Pre-Release Date: October 31, 2022 | Release Date: November 18, 2022 & December 2, 2022


We are pleased to bring you Vault 22R3. Read about the new features below. You can find information on enabling new features in 22R3 Release Impact Assessment. Information on developer features (API, VQL, etc.) is in the Developer Portal.

Platform

Working with Documents

Glossary Terms 

This feature allows users to select text in a document and search for approved Glossary definitions. Users can also copy the term and definition to the clipboard for easy sharing. Admins can view and report on Glossary activity using the Glossary Events object. Admins can also configure an external search engine that users can search. Learn more about the glossary.

Freeze Headers and Columns in Document Grid Layout

When viewing document search results in the grid layout, the column headers are now frozen so they are always visible when scrolling vertically. Users also have the option of freezing columns to make them always visible when scrolling horizontally.

Suppressing Attachment Renditions on Single/Bulk Document/Object Records

To reduce the load on the renditions server and to improve user experience, Vault now renders attachment renditions for document and object records on demand. 

OCR Extended Language Support

With this release, Vault is extending Optical Character Recognition (OCR) support to include files containing non-English text. Admins can also select document languages when re-rendering documents.

Exported Binders: Audit Trail File Naming

With this release, when users export a binder with an audit trail, Vault names the audit trail file based on the latest export version. Prior to this release, Vault based the file name on the earliest export version.

With this release, all configuration settings related to documents have audit events that will display in the System Audit History:

  • Maximum characters for exported file name (including extension)
  • Maximum characters for exported folder name
  • Maximum characters for exported document path

Adding Section to Binder in Outline View Confirmation Dialog

When adding a new section to a binder while in Outline View, the name of the section is now entered in a confirmation dialog. This change in UI is consistent with how users add a new section binder while in Compact View.

Improved Error Handling for Signature Page Generation

With this release, Vault validates the template layout of Advanced Templates upon downloading a signature page to ensure all signatures can be manifested. Templates configured with a maximum row count on the signature blocks that exceed the number of expected signatures trigger an error, prompting an Admin to address the issue.

User Mention Notifications Only Sent for New User Mentions

As part of the Notifications on Replies to Notes feature in 22R1, we updated the conditions under which User Mention notifications are sent. Vault no longer sends User Mention notifications when a user edits an existing Note or Reply with an existing User Mention. Vault only sends User Mention notifications when a User Mention is added to a new or existing Note.

Vault Objects

Lookup Field for High Volume Objects

High Volume Objects (HVOs) now support lookup fields with limitations on faceting, filtering and sorting in comparison to Standard Volume Objects (SVOs).

Select All Option for Complex Relationship

The ‘Select All’ option is now available for Complex Many-to-Many Relationships, in addition to Simple Relationships, which have been previously supported. This makes it easier and faster for users to add records.

Lifecycle & Workflow

Multi-Record Workflows

This feature allows users to send multiple records on the same workflow, increasing productivity and improving user experience for task participants. Admins may now define workflows that support up to 100 records of the same object. Additionally, Admins may enable existing workflows to support multiple records.

Multi-Document Viewer UI Updates

This feature provides user experience enhancements to the multi-document viewer within workflows. The dialog that collects task verdicts now supports pagination and document viewing in the background. The left sidebar now supports document list filtering and infinite scrolling.

Limit Workflow Task Participants

This feature allows Admins to define a maximum number of participants that may be selected for each participant control defined in the workflow’s start step. When enabled, this prevents users from accidentally assigning a task to a large group of users, for example, All Internal Users.

Pre-Populated Values in Document Workflow Field Prompts

Vault now pre-populates document field values in Start and Task step field prompts and single verdict prompts in workflows on a single document when values are present in the related document field.

Reporting & Dashboards

Document with Object Report Types

This feature allows customers to create reports on documents and their associated object records. When Admins define Document as the primary object in a report type, they can now add additional objects to the report type with an up or down relationship. Vault supports the addition of single- and multi-value outbound relationships to Document report types. For objects referenced in document fields, Vault shows the object relationship as an up object if the field is single-value and as a down object if the field is multi-value.

Control Charts

This feature allows users to visualize report data as a control chart. Similar to other dashboard charts, users can generate control charts using reports that contain at least one grouping. Vault completes sigma calculations automatically and highlights them in the chart. Users can also manually add a target line to compare with historical data.

HVO Lookup Field Support in Reports

With this feature, customers can filter on searchable HVO lookup fields in reports. All searchable and non-searchable lookup fields are available to be added as a column in reports. All fields can also be used to group the standard report. Additionally, there are no restrictions in Multi-Pass reports.

Search & Filter

Saved Views on Dynamic Tabs

When using the “Show in Tab” option on a related list, users are now able to save their search criteria to a view within that dynamic tab. These views can be shared with other users who can access the same related list.

Precision Highlighter

Highlighting search terms within search results now bolds matching search terms beyond the exact terms typed into the search box. When a result is matched due to stemming, the inflected form of the word is now highlighted in the results. For example, if a search for “early” matched a document with the term “earlier”, “earlier” will now be bolded in the results.

This update also highlights terms that match because of synonyms. In this case, a search for “IB”, will bold “investigative brochure” in the results if there is an entry for that synonym in the thesaurus.

Document Content Reindex

The content of all documents is being reindexed in preparation for upgrades to the Vault search engine. This reindexing will happen following the release so the changes described below will not be immediately noticeable after the release. This process will happen over the course of several weeks.

After reindexing, Vault will add English Stemming to document content search so that plural nouns (report and reports), verb tense (injecting and injected) and comparatives (early and earliest) are automatically substituted when searching.

Older documents that have not been reindexed for a long time and need to go through the OCR process may have a different set of searchable terms based on the confidence of Vault’s newest OCR process. This means there may be more or fewer searchable terms in those documents based on the OCR confidence thresholds.

Formulas

Object Reference Fields in Formulas

This feature allows Vault expressions to use object reference fields. Users may wrap an object reference field in the Text() function or the ID() function to return the record label or ID as text respectively. Object reference fields that are not wrapped in Text() or ID() will return the object reference directly. Existing uses of object reference fields that return the record ID or the record label as text will continue to return the same value.

Currency Formula Fields

This feature introduces the formula field type, currency, to object formula fields. Currency formula fields return numerical data formatted as a corporate or local currency.

Checklists

Checklists: Ad-hoc Sections

With this feature, Admins can configure checklists so that respondents can add sections to runtime checklists on an ad hoc basis.

Usability & UI Updates

Enterprise Home Page: New Grid View

With this release, in addition to the current card view, a new grid view for the Vault Enterprise Home page (aka the My Vaults page) is available. Users can toggle between the new grid view and updated card views. The grid view provides search and sort capabilities for users with access to a large number of Vaults. Additionally, the Vault selector picklist and the Enterprise Home Page card and grid views now indicate if a Vault is in maintenance or configuration mode when not available.

The new Enterprise Home Page is only visible to users with access to limited release Vaults. It will be visible to all users when the My Vaults page is enabled on their home domain in 22R3.0.

Enterprise Home Page: Card View Redesign

With this release, the Enterprise Home page’s card view has an enhanced user interface that allows users to quickly find the right vault to open.

What’s New Page Content Update for 22R3

The content of the What’s New in 22R3.0 Page has been updated to highlight a few features that help make using Vault easier and faster.

Administration

30-minute Upgrade

Production Vaults will be unavailable for approximately 30-minutes while being upgraded. Immediately prior to the Vault being unavailable, active users will be notified and have time to complete their work. Once a Vault has been upgraded, users will see a “What’s New” notification in the notifications area. Sandbox Vaults will continue to be unavailable for the duration of the maintenance window.

Query Governor

To ensure Vault stability and performance, VQL now enforces constraints on expensive VQL queries. These changes affect API version 22.3 and higher, and existing integrations are not affected. Learn more in the Developer Release Notes.

Editable Vault Name

With this release, administrators can edit the Vault Name field on the Vault General Settings page (Admin > Settings > General Settings). Additionally, the General Settings page now displays Vault URL.

Notifications: Email Notification Status

This feature allows Admins to view the delivery status of email notifications on a new page in the Operations tab. Admins can filter the list of email notifications by date, email address, and status as well as export it to CSV.

Notifications are now only retained within the Vault database for 2 years. Notifications older than 2 years are available for download as zipped CSV files.

Person Object: Duplicate Person Record Detection

This feature helps detect the creation of duplicate Person records by alerting users of potential duplicates when Person records are created in Business Admin or a standalone Person tab. Admins may review and edit duplicate matching criteria in the Settings tab.

Notifications: Read & Unread status

This feature adds a Read and Unread status for each web notification. Users can mark unread notifications as Read from the Notifications panel and Notifications page.

Outbound Packages: Support Migrating Group Data

In this release, there is added support for including User Groups in Configuration Migration Packages and Test Data Packages. Configuration can reference Groups and you can now include Groups as Data Steps. Groups will also be processed and deployed according to dependencies.

Outbound Email Address for Persons

In this release, Vault applications that use outbound email domains can define an outbound email address on Person records.

Configuration Management: Review & Deploy Page Notification for Pending Component Updates

This feature adds a new warning message alerting users of pending configuration changes during the Review & Deploy process. When Vault displays this message, it means that configuration changes are happening asynchronously, and users should allow the changes to complete prior to continuing the deployment.

Test Data Packages: Override Default Reference Lookup Fields

When creating Test Data packages, Admins can now override the default reference lookup to an object with any one of the unique fields available for the object. Previously, this was only available for Migration Packages.

Clarify Atomic Security Reporting in Vault Configuration Report

There is now clarification on Vault Configuration Reports stating that only non-system default Atomic Security are included. The system default state behavior is documented.

Scheduled Data Exports

Scheduled Data Exports: Update Scheduled Start Time

In this release, there is the added ability for an Admin to change and set the start time of a Scheduled Data Exports job.

Scheduled Data Exports: Export Picklist Labels and Names

Scheduled Data Exports of document, document version, and object metadata now include picklist names and labels.

Scheduled Data Exports: Document Metadata in Default Alphabetic Order

Scheduled Data Exports of document and document version metadata now have a default alphabetic order for column headers.

Access Control

Delegate Access Feature: Enablement Available in all Vaults

This release, we made the Delegate Access feature available in all limited release Vaults. It will be enabled in general release Vaults in 22R3.0.

If not previously enabled, the feature is turned off by default, and can be turned on by an Administrator in Admin > Settings > General Settings.

Domain Users: UI Enhancements

The domain administration user interface (Admin > Users & Groups > Domain Users) has been enhanced to scale on domain with hundreds of Vaults. New capabilities include inline edit of Vault memberships, an enhanced add membership flow, and the ability to export a user’s Vault memberships.

System Managed Users: Standardizing Email & Security Policy

Starting in this release, System Managed Users have a standardized security policy (System Managed) and email (no-reply@veeva.com). This change applies to System Managed Users in platform and application Vaults.

Add Delegates to a User: Performance Optimization

This feature optimizes the performance of the drop-down selection for adding new delegates to a user, which is especially useful for Vaults with a large number of users. A banner displays on the Active Delegations page when delegate selection optimization is in progress.

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 current and 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.

Platform Data Model Changes

See 22R3 Data Model Changes: Platform.

Vault Connections

Safety/Clinops: Studies

The Safety to Clinical Operations Vault Connection transfers Study and Study Countries records across Vaults. When users create or edit Study or Study Country records in Clinical Operations Vault, Vault creates or updates the Study record or Study Registration record in the Safety Vault.

RIM to Clinical Operations: Transfer of All Document Versions to Clinical

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 Clinical side of the connection only. This feature is enabled by an Admin setting.

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 in scope for transfer.

RIM/Clinops: Improve Transaction Error Handling

During the connection’s inbound job, some errors, like hitting a field validation rule, cause an entire transaction to fail and the result is that all the records in that transaction fail. In addition, there are no User Exceptions created because User Exceptions are part of that transaction. This feature intends to fix these situations.

Clinical Operations

CTMS

ClinOps/CDMS: Study Pause

Study Pause allows users to pause and resume the Clinops to CDMS connection for specific studies. Paused studies will still be available in the CDMS and CTMS Vaults, but the connection will not create or update any data for them until they are resumed.

Clinical Operations to Medical CRM Connection: Standard Field Mappings

This feature introduces standard Field Rules for the Integration Rules applicable to the Clinical Operations to Medical CRM Connection.

Clinical Operations to Medical CRM Connection: Activity Deletion Support

The Clinical Operations to Medical CRM Connection now indicates when transferred activities or interactions are deleted in the source system.

Yuzu: CTN Change Log Enhancements

This feature improves the automated tracking and support for CTN (Clinical Trial Notification) Data Change Logs used with the Yuzu capabilities for CTMS. CTN Data Change Logs related to CTNs that are created after the CTN Document is generated are now automatically brought forward via the Create Subsequent CTN action.

Addition of Oversight Tab

This feature adds a new menu tab to centralize access to oversight activities. This tab will be leveraged for future enhancements and can be used to organize configured oversight activities.

eTMF

Support for Transferring Inactive Document Types in TMF Transfer

This feature adds support for the transfer of document versions associated with inactive document types. This ensures completeness of the eTMF when receiving transfers from a Vault that has utilized different document types over time.

TMF Bot: Prediction Metrics

This feature provides better in-system metrics for Prediction records. A monthly job generates a record for each classification and displays the number of uploaded Documents, Predictions, and accuracy. This allows for customers to track performance over time, and at a more granular level.

Auto-Classification of Email Attachments

This feature adds support for Documents created from Email Attachments. Learn more about email processing.

Vault Mobile: TMF Bot Support

This feature adds support for Documents created in the Inbox via Vault Mobile, allowing TMF Bot to auto-classify Inbox Documents uploaded to Vault eTMF.

Study Startup & eTMF

Email to Vault: Create Documents from Attachments

This feature leverages platform email ingestion functionality to support inbound email addresses that create an unclassified Vault document for each attachment included in the email that is sent to Vault.

Increment # Expected from Matched Documents

This feature introduces triggers on EDL Item that updates the Requiredness field if it is not equal to “Required” and increments the # Expected field based on EDL Item matching. This feature is enabled by Support in the 22R3.0 release. While an option to enable the feature appears in Limited Release and Pre-Release Vaults, this option can result in errors and should not be enabled.

Vault Payments

Automate Payment Adjustments

With this feature, Vault Payments customers can now automate support for adjusting Payable Items. When enabled, Subject Visits, Procedures, or Site Fee changes will now trigger an automated adjustment process. Additionally, existing Payable Items can be adjusted when a new Fee Schedule is Approved in the system. Learn more about Vault payments and configuring Vault payments.

Generate Payable Items available in Fee Schedule Workflows

Vault Payments customers can now initiate the “Generate Payable Items” functionality via a workflow on a Fee Schedule record. Learn more about Vault payments.

Payment Limits & Date Effectivity

With this feature, Vault Payments now evaluates Fees with Payment Limits, e.g. Maximum or Rate limits, across multiple Approved Fee Schedules at a Study Site. Payable Items related to Fees with the same name, regardless of Fee Schedule, are now considered in evaluating and determining the eligibility of generating additional Payable Items. Learn more about Vault payments.

SiteConnect

Site Connect to Inbox

With this feature, Site Connect customers can designate that certain document artifacts received from SiteVault are always created as Unclassified documents. Additionally, when the Clinical Operations vault is missing a mapping to the necessary Vault Clinical Docs artifact any documents received from SiteVault will now get created as Unclassified documents. Learn more about configuring Site Connect.

Site Connect Single-Study docs

With this feature, Site Connect Admins can ensure that any documents received from SiteVault are always created with a single Study value. An incoming document related to multiple studies in SiteVault will be created as multiple documents in Clinical Operations, each with a single Study value. Learn more about configuring Site Connect.

Site Connect: Additional Vault Clinical Docs Support

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

  • SAE Report Form Template
  • Pregnancy Report Form Template
  • Special Events of Interest Form Template
  • Participant Adverse Event Log
  • Protocol Deviations
  • Investigator Brochure Summary of Changes

Clinical Operations Data Model Changes

See 22R3 Data Model Changes: Clinical Operations.

Commercial

PromoMats

This feature improves the Suggest Links matching functionality and introduces the ability to build the Suggest Links action into the lifecycle process. This feature also introduces support for matching Text Assets related to Multiple Countries & Products while using Suggest Links. Learn more about Enhanced Suggest Links functionality.

Vault CRM to PromoMats Connection

Vault PromoMats now supports a standard connection with Vault CRM. When configured on a document type via a new document type group, this connection automatically sends approved documents from PromoMats to Vault CRM.

eCTD Submission Package

This feature adds the new eCTD Submission Package rendition type. Once configured, users can upload a ZIP file containing many materials, such as audio and video files, to the rendition type. While generating an eCTD Compliance Package, Vault unzips the contents of the rendition type and adds them to the package as Clean Material. Vault does not rename or convert the contents of the ZIP file to PDF.

Add Supporting Documents to eCTD Compliance Packages

This feature allows Vault to automatically pull in supporting documents while generating a Pre Clearance or Post Marketing eCTD Compliance Package. Supporting documents must be one of the new standard Supporting Documents document subtypes and must be linked to the promotional material through the new document relationship eCTD Support Documents. Users can also add additional Clean Materials without duplicate lines on the FDA 2253 form using a new document field.

Add Promotional Documents to eCTD Compliance Packages

With this release, users can add promotional materials to an existing eCTD compliance package. This feature introduces a new user action that allows users to select one or many documents from the library to add to the Compliance Package. Vault regenerates the Compliance Package to include submission ready copies of the new documents, new supporting documents, and linked references when applicable.

Copy Source of Text Assets

This feature introduces a new standard field, Source Text Asset, on the annotation_keywords__sys object. This field automatically populates on the newly created record with the source record when it is created via a Copy Record action.

Multi:Product & Multi:Country Support for Text Assets (Claims and Reusable Text)

This feature introduces two (2) standard join objects, Text Asset Country and Text Asset Product, that allow users to relate multiple countries and products to their Text Asset object records. This feature also introduces two (2) new Admin checkboxes to enable automatic join record creation. When enabled, Vault automatically creates join records when creating a new Text Asset record or editing an existing Text Asset record. 

Multi:Product & Multi:Country Support for Content Modules

This feature introduces two (2) standard join objects, Content Module Country and Content Module Product, that allow users to relate multiple countries and products to their Content Module object records. This feature also introduces two (2) new Admin checkboxes to enable automatic join record creation. When enabled, Vault automatically creates join records when creating a new Content Module record or editing an existing Content Module record.

Modular Content & Claims Data Model Change

This feature adds new configuration to PromoMats to make the creation, management, and usage of Text Assets (Claims & Reusable Text records) and Content Modules simpler and more intuitive.

This feature adds the new standard Related ISI and Related PI relationship types to the Base document type and makes them available for use on all document types. For Vaults where these standard Relationship Types do not exist, we have added the ability to activate these standard Relationship Types and add them to the base document type. Learn more about the Related ISI and Related PI relationship types.

Asynchronous Auto Publish to CRM for Approved Email Fragments

With this release, Vault automatically creates email fragments asynchronously, enhancing the Auto Publish to CRM for Approved Email Fragments feature. Vault notifies users when fragments are created and available for use within Vault.

High Resolution Presentation Slides for CRM & Engage

In this release, Vault allows high resolution generation of CLM Presentation Slides for use with CRM and Engage. A new Application Setting to “Render Presentation Slides in High Resolution” allows Vault to render newly created CLM presentation slides as 96 DPI.

Automated Image Rendition Setting Removal

With this release, we have removed the Application Setting checkbox for “Enable Automated Image Renditions”. The Automated Image Renditions feature continues to provide high quality Image Renditions via configuration of Rendition Types without any changes to the existing feature or configuration. In addition, the “Enable enhanced PSD file image conversion” Application Setting is now available for use without the prior enablement of the “Enable Automated Image Renditions” setting. The maximum number of Automated Image Rendition Rendition Type that you can create is also increased to 25.

MedComms

Define MedComms & MedInquiry Applications in Vault Medical

The existing MedComms Vault will be renamed to Vault Medical. Within Vault Medical, two independently licensable applications will be available: MedComms and MedInquiry.

Data Agnostic Vault Medical to CRM Connection for Medical Inquiry: Push Status Back to CRM

Cases closed in Vault that originated in Veeva CRM will have an update pushed back to the CRM Org in which they originated. This is a status update to say the inquiry has been closed.

Commercial Data Model Changes

See 22R3 Data Model Changes: Commercial.

Medical

MedComms

This feature adds the new standard Related ISI and Related PI relationship types to the Base document type and makes them available for use on all document types. For Vaults where these standard Relationship Types do not exist, we have added the ability to activate these standard Relationship Types and add them to the base document type. Learn more about the Related ISI and Related PI relationship types.

Asynchronous Auto Publish to CRM for Approved Email Fragments

With this release, Vault automatically creates email fragments asynchronously, enhancing the Auto Publish to CRM for Approved Email Fragments feature. Vault notifies users when fragments are created and available for use within Vault.

High Resolution Presentation Slides for CRM & Engage

In this release, Vault allows high resolution generation of CLM Presentation Slides for use with CRM and Engage. A new Application Setting to “Render Presentation Slides in High Resolution” allows Vault to render newly created CLM presentation slides as 96 DPI.

Automated Image Rendition Setting Removal

With this release, we have removed the Application Setting checkbox for “Enable Automated Image Renditions”. The Automated Image Renditions feature continues to provide high quality Image Renditions via configuration of Rendition Types without any changes to the existing feature or configuration. In addition, the “Enable enhanced PSD file image conversion” Application Setting is now available for use without the prior enablement of the “Enable Automated Image Renditions” setting. The maximum number of Automated Image Rendition Rendition Type that you can create is also increased to 25.

Product & Country Become Shared Fields

The Product (product__v) and Country (country__v) document fields are now shared document fields. Admins can remove the fields from the Base document and assign them to explicit document types, subtypes, and classifications. Assigning these document fields to explicit document types increases the flexibility to leverage VQL constraints.

Medical Data Model Changes

See 22R3 Data Model Changes: Medical.

Vault Mobile

Enforce Mobile App Version: iOS Only

This release of the iOS app checks that the mobile app is on a supported version. If there is a newer version of the app available, users see a prompt informing them of the upgrade. If the app version is unsupported (too outdated), users will see a message that requires them to update the app before logging in. This functionality was already released on the Vault Mobile Android app in 22R2.

New Mobile Tab: Notifications

Users can now access all of their notifications through a new Notifications mobile tab. This mobile tab lists mobile push notifications as well as all other Vault notifications. Non-mobile notifications can be opened in a mobile web browser from within the app. 

View All Task Types

Prior to 22R3, only document tasks were displayed in the Tasks mobile tab because only document tasks are completable on mobile. Now, users are able to see all of the tasks assigned or available to them, regardless of type. Tasks that are not completable on mobile can be opened in a mobile web browser from within the app.

Capture & Create New Documents

Users can now use their phone to scan images of document pages and create an unclassified document through the Library mobile tab. This feature provides similar functionality to the Veeva Snap app (which will be deprecated in 2023 as the functionality is moved to the Vault Mobile app), and is available on both the iOS and Android Vault Mobile apps. For Vaults with the certified_copy__v field enabled, users can optionally certify the document before saving to Vault. 

Display Mobile App Version & Privacy Policy

Users can now see which version of the mobile app they are on and copy that value to clipboard. A new button has been added to the bottom of the Vault Selector, which displays the mobile app version as well as a link to the privacy policy. 

BRD updates for Mobiletab component

Documentation addition only. Additional requirements added to the Migration BRD to include the Mobiletab component type.

BRD updates for Mobileshareactionconfig component

Documentation addition only. Additional requirements added to the Migration BRD to include the Mobileshareactionconfig component type.

Training

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

Study Training

Training Matrix Builder

This feature allows an authorized user to rapidly assemble the training needs for a given Study by specifying the training materials that each study team member needs to complete training on.

Using an intuitive, guided process, the user can build and publish a study-specific training matrix. After the training matrix is published, the application will automatically assign training tasks to each study team member. Learn more about the matrix builder.

Quality

Vault Validation Management

Vault Validation Management is a new application added to the Vault Quality Suite currently available to customers participating in the early adopter program. The application helps organizations manage and execute paperless validation across validation disciplines including: Computerized Systems Validation (CSV), Facility, Equipment, and Utility (FUE) commissioning and qualification, process validation, cleaning validation, and method validation.

This first release includes the core data model and automation to help manage the validation inventory, entities, and requirements (user, functional, and design specifications). Automation exists to help facilitate the creation of versions of validation entities as well as requirements. Additional objects have also been introduced to support validation activities and deliverables needed to prove an entity has been validated. Since certain types of deliverables are based on document records, customers must have QualityDocs in their Vault as a prerequisite for organizations to use Vault Validation Management.

The application provides an intuitive user interface to help validation professionals author, review, and pre-approve test scripts before they can be executed. Test script authors can add, copy, and delete setup steps and execution steps to ensure that applicable requirements are challenged effectively. User requirements, functional requirements, and design specifications can be linked to test steps or test scripts which helps with automatic creation of the requirements traceability matrix.

Another key feature included in the initial release is the paperless test execution experience where pre-approved test scripts consisting of setup steps and execution steps can be executed by one or more assigned executors. Executors can easily perform procedures defined by test authors, access requirements being challenged, describe their observed results, and upload attachments to provide objective evidence. Exceptions or discrepancies encountered during execution can be created directly from the test step where the issue was encountered. The discrepancy will then undergo a workflow for investigation, root cause, and corrective action.

Vault Validation Management 1

Once executors have completed test execution, the test script undergoes independent review and required approvals. A review and approval experience has been included in the initial release to streamline the process with a review by exception capability.

Vault Validation Management 2

Learn more about Vault Validation Management.

Vault LIMS

Vault LIMS continues to expand its available features in this release, including the following additional functionality:

  • Continued advancement to creating static data. 
  • Users can manage in-process Material and Batches, including automated logging via Lab Protocols.
  • Lab Tests can now capture Consumables and Instruments.
  • Users can now track shipping details for Lab Samples.
  • Calculations can be created and executed in testing.
  • New capabilities supporting making revisions to a Lab Result after the Lab Test has been evaluated against the specification criteria.
  • New capabilities for reviewing a Lab Test Set, Lab Sample, & Batch with a focus on reviewing any exceptions.

Learn more about Vault LIMS.

QualityDocs

Quality Relationships Document Information Panel

The Quality Relationships Document Information Panel allows users to easily view existing Quality-specific document relationships to Process Navigator Hierarchies, Stations and Training Requirements. Users can also create or remove these relationships from this panel.

Quality Relationships Document Information Panel

Process Navigator: Show Associated Process Documents

This enhancement adds a new checkbox option in the Documents section of the Process Navigator detail page that expands the section view to include documents associated with the current process navigator hierarchy as well as its immediate parent and children processes. This feature introduces a new Associated Processes column in the Documents section that displays the process navigator hierarchies that a document is associated with. Additionally, the default non-editable columns that display in the Documents section have been pared down to the Name and Associated Processes columns only.

Training

Instructor-Led Training: Simplified Experience

This new experience for Instructor-Led Training drastically simplifies the setup and administration of Classroom Training Requirements. In addition to an intuitive UI designed with Instructors in mind, it also provides a simple way to report on classes that were not run through Vault Training. Learn more about the new Instructor-Led Training experience.

Instructor-Led Training Simplified Experience

Quiz: Hide Missed Questions

You can now choose whether Learners see which questions they missed on a failed Quiz attempt. Depending on your configuration, they will either see which questions were correct/incorrect, or will simply see their overall quiz score with no indication of correctness at the question level.

Prevent Delegate Completion

Delegate users will no longer be able to complete training on behalf of a user. 

Option Not to Issue Quiz for Document Revision Training

This feature allows Admins to decide whether a quiz, if configured on the Training Requirement, is included when a Training Assignment is created due to document revision. Training Assignments created due to reasons other than document revision will always receive the quiz.

Disallow Quiz Design Population for Classroom Training Requirements

Users are now prevented from misconfiguring Classroom Training Requirements by populating the Quiz Design field on a Classroom Training Requirement.

Note: This feature does not remove the ability to add a Quiz to a Classroom Training Requirement. It simply enforces that a Quiz is added in the correct place, rather than through the Quiz Design field.

QMS

Batch Release Templates & Automation

This feature will drastically reduce the manual overhead associated with the batch release process using three new capabilities:

  • Customers can now define Batch Release Templates, which they can use to define all of the documents and system checks to be performed for each batch to be released. Customers can define these templates at different granularities, such as Country or Facility.
  • Once the Batch Release Template has been defined, the Create Batch / Lot Disposition Record action can be utilized to create new Batch / Lot Disposition records from a Batch Release Template. When executed, the action creates a new Batch / Lot Disposition record and the document and system checks that were defined for the Batch Release Template are automatically created.
  • In addition, the batch release process has also been augmented to include a new action, Populate Related Quality Events, which can be leveraged to automatically find any Quality Events associated to the batch that is being disposed and eliminate the need for users to manually associate Quality Event records.

Learn more about setting up Batch Release Templates & Automation.

Duplicate Detection Check

With this feature, Vault QMS replaces the complex manual process of identifying a duplicate Complaint with an intelligent search functionality and user experience. The existing Quality Record Check functionality is enhanced to allow Admins to configure new Duplicate Check record check types for the standalone Complaints object and the Complaints and MedTech Complaint object types on Quality Event.

The Duplicate Check record check feature has the following key capabilities:

  • A search capability to identify potential duplicates based on duplicate check rules that utilize exact match fields, similar match fields, and related object exact match fields
  • A purpose-built UI to view potential duplicates and review those that are provided a verdict before completing the process
  • An asynchronous job automatically relates duplicates and follow-ups to the main record and performs a state change on the duplicates or follow-ups to an appropriate lifecycle state

Learn more about configuring duplicate detection checks.

This feature enhances existing QMS security to allow Admins to configure an entry or user action that assigns the appropriate application role, such as Viewer, on a related object record to the user(s) assigned to a defined role on an associated object record. This ensures that the user(s) who are assigned to the object record, such as a CAPA action, will be able to access and view the related object record, such as the related Deviation, to assist in performing their assigned tasks while still preventing them from being able to access and view unrelated records. Learn more about configuring this action.

Standalone Complaints Data Model

With this feature, QMS now supports the Complaints process as a standalone data model separate from Quality Events. This will allow customers to manage their Complaints Lifecycle separate from the Quality Event Lifecycle.

New implementations are encouraged to utilize the standalone Complaints data model. Customers who are already live or in the process of implementing the existing Complaints object type on Quality Event are strongly encouraged to continue leveraging their existing configuration. There will be no functional differences between the two models and there is no need or functional requirement to move to the standalone Complaints data model if already leveraging the existing Complaints object type on Quality Event.

Complaints: Relationship Automation, Recurrence Check, & Checklist Support

This feature extends support for Relationship Automation, Recurrence Check, and Checklists features to also support the standalone Complaints data model. This feature automatically provisions objects to support Checklists on the Complaint object.

Complaints: Generate Document, Effectiveness Check, & External Notification Feature Support

This feature extends support for the three Generate Document actions, the Create Effectiveness Check, and the External Notification feature to also support the standalone Complaints data model.

Set From Email Attributes on Complaint Emails

External Notifications sent for Complaints or Medtech Complaints on the Quality Event or Complaint object now support customizable From: email addresses. For example, instead of emails appearing like they are sent from Vault, customers have the ability to utilize a From: email address that appears that the email was sent from Verteo Complaints.

This feature also automatically enables the Outbound Email Address feature which allows Vault Admins to configure Outbound Email Addresses.

Quality Team Assignments: Update Audit Log to Display the User who Performed the Team Assignment Update

When performing a Quality Team assignment, the associated audit log entries on the Team Member object now specify the user which the system is creating the assignment on behalf of. Prior to this feature, the audit log only displayed System. This enhancement makes it easier to view the user which triggered the Quality Team change when viewing audit log entries of the Team Member object.

External Notification: Support for Standard & Custom Object Types on Quality Event & Audit Objects

With this enhancement, the existing External Notification feature now supports all standard and custom object types on the Quality Event and Audit objects, and allows users to send notifications as well as share documents to Vault Users as well as non-Vault users through the Send External Notification action.

Part, Asset & Service Data Model Updates

New standard objects have been created to replace the object types of the context object. The following standard objects are now available:

  • Part (part__v)
  • Asset (asset__v)
  • Service (service__v)
  • Quality Event-Asset (quality_event_asset__v)
  • Quality Event-Part (quality_event_part__v)
  • Quality Event-Service (quality_event_service__v)
  • SCAR-Asset (scar_asset__v)
  • SCAR-Part (scar_part__v)
  • SCAR-Service (scar_service__v)
  • SCAR-Material (scar_material__v)

Quality Data Model Changes

See 22R3 Data Model Changes: Quality.

Regulatory

RIM Registrations

Bulk Create Activities, Submissions, & Regulatory Objectives Wizard Linking Enhancement

This feature allows users to follow a two-step process in their execution of change controls and corresponding usage of the Create Related Records wizard. They can create an Event and corresponding Activities to first assess the extent of changes needed and finalize related data. Then, they can use the Create Related Records wizard to create Regulatory Objectives and Submissions linked to Activities with impact identified to facilitate regulatory actions and cascade finalized supporting data from the Event.

DADI Output Report

With this release, a new action on the regulatory objective has been created. When executed, a series of reports will be generated. This supports the population of the DADI form, required for EU submissions starting in 2023.

IDMP / DADI Data Model Updates

This feature updates source objects, output objects, and the data model algorithm supporting IDMP per EU IG v2.1 and the DADI form for human variations.

XEVMPD Support for Investigational Products

This feature extends XEVMPD functionality to Investigational Medicinal Products, including the management of investigational medicinal product data, data aggregation, and gateway submission. Bulk update and submission functionalities are also extended to Investigational Medicinal Products.

EUDAMED UDI Business Rule Validation

With this release, UDI submissions can be validated against business rules published by the European Commission to surface issues that would result in a rejection by EUDAMED.

EUDAMED UDI XML Generation Updates

EU UDI submissions are now generated using the EUDAMED XML Schema v2.0.4. Also, the Vault-generated XML now includes source values supplied for enumeration fields even if the values are invalid, which will result in validation errors and make troubleshooting easier.

Activity Country Dependency Enhancements

This feature allows Admins to define more specific country dependencies for planned changes. A new trigger will run at the time of Activity-Registration record creation to check against these more specific rules, allowing Activity Dependency records to be created only where specific Product, Product Variant, and Packaging records are impacted.

RIM Submissions

Drag & Drop Documents from Desktop to Content Plan Item

With this release, users can drag and drop one or more files from a file explorer to a Content Plan Item in the Content Plan Viewer to upload and create documents in Vault and match to the Content Plan Item. The document creation and matching progress is tracked in real time with a toast dialog, allowing users to navigate to other pages within Vault while the process completes. Additionally, when duplicate detection is enabled, existing documents with the same checksum as a dropped file will be matched instead of creating duplicate documents.

Display Document File Type Icons in the Content Plan Viewer

With this release, each matched document row in the Content Plan Hierarchy Viewer displays the icon corresponding to the document file type.

Display Document File Type Icons in the Content Plan Viewer

Create Content Plan as Inactive

With this feature, a new configurable checkbox is available on the Create Content Plan and Content Plan Items system action. When configured, all Content Plan and Content Plan Item records are created in the Inactive lifecycle state, except for Content Plan Items where the source Content Plan Item Template record field Create as Active is set to true. Starting with an entirely inactive Content Plan and activating the records which need to be submitted allows small/daily submissions to be assembled more quickly.

Inactive Content Plan Records Cleanup Job

With this release, a new daily job, Delete Inactive Content Plans, is available for RIM customers. The job deletes inactive Content Plan and Content Plan Item records which meet the following criteria:

  • Status is “Inactive”
  • The Content Plan Item’s All Document Count (all_doc_count__v) equals zero (0)
  • For submission content plans, the Submission record’s Actual Submission Date (actual_submission_date__rim) is at least 365 days earlier than the current date
  • For report level content plans, the Last Published Date (last_published_date__v) is at least 365 days earlier than the current date
  • For Global Content Plans, the Event Complete Date (event_complete_date__v) is at least 365 days earlier than the current date

Dispatch Global Content Plan Harmonization: Application Relationships

With this release, the Dispatch Global Content Plan action has been updated to be compatible with the new data flow introduced with the Submission Wizard in the 22R1 release. In Vaults where the Enable Application Relationships setting is enabled, this process will leverage the Application relationships as the source data for creating Submission relationships.

Content Plan Creation Update to Set Language for Submission

The Content Plan create, update, and copy processes have been updated to set the Language for Submission field (language_for_submission__v) on Content Plan Item records in repeating language sections. This allows Language for Submission to be used for auto-matching.

Content Plan Creation Update to Set Language for Submission

Content Plan Token Support for Submission Fields

This feature extends Content Plan tokenization support so that text and object reference fields on the related Submission are tokenizable. Previously, only the ${submission__v.xml_submission_id__v} token was supported.

Update Set Version Locking on Matched Documents Action

With this release, the Include Latest Lockable State Version configuration option is available for the locking action types on the Set Version Locking on Matched Documents user action. When configured, these actions lock the latest lockable-state version of a matched document instead of only the latest steady state version.

RIM Publishing

Reference Leaf UI

With this release, users are provided with an interface to set a reference leaf. When selected, the action displays a hierarchical view of documents from published submissions for the user to choose a reference leaf. 

US FDA Validation Criteria v4.4 Support

With this release, Vault Submissions Publishing supports validation of US submissions against the US FDA validation criteria version 4.4.

Taiwan eCTD DTD 1.0 Publishing & Validation

With this release, RIM Submissions Publishing supports the TW FDA v1.1 (DTD 1.0) specification. Users can now create Content Plans and generate submissions that are compliant with TW FDA v1.1 specification. Vault validates these submissions based on the corresponding TW FDA v1.0 Validation Criteria Version.

RIM Submissions Archive

New Submissions Archive Viewer

In this release, a new Submissions Archive Viewer has been added. The new user interface streamlines the review process with advanced searching, filtering, and document viewing capabilities.

EAEU Import Updates

This update to the RIM Submissions Archive EAEU dossier type submission display supports the latest amendments to the Rules for Registration and Examination of Medicinal Products for Medical Use in EAEU.

RIM Submissions, RIM Submissions Archive

Set Blank Active Dossier Item Country Status

With this release, the Set Active Dossier Item Country Status system action has been updated to allow for setting a blank value. This can be leveraged to clear out the Submitted status for a country on Active Dossier Item records when the related regulatory objective has been withdrawn or rejected.

22R3 RIM Data Model Changes

See 22R3 Data Model Changes: Regulatory.

QualityOne

QMS

Enhancing In-Process Inspection Object Actions to Exclude Samples

This feature allows users to exclude Inspection Samples from In-Process Inspection analysis when users trigger the Analyze Inspection and Analyze Inspection Sample actions. For In-Process Inspections, whenever new Inspection Samples are generated using the Generate Samples action, Inspection Samples created and generated previously will be marked for analysis exclusion. For other Inspection object types, users can manually exclude Inspection Samples by selecting the “Yes” value in the Exclude from Analysis field. Learn more about excluding samples.

Object Sharing Rule Record Uniqueness

This feature improves maintenance of Object Sharing Rule records by preventing the creation of duplicate records containing the same combination of User, Organization, and Application Role values. Learn more about COA Inspections.

Ad Hoc Question Support for QualityOne Audit Checklist Mobile

This feature allows users to create Audit Checklist questions directly from the QualityOne Audit Checklist Mobile (iPadOS) application. Auditors can respond to audit feedback quickly by creating questions in the moment without leaving the application or accessing Vault.

QualityOne Audit Checklist Mobile features are targeted for tentative availability on December 13th.

HACCP Management Data Model Enhancement

We’ve introduced the Process Step Connection and HACCP Plan Process Step Connection objects to allow users to define the flow between the process steps of a particular process, and store similar information for HACCP Plan process steps. The flow can be managed by defining the input steps and output steps of individual process steps. Learn more about HACCP Management objects.

Multiple COA Attachment Support for Automated Email Intake

This feature extends External Collaboration to allow external users, such as suppliers, to submit multiple Certificate of Analysis (COA) files to Vault. The External Collaborator can reply to a Vault email notification with multiple attachments for upload and analysis for a given COA Inspection object record. Learn more about COA email intake.

COA Inspection Enhancements

This feature extends the processing capability to allow for a wider range of COA formats that can be accurately ingested. Learn more about COA Inspection enhancements.

Improved Unit Matching

This feature improves the unit matching behavior to help avoid scenarios where the unit mismatch is incorrectly determined.

Below Detectable Limit Variant Support

This feature enables Vault to accurately process Variable Specifications when the specifications are reported to be below a detectable threshold.

Analyze COA Action Update

This feature updates the Analyze COA object action by removing the need to specify a Purchase Order or Purchase Order Line Item to run the action for COA documents.

Table Cell Consistency & Format

This feature enhances Vault to more reliably process COA files when there is no explicit demarcation between rows of data.

Document Control

QualityOne Process Navigator

Process Navigator provides a visual interface for users to navigate through processes and supporting documents in QualityOne. Hierarchies will allow users to create and define customized visual hierarchies using a standard data model, and to associate documents to various levels of hierarchies. Learn more about Process Navigator.

Document Control Hierarchy Page

Data Model Changes

See 22R3 Data Model Changes: QualityOne.

RegulatoryOne

RegulatoryOne features are targeted for tentative availability on December 13.

Compliance Management

Relabel Compliance Assessment Object to Qualitative Assessment

This feature changes the label of the compliance_assessment__v object from “Compliance Assessment” to “Qualitative Assessment” in Vaults created after the 22R3 release. We recommend Admins update this label in their Vaults.

Registration & Dossier Management

Global Change Impact Assessment

This feature enables users to see a list of potential Registration Items that must be assessed after a global operational change, such as a supplier change or a label change.

Users can select a set of registration attributes for an event and define a change from one value to another. Vault displays a list of existing Registration Items that that are potentially impacted by the operational change and may require registration activities such as a submission for a new registration or an amendment to an existing Registration. Learn more about Global Change Impact Assessments.

Copy & Amend Dossier

With this feature, users can re-use existing dossiers instead of creating new ones every time. This can be beneficial when you must create new local dossiers from a global dossier or when you want to copy a previously submitted dossier and re-submit it with modifications, while keeping track of both versions. Learn more about reusing shared requirements.

Non-Registration Dossiers

This feature allows Admins to configure the Generate Requirements action on both the Registration and Registration Item objects. This enables Regulatory Affairs users to generate requirements from Registration Objectives for dossiers they will submit to Regulatory Authorities, in addition to generating requirements from Registration Items for internal dossiers not intended for obtaining registrations, such as those created by global teams.

Prior to this release, Admins could only configure the Generate Requirements action on either the Registration or Registration Item objects, not both. Learn more about configuring Registration Item Requirement generation.

Select Requirement Dialog Enhancements: Sorting & Resizing

This feature enhances the Select Requirement dialog displayed when users run the Generate Requirements action, enabling users to search for root Requirement records more efficiently. Users can now filter records with the help of a filter builder and can also sort and resize the columns.

Local Impact Assessment Registration Selection Enhancements: Resize & Edit Columns

This feature enhances the Search Registration dialog to allow Admins to add and remove columns displayed to users when they run the Local Impact Assessment action. Users can also resize columns on the list of Registrations they see in the dialog.

Data Model Changes

See 22R3 Data Model Changes: RegulatoryOne.

Veeva Claims

Veeva Claims features are targeted for tentative availability on December 13.

Veeva Claims

Comment Threads for Claims & Projects

This feature enables users to capture and visualize discussions and decisions on Claims and Projects in a new single-level threaded comment view. This new section allows users to create new comments and reply to existing comments. Users can use existing comment functionality to mention and tag other users. Learn more about using comment threads.

Veeva Claims Comment Thread

Comment Threads for Objects

This feature enables users to capture and visualize discussions and decisions on Local Adaptations and Pack Copies in a new single-level threaded comment view. This new section allows users to create new comments and reply to existing comments. Users can use existing comment functionality to mention and tag other users. Learn more about configuring comment threads for objects.

Bulk Add Elements to Pack Copy

This feature enables users to add multiple Element records to multiple Panels of an existing Pack Copy using a bulk object record action. When configured, users can select Add to Pack Copy after selecting the option to perform a bulk action from the All Actions menu. Learn more about adding Elements to pack copy.

Pack Copy Reference to Panel

This feature enables customers to report better on Pack Copy elements by providing a clear relationship between Pack Copy and associated Panel records. This feature also enables customers to exclude certain fields from copying to new Pack Copy records when generating records with the Cloning Pack Copy and Localize Pack Copy actions. Learn more about Pack Copy Management.

Panel Element Hierarchical Copy

In this release, we have added the ability for Admins to enable the Allow hierarchical copy attribute for the Element (element__v) and Panel (panel__v) field on the Panel Element (panel_element_join__v) object.

Project Hierarchy Enhancements

This enhancement enables users to filter the project hierarchy only on the Claim > Statement values, which are joined with the Project. Learn more about the Project Hierarchy Viewer.

Data Model Changes

See 22R3 Data Model Changes: Veeva Claims.