depending upon the context.

Learn more about bulk creating activity, submission, and regulatory objectives.

Switzerland eCTD DTD 1.4 Publishing & Validation

With this release, RIM Submissions Publishing Vaults support the CH Swissmedic v1.4 (DTD 1.4) specification. Users can now create content plans and generate submissions that are compliant with CH Swissmedic v1.4 specifications. Vault validates these submissions based on the corresponding CH Swissmedic v1.4 Validation Criteria. Learn more about working with Swiss regulatory submissions.

Enablement Change: Allow Multi-Select on Standard Document Fields

With this release, Admins can configure the following standard document fields to be multi-select, without having to contact Veeva Support:

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

RIM Data Model Updates for 20R1

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Regulatory data model to support new features:

Added the following components to support Enhancements to Create Related Records Wizard:

• Added the Event Regulatory Objective (event_regulatory_objective__v) join object*
• Added the Complex Product Type (applicable_product_type__v) field to the Product (drug_product__v) object
• Added the Source Applicable Product Type (source_applicable_product_type__v) field to the Object Type Mapping (object_type_mapping__v) object
• Added the Applicable Product Type (applicable_product_type__v) field to the Activity (activity__v) object
• Added the following object types to the Object Type Mapping (object_type_mapping__v) object:
  • Event Mapping (object_type_mapping__v.event_mapping__v) object type
  • Application Mapping (object_type_mapping__v.application_mapping__v) object type
• Added the Applicable Product Type (applicable_product_type__v) picklist field to the following objects and object types:
  • Event (event__rim) object
  • Labeling Event (event__rim.labeling__rim) object type
  • Manufacturing Event (event__rim.manufacturing__rim) object type
  • Other Event (event__rim.other__rim) object type
  • Regulatory Event (event__rim.regulatory_event__rim) object type
  • Activity (activity__rim) object

*These objects only exist in RIM Registrations Vaults

Added the following components to support Switzerland eCTD Publishing CH 1.4:

• Added the Application Pharmaceutical Form (application_pharmaceutical_form__v) object with fields:
  • Application (application__v)
  • Pharmaceutical Form (pharmaceutical_form__v)
  • Pharmaceutical Form Translation (pharmaceutical_form_translation__v)
  • Swissmedic Number (swissmedic_number__v)
  • Translation (translation__v)
  • Translation Language (translation_language__v)
• Added the Submission Pharmaceutical Form (submission_pharmaceutical_form__v) object with fields:
  • Application (application__v)
  • Pharmaceutical Form (pharmaceutical_form__v)
  • Submission (submission__v)
  • Swissmedic Number (swissmedic_number__v)
  • Translation (translation__v)
  • Translation Language (translation_language__v)
  • Use for Content Planning (use_for_content_planning__v)
  • Controlled Vocabulary (controlled_vocabulary__v)
• Added the Controlled Vocabulary Translation (controlled_vocabulary_translations__) object with fields:
  • Language (language__v)
  • Language Vault RIM UUID (language_vault_rim_uuid__v)
  • Translation (translation__v)
• Added the following field to the Language (language__rim) object:
  • Vault RIM UUID (vault_rim_uuid__v)
• Added the following fields to the Content Plan (edl__v) and Content Plan Item (edl_item__v) objects:
  • Submission Pharmaceutical Form (submission_pharmaceutical_form__v)
  • Pharmaceutical Form (pharmaceutical_form__v)
• Added the following shared document field:
  • Pharmaceutical Forms (pharmaceutical_form__v)

We’ve also added the following component to the RIM data model:

• Added an External ID (external_id__v) field to the Regulatory Objective (regulatory_objective__rim) object

In this release, we have also enabled numerous attributes, such as Required, System Managed Name, and more, on many standard objects and fields. These attributes allow organizations to configure these components according to their business requirements without needing to contact Veeva Support or Product Management to make these configuration changes. In order to utilize these newly-enabled attributes, Admins must perform the desired configuration to make them available for users.

RegulatoryOne

Generate Submission Ingredients

A utility function that helps users generate the list of Submission Ingredient records through an action instead of creating each Submission Ingredient one at a time. This list will be pulled from the list of Submission Formulas and its relationship to Formula Ingredients.

Ingredient Lists

Ingredient lists are required by regulatory agencies on all cosmetic products to be printed on a product’s label in the generally correct ingredient order, with the correct ingredient names for the consumer to see.

This feature allows users to generate a word document for a product or list of products with a list of ingredients using the ingredient’s INCI names, separated by commas. Ingredients are listed in the document in descending order of concentrations, with allergens listed before colorants, and colorant ingredients listed last surrounded by [+/-].

Safety

Safety features are targeted for tentative availability on February 13, 2020.

Masked Content Protection for Patient and Blinded Study Data Configuration

Vault Safety now supports the ability to selectively mask sensitive information on Individual Case Safety Reports (ICSRs). For each study or product, you can choose to protect confidential or blinded data, such as all of a patient’s identifiable and health information, only identifiable information, and/or general study data.

Through this feature, you can generate masked distributions for partner organizations while continuing to generate unblinded records for agency submissions.

This feature also includes a new blinded narrative template that can be configured for blinded studies, to protect all information that needs to be masked.

Learn More:

• Enable Masked Distributions
• Generate Masked Distributions
• Manage Narrative Templates

Blind-Protected Regulatory Report Generation Auto-on

Vault Safety now supports the ability to generate protected views of Individual Case Safety Reports (ICSRs) during case processing with sensitive study data hidden for any blinded studies. This includes E2B, CIOMS I, and FDA 3500A generation. Users that have access to unblinded study data, such as users in the Head of Safety role, can continue to generate these reports with all study data visible.

Learn More: Blind-Protection on Regulatory Report Previews

Standardized MedDRA Queries and Custom Queries Configuration

Vault Safety now supports Standard MedDRA queries (SMQs) and Custom MedDRA queries (CMQs) as safety signal detection tools. You can utilize comprehensive search options to generate query reports for specific organizations, products, and studies to identify safety signals.

Learn More:

• Enable Standardized and Custom MedDRA Queries
• Use MedDRA Queries

Study Arms Configuration

Administrators now have the ability to pre-configure Study Arms and add blinded names for products in blinded arms, for example Cholecap vs. Placebo. Users can maximize efficiency and avoid errors by selecting either open or blinded arms from the Product Library during intake.

This feature includes the ability to configure Standard of Care products and add multiple Study Products to a Case. Study Arm Cases can also be unblinded directly from the Case page without having to unblind each Case Product individually. Dosage and Indications for Study Arm Products can be automatically populated on the Case, depending on the Study Arm configuration.

Learn More:

• Enable Study Arms
• Manage Studies
• Enter Adverse Event Report Information

Study Site Reporter Configuration

Vault Safety now supports the ability to configure Study Contacts for use as Site Reporters during the initial intake of Study Cases.

Once an administrator configures Study Contacts, users can select the appropriate Site Reporter during case intake. Upon Case promotion, all required details of the Site Reporter will be automatically populated on the Case, increasing data entry efficiency and accuracy.

Learn More:

• Enable Study Site Reporter
• Manage Studies
• Enter Adverse Event Report Information

Configurable Controlled Vocabularies Auto-on

To offer maximum flexibility when entering case data, Vault Safety now allows administrators to modify Controlled Vocabulary records while ensuring E2B compliance.

You can now customize select system-generated Controlled Vocabulary records to align with organizational safety requirements or study protocols, as well as delete or modify user-created records without impacting Vault functions or E2B transactions.

Learn More:

• Enable Controlled Vocabulary User Actions
• Configure Controlled Vocabularies

Frequency Control Enhancement Auto-on

This release features an enhanced Frequency control option that allows for a more efficient and user-friendly data entry process. Users can simply enter medication administration intervals in everyday terms and Vault Safety will automatically calculate and enter the respective E2B values, ensuring accuracy and compliance.

Learn More: Enter Case Data

Enhanced E2B Import and Export Notifications Auto-on

This release improves the handling of errors and warnings during E2B import and export actions. These improvements include direct links to the relevant Case or AER referenced in the E2B notification messages.

Enhanced Product Matching During E2B Import Auto-on

During an E2B import, Vault Safety can now match non-blinded case products to the Product Library using the registration number or product name. This feature expands upon the existing functionality to match products to the Product Library using the MPID, PhPID, or Substance ID.

Enablement Details

Name	Enablement	Application
Usability & Interface Improvements
Single Create Button Across All Tabs	Auto-on	Platform
Navigation Panel Update	Auto-on	Platform
Updated Document Picker Dialog	Auto-on	Platform
New Tab-based UI for Vault File Manager	Auto-on	Platform
Working with Documents
Collaborative Authoring with Microsoft Office: PowerPoint & Excel Support	Auto-on	Platform
Collaborative Authoring with Microsoft Office Usability Enhancements	Auto-on	Platform
Update Flow for Upload Document in a Record's Related Document Section	Auto-on	Platform
Enable External Users to Bring Forward Anchor Annotations	Configuration	Platform
Document Archive Changes for Merge Fields & CrossLinks	Auto-on1	Platform
Eliminate Separation on Mid-Word Changes to Font Face, Size & Style	Auto-on	Platform
Document Rendering
Merge Fields Sorting	Auto-on	Platform
Prevent Merge Fields in Steady State	Auto-on	Platform
Unmodified Source Rendition Type for Modified Vault Documents	Auto-on	Platform
Vault Objects
Additional Deletion Rule for Document Reference Fields	Configuration	Platform
Prevent Null Checkboxes	Auto-on	Platform
Lifecycles & Workflows
Multi-Document Workflow: Single Verdict for All Content Documents	Configuration	Platform
Entry Criteria: Content Must Not be Checked Out	Configuration	Platform
Multi-Document Workflow: Bound Document Versions	Auto-on	Platform
Multi-Document Workflow: Add Participants	Auto-on	Platform
Optional Tasks for Object & Multi-Document Workflows	Configuration	Platform
Advanced Criteria for Entry Actions on Related Records	Configuration	Platform
Removing Validation that Prevents State Changes in Multi-Document Workflows When a Document is Checked Out	Auto-on	Platform
Record Workflow Action Enhancement: Display Custom Participant Group on Object Workflow Start Dialog	Configuration	Platform
Managing Users
New Domain Admin UI	Auto-on	Platform
User Object Admin Page	Auto-on	Platform
System Owned User Field	Auto-on	Platform
Searching & Filtering
Object References in Advanced Search	Configuration	Platform
Exclude Inactive Picklist Values from Filter Lookups	Auto-on	Platform
Checklists
Aggregate Checklist Designs	Configuration	Platform
Checklist Design Versioning	Configuration	Platform
Attach Multiple Documents in Checklist Responses	Configuration	Platform
Administration
Test Data Packages	Auto-on	Platform
Formatted Output: List of Attachments	Configuration	Platform
Vault ID Filter for Login Audit History	Auto-on	Platform
Reporting
Excel Templates for Reports	Auto-on	Platform
Define PDF Export Option in Reports	Auto-on	Platform
Formulas
New Functions and state__v Support	Auto-on	Platform
Platform Data Model Changes
Platform Data Model Changes	Auto-on	Platform
Commercial
Auto Claims Linking: Prevent Move & Edit References on Approved Links	Auto-on	PromoMats
Auto Claims Linking: References in Audit Trail	Auto-on	PromoMats
Auto Claims Linking: Hierarchical Copy on Claims	Auto-on	PromoMats
Auto Claims Linking: Make Dependent on Link Annotation Enablement	Auto-on	PromoMats
Open Portal Experience from Vault	Admin Checkbox	PromoMats, MedComms
Enhanced Configurability of Standard Fields on Select Medical Inquiry Standard Objects	Auto-on	MedComms
Clinical Operations
Streamlined Reuse for Product/Person/Org Documents	Configuration	CTMS, eTMF, Study Startup, Vault Payments
Fee Schedule Date Effectivity	Auto-on	Vault Payments
Multi-Status Fees	Auto-on	Vault Payments
Yuzu: Japanese Clinical Trial Notification Generation	Support	CTMS
Clinical Operations Configuration for Object References in Advanced Search	Auto-on	CTMS, eTMF, Study Startup, Vault Payments
Delay & Batch Milestone Autocomplete Job	Auto-on	CTMS, eTMF, Study Startup, Vault Payments
EDL Hierarchy Viewer: Behavior Change for Navigating EDLs	Auto-On	CTMS, eTMF, Study Startup, Vault Payments
Clinical Operations Data Model Changes	Auto-on	CTMS, eTMF, Study Startup, Vault Payments
Quality
Person Object: Remove User Restrictions When Adding a Learner Role	Auto-on	Vault Training
External Training Type	Configuration	Vault Training
Direct Assignment to Multiple Learners	Auto-on	Vault Training
Direct Assignment to Curriculum	Configuration	Vault Training
Complete Training Assignment Workflow Visible in Admin	Auto-on	Vault Training
Improvements to Learner Task Page	Auto-on	Vault Training
Training Requirement Object Type Limitation	Auto-on	Vault Training
Auto-Recall Controlled Copies	Configuration	QualityDocs
Display Mandatory Participants in Workflow Start Dialog	Auto-on	QualityDocs
Station Manager: Additional Fields on Station Device	Auto-on	Station Manager
Quality Data Model Changes	Auto-on	QualityDocs, QMS, Vault Training
QualityOne
QualityOne Mobile for iOS	Configuration	QualityOne
Regulatory
Start Multi-Document Workflow from Content Plan Viewer	Auto-on2	RIM Submissions
Enhancements to Create Related Records Wizard	Auto-on	RIM Registrations
Switzerland eCTD DTD 1.4 Publishing & Validation	Configuration	RIM Publishing
Enablement Change: Allow Multi-Select on Standard Document Fields	Configuration	RIM Submissions, RIM Submissions Archive, RIM Publishing, RIM Registrations
RIM Data Model Updates for 20R1	Auto-on	RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive
RegulatoryOne
Generate Submission Ingredients	Configuration	RegulatoryOne
Ingredient Lists	Configuration	RegulatoryOne

¹ In Vaults with Document Archiving enabled

² In Vaults with an active multi-document workflow configured

See the following explanations for enablement options:

Enablement	Description
Auto-On	Automatically activated and no configuration is required before using the feature; note that in some cases, a new feature is dependent on another feature that must be enabled or configured.
Admin Checkbox	Admins must turn on the feature with an Admin checkbox. Note that some “Auto-On” features have a checkbox setting that hides the feature; these will show “Auto-On.”
Configuration	Admins must configure the feature (separately from an Admin checkbox) before it is available to use or is active; for example, an Admin must add document templates before users can create documents from templates.
Support	On/off option controlled by Support.