What's New in 22R2

Pre-Release Date: July 11, 2022 | Release Date: July 29, 2022 & August 5, 2022

We are pleased to bring you Vault 22R2. Read about the new features below. You can find information on enabling new features in 22R2 Release Impact Assessment. Information on developer features (API, VQL, etc.) is in the Developer Portal.

Platform

Working with Documents

EDLs: Match EDL Items to Documents Job Excludes Inactive Document Types

With this release, the EDL Item to Document Matching feature now excludes inactive document types.

Google Drive Integration: Microsoft Office Files Check-in Enhancements

In previous releases, when users checked in MS Office files (Office, PowerPoint, and Excel) that had been edited in Google Drive, in some cases the latest edits were not included in the file checked into Vault due to a content synchronization delay in Google Drive. With this release, Google Drive Integration is enhanced to ensure the latest edits are included when checking in the file from Google Drive into Vault.

With this release, Vault allows, in some cases, reclassifying a CrossLink document even if the rendition types supported on the document types do not match. For example, if the user is trying to reclassify a CrossLink document of type Training Material to a document of type Process Guide, Vault will allow the reclassification even if Training Material and Process Guide document types support different rendition types as long as there are no uploaded renditions of any rendition types not supported in the Process Guide document type. This enhancement is made to allow easier operation and management of CrossLink documents.

Document Fields Behavior Change When Document Enters New Major Version

In an effort to improve product reliability and consistency, we are introducing a behavior change when a document enters a new major version. For custom shared fields that are no longer associated with a document type through Admin configuration, any values on that field will be cleared if the user initiates a new major version. The new behavior matches the existing behavior when updating a document directly and will only affect the latest document version. Any field values of such fields in previous document versions will be preserved and remain unchanged. Any disabled custom document field continues to have its value cleared as in previous releases, but now triggers an audit trail entry for the event.

Vault Objects

Freeze Columns & Headers on Object Tabs

When searching records in an object tab, column headers are now frozen so that the names of the columns are always visible, making it easier to navigate the results when scrolling vertically. With this enhancement, the search results have been increased to 50 since the context will never get lost when scrolling deep into the results. Users can now freeze additional columns to make scrolling horizontally easier as well.

This enhancement also streamlines the custom object tab page by removing the “extra” grey Create button above the first column. The main blue Create button remains on custom object tabs for users with appropriate permissions.

Users can now freeze columns in related object sections, meaning they can select one or more columns to remain visible while scrolling horizontally.

Number Field Decimal Places Enhancement

In this release, number fields with one (1) or more decimal places now display the exact value that the user entered, even if it includes trailing zeros. 

For example, if a user has saved a record with a value of 100.500 in a number field that allows up to three (3) decimal places, Vault will display 100.500 exactly (with trailing zeros) when a user views or edits that record. 

Fixed Header for Record Selection Dialog

Record selection dialog now has a fixed header and horizontal scroll bar that is always visible while scrolling through records.

When adding fields to objects, users can now add a PermalinkLink function when configuring a formula field with Return Type: Link. This new function allows users to link fields in an object record to permalink targets.

Lifecycle & Workflow

Save Task Information

With this release, Vault automatically saves information entered into a task dialog until the subsequent automatic next steps in a workflow are complete. When a user completes a task and a subsequent entry criteria or action fails, they do not need to redo their work in the task dialog. Additionally, workflows on documents prompts for fields now display the current value of the field if populated when the workflow contains a single document.

Task Instruction Visibility

This feature makes task instructions for workflows more visible. Both task instructions defined by the workflow initiator and configured on the task are now visible on the homepage when a user selects Show more and by default on record or document pages.

Document Notification Templates in Workflows on Single Documents

This feature allows admins to select document notification templates in their OneWorkflows on documents. In order to select document notification templates, the document workflow must be configured to only support a single document, ie, it must have the flag “Use workflow for single document” enabled.

Increase in Workflow Start Step Rules

This feature increases the limits on workflow start step rules in order to help customers move from legacy workflows. Admins can now define up to 20 start step rules instead of 10. If admins select the ‘Use workflow for single document’ flag, they may define up to 30.

Include Users Allowed in Role

This feature allows participant controls in workflows on documents to expose users that are allowed in a certain document lifecycle role. This feature supports users and groups allowed for a Dynamic Access Control-enabled role as well as via role defaults and override rules. Admins may enable this feature for a specific participant control by selecting the flag Display users and groups allowed in role.

New Operators for Workflow on Documents

This feature adds new workflow operators for evaluating fields in documents. Admins may now select all, none, or at least one blank field. In addition, this feature adds several user experience enhancements including indicating whether an item in the multi-document viewer has been viewed or not by bolding and unbolding the name of the item.

Enhancement to Document Multi-Value Fields in Expressions

With this release, multi-value picklist and multi-select object fields on documents return all selected values when used in lifecycle and workflow expressions. Prior to this release, Vault returned a single value, even when multiple were selected.

Automatically Name Envelope Records Flag Exposed in Settings

With this release, Admins can enable automatic naming of envelope records used in OneWorkflows. This functionality previously required enablement from Veeva Support.

Reporting & Dashboards

Additional Aggregate Functions in Reports

With this release, Vault supports additional aggregate functions in grouped reports. The List and Distinct List functions return a concatenated list of records in a single cell. The Std Dev and Std Dev Samp functions return the standard deviations for a distribution.

Support Document Roles as a Reporting Object

This feature allows users to report on document roles. Users can report on all documents and the users with access to them. Admins can create the Document Role and Document with Document Role report types to enable users to generate reports on document roles. This feature supports all standard, matrix, and multi-pass report types. 

Dashboard Exports for Large Charts

This feature allows customers to download large images for dashboard charts. This enhancement improves chart readability by displaying more data points, similar to what users see on the expanded chart in the report viewer. The size of the large image depends on the size of the browser window. Users can also continue to download the chart in the smaller size of 600 pixels in width.

Search & Filter

Add Archive Option to Search Settings

Until now, customers needed to request for document archiving to be enabled on their Vaults. The archiving option has been added to the search settings so administrators can enable it themselves if needed. 

Note: This is a one-way enablement so it can’t be turned off. A warning will appear at the time of enablement, alerting the Admin who is doing so.

Add CJK Indexing Option to Search Settings

Customers with a lot of Japanese, Chinese or Korean text in their object records could contact support to optimize searching in these languages. We’ve now added this option to the search settings so administrators can enable or disable it themselves. 

Customers can now add documents to a collection, which enables expanded searches across documents and objects for the first time. When adding documents to a collection, Admins can choose to include all documents or a subset by choosing a specific document type. If documents are participating in a collection, any tabs sharing the same Document type as a scope can include the option for expanding a search to that collection.

Both documents and objects in a collection have a new option to apply VQL criteria to the configuration so that filtering can be applied to each section within an expanded search.

To enable direct navigation to an expanded search, the search context selector has been redesigned to allow selecting any searchable tab or collection. Available collections are nested under the tab they are assigned to. Vault displays searchable tabs in the same order as the navigation, so sub-tabs are nested under their respective menus and duplicate tab names are no longer grouped together.

Checklists

Checklists: Negative Scoring

This feature allows Admins to set a negative score for available answers to reduce overall score for checklists.

Usability & UI Updates

Vault Help: Application-Specific Help Pages

With this release, Vault Help is divided into application-specific URLs designed to present the information most relevant to each Application Suite. Learn more links are directed to a specific area where users have access to the corresponding information as well as the applicable Platform features. Search is streamlined to supply results from the specific URL.

Notification Template Tab

This feature combines the Document Messages tab and the Object Messages tab into a single tab called Notification Templates.

Notifications: Rich Text in Email Body & Notification Text

This feature allows Admins to include rich text fields in the Email Body and Notification Text sections of Vault notifications while preserving the formatting specified in the rich text editor.

Localize Vault to Norwegian

The Vault UI now supports Norwegian localization. Administrators can fully localize Vault to Norwegian by using Bulk Translation or by modifying individual configured labels. Users can then update the language Vault displays for them by changing the language settings on the User Profile page. Vault also supports setting Norwegian 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.

Increase Number of Tabs Allowed

Admins are allowed to create a total of 20 custom tabs, an increase from the current limit of 10 custom tabs allowed.

Preserve eSignature Page Signer Info

Signature pages are generated upon the first view of the page and after a new signature is captured. For signatures captured after 22R2, a regenerated page reflects the signer’s title at the time of signature. If a delegate user adds the signature, their name and title also reflect the values from the time of signing.

Administration

Outbound Packages: View & Add Dependencies

With this release, you can review and include any blocking component dependencies in an outbound package prior to exporting the VPK so that the outbound package has all the required components for a successful deployment.

Person: First Name or Last Name is Required

With this release, the First Name or Last Name field is required for a Person record when it is not associated with a User. This is enforced when both fields are empty and an Admin attempts to save a Person record.

Jobs: Audit Logs for External URL Call Jobs

With this release, audit log entries for external URL call jobs now contain the username configured as the Run As user for the job. The login audit entry now includes the Job ID.

Scheduled Data Exports: Update Scheduled Start Time

Admins can update the scheduled start time of the scheduled data export job.

View Delete Warning when Deleting a Tab

When an Admin deletes a tab, all the views associated with that tab are deleted as well. With this release, to help prevent Admins from deleting those views in error, Vault now displays a warning when attempting to delete a tab. This functionality was added in the 22R1 release.

Access Control

Display System-Managed Users in Search & Filters

Starting from this release, Vault exposes System Managed users (such as Application Owner, Java SDK Service Accounts and product family-specific users such as Clinical Transfer) in a consistent way in all user (or users and groups) selection.

When selecting users for data entry purposes (object records, documents, configurations), System Managed users do not appear. For example, this behavior is enforced when selecting users on a user object reference field or when adding users into a role on a document or object records using manual assignments.

When selecting users for search or filtering purposes, System Managed users do appear. For example, this behavior is enforced when selecting users for filtering audit log entries by user, when using filters or conditional filters on Vault Reports, or when selecting users while searching for documents or object records, for example, filtering on the Created by field.  

Delegate Admin CSV Export Enhancement

When exporting active Delegations (Admin > Users & Groups > Active Delegations), the limit of a maximum of 1024 active delegations in the export is now lifted: all active delegations are now exported.

Vault Loader

Vault Loader: Trailing Zeroes Included in Extracts for Number and Currency Fields

The Vault Loader UI and Command Line tool (CLI) now provide trailing zeroes in the CSV export for number and currency fields.

Auto-on in Vaults with Vault Loader enabled.

Vault Java SDK

Vault Java SDK Service Account

This feature adds the Run Custom Code as Java SDK Service Account setting to Admin > Settings > General Settings. This setting is not available in pre-release Vaults. If this setting is enabled in your Vault:

  • Custom code executes as the Java SDK Service Account, which has System-level access.
  • By default, Vault sets the Java SDK Service Account as the owner of object records and documents created by custom SDK code.
  • Audit logs entries for documents and object records affected by vault extensions identify the change with Java SDK Service Account on behalf of the user initiating the request.

The Java SDK Service Account user appears in the Users & Groups Admin tab in all Vaults, but does not affect license counts.

Default behavior for this setting will change as follows in upcoming releases:

  • 22R2: Off by default, Admins can enable from the General Settings page.
  • 22R3: On by default, Admins can disable from the General Settings page.
  • 23R1: On in all Vaults and will no longer appear on the General Settings page.

Vault File Manager

Action UI for Vault File Manager

This feature updates Vault File Manager to match the look and feel of Vault Action UI, giving users a more enjoyable and consistent experience on the desktop client. Vault File Manager now features better spacing, color, highlighting, and icons to help users remain focused and to increase productivity. Similar to the Action UI enhancements in Vault web applications, these visual updates do not change any existing functionality and do not change the locations of common visual elements that users are familiar with.

Upload Source Files Using Vault File Manager

Vault File Manager now supports uploading source files to documents in Vault.  Users have the option to upload via Vault File Manager when they attempt to upload new version, create new draft, or upload to placeholder in Vault.  Additionally, the Vault source file size limit of 4GB is relaxed and users can upload source files up to 100GB in size when using the Vault File Manager.  The file size limit when using the web browser remains at 4GB.  

Platform Data Model Changes

See 22R2 Data Model Changes: Platform for changes relating to the above features.

Vault Connections

Protect Vault Connection Performance and Scalability (All Connections)

The RIM to Clinops Connection will have one Inbound Job and multiple Job Workers for each run (one per active Integration) on the RIM Vault instead of just one Job. The Job Logs will present multiple Job Tasks.

Rim-ClinOps: Transferring All Document Versions (RIM Side)

This feature adds the ability to transfer all steady state and superseded versions of a document that occur within a 5-minute Job run window instead of only the latest steady state version when the connection Job runs. This will be implemented on the RIM side of the connection only. This feature is enabled by a setting in the Admin menu.

Customers should consider this feature only if they have cases where document versions are created in such rapid succession (e.g. less than five minutes) that earlier steady state or superseded versions are not in scope for transfer.

Clinical Operations

CTMS

Recruitment Planning: Metric Over Time Expansion

This feature revises the logic for creating Metrics Over Time records to allow for the creation of Metrics Over Time records for the largest expected range of the recruitment period. Vault uses the earliest of the Baseline Finish Date, Forecast Finish Date, or Planned Finish Date for the relevant Milestone as the starting date of the Metrics Over Time date ranges. Vault uses the latest date for the end date of the Metrics Over Time date range.

Metrics: Status Snapshot Refinements

With this feature, for CTMS Studies for which Vault tracks metrics as Status Snapshot, or when no value is selected, Vault only creates Enrollment Status Log records when there is a change to Subject data in the Study.

Recalculate Enrollment Actuals: Notification

Vault CTMS sends a notification to the user who initiates the Recalculate Enrollment action when the action is complete.

CTMS Oversight Metrics

This feature extends Vault CTMS by adding support for managing Enrollment Metrics in studies where the subject data are not tracked in Vault. Once enabled for a Study, Vault CTMS tracks changes to Metrics values and roll-ups changes from lower levels.

Yuzu CTN: Site Medical Department Not Required

Vault CTMS customers that have enabled Yuzu, the Japan CTN functionality, can now generate CTNs even if the CTN Medical Department field on the Study Site CTN data record is blank.

Standard Content Fields on CTMS Objects

This feature adds a standard Content (blinding__v) field on select CTMS objects.

Clinical CRM Connection

This feature enables Vault Clinical to transfer HCP-related Activities between Vault Clinical and Medical CRM.

Prevent Duplicate Monitored Subjects & Monitored Subject Visits

Users are now prevented from creating duplicate Monitored Subjects and Monitored Subject Visits for a Monitoring Event.

Vault Clinical Operations to CDMS Connection: Restricted Data

This feature enhances the ClinOps to CDMS Connection, making restricted data for subject visits and protocol deviations identifiable when transferred from CDMS to CTMS, and CTMS can control access to restricted data through permissions.

Vault Clinical Operations to CDMS Connection: Arms & Cohorts

This feature contains enhancements to the CDMS & Clinical Operations connector for transferring subjects’ arms and cohort assignments.

eTMF

TMF Bot: Document QC Step

This feature allows customers to use TMF Bot as part of their document processes, without using the Document Inbox. A TMF Bot QC check can be added as a step to any document workflow to surface possible issues with a document’s classification.

TMF Bot: Auto-Classification Enhancements

Every release we target enhancements to TMF Bot Auto-classification functionality. This feature includes adding Email Ingestion support, streamlining the pipeline to maximize TMF Bot’s potential, and standardizing the report and Excel templates.

Clinical Archival Validation Check

This enhancement introduces an error notification when unclassified documents are present for a Study during Archival. Vault cannot archive a Study with unclassified study documents.

Study Startup

Clinical Application Management

This feature adds standard objects to support milestone-specific work and information regarding specific documents, and an action to seed those records based on documents currently linked to the milestone, in order to better manage clinical submissions.

Email Checklists Based on Study Person Records

This feature extends our clinical capability of sending checklists to non-Vault users by introducing a behavior that allows a checklist to be sent to a specific study person. It includes an action to generate new survey links for any subsequent new respondents. Sending a checklist to a non-Vault user via organization is still supported.

ePRO & eConsent

ePRO in Clinical Operations

With this feature, MyVeeva ePRO customers can now launch ePRO for studies within their Clinical Operations Vault.

MyVeeva ePRO is being released for the first time to early adopters in 22R2. MyVeeva ePRO supports the ability to set up surveys, schedules, notifications, translations, and events for a study’s ePRO in the ePRO Module, work with sites to connect ePRO and set up/manage study participants, and send surveys and notifications to study participants in the MyVeeva for Patients application.

eConsent Documents to SiteVault

With this feature, eConsent customers can now exchange eConsent documents with SiteVault sites directly from Vault Clinical Operations without Site Connect.

Connected Studies for ePRO & eConsent

With this feature, ePRO and eConsent customers will be able to automatically establish Connections to SiteVault and send Study-specific invitations to SiteVault sites.

Site Connect

Site Connect Safety Distribution Update

With this feature, Site Connect’s Safety Distribution functionality has been improved to handle distributing to thousands of Study Sites in a single send action. 

Additionally, study site filters can now be pre-configured on the Safety Distribution Default object, allowing for automated filtering of study sites based on field criteria. With this auto-filtering enhancement comes a behavior change whereby the manual filtering of study sites is no longer available during the sending flow when the ‘Distribute to Sites’ action is taken on a Safety Distribution.

Site Connect: Additional Vault Clinical Docs Support

This feature adds support to transfer new document types to SiteVault via Veeva Site Connect.

  • Other Submissions
  • Source Data Agreement

Connected Study Types in Clinical Operations

Site Connect, eConsent, and ePRO customers can now designate a Connected Study appropriately using the Connected Study Type field. This field must be populated in order to:

  • Send Connected Study Invitations / Agreements to SiteVault
  • Send Safety Distributions
  • Launch ePRO
  • Send eConsent forms to SiteVault

For existing Site Connect customers, the new Connected Study Type field defaults to Document Exchange and Safety Distribution for all new and existing Studies.

Sync Principal Investigator Field with Study Person

This feature extends our clinical capabilities by introducing a bi-directional update of the Principal Investigator field on the Site and Study Person objects. Vault updates the Principal Investigator field whenever a new Study Person with the role of Principal investigator is created. Additionally, if the Principal Investigator field is updated and a corresponding Study Person does not exist, Vault creates a Study Person record with the role of Principal Investigator.

Reference Sites

This feature will support the designation, within a study country, of a single Reference Site. Users will be able to tailor expected documents for that site, push that expected document plan out to existing sites, and use the reference site as the basis for expected documents subsequently created at sites within that country.

Clinical Operations Data Model Changes

See 22R2 Data Model Changes: Clinical Operations.

Commercial

MultiChannel

Auto Publish to CRM for Approved Email Fragments

This feature introduces new document fields and lifecycle entry actions to automate the creation of Email Fragments and their lifecycle state changes. Vault now keeps specific document fields in sync between the related piece/medical content and the email fragment.

Admins can define approved Master Email Fragment Templates for combinations of Targeted Document Type, Country, Language, and Product to help automate template selection.

Automated Image Rendition Flattening

This feature adds a new option when configuring Automated Image Renditions to request the rendered image be flattened. A flattened image has the same appearance but contains all of the image contents in a single layer.

OCR Pages with Images & Text

With this release, Vault performs OCR on PDF documents that contain both images and text. Prior to this release, Vault only performed OCR on PDFs that contained images.

Packaging of CLM Content on CDN (Engage Share)

This feature adds content for CLM on staging and production CDN environments in an unzipped format alongside the zipped distribution package to support the new Engage Share feature.

AIR PSD Image Enhancements

This feature introduces the option to improve the image quality of .PSD images which may have imperfections in .PNG Automated Image Renditions.

MedComms

Alternative Response Contact for Medical Inquiry Case Response

With this release, Admins can add a new Response Contact field to the Case Response object page layout in MedComms. This allows users to select an alternative recipient of case response emails.  If this field is added and left blank, Vault sends the email to the existing Case Contact on the Case Response object (rather than the Case object). This feature provides more flexibility when sending case response emails, and allows Admins to configure other Case Response types. For example, you may need to send emails internally, within your organization.

Network (OpenData) Connection to Look Up HCP Reference Data for Medical Inquiry

This feature introduces a new connection to Veeva Network. For eligible customers, this connection allows MedComms users capturing Medical Inquiries to search OpenData for reliable, accurate HCP reference data when creating a Case Contact.

Data Agnostic MedComms to CRM Connection for Medical Inquiry

This feature introduces a new connection to Veeva CRM to pull Medical Inquiries. This only pulls information entered onto the Medical Inquiry in CRM, and does not require Accounts to be synced. When the Inquiry is pulled into MedComms, Vault either assigns it to an existing Case Contact if present or creates a new Case Contact.

PromoMats

Optional Linked References for Pre Clearance Packages

With this release, users can select whether to include linked references for Pre Clearance eCTD Compliance Packages. This matches existing functionality for Post Marketing Compliance Packages.

RIM-PM Connector Label Change in PromoMats

In this release, the PromoMats to RIM connection was relabelled to RIM to PromoMats. The PromoMats to RIM Connection document type group was also relabelled to RIM to PromoMats Connection. There are no behavioral changes to the connector.

Commercial Data Model Changes

See 22R2 Data Model Changes: Commercial.

Vault Mobile

Audit Document Views

When a user views a document on mobile, this will be logged to the Document Audit as a Viewed Document event. Previously, documents viewed on mobile were logged as a Rendition Downloaded event which was not accurate.

Library Named Views

This enhancement allows users to select a standard view when looking at documents on the mobile Library screen (e.g. All Documents, Recent Documents, My Documents, and Favorites) to more easily find documents. The selected view does not apply when using the search bar - that will always search across All Documents, regardless of the view selected.

Option to Open Document in Browser

When viewing a document in the mobile app, users will now see a new ellipses menu option to Open in browser. This launches a browser on the phone and allows users to log in and view the document on their mobile browser. This allows users to access Vault on a mobile web browser in case there is needed functionality that is unavailable in the mobile app.

Mobile Tabs

Administrators can now configure some settings of the mobile tabs that are displayed in Vault Mobile. This includes updating the mobile label of a tab, re-ordering the mobile tabs, deactivating a mobile tab, and updating permission sets to view mobile tabs.

View Dashboards

Now users can view their dashboards on mobile. A new mobile tab called Dashboards lists all the dashboards to which they have access. When viewing a dashboard, users can also update the filter values in the mobile app. At this time, tapping on a dashboard chart will not launch a report like it does on web.

Mobile Task Completion

With this release, users can view and complete their document tasks from the mobile app. Other types of tasks are not displayed in the app. Users can see their tasks on a new mobile tab, accept/undo acceptance on a task, view the document(s) included in the task, and complete the task within the app. This includes the ability to provide an eSignature using the phone’s secure biometrics.

App Version Enforcement: Android Only

This release of the Android app checks that the mobile app is a supported version. If there is a newer version of the app available, users periodically see a prompt informing them of the upgrade. If the app version is unsupported, users see a message that requires them to update the app before logging in.

Station Manager

Use the iOS App Store™ to download Station Manager for iOS:

Station Manager for iOS

Use the Google Play Store™ to download Station Manager for Android:

Station Manager for Android

Alternatively, you can download the latest version of Station Manager for Android as an APK file.

Support Landscape Orientation on Android Station Manager App

With this release, the Station Manager on Android supports reorientation of the app if the device is tilted to landscape orientation.

Highlight Recently Added/Updated Documents on Android

With this release, the Station Manager Android app provides an indication in the UI that documents have recently been added or updated on the device. If a document is new or a document has been updated as of the most recent sync, the document will have an indicator that it is new or updated. The duration of the UI treatment can be configured via an EMM variable.

Highlight Recently Added/Updated Documents on iOS

With this release, the Station Manager iOS app provides an indication in the UI that documents have recently been added or updated on the device. If a document is new or a document has been updated as of the most recent sync, the document will have an indicator that it is new or updated. The duration of the UI treatment can be configured via an EMM variable.

Training

Study Training

Study Training is the first application in the Training application family. Study Training simplifies the training of personnel at sponsors, CROs, and sites for greater compliance and inspection-readiness in trials. With Study Training, trial stakeholders can use a single unified system to transform clinical training content into role-based study training. Learn more about setting up Study Training.

Training receives functionality and data model updates in parallel with the Quality Suite: Vault Training application.

Quality

QualityDocs

Auto-Accept Document Change Requests & Periodic Review Records into a Document Change Control

In this release, we are providing the ability to configure a new entry or user action on the Document Change Control lifecycle to automatically link Document Change Requests and Periodic Reviews. Previously, a user would have to manually add these records through the appropriate section. Automatically pulling in these records will allow for a more active process of reviewing and accepting change requests and periodic reviews as part of a Document Change Control. Learn more about configuring document change control.

Document Change Request (DCR): Send Notification to Document Owner

With this release, we allow a new event action to be configured on the Document Change Request (DCR) lifecycle, that sends a notification to the document owner when a DCR record is created for the document. These notifications will provide document owners better visibility and awareness of DCRs raised against their documents. Learn more about configuring document change control.

QMS

Quality Team Conditional Role Exclusivity

This feature is being introduced in addition to the existing Quality Teams Role Exclusivity feature to enable users to define specific role membership restrictions for each role within the Quality Team. This enhancement allows greater flexibility so that a user can be selected for more than one role on a team, as necessary, while simultaneously providing exclusivity where it is required. Learn more about creating Quality Team roles.

External Notifications: Distribution Group Filter Fields & Membership Automation

Administrators can now define distribution group filters and leverage these filters to constrain person records to only display persons whose associated field values match that of the record.  In addition, the Create Distribution Group Memberships action can be leveraged to automatically create distribution group memberships based on the filters defined for the distribution group. Learn more about configuring external notifications.

External Notifications: Set Reply To Email Attributes on Complaint & Medtech Emails

The External Notification feature now supports Reply To capability for Complaint and Medtech Complaint external notifications. Users can now utilize the Reply To field to reference a Person record as the reply to email address for emails sent through the External Notification feature.  Email recipients can now directly reply to the email address associated to the Reply To person provided on the email. Learn more about configuring external notifications.

Extend Recurrence Check to Support Standard Object Types on Quality Event

The recurrence check feature has now been expanded to support the additional standard object types on the Quality Event object:

  • Change Control
  • Proactive Initiatives
  • External Findings
  • Internal Findings
  • Lab Investigations
  • Nonconformance

The Synchronize Columns button in the Recurrence Check interface’s Related Object viewer is intelligent and is now only displayed if the user makes a change to one of the related object data grids. No functionality changes were made to the Synchronize Columns button when clicked. In addition, the row-level action gear when viewing related objects has been removed and records can no longer be edited from the Related Object interface. Learn more about using Recurrence Checks.

Risk Thresholds

This feature allows users to create Risk Levels for a quantitative Risk Matrix by defining Risk Thresholds. The system will automatically assign Risk Levels to the Risk Matrix Setup object records as well Assessment Risks and Risk Event object records based on these Risk Levels. Learn more about Risk Management in Vault Quality.

Support 1/2/3 Dimensions for Risk Matrix

This feature allows Admins to configure which dimensions (Severity, Occurrence, Detectability) should be required for users when creating Risk Matrix irecords. This feature provides the flexibility to create a Risk Matrix with one, two, or all three dimensions. Learn more about Risk Management in Vault Quality.

Additional Standard Fields & Objects

Additional standard fields and objects have been added to the QMS data model that standardize commonly utilized fields and relationships between QMS entities. These standard fields and objects can now be leveraged instead of having to define custom fields or objects.  

VPS: Data Model Updates

This feature updates the Vault Product Surveillance data model to better support evolving needs and new feature functionality. With this release, we are removing the following fields from the Quality Event object:

  • AR Contact Person (ar_contact_person__v)
  • AR Contact Person’s Details (ar_contact_details__v)
  • Authorized Representative (authorized_representative__v)
  • Importer (importer__v)
  • Importer Contact Details (importer_contact_details__v)
  • Incident - Healthcare Facility (incident_healthcare_facility__v)
  • Manufacturer (manufacturer__v)
  • Manufacturer - Contact Person (manufacturer_contact_person__v)
  • Manufacturer Contact Details (mfg_contact_details__v)
  • Manufacturing Site - Contact Info (mfg_site_contact_info__v)
  • Product Categorization (product_categorization__v)
  • Reporter’s Contact Information (reporter_contact_info__v)
  • Reporter - Occupation (reporter_occupation__v)

Training

Recurrence: Assign Training Assignment In Advance

A common use case for training recurrence is to assign a Training Assignment every N years, such as 2 years, based on the Assigned Date or Completion Date. For some use cases, however, there may be a need to assign the Training Assignment in advance of 2 years, perhaps 90 days ahead of the recurrence date. This feature allows a Training Admin or authorized user to determine how far ahead to assign the recurrence-based Training Assignment. Learn more about Vault Training recurrence.

Updatable Quiz Design for Individual Training Assignment

With this release, the Quiz Design reference can now be directly updated on a Training Assignment record. Previously, you could only update the Quiz Design reference by updating the corresponding Training Requirement.

Training Record Actions: Bulk Action Support

Vault Training now supports executing the following Training actions in bulk:

From Job History, clicking into Update Training Assignment job, shows related jobs that were started. This allows an authorized user to quickly view related training jobs, without having to go to the Training Job Status page.

Classroom Training: Cancel Training Assignments Part Of Class If No Valid Path Exists

With this update, if a Learner’s Classroom Training Assignment is part of a Class Roster and if it is no longer valid due to a training matrix update, the Classroom Training Assignment is now canceled. Previously, the Classroom Training Assignment would not be canceled since it was part of a class. Training matrix updates include the following scenarios: removing the Training Requirement from a Curriculum, removing the Curriculum from a Learner Role, or removing the Learner Role from a Person.

Vault Training: Data Model Updates

The LearnerRole-Person join object was made a complex join to support the new Study Training application. This causes a few differences when viewing a Learner Role assigned to a Person or vice versa. These changes are primarily visual, and do not affect the functionality of Vault Training:

  • The first column displayed is the join record ID. Previously, the Name was displayed in the first column.
  • The column labels may contain a >.
  • Users will need to open the related record in order to perform actions on it.
  • Adding the same join record again is possible, but an alert symbol is presented to the user in the selection dialog and an error prevents adding the same join record again.
  • The label for the Remove action is now Delete from the Actions menu for a join record.
  • The Copy Record action appears from the Actions menu for a join record.
  • Criteria VQL filters on LearnerRole-Person on the Learner Role or Person object will be removed.

Vault LIMS

With this release, Vault LIMS continues to add features to support static data management and test execution, including the evaluation of lab results. Vault LIMS is available in 22R2 for Early Adopters.

Field Display Update for Quality Error Messages

All Quality applications now display the field’s Label in error messages, rather than the Name (public key). For example:

You cannot edit record_owner__v is replaced by: You cannot edit Record Owner

Unit of Measure Object

A new unit of measure object has been introduced to the Quality Suite. The object label is Unit and name is quality_unit_of_measure__v. All Quality applications and customers may utilize this object to further describe a number or quantity with its associated unit of measure using metric or imperial units. Other applications or customer configurations can reference this object to select the appropriate unit of measure as required.

Quality Data Model Changes

See 22R2 Data Model Changes: Quality.

Regulatory

RIM Publishing

Merge & Publish Submission Content Plan

With this release, users are able to create a single PDF file of all PDF files matched within a Submission Content Plan.

Publishing Progress Indicator Enhancements

With this release, all continuous publishing jobs are included in the publishing progress indicator. In the CSV file downloaded from the Publishing Progress Indicator, users can see the current stage in the publishing process.

Support US 4.3 Validation Criteria

With this release, US FDA submissions can be validated using US 4.3 Validation Criteria.

Japanese Validation Criteria Item 7 Support

With this release, Vault Submissions Publishing has been updated to support the Japanese Validation Criteria update to Item 7, allowing for up to 500MB file sizes.

Health Canada Validation Criteria v5.1 Support

With this release, Vault Submissions Publishing supports validating Canadian submissions against Health Canada’s v5.1 Validation Criteria specification.

RIM Publishing, RIM Submissions

RIM PDF Standardization

With this release, Vault will preprocess Submission Publishing documents to produce PDFs compliant with common health authority validation criteria. Customers who enable Renditions Profiles will see a new option to generate a compliant viewable rendition for source PDFs.

Publishing Completeness Check on State Change

With this release, the Content Plan Hierarchy State Change User Action can be configured to prevent entry into a state when there are still pending publishing jobs.

Open Validation Results Behavior Updates

With this release, the Open Validation Results field will be updated to show a count of the Validation Results records, rather than a sum of the occurrences. Additionally, informational validation results for bookmark and hyperlink counts will no longer be included in the count.

RIM Registrations

EU UDI Submission Viewer

A new Registrations wizard will be provided to review the data quality of UDI submissions that have been generated for EUDAMED.

EUDAMED UDI XML Generation Updates

EU UDI submissions will now be generated using the EUDAMED XML Schema v2.0.2. Also, required elements will now always be included in the XML, making it easier to troubleshoot when they do not have a value.

Multiple Gateway Support

This feature enables users to create and apply multiple health authority gateway profiles for XEVMPD submissions.

Labeling Change Management Automation

This release adds several automations to the labeling change management process, including creating Labeling Deviation records based on the outcome of workflows and lifecycles, automatically associating Labeling Concepts with Activities to allow for market-specific dispositioning, and calculating Safety Category and Lead Reference Market Due Date to assist with market-specific due date calculation.

Bundling & Splitting Enhancements

The Bundling and Splitting wizards now support the bundling and splitting of Regulatory Objective and Submission details for medical device- and shelf life-related information. Also, Vault can create bundled or split Regulatory Objective and Submission details with a mix of object types when the internal names of the source and target object types match.

Registrations Wizards Harmonization: Application Relationships

This feature updates the existing Registrations wizards to be compatible with the new data flow introduced with the Submission Wizard. For customers who enable the Submission Wizard, new Application relationships serve as the superset and primary source for Application data, which can then be used by subsequent Regulatory Objectives and Submissions. To ensure proper end-to-end flow, the Create Related Records wizard and Bundling wizards are updated to populate and utilize these new Applications relationships.

Country-Language Enhancement

This feature updates the RIM data model, adding the Use for XEVMPD/IDMP field (use_for_xevmpdidmp__v) to the Country Language object to identify records that must be considered for XEVMPD and IDMP. Additionally, the XEVMPD and IDMP data aggregation algorithms were updated to reference the field when identifying attachments for inclusion.

RIM Registrations, RIM Submissions

Global Content Plan Object Type Support

With this release, Global Content Plan creation and dispatch will generate Submission relationship records with the appropriate matching object type as the Event relationship records. Previously, Vault used the default object type on the Submission relationship object, regardless of the Event relationship record’s object type.

RIM Submissions

Content Plan Bulk Actions on Matched Documents

With this release, bulk document actions can be initiated on matched documents in the Content Plan Hierarchy Viewer when the Type = Matched Document filter is applied. Also, filtering in the viewer is available for two additional document fields: Lifecycle State and Ready for Publishing.

Bulk Update Tokens Action

With this release, a new Update Tokens in Fields action is available on the Content Plan object lifecycle. When configured and initiated on a Content Plan record, the action resolves tokens on all descendant Content Plan Items and sends the user a notification and log of the results once complete. Users no longer need to run Update Tokens in Fields one at a time for each node, and can instead run the action at a higher level Content Plan record.

Content Plan Creation Refactoring & Harmonization

With this release, Content Plan creation, update, and copy processes have been refactored to be more efficient. Instead of copying all records and subsequently updating select field values and deleting irrelevant records, these processes create the relevant records with the new field values inserted at creation. 

Additionally, the Copy Content Plan and Copy Into Content Plan actions have been updated to be compatible with the new data flow introduced by the Submission Wizard in the 22R1 release. For Vaults where the application relationships flag is enabled, these processes will leverage the application relationships as the source data for the Submission relationships that are copied.

Create Binder from Content Plan: Allow Document to be Linked Multiple Times in the Same Binder Section

With this release, binders created from Content Plans using the ‘Create Binder from Content Plan’ action will support documents that are linked multiple times in the same binder section. This allows documents where different versions of the same document are submitted in the same section, such as protocols, to be properly linked into the Content Plan binder for export.

XML Element Name Tokenization Support

With this release, tokenization support has been extended so that content plan tokens used in the XML Element Name field on Content Plan Template records are resolved during the actions that currently support content plan token resolution. This reduces manual effort for non-eCTD submission publishing.

Content Plan Viewer Indicator Update

The Content Plan Viewer indicator and pre-validation locking functionality are updated to include all asynchronous state changes.

RIM Submissions, RIM Submissions Archive

Active Dossier Hovercard Update

With this release, the Active Dossier hovercard has been updated to more clearly display related documents in the Active Dossier Viewer. The Active Dossier source document, translation, and submitted documents are now displayed in a grid on the hovercard along with their language and status.

Active Dossier Hovercard

RIM Submissions Archive

Submissions Archive Binder Import Behavior Update

With this release, to improve import performance, the Submissions Archive binder node ordering is no longer calculated during the import process. The binder node ordering calculation during view time remains unchanged.

Restrict Submissions Archive Access to Full User Licensed Vault Users

With this release, Vault will enforce Submissions Archive application licensing. In all RIM production Vaults, users without a Full User application license are blocked from accessing any Submissions Archive functionality.

Submissions Archive Harmonization Job to Correct eCTD Submission Placeholder Files

With this release, the RIM Submissions Archive Harmonization Job has been extended to address the placeholder files created in error during asynchronous eCTD Submission imports.

RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive

Application Indication Data Model Harmonization

To harmonize data model inconsistencies across all RIM Vaults, the Indication field name and Indication field inbound relationship name on the Application Indication (application_indication__rim) object have been corrected in Vaults which currently contain the incorrect field name or inbound relationship name as follows:

Attribute Incorrect Value Corrected Value (in 22R2)
Indication field name indication__rim therapeutic_indication__rim
Indication field outbound relationship name indication__rimr therapeutic_indication__rimr

Customers with integrations or customizations that leverage these attributes should work with their Veeva representative to assess impact and plan updates for the 22R2 General Release. This renaming will not break existing Vault configuration referencing these attributes, such as reports and object field criteria VQL.

22R2 RIM Data Model Changes

See 22R2 Data Model Changes: Regulatory.

Safety

Safety features are targeted for tentative availability on August 4, 2022 & August 12, 2022.

Safety

E2B Rendition Auto-on

Vault Safety will now automatically generate a visual E2B rendition during an import to Inbox Item, showing each E2B element ID, name, the value imported, as well as any E2B import issues.

Learn More:

Field Limit Updates for E2B (Enablement Change and Data Migration) Auto-on

Vault Safety now supports the maximum E2B-compliant field limits for Dose Text, Transmission Reason, and Test Result Value. This feature was originally introduced in 22R1 through Support-enablement. In 22R2, this feature is automatically supported in all environments.

The Case Product Dosage > Dose Text field and Case Test Result > Test Result Value fields will be automatically replaced on page layouts and available for data entry. However, the Localized Case Product Dosage > Dose Text and Transmission > Transmission Reason fields must be replaced on page layouts, if required for data entry. Existing field data and security configuration will be copied from the pre-existing Dose Text, Transmission Reason, and Test Result Value fields to the new fields.

Learn More

Respect User Default Localization on Inbox Item Auto-on

Inbox Items now display Object Reference field values in the language set on the Default Localization field of your user profile. For example, when User Default Localization is set to Japanese (Japan), the Report Type field will display values in Japanese.

Learn More:

Domestic Case Processing for Agency Jurisdictions Configuration

This release brings multiple enhancements to domestic case processing. Administrators can now manage a Country State/Province library with configurable support for state/province codes. You can select the Country State/Province from a picklist during intake and case processing. The system will map the domestic state codes upon E2B(R3) import and export. This enhancement is for domestic cases originating in a country, such as Spain or Italy, where the state code is required in submissions to a specific agency, such as the EMA.

Administrators can also now manage the type and scope of localization for domestic case processing. The localization scope can be for all fields or specific to Narratives and/or Company Comments. If configured, the localized values for Company Comments and Narratives will also be exported in E2B formats.

Additionally, this feature introduces two new Vault Settings for system administrators. One setting is to configure Inbox Item localization to default based on Reporter Country and Language. Another setting is introduced to prevent auto-submissions when a Case contains unapproved Localized Cases.

Learn More

Combination Product FDA E2B(R2) Export and Case Processing Enhancements Auto-on

In this release, Vault Safety provides multiple enhancements for FDA E2B(R2) generation related to drug/biologic-led combination products having device constituents. Combination Products are now exported as a single drug block, with the device constituent referenced within the block. In addition, device product codes and brand names are exported to FDA E2B(R2). Vault Safety will also support adding combination products during data entry after Case promotion. Finally, Vault Safety will no longer automatically generate Case Assessments or Expectedness records for device constituents, which can be error-prone and lead to unnecessary work during case processing.

Learn More

Narrative Templates for Report Types and Studies Configuration

This release enhances the administration of narrative templates. You can now configure and maintain narrative templates by Organization, Report Type, Study Type, Study, and Localization. During Case promotion, the system matches the Case to an appropriate template based on the specified fields. Also, you can now re-render a Case narrative document to refresh merge field tokens without versioning the document.

Learn More

Pagination in Dose Section Control Auto-on

With this release, the Dosage section control supports paging and the manual creation of more than 10 dosages per product on a Case.

Learn More

Auto-Calculations: Warnings for Overridden Values Configuration

Vault Safety now provides a user option to enable or disable auto-calculation for certain fields. While editing a field on the Case, the system informs you when this field change will impact other field values. Upon saving the record, the system will also notify you when a previously manually entered field value will be overridden with a system-calculated value, if auto-calculation is enabled.

Learn More

Partial Date Support for Product-Level Device Fields Configuration

Vault Safety now supports partial date entry for Combination Products with device constituents for Implanted Date, Explanted Date, and Returned Date. The system will support E2B import and export of these partial dates for FDA E2B(R2). All existing field data and security configuration will be automatically copied from the pre-existing fields to the new partial date fields.

Learn More

Partial Date Support for Dose-Level Expiration Auto-on

Vault Safety now supports partial date entry at the Case Product Dosage-level for Expiration Date. This feature is auto-on for customers using the Case Product Dosage section control. All existing field data and security configuration will be automatically copied from the pre-existing expiration_date_v field to the new expiration_date_idate_v field.

Learn More

Copy Patient Information from Existing Case Admin Checkbox

Upon promoting an Inbox Item, Vault Safety now supports the ability to copy patient information from previous Cases. You can select the following case information to be copied from an existing case to a new case: Patient Details (required), Medical History, Drug History, Case Contacts, Test Results, and Suspect/Interacting Products. Additionally, Adverse Events can be copied to Medical History and Concomitant Products can be copied to Drug History.

Learn More

Foreign Localized Case Synching (Enablement Change) Auto-on

On a follow-up Localized case, Vault Safety performs a one-time data sync from the global case to the localized case when the associated transmission record is created. The system also prevents user edits to the follow-up Localized Case until it is ready for transmission evaluation. This feature was originally introduced in 22R1 through Support-enablement. In 22R2, this feature is automatically supported in all environments.

Support for Unconstrained UCUM for Test Result Units Auto-on

Vault Safety will now support test result units from the unconstrained (infinite) UCUM dictionary to align with E2B(R3) specifications. This support will extend to migrations, E2B imports, E2B/CIOMS/3500A generation, and Case processing.

Learn More

Improvements to WHODrug Browser and Substance Coding Auto-on

When selecting an External Product from the WHODrug browser, the Substance information is now snapshotted to the Case, which aligns with E2B(R2) Submission requirements. Some improvements have also been made to the WHODrug Browser, such as the order of columns and filters prioritizing the most referenced product details. This makes it easier to select external products.

Learn More

EDQM Dose Forms and Routes of Administration Admin Checkbox

To support mandatory EDQM standard terminology for pharmaceutical dose forms and routes of administration when reporting to EudraVigilance, Vault Safety now supports mapping those fields to the latest EDQM terms when importing and exporting E2B files. When EDQM terms are added or changed, Vault Safety will update its EDQM Dictionary through maintenance releases.

Learn More

Receiver Information Export for E2B(R2) and PMDA E2B(R3) Configuration

Vault Safety now supports the generation of the Receiver Block in the E2B(R2) formats. Additionally, this release updates the export logic for PMDA E2B(R3) to include recipient information in the J2.18 block.

Learn More

Generate and Manage Standalone CIOMS II Line Listing Configuration

Vault Safety now provides the ability to generate the CIOMS II Line Listing as a standalone report, independent of the PSUR aggregated report. All features available in the current PSUR line listing are also available in the standalone CIOMS II. Additionally, both masked and unmasked versions can be generated.

The default version of the report contains all the data required to meet regulations. Optionally, users can choose to include additional fields to the report (for example, Study ID, Patient ID, EUDRA CT number, Seriousness, Assessment Results, and Action Taken).

Learn More

One Last Time Reporting Rule Evaluation for Downgrade Scenarios Auto-on

Vault Safety can now accommodate downgrade scenarios when evaluating if a case qualifies for a one-last-time reporting rule to a specific destination. This enhancement was previously patched in the 22R1.0.8 maintenance release requiring Support enablement, but with 22R2 this enhancement becomes Auto-On.

Optimized BFC E2B(R2) Export Auto-on

Vault Safety now supports the generation of E2B(R2) formats with optimized backward-forwards compatibility logic. This export logic enhances support for global health authorities including Health Canada.

Learn More

Case Data Validations and Always Evaluate Criteria Configuration

Vault Safety can now validate case data without an E2B-based submission format. It can also evaluate validation criteria regardless of reportability (for example, submissions to health authorities).

Learn More

Multi-Format Submissions and Distributions Configuration

Vault Safety now supports the automated generation of multiple document formats within a single transmission record. For example, a CIOMS I and MedWatch 3500A form can be generated within the same Distribution record to transmit to a partner or ethics committee. Additionally, Transmission Profile overrides are now considered when determining which file format validations should be run.

Learn More

Reporting Family Jurisdictions and Distribution List Management Configuration

This release includes three enhancements to Reporting Families for Distributions.

Vault Safety now supports specifying Reporting Family Jurisdictions on Partner Distribution Lists. When evaluating the Case, the system uses the list of countries defined to create Distributions for each Partner. In addition, you can now specify the Transmission Profile Override parameter on a reporting rule to override the standard Transmission Profile selection. Finally, MAH Distribution Lists are now automatically removed when the MAH or Reporting Organization value is deleted from all related Product or Study Registrations.

The Transmission Profile override and deletion of MAH Distribution List enhancements are automatically available. However, defining jurisdictions for partner distributions requires configuration.

Learn More

Admin users will now be able to switch the import of E2B through the Receive E2B API and Safety Link to the Inbox Item using the Transmission Profile “Import to Inbox Item”. The field is now available on all Transmission Profile types, including the Partner Exchange Transmission Profile type.

Learn More

Enable Configurable Deletion Rules for Standard Case Grandchildren, Localization, Transmission, Inbox Item Objects Configuration

The Vault platform capability for configurable object Deletion Rules is now available for Case Assessment children (Assessment Results, Assessment expectedness), Case Product children (Case Product Dosage, Indication, Substance), Localized Case children (for example, Localized Case Assessment), Transmission children (Transmission Message), and Inbox item children (Inbox Item Control). Administrators can configure the Deletion Rules for these objects to “Cascade delete children records” for easier object record maintenance.

Learn More:

See Vault Help for more information about this feature.

Safety Suite Manifest Update and Tabs Configuration

Vault SafetyDocs has an increased number of standard objects available. Tabs have been added to the application manifest. Appropriate tabs will appear as Safety applications are enabled and disabled.

Learn More:

Data Model Changes

See 22R2 Data Model Changes: Safety.

SiteVault

Veeva ePRO in SiteVault

This feature introduces Veeva ePRO to SiteVault. When enabled, Veeva ePRO provides SiteVault users the ability to perform the following electronic patient-reported outcomes (ePRO)-related tasks in SiteVault:

  • Use ePRO in conjunction with a study
  • Establish approved ePRO documents for use on a study
  • Assign and distribute ePRO documents to study participants in MyVeeva for Patients
  • Monitor and analyze the outcomes reported by participants in MyVeeva for Patients

Digital Delegation: Usability Optimizations

This feature introduces various enhancements to the Digital Delegation functionality:

  • Easy Enablement and Disablement: Additional automated triggers are in place to simplify the enablement process.
  • Data Validation: Enhanced logic is applied to eliminate unnecessary workflows and tasks.
  • Bulk Edit Staff Delegations: Users will now have the ability to add/remove multiple delegations from a staff member at once, simultaneously add/remove multiple staff delegations, and edit delegations without leaving the study person details page.

Site Viewer System Role

With this feature, the Site Viewer site-level system role is available. This system role provides users limited view-only access to SiteVault.

Support Microsoft Word Documents for eConsent Forms

With this feature, users can upload Microsoft WordTM informed consent forms (ICFs) to SiteVault and transform them into electronic consent (eConsent) forms using the Veeva eConsent editor.

User Administration for Large Research Organizations

This feature enhances the process of creating new users for large research organizations. When a Research Organization Administrator user in a Research Organization with more than three Sites creates a new user, all of the site-level system roles default to No Access.

Filter User Profiles by Site

With this feature, when a SiteVault user has a site selected in the Vault Selector and views a list of User Profile (person__sys) records, only the records relevant to the currently selected site are displayed.

New Exchangeable Document Types on Connected Studies

This feature adds support to transfer the Ancillary Committee Submission document type to a Sponsor/CRO’s vault on a Connected Study.

Connected Study Type on Study

This feature adds the Connected Study Type field to the Study object. This system-managed field indicates which Connected Study components have been enabled by the Sponsor (Document Exchange, Safety Distribution, ePRO, or eConsent).

SiteVault Data Model Changes

See 22R2 Data Model Changes: SiteVault.

QualityOne

QMS

QualityOne Mobile for Android

This feature introduces Incident Management, an extension to QualityOne HSE, with Android™️ support for QualityOne Mobile. Users can log HSE Incident records remotely from an Android device with visual evidence. This application operates in environments where cellular data or WiFi connectivity is unavailable.

SVO to HVO Migration: Purchase Order Line Item Object

This feature migrates the Purchase Order Line Item standard Vault object (SVO) and its data fields to a High Volume object (HVO) to deliver increased performance and scalability.

HVO Migration Preparation: Inspection Sample Test Result Object

This feature prepares the migration of the Inspection Sample Test Result standard Vault object (SVO) to a High Volume object (HVO) planned for 22R3. To prepare for HVO migration, the following changes have been made to the Inspection Sample Test Result object:

  • Standard lookup fields have been replaced with field types compatible with HVO, such as object reference fields and formula fields.
  • Dynamic Access Control (DAC) has been replaced with Application Security.
  • Functionalities related to DAC, such as Sharing Settings, have been replaced by Application Security’s Object Sharing Rule and Record Matching Rule.
  • Role-based participant assignment is no longer supported.
  • Field types that support field-level encryption are no longer supported.
  • Only two (2) multi-value picklist fields can be configured on the object.

In place of DAC, a layer of Application Security will be added to the Inspection Sample Test Result object to allow role setup for individual Users and User Groups. Learn more about Inspections to prepare for the HVO migration.

Application Security for Inspection Sample Test Result (ISTR) High Volume Object

This feature adds a layer of Application Security to the Inspection Sample Test Result (ISTR) object to anticipate and support the conversion of the ISTR standard Vault object (SVO) to a High Volume object (HVO) delivering in 22R3. To support Application Security, two (2) objects are introduced to allow System Administrators to set up roles for individual Users and User Groups:

  • The Object Sharing Rule (OSR) object allows System Administrators to assign an Application Role to a User Group for a secured object (Inspection Sample Test Result object).
  • The Record Matching Rule (RMR) object allows System Administrators to assign an Application Role to individual Users for a secured object (Inspection Sample Test Result object).

Learn more about application security for the ISTR secure object.

Populating HACCP Plans with Hazard Analysis Details: Entry & User Action

This feature adds the Populate HACCP Plan object action that allows users to populate HACCP Plan details such as a list of ingredients, process steps, and their related hazard analysis records. This object action is available to configure as a user action and an entry action. Customers can maintain the list of Hazards to analyze using the Ingredient Hazard Template and the Process Hazard Template records. Learn more about the Populate HACCP Plan action.

Deep Copying HACCP Plans: Entry & User Action

This feature adds the Deep Copy HACCP Plan object action that allows users to create a copy of HACCP Plan and its related records; HACCP Plan Ingredient, HACCP Plan-Process Step, Ingredient Hazard Analysis, Process Hazard Analysis, and CPP-Hazard Analysis records. This object action is available to configure as a user action and an entry action through HACCP Plan object record actions. Customers can save time and effort by using this action to maintain and reuse content from a HACCP Plan as a template. Learn more about the Deep Copy HACCP Plan action.

Automated Email Intake for Certificate of Analysis (COAs)

This feature adds a capability for External Collaborators, such as suppliers, to submit a Certificate of Analysis (COA) document by email to Vault for a particular COA Inspection record for analysis. External Collaborators are assigned a workflow task to upload a COA file by replying to an Admin-defined email address with the file attached. Vault ingests the incoming document and attaches the document to the correct COA Inspection record by verifying the COA Inspection Record ID string in the subject line of the email reply. Automating email intake for inspection drives efficiency for customers by allowing external collaborators to submit the file to the record without using training resources for external collaborators to learn to use QualityOne Vault: with minimal training required for external collaborators, the submission rate for COAs will increase. Learn more about configuring automated email intake for COAs.

Risk Management Framework for HAZOP & FMEA

This feature allows customers to model HAZOP (Hazard and Operability Study) and P-FMEA (Process Failure Mode & Effects Analysis) risk studies within Vault. Customers can perform HAZOP and P-FMEA assessments and create custom Risk Studies from scratch or from an existing Risk Study. Learn more about the new Risk Management framework.

HAZOP Risk Assessments

Customers can perform HAZOP Risk Studies by defining the installation nodes and applying deviations for each node. Risk assessors can assess each node’s risk based on the possible deviations (such as no pressure, no flow, and low temperature). The risk team can define the possible cause, consequence, and risk level for all possible deviations and identify mitigation actions to assign to the appropriate risk team.

Process FMEA Risk Assessments

Customers can perform P-FMEA Risk Studies by defining the process steps and their list of failure modes for each process step for risk assessment. For each mode of failure within each process step, risk assessors can detail the effects of those failures, the causes for those effects, and the controls in place to mitigate such causes. Each element of a possible failure (mode, cause, effect, control) is given a score used in calculating a Risk Priority Number. The risk assessor can identify the actions to mitigate those failures and assess the resulting scores for the mode, cause, effect, and control combination after mitigating action implementation.

External Collaboration Management on NCR, Audit, Change Control & Inspection

Internal users manage a “contact list” of persons associated with the third-party organizations, tagging NCR, Audit, Change Control, and Inspection records with a relevant External Collaborator for Vault to automatically create, activate, or inactivate. When the user account for the External Collaborator is created, activated, or inactivated, the relevant email is sent to those persons as part of the process.

This feature extends the External Collaboration Management functionality, previously introduced, for the following four (4) objects that require collaboration with third-party collaborators: NCR, Audit, Change Control, and Inspection. Internal users can manage a “contact list” of persons associated with the third-party organizations, tagging NCR, Audit, Change Control, and Inspection records with a relevant External Collaborator for Vault to automatically create, activate, or inactivate. When the user account for the External Collaborator is created, activated, or inactivated, the relevant email is sent to those persons as part of the process. Learn more about the supported records in External Collaboration Management.

COA Inspection Enhancements

This feature provides several capabilities that enhance and prepares the Early Adopter Program (EAP) of the COA Inspection functionality to be available to all customers for a future release. Learn more about COA Inspection enhancements.

Drop-down for Matching Rules

This feature improves the user experience when defining Matching Rules to allow users to select from a drop-down list of fields they can map to.

Lenient Unit Matching Enforcement

This feature modifies our unit matching strategies to reduce the likelihood of false negatives.

Linking Complaint, NCR, CAR, CII & Change Control to Material

This feature offers the ability to reference the Material object when creating Complaint, NCR, CAR, CII, and Change Control object records.

FSVP: Including Hazards on the Review & Completed Checklist Page

This feature enhances the functionality of the existing MV Checklist by displaying the list of Hazards on the Checklist Review and Completed page. The name of the Material on the Material Verification record, if available, is displayed at the start of a Checklist Design title as a reference in the Checklist Respondent page.

Data Model Changes

See 22R2 Data Model Changes: QualityOne.

RegulatoryOne

RegulatoryOne features are targeted for tentative availability on August 16th.

Compliance Management

Import Formulation Questionnaires

This feature automates the creation of Compliance Assessment records via Admin-defined mappings by enabling users to import responses to completed formulation questionnaires (checklists). Users can view the generated Compliance Assessments on the right side of the Formulation Composition Viewer for the related Formulation. Learn more about importing formulation questionnaire data.

Regulatory Request Management Enhancements

This feature allows Admins to use Criteria VQL to constrain the Formulations users can select when creating Regulatory Requests so they can quickly find the appropriate Formulation record. This feature also improves the errors Vault displays when Admins configure the Matching Fields and Request Grid Columns fields in the Similar Request section of the Regulatory Request object page layout. Learn more about Regulatory Request Management.

Registration & Dossier Management

Export Dossier Binder

A new Export Binder action is available on the Registration Item Requirement object that allows users to export all documents of a Dossier Binder for a Registration Item Requirement as a ZIP file while maintaining the requirement hierarchy as a hierarchy of folders in the export. Learn more about Dossier Binders.

Propagate Fields from Registration Items to Registration & Registration Objective

Users often need to fill out data on a Registration Item that also applies to the corresponding Registration or Registration Objective. This can become duplicative over time when dealing with large volumes of records. With this feature, users can now minimize repetitive data entry by running the Populate Registration Record action on Registration and Registration Objective records, which populates an Admin-defined set of fields based on their related Registration Items. Learn more about populating Registration fields.

Root Requirement Selection from Registration Item

In previous releases, when users ran the Generate Requirements action on a Registration Item, Vault generated Requirements based on Admin-defined Criteria VQL. This enhancement gives users the option to manually select which root Requirements to trigger the Generate Requirements action on, allowing more flexibility for requirement generation. Learn more about generating Registration Item Requirements.

Relational Token Error Handling

This feature gives Admins more information about errors related to Relational Tokens that makes it easier to identify reasons for failure so they can easily resolve issues.

Regulatory Documents

Regulatory Study Object Data Model to Support Endpoint Studies

This feature allows users to capture study details and corresponding formulations in a single Regulatory Study record, which can be easily found and re-used when preparing product registrations. Learn more about RegulatoryOne Regulatory Documents.

Data Model Changes

See 22R2 Data Model Changes: RegulatoryOne.

Veeva Claims

Veeva Claims features are targeted for tentative availability on August 16th.

Veeva Claims

Remove Statement & Associated Records from Project

This feature enables Claims and Project Leads to bulk remove erroneous Statements, Claims, and Local Adaptations from a Project record. When configured, users can run the Remove Statement and Related Records action on a Project record and pick which Claims and Local Adaptations to remove by selecting the associated Project Statement and reviewing related records. Learn more about removing Statements and associated records from a Project.

Bulk Add Substantiation

This feature enables users to add an existing Substantiation record to multiple Claims using a bulk object record action. When configured, users can select Bulk Add Substantiation after selecting the option to perform a bulk action from the All Actions menu. Learn more about bulk adding a Substantiation to multiple Claims.

Bulk Add Claim Comments

This feature enables users to add a Claim Comment to multiple Claims using a bulk object record action. When configured, users can select Bulk Claim Comments after selecting the option to perform a bulk action from the All Actions menu and add the same comment to all selected Claim records. Users can also mention other users by entering the “@” or “+” keys in the Claim Comment. Learn more about bulk adding a comment to multiple Claims.

Bulk Add Project Comments

This feature enables users to add a Project Comment to multiple Projects using a bulk object record action. When configured, users can select Bulk Project Comments after selecting the option to perform a bulk action from the All Actions menu and add the same comment to all selected Project records. Users can also mention other users by entering the “@” or “+” keys in a Project Comment. Learn more about bulk adding a comment to multiple Projects.

Selective Local Adaptation Creation from a Project Enhancement

This enhancement allows organizations to pre-filter the list of available Claims for Local Adaptation generation. Admins can specify Lifecycle states for the Claim object in the appropriate Claims Admin Setting and only the records with defined Lifecycle states are available for user selection in the Generate Local Adaptations dialog, providing users with a more effective process for generating Local Adaptations from a Project. Learn more about configuring selective Local Adaptation creation from a Project.

Enhanced Configurability for the Claim Project Join Object

In this release, we have added the ability for Admins to enable the Allow hierarchical copy attribute for the Claim (claim__v) field on the Claim Project Join (claim_project_join__v) object.

Data Model Changes

See 22R2 Data Model Changes: Veeva Claims.

Enablement Details

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.