What's New in 20R1

Pre-Release Date: March 23, 2020 | Release Date: April 10 & April 17, 2020

We are pleased to bring you Vault 20R1. Read about the new features below. You can find information on enabling new features in 20R1 Release Impact Assessment. Information on developer features (API, VQL, etc.) is in the Developer Portal.

Working with Documents

When viewing an object record’s related documents and clicking the Add button, the button on the Search: Documents dialog previously called Upload has been changed to Create. Clicking Create now allows you to create new documents either by uploading a file, or by selecting a document template without having to navigate away from the object record. The relationship to the object record will automatically populate on the new document.

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. When clicking Upload, users no longer see an upload dialog but go straight to step one of the normal upload flow.

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.

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 Unmodified Source rendition.

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, a document could be in Steady State with Merge Fields set to Yes, which could result in updates to the content. This feature prevents merging when the document enters Steady State, even if Merge Fields is set to Yes. Learn more about Merge Fields.

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, locking it to the current latest version of the source document.
  • The new Archived Date field updates time a document enters the archive.

In the Doc Info Bookmarks panel, users can view and navigate bookmarks that target external URLs. When a user clicks a bookmark, the target opens in a new tab or browser window. When the user clicks the Copy Link icon, Vault copies the URL to the clipboard.

Footnote & Endnote Linking in PDF Renditions of MS Word Files

This viewable rendition linking enhancement adds support for clickable cross-reference links for footnotes and endnotes in Microsoft Word files. This support is in addition to the other types of internal links (hyperlinks, ToC links) and embedded web links that are already supported. Learn more about viewable renditions.

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.

New OCR Limits

This feature improves usability and supportability of the OCR (Optical Character Recognition) rendering feature by clearly defining maximum default limits for documents to be processed for OCR. These new limits include a maximum number of pages for PDF and TIFF files, as well as maximum file sizes for all documents that support OCR. Learn more about viewable renditions.

Collaborative Authoring

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 Microsoft Office Usability Enhancements

The Collaborative Authoring with Microsoft Office feature has been updated:

  • We’ve reduced the number of user clicks required to check out or edit a document from Vault.
  • The Edit button has been updated to be consistent with Vault design standards.
  • Users have a new option in the Actions menu: Edit in Microsoft Office. This option checks out the document and starts a collaborative authoring session. If the document is already checked out for collaborative authoring, this option opens the Microsoft Office editing view.

Learn more about Collaborative Authoring.

Multi-Document Workflows

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.

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.

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.

Multi-Document Workflow: Add Participants, Reassign Tasks & Start Workflow Respect Constraints

In past releases, participant controls did not respect the Roles allowed to participate constraints configured in the workflow start step. With this release, Vault will respect those constraints when adding participants, reassigning tasks, and starting multi-document workflows. If a workflow configuration uses this setting, Vault will only allow selection of a user who belongs to the specified role in all content documents. Learn more about Multi-Document Workflows.

Vault File Manager

New Tab-based UI for Vault File Manager

The Vault File Manager UI has been updated to be consistent with the Vault UI, making it easier for users to know where to go to change Vaults, and access Vault Help, and log out. The new UI features a Checked Out tab, with a number to indicate how many documents are currently checked out to Vault File Manager. This new tab-based UI will allow Vault File Manager to expand beyond being simply a check out application. Learn more about Vault File Manager.

Vault File Manager Access without API Permissions

Users logging in to the Vault File Manager desktop application no longer need to have API access in their security profile’s permission sets. If the user does not have API Access, Vault File Manager will not display their profile picture and will display their username instead of their full name. Learn more about Vault File Manager.

Vault Objects

Updated Record Picker Dialog

This feature introduces an updated dialog for selecting object records. In the updated single-select dialog, users select a record using radio buttons. In the updated multi-select dialog, users select multiple records using checkboxes. These radio buttons and checkboxes replace the green plus (+) and red minus (–) icons that were previously used in object record search dialogs. Users can also resize columns in the updated dialog.

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.

Checklists

Enable Checklists Feature in All Vaults

In previous releases, the Checklists feature was introduced for all Vault applications. In this release, we’ve extended checklist functionality, allowing Admins to enable checklists for any Vault application.

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 that 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.

Enhanced Checklist Workflow Task Completion

This feature provides an important enhancement to workflow task behavior when a checklist is completed. Previously, when a user completed a checklist from the Checklist response UI, the workflow task could only be completed if workflow task prompts were not configured (Prompts for Comments, Prompts for Verdicts, Prompts for Fields). This feature now allows Admins to configure checklist workflow task prompts. When a user completes a checklist from the Checklist response UI, the behavior is now consistent with completion of a task from the Home > My Tasks page. The task popup will now always appear when a user clicks “Complete” from the Checklist response UI regardless of whether a prompt is configured.

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.

Multi-Pass Reporting: Ladder Scenario

This enhancement to the Multi-Pass reporting feature adds further flexibility to the data models it can support, and introduces a Date report type. Admins may now define multi-pass report types that contain entities with multiple inbound references and the entities making those references. For example, a parent with multiple children. The Date report type can be used in multi-pass reports to present activity timelines, such as Regulatory’s Application Chronology Report. Learn more about Multi-Pass reports.

Define PDF Export Option in Reports

In previous releases, Vault always split reports with long rows and more than one column onto multiple pages when exported. This feature provides users with more flexibility when exporting a report to PDF.

Users may now choose whether to export the report with all of the columns fitting onto the page or to use the existing formatting. By default, all reports will have the fit to page option selected, but this may easily be modified. Learn more about exporting reports.

Task Verdict Comment in Reports

This feature adds support for the Task Verdict Comment field in Workflow with Object reports. Currently, Admins have the ability to configure object workflows to include task verdict comments but they can only be viewed from the workflow timeline. This feature allows report viewers to see task verdict comments directly on the report. Learn more about Creating Reports.

Searching & Filtering

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.

Constrain Filter Value Lookups by Search Results

With this feature, Vault constrains object reference field values in filter value searches on document tabs. These filters now only return values that are included in a user’s search results. Vault no longer supports using double quotation marks when searching for filter values, but users will not need to use these when searching for multi-term values.

Usability & UI Updates

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 menu on the right. The Create menu also shows the current user’s three (3) most recently created item types, allowing them 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.

Customers using Limited Release Vaults may note that while in the April 10th General Release, the contextual Create button functionality applies to related record pages, this functionality is removed in the April 17th General Release.

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.

Dynamic Tabs

Clicking Show in Tab on the object record list page will show the related list of records in a dynamically generated tab. All related lists will now have a Show in Tab link, including related lists for those objects that don’t have a custom tab.

Vault will also show the Show in Tab link for related lists with filters, and the tab will show the filtered set of records.

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.

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.

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 jump links, 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.

Truncate Long URLs on Internet Explorer

On Internet Explorer™ browsers, Vault now shortens URLs that contain more than 2,000 characters. This can happen when users search for documents or object records using many filters or when the grid view displays a large number of columns.

Localize Vault to Dutch

The Veeva Vault UI now supports Dutch for customers that request it through Veeva Support. Users can update the language Vault displays for them by changing the language settings on the User Profile page. Vault also supports setting Dutch translations for labels in user-configurable data such as document types, fields, picklist values, and lifecycle names. Learn more about supported languages and localization settings.

Configuration

Document Type Support for Reference Lookups

This feature is intended to help developers building Spark integrations. It is common to have Vaults with document types that are the same but with different names, especially across Vault application families. With document type reference lookups, Spark Integration developers can map source document types to target document types, avoiding the need to hard code the mappings. Learn more about Creating & Managing SDK Reference Lookups.

Asynchronous Task Processing

Admins can now configure an object workflow task to complete asynchronously. We recommend using this feature for tasks that your organization regularly assigns to over 100 users. This change allows users to complete individual tasks without affecting other workflow tasks or processes. If the workflow encounters an error, it will take the configured alternate next step. Before implementing this configuration, please consult with your Vault representative.

Lookup Field on Lifecycle State

Vault Admins can now create Lookup-type fields that reference Lifecycle (lifecycle__v) and Lifecycle State (state__v) fields. With this enhancement, organizations can set up fields that allow users to view states of related objects.

Run Job on Latest Steady State Version

With this feature, any document state change job can be configured to run on the latest Steady state version of a document rather than the absolute latest state. This allows the state change job to run on a document that has advanced to a later draft state. The prior Steady state version will be expired by the job.

Prior to this release, a CrossLink document’s viewable rendition always contained any overlays and signature pages applied to the source document’s viewable rendition. Now, there are two new checkboxes on the Admin > Settings > General Settings page that allow Admins to exclude overlays, signature pages, or both when Vault creates a CrossLink’s viewable rendition from the source document. This helps prevent duplicate overlays and signature pages when Admins have these defined in the CrossLink document’s Vault. Learn more about configuring CrossLinks.

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).

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).

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.

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.

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.

Additionally, Vault will now help prevent administrator confusion by identifying unsupported VQL clauses within Formatted Output template configurations. Learn more about Formatted Output templates.

Deletion Rule Label Updates

This feature updates the labels of the Deletion Rule drop-down options on both object reference fields and document reference fields to more accurately reflect the functionality.

For example, the rule to block object record deletion is now labeled Prevent deletion of related object record. The rule to allow object record deletion is now Set field to blank when related record is deleted. Learn more about deletion rules for document reference fields and object reference fields.

Users & Groups

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.

Manager Groups

When this functionality is enabled, Vault creates system-managed groups that include each user’s direct manager. Manager Groups is a platform feature, but it also supports the Manager Access to Training Records feature for Vault Training. Learn more in Creating & Managing Groups.

This feature leverages the Manager field on User object records. If this field is blank for someone’s User record, Vault will create the manager group, but it will have no members. When the reporting hierarchy changes and an Admin updates User records, Vault updates the manager group memberships accordingly.

Manager groups show throughout Vault in user and group selectors. Each user’s manager group will appear directly below the user. Manager groups can be used like other user groups, for example, to provide access to a document or object record.

Example Manager Groups

Gladys is a manager. Her direct reports are Carla and Cody. Gladys also has a manager, Theresa. Theresa’s User record does not include a manager.

Manager Groups functionality automatically creates the following groups:

  • Carla – Manager:
    • Gladys (direct manager)
  • Cody – Manager:
    • Gladys (direct manager)
  • Gladys – Manager:
    • Theresa (direct manager)
  • Theresa – Manager:
    • No members because the Manager field on Theresa’s User record is not populated

System Owned User Field

In this release, the Veeva Clinical Network User is now correctly set as Yes for the System Owned User. Admins can no longer edit any fields for the Veeva Clinical Network User.

Authentication & Security

User Name & Password Retrieval During Login

This feature merges the credential recovery process into a single “Having trouble logging in?” flow. A new Having trouble logging in? link replaces the Forgot user name? and Forgot password? links on the login and welcome pages. The new link directs users to a Having trouble logging in? page, where users enter an email address to request user names be sent via email. The sent email contains a login and password reset link for up to 100 user names. Users can also request a forgotten password using the Forgot password? link on the Having trouble logging in? page.

Include KeyInfo in SAML Requests

SAML Requests will now include a KeyInfo attribute in all domains provisioned as of the 20R1 release. Customers with existing Vaults can contact Veeva Support to request this feature.

Auditing

Expand Time Period for Login Audit Logs

In previous releases, we limited the time period that Admins could view and export from Admin > Logs > Login Audit History to two weeks. This release removes this restriction so that Admins can enter any date range to view and export the login history.

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.

Integrations

Spark Message Delivery Event Handler

The Spark Message Delivery Event Handler provides a mechanism for Admins and Spark-integration developers to handle undelivered Spark messages. Once a developer implements the class in custom code, an Admin has the option of assigning that handler and a user to an outbound queue. When an undeliverable message is encountered, Vault executes the actions coded in the handler. For example, if the target Vault is unavailable, a developer may choose to put the message back on the queue in 24 hours, notify a specific user, or take other actions. Learn more about Spark Message Delivery Event Handlers.

Migration Tools

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.

Record Migration Mode for Configuration Migration Packages

Record Migration Mode allows Admins to use outbound packages with dataset items to create object records in non initial state.

This feature introduces a new field, Record Migration Mode (record_migration_mode__sys) to the Inbound Package Data (vault_data_package__v) and Dataset Item (dataset_item__sys) objects. Learn more about Using Configuration Migration Packages.

Platform Data Model Changes

See 20R1 Data Model Changes: Platform.

Clinical Operations

Vault EDC/CTMS Connection with Spark

In previous releases, customers could use the EDC to CTMS Connection feature to facilitate the exchange of data from an EDC Vault to a CTMS Vault using an FTP server.

This new feature introduces an improved method of connecting EDC and CTMS Vaults using Spark Messaging. This connection adds the capability for customers who own both the Vault EDC and Vault CTMS applications to transfer the following record data:

Vault CTMS to Vault EDC:

  • Studies
  • Study Countries
  • Sites

Vault EDC to Vault CTMS:

  • Subjects
  • Subject Visits (Events in Vault EDC)
  • Visit Definitions (Event Definitions in Vault EDC)

Learn more about the EDC/CTMS Spark connection.

eTMF to Submissions Connection

This feature leverages the Spark Messaging framework to connect Clinical Operations eTMF Vaults to RIM Submissions Vaults and automate the creation of CrossLink documents between the two Vaults. Using Spark Messaging, Vault can:

  • Transfer Clinical Studies and Sites from the eTMF Vault to the Submissions Vault when a user creates or updates a record
  • Transfer Product Family records from the Submissions Vault to the eTMF Vault when a user creates or updates a record
  • Automatically create a CrossLink document in one Vault after the document is approved in the other

The eTMF to Submissions connection uses Spark Messaging Integration Rules to define which documents, records, and fields to transfer, as well as Reference Lookups to translate field values across Vaults. Learn more about configuring the eTMF & Submissions Spark Connection and how the eTMF & Submissions connection works.

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.

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.

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.

Agreement Wizard

Agreement Wizard is a new interface that streamlines and improves the process of accepting a Clinical Network Agreement by making the associated changes clearer and more readable. Users assigned the task of accepting an incoming agreement will see this new interface. This presents a short description of the changes the agreement will make in their Vault. Next, they have the option of linking the agreement to an existing study in their Vault or allowing the agreement to create a new study.

Study Team Role Field Enhancements

This feature allows users to edit the following fields on a Study Team Role record when the Study Team Role record is referenced by a User Role Setup record:

  • Name (name__v)
  • Description (description__v)
  • Monitoring Visit Participant (monitoring_visit_participant__v)
  • Link (link__sys)

Delay & Batch 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.

Clinical Operations Data Model Changes

See 20R1 Data Model Changes: Clinical Operations.

Commercial & Medical

Enablement Change: Standard Metrics (Non-Mandatory)

The PromoMats Standard Metrics feature allows brand and MLR teams to unlock key metrics about their content and MLR process. Released in 19R3 as an optional feature, Standard Metrics will be auto-on for all customers in 20R1.

Standard metrics introduces the following document fields:

  • Global Content Type
  • Content Creation Currency
  • Content Creation Cost

For existing documents, Vault automatically sets any blank values for these fields to Not Specified.

Permission Sets

By default, the following permission sets include Read access to the Content Creation Currency and Content Creation Costs objects:

  • Custom permission sets included in the PromoMats template: PromoMats User Action and External PromoMats User Action
  • Standard permission sets: Business Administrator Actions, External User Actions, Full User Actions, Read Only User Actions, System Administrator Actions, and Vault Owner Actions

Any new permission sets created after 20R1, Admins will need to update permission sets to allow Read access to these objects so that those users can add the standard metrics records for cost and currency. Users need to have this access in order to populate the newly required fields.

Auto Claims Linking Enhancements

Auto Claims Linking: Match Text Variations

This feature extends the efficacy of Automated Claims Linking by allowing users to add multiple approved match text variations (alternate phrases) to each Claim record, and for the Automated Claims Linking feature to find and link each variation to the defined set of references on the Approved Claim.

This feature introduces the Match Text Variation (match_text_variation__sys) object to PromoMats Vaults. Learn more about Match Text Variations.

This feature introduces the Suggested Links (annotations_suggested__v) document field to PromoMats Vaults with Automated Claims Linking enabled. This field contains the count of Pending state Suggested Link annotations. Once a user accepts, rejects, or removes a suggested link, that link is no longer included in the count. This field can be added as a column in document tabular views, as a filter criteria in document reporting, as a lifecycle state entry criteria, and as a condition for a lifecycle state entry action.

This feature allows users to perform the Remove Suggested Links action, which removes all Suggested Link annotations on the document. The Remove Suggested Links action only appears to users with permission in annotate mode when Suggested Link annotations exist

Learn more about the Remove Suggested Links action.

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: 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.

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.

Auto Claims Linking: Where Used Component

The Where Used component is visible in PromoMats Vaults where Auto Claims Linking is enabled. From the Claim Detail page, it displays a list of documents where suggested links have been generated from the Claim. Each row includes the linked document and version, as well as sortable columns containing counts for total Suggested Links plus totals for each suggestion’s status: Pending, Accepted and Rejected. Learn more about the Where Used Component.

Enhanced Medical Inquiry Email Capabilities

Medical Inquiry allows users to respond to medical inquiries via email directly from MedComms. This feature enhances these email capabilities by:

  • Tracking sent emails and notifying the user if and why an email was not successfully delivered
  • Logging sent emails by writing the status of the email in the audit trail and storing a record what was sent
  • Including a “Reply to” email address in the response sent, so that the recipient can easily reply to the user who emailed the response by clicking reply in their email client

Learn more about Medical Inquiry and Configuring Email Tracking.

New Shared Field for CLM iOS Native Resolution

For 20R1, Veeva CRM for iOS is implementing native resolution for CLM content. Currently, all CLM content, regardless of iPad size and resolution, is fixed at 1024 x 768 px. With the introduction of native resolution, CLM content renders in the actual resolution for 10.5″, 11″, and 12.9″ iPads.

This CRM change has the potential to cause content that is hardcoded to 1024 x 768 px to display incorrectly. To better support existing content, users can populate the new shared document field iOS Resolution (ios_resolution__v). This field will control how CRM adjusts and renders content:

  • Default for Device displays in the device’s native resolution
  • Scale to 1024×768 fixes the resolution and displays the content centered and letterboxed
  • Scale to Fit stretches the content to full screen

If the field is not populated, Vault will default it to Scale to 1024×768.

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.

Update BEE Editor Support – 20R1.0

With this release, we have upgraded Vault to use version 3 of the BEE email template editor. As a result, users will no longer be able to delete folders if they contain files or other folders.

Version 3 of BEE Editor supports the following browsers:

  • Google Chrome
  • Mozilla Firefox
  • Microsoft Edge
  • Safari

MedComms Data Model Changes

See 20R1 Data Model Changes: MedComms.

PromoMats Data Model Changes

See 20R1 Data Model Changes: PromoMats.

Quality

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.

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.

Manager Access to Training Records

In many organizations, managers are responsible for the training completion status of the employees that report to them. With this release, Vault Training introduces the ability for a Learner’s direct manager to have visibility into Learners’ Training Assignment records, as well as other training-related records.

When Vault Training issues a Training Assignment to a Learner, it also automatically adds the Learner’s manager group to Sharing Settings for that Training Assignment record. This Sharing Settings access allows the Learner’s manager to monitor the Learner’s training progress.

The Manager Groups feature must be enabled before configuring this feature in Vault Training. Learn more about Manager Access.

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 completing Vault Training assignments.

Station Manager: Document Categorization

An organization may share a Station Manager tablet across multiple roles, products, assays, or pieces of equipment. This feature allows the categorization of documents assigned to a Station. Categories are defined and managed in Vault and surfaced on the mobile app so operators can pick a category and browse only the documents relevant to their current task. Learn more about Station Manager Document Categorization.

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

Learn more about setting up Station Manager.

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.

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.

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 Training Requirement object types.

Training Requirement ZIP File Limitation

To ensure Vault Training requirements function as intended, ZIP files cannot be added to the Related Training Materials page section for Training Requirements, regardless of object type. Learn more about creating Training Requirements.

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.

Quality Data Model Changes

See 20R1 Data Model Changes: Quality.

Station Manager

Document Categorization

A Station Manager tablet can be shared across multiple roles, products, assays, or pieces of equipment. This feature allows the categorization of documents assigned to a Station. Categories are defined and managed in Vault and surfaced on the mobile application so operators can pick a category and only browse the documents relevant to their current task.

Improved Document Search Performance on Android

With this release, Android Station Manager supports faster searching within viewable document renditions. This enables end-users to quickly search for keywords within procedures and instructions and increase efficiency on the shop floor.

Enforced Document & Size Maximums

With this feature, the Station Manager mobile applications enforce maximums of 1000 documents per Station, 10gb total rendition size, 100mb per PDF rendition, and 500mb per video rendition.

Regulatory

Content Plan Hierarchy Viewer: Tree Grid

The new Content Plan Grid Viewer displays Content Plan records, Content Plan Item records, and matched documents together in a hierarchical structure within the grid. The new grid offers more robust search and filter functionality. Users can also view and perform actions on matched documents within the grid so they don’t need to navigate to a new screen or lose their location in the content plan.

Drag & Drop Documents into Content Plan Structure

This feature improves and simplifies the process of matching documents to a content plan. Users no longer need to navigate away from the grid viewer to match new documents. Instead, users can now open a document in the Library, Cart, a report, or elsewhere in one browser window, drag the document link into the grid viewer in a separate window, and drop the link directly onto a Content Plan Item record to match the document.

When configured, users can also drop a document link onto an Inactive Content Plan Item record to move to the Content Plan Item record and its parent records to an Active state before matching the document. Learn more about dragging and dropping to match documents in the Content Plan Hierarchy Viewer.

Submissions to eTMF Connection

This feature leverages the Spark Messaging framework to connect RIM Submissions Vaults to Clinical Operations eTMF Vaults and automate the creation of CrossLink documents between the two Vaults. Using Spark Messaging, Vault can:

  • Transfer Product Family records from the Submissions Vault to the eTMF Vault when a user creates or updates a record
  • Transfer Clinical Studies and Sites from the eTMF Vault to the Submissions Vault when a user creates or updates a record
  • Automatically create a CrossLink document in one Vault after the document is approved in the other

The Submissions to eTMF connection uses Spark Messaging Integration Rules to define which documents, records, and fields to transfer, as well as Reference Lookups to translate field values across Vaults. Learn more about configuring the eTMF & Submissions Spark Connection and how the eTMF & Submissions connection works.

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.

With this release, Vault can now publish CrossLink documents that are matched to Content Plan Item records during submissions publishing and report level content plan publishing. For organizations with multiple Vaults, this allows users to create and manage submission content within the appropriate Vaults. Users no longer need to copy documents to the RIM Vault manually to include those documents in the published submission.

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.

Australia eCTD XSD 3.1 Publishing & Validation

With this release, RIM Submissions Publishing Vaults support the AU TGA v3.1 (XSD 3.1) specification. Users can now create content plans and generate submissions that are compliant with AU TGA v3.1 specifications. Vault validates these submissions based on the corresponding AU TGA v3.1 Validation Criteria. Learn more about working with Australian regulatory submissions.

Manage Registered Details Updates

This feature delivers a new user interface for the Manage Registered Details wizard. In the wizard, users can now update registration data as well as the Registered Detail records. The new UI also removes the aggregate data updates. Users can now perform targeted data updates, either individually or in bulk, so changes impact only the intended registrations. This additional level of granularity supports regulatory approval in multi-market regions, such as the European Union. Learn more about managing registered details.

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.

XEVMPD Bulk Updates

Organizations generate and submit XEVMPD data at a very granular level: per strength, per country, per package, per language. However, some updates impact all medicinal products, such as changing the company’s Qualified Person for Pharmacovigilance (QPPV), while others impact a large subset of medicinal products, such as updating labeling documents for 20 strengths in 30 countries.

With this feature, Vault users can select impacted medicinal products, recreate the product report structures, and submit the updated XML to the EMA in bulk. Learn more about updating and submitting XEVMPD data in bulk.

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

See 20R1 Data Model Changes: Regulatory.

Safety

Safety features are targeted for tentative availability on April 16, 2020 & April 24, 2020.

Study Arms and Blinded Product Names

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:

Study Site Reporters

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:

E2B Import: Product Matching Enhancements

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.

Medical Review Enhancements

This release includes multiple enhancements to support medical review activities throughout case processing.

Auto-Create Assessment Results Grid

When a Case is opened, Vault Safety now automatically generates two placeholder Assessment Result records under each Case Assessment. The system generates one Assessment Result for the sponsor’s assessment, and another for the reporter’s assessment (investigator, HCP/non-HCP).

Auto-Designate Reporting Source Qualification

Vault Safety now automatically populates the HCP Confirmed field on the primary adverse event, based on the qualification of the reporting source specified on the initial Adverse Event Report. In turn, for reporter Assessment Results generated for post-market cases, Vault Safety automatically assigns the Source as either HCP or non-HCP, as appropriate.

Learn More: Enter a Case Assessment

Symptom Classification for Adverse Events

You can now classify Case Adverse Events as symptoms. Multiple symptoms can be connected by a MedDRA-coded diagnosis, whether provided by the reporting source or determined during medical review.

Learn More: Enter Case Data

Case Level Relatedness and Automatic SUSAR/SAE Detection

Vault Safety now provides better transparency in Relatedness. Users can now view the Relatedness for the primary assessment at the Case-level.

As part of this enhancement, users can now enter the Reporter Assessment Result during Adverse Event Report intake.

In addition, new and revised Case Assessments and Cases that meet the appropriate seriousness criteria are automatically tagged as a SUSAR or SAE to aid in ad-hoc reports and data analysis.

Learn More:

Blinded Case Previews

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

Controlled Vocabulary: Extended Configurability

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:

Case Product Dose and Indication Sections

This enhancement enables users to enter product dosages and indications directly on the Case Product page, ensuring faster data entry and more intuitive usability.

Learn More:

Frequency: Multi-Option Control

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

Learn More: Enter Case Data

Uniform Control Enhancements

User interface controls have been enhanced to improve legibility and data entry efficiency.

Precise Naming for Assessment Matrix, Case Product, and Adverse Event

For clarity and improved user experience, new and revised Case Products, Adverse Events and Assessments will now use precise naming instead of the earlier convention (i.e. VV-##### and AE-#####).

Learn More: Naming Conventions for Case Child Records

Case Product Drug Role: Treatment

Users can now assign the drug role of a Case Product to be a treatment of the adverse event.

Learn More: Enter Case Data

Auto-Expectedness: Expedited Field Default Setting

The system no longer sets the Case Expedited field to No for serious and expected Cases. Instead, the system leaves the Expedited field blank.

MedDRA Auto-Coding

Vault Safety now supports automatic coding of medical terms from the MedDRA Dictionary.

After entering a reported medical event description, you can use the auto-code button to automatically match the reported term with the MedDRA term.

Learn More:

xEVMPD Dosage Forms

In order to offer users a more comprehensive list of dosage information options, Vault Safety now supports a selection of dosage forms from the Extended Eudravigilance Medicinal Product Dictionary (xEVMPD).

Learn More:

Non-Standard Dose Units

Users now also have the ability to enter custom, E2B compliant dose units outside of the standard Units of Measurement (UoM) dictionary.

Additionally, a new combo box field allows users to enter Routes of Administration (RoA), Dosage Forms, and dose units more easily.

Learn More:

AESI and Configurable Watchlists

Vault Safety now supports the ability to maintain watchlists for Adverse Events of Special Interest (AESI) and other Important Medical Events (IMEs) that require monitoring. Administrators can configure watchlists to expedite Cases, regardless of expectedness or causality.

Watchlists can be created for both marketed products and studies. Cases with an adverse event that matches a watchlist MedDRA term are automatically tagged with the watchlist name during case processing. As part of this feature, the Watchlist Tags field now supports a Case being tagged with multiple watchlists.

Administrators can configure the Case Processing workflow to always transition a Case with a watchlist tag, such as AESI, to the Medical Review stage, regardless of seriousness, in accordance with Good Pharmacovigilance (GVP).

Learn More:

Standardized MedDRA Queries and Custom Queries

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:

Masked Content Distributions

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:

CIOMS I Form Update and Comprehensive Overflows

This release features a revised CIOMS I form with a new format in line with ICH guidelines and additional pages to enable the overflow of information from fields. All suspect products, doses, and indications related to adverse events will now be displayed on the form, as well as ISO country code and name.

Additional enhancements include the ability for customers to add case comments in section 7 + 13, additional seriousness criteria, and numbering for suspect products, doses, and indications. Some formats have also been changed, for example, Lab Test Results will now be sorted alphabetically and all dates will be written as (dd-mmm-yyyy).

Learn More: CIOMS I Generation Data Mapping

FDA 3500A Comprehensive Overflows

This release features updates to the FDA 3500A form template, such as additional pages to enable the overflow of information from fields. All suspect products, doses, and indications related to adverse events will now be displayed on the form, as well as ISO country code and name.

Additional enhancements include the ability for customers to add case comments in section B5, and the alphabetical sorting of Lab Test Results.

Learn More: FDA 3500A Generation Data Mapping

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.

Import Narratives API Endpoint

This feature introduces a publicly accessible API for importing a Vault Safety Case narrative. This will assist with non-E2B database migrations to Vault Safety.

Learn More: Vault Developer Portal

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.

Create Action Items Directly from Quality Event Checklists

In QualityOne Vaults, this feature allows Admins to configure questions to allow users to create one or more action items directly from the checklist response UI for the Quality Event Checklist Type. When configured, suggested actions can appear when users hover over the help icon to provide recommended actions to help users decide what action item records to create. These action items are common as part of the change control process when deciding what actions to complete as a result of the change control impact assessment. Learn more about the configuration for action items in checklists.

Enhanced Configurability for QualityOne

With every release, we update the data model to better support evolving needs and new feature functionality. These data model updates are automatically included in all QualityOne Vaults.

This release introduces Enhanced Configurability to various components in QualityOne Vaults. Enhanced Configurability adds the ability for applications to determine which field attributes in a standard object’s configuration an Admin should be able to edit. Depending on your Vault application’s data model, you may be able to edit additional settings, such as system-managed naming or if the field is required, or editing may be blocked on some of these attributes. See Data Model Changes.

Data Model Changes

See 20R1 Data Model Changes: QualityOne.

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 [+/-].

Data Model Changes

See 20R1 Data Model Changes: RegulatoryOne.

Veeva Claims

Comments on Objects

This feature provides the ability for Admins to configure comments for both custom and standard objects, enhancing collaboration for users. Users can mention other users in comments via @/+ mentions, and those users will receive email and in-app notifications. Learn more about configuring comments on objects.

Local Adaptations of Claims

This feature provides users with the ability to create local adaptations of claims in order to adapt claims for certain local markets. Local adaptations are created in the initial (Proposed) state. Users can quickly and easily create local adaptations for multiple countries at the same time using a bulk action. Learn more about local adaptations.

Product Line Extension Claims

This feature provides the ability for users to copy claims from one product to another product (for example during a product line extension such as new flavors, colors, or forms) so the claims can be reused with improved efficiency. Users can optionally specify if they want to relate existing substantiation documents to the new claims. Learn more about product line extensions.

Data Model Changes

See 20R1 Data Model Changes: Veeva Claims.

SiteVault

SiteVault Family Data Model Changes

We have added the Investigator? field to the Person object as an alternative to using existing Person object types.

Additionally, we have added three fields to the Study object to provide a quick link to the study’s CDMS system.