New in 21R3.4: Breadcrumb Enhancements for Object Tabs, and more

Release Date: February 11, 2022

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

Working with Documents

Caption Bookmark Exclusions

This feature builds on Vault’s ability to generate bookmarks in a PDF Viewable Rendition based on captions in Microsoft Word documents. With this release, Admins can exclude specific captions when generating bookmarks and can control generation of “Lists of” bookmark sections based on captions, which previously required enablement from Veeva Support.

Annotate Usability Improvements

With this release, we have made the following enhancements to improve the user’s ability to interact with documents and annotations:

Annotation filters: Filter by Author includes reply authors, and the Links section differentiates document links from permalinks.
Permalinks have the distinct document field “Annotations (Permalinks),” which is available in Library view, Reporting, and other locations.
Rotate Page is replaced by Rotate Page and Rotate All Pages, allowing users to temporarily rotate all pages during a viewing session.
Zoom, Fit, and Full Screen are applied with buttons instead of menus.
Toolbar buttons that previously dismissed unsaved annotations are visibly disabled while composing annotations.
Users can now scroll, zoom, apply fullscreen, fit width, and height while composing annotations.
Admins can opt into a new “strict” permission requirement for Copy Text functionality.

Text Indexing & Combination Enhancements

This enhancement improves Vault’s ability to correctly index, find, and highlight text in documents that contain specific kinds of punctuation that serve as word separating characters, including periods, commas, semicolons, and dashes. This enhancement also improves its ability to handle formatting variations of single and double quotation marks. Users see better results when performing certain actions on documents, including Find in Document, Create annotation, and Suggest Links (PromoMats).

Collaborative Authoring Troubleshooting Page

This feature introduces a logs page that allows users to view all Microsoft Graph API errors that occur when using Collaborative Authoring with Microsoft Office. This provides users with a self-service method for troubleshooting issues with Collaborative Authoring. Learn more about the Collaborative Authoring Error Log.

Google Drive Integration: Create New Document

This enhancement allows users to browse for and select files from their Google Drive when creating a new document in Vault.

Enhanced Bulk Document Update: Validation Behavior Changes

This feature introduces several changes to bulk document update validation:

For any UI errors which did not previously have a defined error message, Vault now displays a generic error message.
Vault now displays an error if a user attempts to update a read-only field on a document.

Legacy Feature Enablement Updates

With this feature:

The Enable checkout to Office Online feature is now disabled on all Vaults.
The Searchable document type picker and Sort multi-select field values in alphabetical order features are now enabled on all Vaults.

EDLs: Configurable States for Document Version Locking

Customers can configure which document lifecycle states support document version locking for EDL matched items, allowing customers to lock document versions in states other than Steady or Superseded. The EDL Match Job will take a little longer to complete the first time it runs after this update due to the data model updates. The completion time for subsequent runs of the EDL Match Job will return to their normal run time.

Vault Objects

High Volume Object Multi-Value Picklist Field

This feature provides support for the multi-value picklist field in high volume objects. You can create up to two (2) multi-value picklist fields per high volume object.

Lifecycle & Workflow

Consistent Steps Across Workflows

This feature makes workflow steps consistent across Workflows on Documents and Objects. The Action step now combines the former object workflow State Change, Update Record Field, and Update Related Record Field steps, and allows users to perform them conditionally. Additionally, state changes performed within an Action step no longer check entry criteria or fire entry actions when the target state is the same as the existing state. Learn more about configuring workflows on documents and objects.

Populate Object Reference Fields with Workflows & Lifecycles

This feature provides the ability to update object reference fields in lifecycle or workflow actions using expressions. Users may return specific records using the new RecordByLabel() function.

Enhanced Stages Chevron Card for Workflows

In previous releases, users had to navigate to the timeline view to see actions on open tasks. With this release, lifecycle stage chevron cards now display actions on open tasks as well as additional workflow information, saving users clicks and providing easier access to this info.

Show More on Tasks in Home Pages

This feature makes it easier for users to manage their tasks by providing additional task and workflow information on the homepage. It also enables Admins to configure whether or not users may complete a task directly from the homepage.

Remove Default Task Link in Label

This feature allows Admins to turn off the default link provided with the task label.

Bulk Actions on Record Actions

Applications and customers may now expose SDK Record Actions within Vault’s bulk actions. Admins will now see a Record Actions option within the bulk action interface for objects. Learn more about bulk object record actions.

Reporting & Dashboards

In Operator for Name Report Filters

With this release, users can view and select the names of the object or document records and add them as filter values in a report. This feature also adds the conditional operator “in” to the report filters for the Name fields. Users can then view record values before adding them to the filter, and can select up to 100 values in a single filter. This user experience is similar to the object reference field selector and is supported for both standard and HVO objects.

Optional Prompts

With this release, report creators can make prompts optional, allowing users to run a report without adding a value to the report prompt. Users may view all the records or a subset of the records from the same report. Reports are more flexible, allowing one report to solve the use cases of two reports previously. Users can also filter on a null or blank value.

Additional Document Field Support in Report

With this release, Vault supports the Checked Out By, Checked Out Date, Checked Out, and Description fields on Document reports.

Usability & UI Updates

As users view data in an Object tab, each click to view details of a record or drilldown to view a related record or document is tracked by a breadcrumb. Users can mouseover the breadcrumb to display a hovercard that identifies the previously viewed record before navigating back to that page. Previously bookmarked Object Record Detail pages no longer display the breadcrumb generated when the page was originally bookmarked. Such breadcrumbs are stale and prone to errors as data changes over time.

Notifications: View Full Content in Panel

Users can now expand the content of longer notifications directly within the notification panel to view up to 25 lines of text without opening the notification page. This allows users to view longer notifications without having to navigate away from their current task. For notifications longer than 25 lines of text, the notification includes a hyperlink to navigate directly to the full text on the notification page.

Notifications: Email Burst Threshold

With this feature, Admins can set a burst threshold for the number of emails Vault sends for the same notification template in a 30-minute period. Once the burst threshold is reached, Vault throttles the sending of additional email notifications for that template. The burst threshold is a guardrail for customers whose email provider or infrastructure cannot handle a large influx of emails. Learn more about email administration.

Email to Vault: Create Records for Bounced Emails

With this feature, when Vault bounces an inbound email because it is considered spam or because the sender fails SPF or DKIM authenticity checks, it now creates an Email object record in the Bounced lifecycle state. This provides Admins with the ability to report on bounced emails, inspect these emails, and have Vault process them if deemed legitimate.

Updated UI Style on Users & Groups Pages

In this release, we have updated the Security Profiles, Permission Sets, and Groups list views (Admin > Users & Groups) with our new UI style (Create button, filter, and search UI element placement). There is no functionality change. This feature was added in 21R3.2.

With this release, clicking on a chevron button with only one workflow action available displays a drop-down instead of initiating that workflow action. Users can then click on the action label in the drop-down to initiate it, or click elsewhere to cancel. This enhancement helps prevent users from accidentally triggering workflow actions.

Rich Text/Long Text Pop-up Window Size Update

This change makes the Rich Text and Long Text field pop-up window size bigger when viewing a record so that it is the same size as when editing the record. This change provides a consistent experience between viewing and editing Rich Text and Long Text fields.

Auditing

Audit Trail Enhancements to Track Lookup Field Changes in Object Records

This enhancement allows the Audit Trail to log an entry on object records with lookup fields whenever the values change due to source field changes, reference object changes, and changes caused by lookup field initializations.

Administration

Scheduled Data Exports: Initial Full Data Export

This feature provides users with the ability to export all of their Vault object data and document metadata records in an initial load of Vault data into their data lakes and data warehouses.

Scheduled Data Exports: Escaping characters in CSV Output

Currently, when Vault exports picklist fields with Scheduled Data Exports, commas contained within picklist items are escaped by an extra comma. For example, ["value1a,,value1b"]. With this release, commas contained within picklist values are escaped by two pairs of double quotes. For example, ["""value1a, value1b"", value2"] for multi-value and ["value1a, value1b"] for single value.

Additionally, empty values for multi-value object reference fields no longer contain commas in the output, and the exported field value is empty.

Finally, field values with backslashes no longer include an additional backslash.

Scheduled Data Exports: Including Inactive Document Fields by Default

With this release, Vault automatically includes inactive document fields in exports when users select the Document entity in a scheduled data export. Prior to this release, Vault only exported active document fields in Document exports.

Scheduled Data Exports: Increased precision on field values

With this release, currency fields exported in Vault Objects now have an extra decimal place. For example, 1.0 now exports as 1.00. Additionally, DateTime fields on Document and Document Version exports now include seconds in the timestamp.

Scheduled Data Exports: Uploading CSV Files to S3 with Bucket Owner Full Control ACL

With this release, customers using a self-managed AWS S3 bucket as a storage option for Scheduled Data Exports can be the S3 object owner for every export file uploaded to the bucket. Additional AWS S3 configuration may be required. This feature is Auto-on in Vaults configured for Scheduled Data Exports.

Object and Document Field Types for Integration Field Rules

This feature allows Vault Admins to configure the field type for an object or document Query field when creating field rules within Spark integration rules.

Configuration Management

Configuration Management: Allow Outbound & Inbound Packages enabled by default on Align Vaults

Align Vaults will now have Allow Outbound Packages and Allow Inbound Packages enabled by default. These settings can be found under Admin > General Settings > Configuration Management.

Data VPK: Validate VQL in Dataset Filter

This feature allows users to validate Criteria VQL prior to saving a dataset filter.

Access Control

Object Control Security

Object Controls are interface controls delivered by Vault Applications, allowing Admins to put them in the Object Record Detail Page layout to provide a tailored experience. For instance, in Vault Safety, users see object controls when viewing or editing a case object record.

This feature allows Admins to configure which object controls Vault displays at runtime. Admins can configure security profiles and permission sets to control the visibility of these controls at the object level (View permission). They can also use Atomic Security for fine-grained control of visibility on the object record details page, based on the object record state and role assigned to users.

Search

You can now configure Search Collections to include relationships between objects. This allows expanded searches to return results in one object section because of their relationship to records matching the search criteria in another object section. For example, if there is a relationship between Product and Country to manage the list of countries in which each product is marketed, you could set up a Collection to return all of the country records related to the search results from Products. As you filter down Product results, the Country results update as well.

Field Centric Strict Matching

To facilitate multi-term synonym searches, we’ve changed Vault searches with more than one term to allow a search like “myocardial infarction” to appear as a phrase in the thesaurus and match to other phrases like “heart attack.” This update also makes the Strict matching option more field-centric, meaning that the minimum required matching terms must be in the same field rather than split between multiple fields. Strict matching is optional, so Admins can enable or disable it at any time under Admin > Settings > Search Settings.

Checklists

Checklists: Add Reference Documents to Questions

Checklist designers can link one or more Vault documents to their questions as reference material for checklist respondents to review when providing answers in the checklist.

Checklists: Dependent Sections

Multiple-choice question responses can now control the appearance of one or more sections in a checklist.

Checklists: Hide Unseen Questions on Review Page

The checklist review page no longer displays dependent questions that the respondent did not see when completing the checklist.

Auto Claims Linking

Auto Claims Linking: View Claim Details from Select Claims Dialog

With this release, when manually linking to Claims, users can click to view the Claim record in detail from the Select Claim dialog. This enables a more informed selection, and replicates the existing experience when linking to documents and anchors.

Auto Claims Linking: Ignore Superscript & Subscript Characters When Matching to Claims

This feature allows Vault to ignore superscript and subscript characters at the end of words in documents when determining matches to approved Claim records. This eliminates the need for a majority of wildcards in match text values, which were previously necessary to account for variable footnote and endnote references in content.

Vault Formulas

Workdays & Holidays

This feature allows users to perform calculations in expressions that factor out weekends and holidays, making timeliness metrics and due dates more accurate. The new function NetWorkdays() returns the difference between two dates excluding weekends and optionally holidays. Workday() returns a date that is N days in the future excluding weekends and optionally holidays. Admins can define Holiday Schedules and their children Holidays, and can select a Holiday Schedule record for each user.

RecordByLabel() Function in Expressions

This feature allows users to return object references based on object record labels in expressions. The RecordByLabel() function accepts object labels and returns object references which can then be used to populate fields. This feature is only available in workflow and lifecycle actions.

Significant Figures in Expressions

This feature modifies the Round function to accept an optional parameter that can either be “significant” or “significant-astm”. This enables users to round their numbers down to the appropriate number of significant figures based on two common methodologies.

Vault File Manager

VFM Download Rendition Usability Enhancements

This feature provides usability enhancements when downloading rendition files using Vault File Manager, including: providing additional error messages when a file fails to download; including Vault Overlays on files downloaded with VFM; and displaying a dialog to users with VFM permissions suggesting they download using VFM. Vault provides this suggestion when applicable users attempt to download a rendition file larger than 4GB in their browser from the Library Action Bar, Document Info Action bar, and Document All Actions menu.

Pause & Resume Uploads & Downloads with Vault File Manager

This feature allows users to pause and resume in progress uploads and downloads in the Vault File Manager application. Users can also sort files on the Uploading and Downloading tabs by the order in which they will be uploaded and downloaded.

Vault Loader

Vault Loader: Return Updated Roles in Success Log

With this release, when updating document roles using Vault Loader, the success log now contains the updated role IDs. *Auto-on with Vault Loader enabled

Vault Loader: Log Skipped Lines in Failure Log

With this release, Vault Loader failure logs now include any input CSV lines that were skipped due to errors. *Auto-on with Vault Loader enabled

Vault Loader: Disabling Workflow System Objects from Load or Extract Requests

With this release, the envelope__sys and envelope_content__sys system objects are no longer available for load or extract using Vault Loader. These objects drive the behavior of Vault workflows, and excluding them from Vault Loader ensures data integrity within these objects. *Auto-on with Vault Loader enabled

Vault Java SDK

Enhancements to Reference Lookups

With this feature, we’ve introduced a new Reference Lookup Type, Generic, which enables Administrators to configure lookups for mismatched data types. Additionally, the new Generic option provides support for any-to-any mapping for all single-value fields which were previously unsupported, such as Boolean. Multi-value fields such as multi-value picklists are not supported.

Object and Document Field Types for Integration Field Rules

This feature allows Vault Admins to configure the field type for an Object or Document Query Field in Field Rules. Additionally, developers can access this value in Vault Java SDK and use the value to create call-back VQL queries with the necessary VQL functions such as LONGTEXT(), RICHTEXT, and TONAME().

SDK Runtime Logs

This feature provides Vault Admins and developers runtime logging for SDK requests. Daily logs are available via the Vault UI and Vault REST API, and log entries include SDK exceptions and custom code usages of LogService. Vault Admins can configure the current log level as DISABLED, EXCEPTIONS (default), ERROR, WARN, and INFO. SDK Runtime Log entries are available 15 minutes after the request has completed and can be accessed for 30 days. Logging is limited to 10KB for Exceptions and 40KB for LogService entries.

Vault Tokens

This feature introduces a new component type, Vault token, and adds the new Vault Tokens permission type. Admins with the Vault Tokens: Create permission can configure up to ten (10) Vault-wide tokens using MDL. Learn more in the Vault Developer Portal.

Platform Data Model Changes

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

Added the Generic (generic__sys) value to the standard Reference Lookup Type picklist to support the Enhancements to Reference Lookups feature.
Added the Locked Document Count (locked_doc_count__sys) field to the EDL Item (edl_item__v) object to support the EDLs: Configurable States for Document Version Locking feature.
Added the Full Data File (full_data_file__sys) field and Full Data Export (full_data_export__sys) type to the Scheduled Data Exports (scheduled_data_export__sys) object to support the Scheduled Data Exports: Initial Full Data Export feature.
Added the Annotations (Permalinks) (annotations_permalink__v) document field to support the Annotate Usability Improvements feature.
Made the following changes to support the Workdays & Holidays feature:
- Added the Holiday Schedule (holiday_schedule__sys) object and its child object Holiday (holiday__sys)
- Added the Holiday Schedule (holiday_schedule__sys) reference field to the User object
Added Question Design Reference Document (question_design_reference_document__sys) as a child object of the Question Design object to support the Checklists: Add Reference Documents to Questions feature.
Activated the existing but inactive Section Dependency object type (section_dependency__sys) to support the Checklists: Dependent Sections feature.
Added the Bounce Reason (bounce_reason__sys) field to the Email (email__sys) object to support the Email to Vault: Create Records for Bounced Emails feature.

Vault Connections

PromoMats/RIM: Conditional Transfer Support Using Query Object Rules (QORs)

This feature supports Query Object Rules for RIM Vaults using the PromoMats/RIM Connection, adding the ability to filter out the documents and records transferred in an Integration Rule. Query Object Rules are already supported in PromoMats Vaults.

Clinical Operations

Milestone Roll Up Enhancements

This feature delivers improvements to Milestone Rollup behavior. When the Milestone Rollup Enhancements setting is enabled and Rollup (max) and/or Rollup (min) Milestone Dependencies are configured, Vault will reassess rolled-up dates when a previous Milestone’s date is set to null, updated, or a related Milestone Dependency is inactivated. This feature supports “First” and “Last” Site and Subject-related Milestones tracked in Vault Clinical.

Support to Identify Non-enrolling Sites

This feature identifies Sites that did not enroll any Subjects when the Enable Automated Enrollment Milestones setting is enabled, and the “No New Subjects” field is checked for a Site, allowing users to quickly inactivate Subject-related Milestones for the non-enrolling Sites with additional configuration.

Non-User Viewing of Documents in Surveys

This feature extends the Clinical capabilities on Checklists to allow non-users to view a Vault document in the context of completing a Checklist in Vault.

Restrict Doc Study to Single Value

This feature introduces a Vault-wide setting that prevents non-system-managed users from populating more than one Study on a document. Documents cannot be limited to a single Study if you have configured Vault for streamlined document reuse.

Automate Milestone State Changes: Additional Date Field Triggers

This feature introduces additional triggers that fire following the update of a milestone’s planned start, planned finish, and actual start dates; and which updates other milestone date fields, metrics, or state without relying on lifecycle actions.

CTMS/CDMS: Single Study Refresh

This feature adds support for re-syncing CTMS data under a single study. This feature replaces the “full refresh” functionality that was available via the “refresh inbound” action.

Site Document Exchange Section

This feature introduces a new section to the Study Site page layout that increases visibility into documents sent and received from Sites, condensing the five existing sections currently used to view this information into a single section.

Monitoring Schedule Planning

This feature allows for the triggered and ongoing creation of Monitoring Events in Vault CTMS based on updates to milestones in a CTMS Vault. This functionality automates the creation of future Monitoring Events and allows users to assess the timeliness of created monitoring visits. Vault can create monitoring Schedule Templates at a Study- or Study Country- level to define the expected schedule.

Site Payment Holdbacks

This feature extends support for Payments to allow for holdback and overhead tracking in the delivered application. Fees defined as holdback fees generate two payable items to track accrued costs and make the initial payment to the Site. A new system action allows updating holdback items in bulk at the Site-, Study Country-, or Study- level if the matching payment criteria are still valid.

Additional Site Payment Rules

This feature allows Vault Payments customers to add additional Payment Rules to their Fees. You can add Subject Status as a required criterion for a Visit or Procedure fee, and use Source Data Verification status as a criterion for a Visit fee.

Vault Payments Overhead

Vault Payments can now define whether Fee and Fee Templates should expect the addition of Overhead. If added, Vault Payments will calculate the Total Amount field value with the matching Overhead Percentage.

Transfer CSV Reports for TMF Transfer

This feature provides greater visibility into TMF Transfer activity on both the sending and receiving Vaults. Vault provides two CSV reports to each Agreement Transfer record to specify the Names and Global IDs of each transferred item:

Compare CSV compares the items that have been transferred from Source to Target over the life of the Agreement.
Transferred Items CSV shows the specific items transmitted by TMF Transfer as part of a specific transfer action.

TMF Bot : Auto-classification Customer Feedback (22R1)

This feature incorporates several changes derived from feedback received from customers, including changing auto-on models to .95 Prediction Confidence, and excluding Documents with null pages when training the auto-classification model.

Site Connect: Additional Vault Clinical Docs Support

This feature adds support to transfer the following new document artifacts via Veeva Site Connect.

IP Storage Condition Excursion Documentation
Additional Monitoring Activity
Trial Initiation Monitoring Report

Site Information on Documents

Site Connect customers can now see additional details regarding documents sent and received over Site Connect. A new Site Information section is available on documents to display the below items directly within the document metadata.

Sent to Site(s)
Initial Sent to Site(s) Date
Last Sent to Site(s) Date
Received from Site Date

Cancel Site Connect Agreement Invitation

This feature allows Site Connect customers to cancel Pending Site Connect Study Invitations, deactivating the invitation and canceling the workflow task in SiteVault.

Mark Site Connect document as Rescinded

With this feature, Site Connect customers can now take a Mark Rescinded user action on documents sent over Site Connect. Taking this action will update the Marked Rescinded by Sponsor/CRO field to Yes on the corresponding document in SiteVault.

Site Connect Details User Action

Site Connect customers can now access more details regarding a document’s distribution to Sites via a Site Connect Details user action. This action launches a dialog to display tracking information and the document’s comment history exchanged with a site.

Clinical Operations Model Changes

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

Added the following items to support Site Connect Enhancements:

New document section: Site Information (site_information__v)
New document fields:
- Sent to Site(s) (sent_to_sites__v)
- Initial Sent to Site Date (initial_sent_to_sites_date__v)
- Last Sent to Site Date (last_sent_to_sites_date__v)
- Received from Site Date (received_from_site_date__v)
New field on Distribution Task: Originating User (originating_user__v)
New message template: Received from SiteVault (received_from_sitevault__v)

The following changes were made to improve configurability of Clinical Operations Vaults:

System managed field value (read-only) setting is now editable in the Name (name__v) field for the Employment Relationship (person_employment_relationship__clin) object
Maximum value setting is now editable for the following fields on these objects:
- Clinical User Task (clinical_user_task__clin)
  - Days Open (days_open__clin)
  - Days Implementing (days_implementing__clin)
  - Days Investigating (days_investigating__clin)
- Quality Issue (quality_issue__v)
  - Verdict Reason (verdict_reason__v)
  - QC Issue Comments (qc_issue_comments__v)
- Study Site (site__v)
  - Days to Greenlight (days_to_greenlight__v)
  - Days, Decision to Qualify (days_decision_to_qualify__clin)
  - Days, Identification to Fully Qualified (days_identification_to_fully_qualified__clin)
  - Days, Identification to Rejection (days_identification_to_rejection__clin)
  - Days, Identification to Selection (days_identification_to_selection__clin)
  - Days, Site to Complete Survey (days_site_to_complete_survey__clin)

Added the following items to support Monitoring Schedule Planning:

Monitoring Schedule Template (monitoring_schedule_template_v) object
Monitoring Schedule Template Items (monitoring_schedule_template_items__v) object
Monitoring Schedule (monitoring_schedule__v) object
Monitoring Schedule Items (monitoring_schedule_items__v) object
Monitoring Schedule Parameter (monitoring_schedule_parameter__v) picklist

Added the following items to support Site Payment Holdbacks:

Add Holdback Percentage (default_holdback_percentage__v) field on the Fee Schedule (fee_schedule__v) and Fee Schedule Template (fee_schedule_template__v) objects
Add Include Holdback (Y/N) (include_holdback__v) and Holdback Percentage (holdback_percentage__v) fields on the Fee (fee__v), Fee Template (fee_template__v), and Payee Override (payee_override__v) objects for Site Fee, Visit Fee, and Procedure Fee types
Add Holdback (Y/N) (holdback__v) field to the Payable Item (payable_item__v) object for Site Fee, Visit Fee, and Procedure Fee types

Added the following items to support Site Overhead Calculation:

Add Overhead Percentage (default_overhead_percentage__v) field to Fee Schedule Template (fee_schedule__v) and Fee Schedule Template (fee_schedule_template__v) objects
Add Include Overhead, Overhead Percentage, and Base Amount (fee_base_amount__v) fields on the Fee (fee__v) and Fee Template (fee_template__v) objects for Site Fee, Visit Fee, and Procedure Fee types

Added the following fields to the Fee (fee__v) and Fee Template (fee_template__v) objects to support Subject Payment Tracking Rules:

Subject Status (subject_status__v) field as a multi-select picklist
SDV Complete (Y/N) (sdv_complete__v) field
SDV Complete When SDV Required (Y/N) (sdv_complete_when_sdv_required__v) field

Commercial

Document Notifications: Support for “Based On” Relationship

This feature provides the ability to notify the Document Owner of a document that is related to a document via the “Based On” Relationship. Admins can configure the “Send Notification to Based On Content” action on a state entry action or user action. The action sends a notification to the owners of documents created from a source document via the Make A Copy action. Learn more about parent document notifications.

Modular Content Approval Document Enhancements

This feature expands the functionality and generation of the Content Module Approval Documents to support CJK languages, increase rich text formatting options, and support text background colors.

External Viewer: Number Of Views

This feature allows users to report on the number of views through an external viewer per document. Users can also report on which external viewer was used, such as which CRM Org or which Public Content Distribution channel, including SharePoint or Website. This assists marketing managers in understanding the effectiveness of content viewed through the external viewer. Learn more about the external viewer.

Medical Inquiry UI: Admin Page

The dedicated Medical Inquiry user interface was added to MedComms in 21R3. This feature updates the user interface configuration screen to provide a better user experience for Admins. The screen is used for both the initial setup of the user interface and ongoing maintenance. Admins can define the objects, fields, and user interface layout that medical inquiry users see.

Medical Inquiry UI: Case Contact Section

This feature adds a section to the Medical Inquiry user interface containing information on the Case Contact. If the contact already exists, Medical Inquiry users can modify the Case Contact record during the interaction. If the contact is new, users can capture and save their details as a new Case Contact record. This streamlines the process of capturing Case Contact details and collects all Case and Case Contact information in one place, rather than across multiple screens.

Allow Case Response Emails to be Deleted

Medical Inquiry allows users to respond to requests for medical information via email directly from MedComms. Vault stores this email content in the system as a referenceable, auditable record of what was sent to the contact. This feature allows users with the required permissions to permanently delete these records from the system.

Today, duplicate accounts in Veeva CRM can be merged together. This feature adds support to the standard integration between MedComms and Veeva CRM for sharing Medical Inquiry data to reflect this in MedComms, maintaining consistency across the two products.

Automated Image Rendition: Include Source Document Name

For Automated Image Rendition types, Admins now have the option to concatenate the document name with the rendition type. Vault applies the prepended name when creating the rendition, and the name is visible on downloads.

eCTD Binder Generation Failure Notifications

With this release, Vault provides more detailed notifications when eCTD binder generation failures occur due to insufficient permissions or other configuration related causes.

Commercial Data Model Changes

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

The following components were added to MedComms and PromoMats Vaults to support the External Viewer: Number Of Views feature:

Added object External Viewer Data (external_viewer_data__veeva__v)
Added job External Viewer Data Mining (jobsch_external_viewer_data_miner__v)

The following component was added to MedComms and PromoMats Vaults to support the Automated Image Rendition: Include Source Document Name feature:

Added flag Include Document Name to the Automated Image Rendition creation page

The following changes were made to MedComms Vaults to support the CRM Data Sharing: Support Merged CRM Accounts feature:

Made the following fields on the Merged Contact (merged_contact__v) object optional:
- Original Contact (original_contact__v)
- Merged Into Contact (merged_into_contact__v)

Quality

Send Email to Non-Vault Users

Organizations often need to send emails to internal and external recipients for various processes in QMS. With this release, customers can define distribution groups, notification templates, send emails and share documents for the following processes: Audits, Complaints, and Issue Escalation. This new functionality addresses several scenarios that organizations may encounter:

When an Audit report is completed, that report often needs to be sent to an external recipient, such as the supplier contact, as well as persons associated with the Audit or supplier.
In Complaint processes, customers often need to send correspondence letters and forms to the complainant or the reporter associated with the Complaint at various times during the Complaint lifecycle.
If a serious issue is encountered, such as a critical deviation, upper management external to Vault may need to be notified of the serious event.

In addition, when using this feature with Complaint records, the sender of the email will be notified if the email was not successfully delivered to the recipient’s email address. Learn more about configuring external notifications.

APQR/QMR

With this release, Vault QMS now supports management of APQR and QMR processes.

The APQR process is an annual evaluation of the quality standard of a drug product to determine the need for adjustments in drug product specifications, manufacturing, and control procedures. It is a collaborative effort to generate the final APQR report, which is a compilation of data from multiple data sources, the summarized results, and the recommendations from distinct SMEs.

The QMR process is very similar to the APQR process but does not require the generation of a final summary report, but does require the capturing of meeting notes, meeting attendees, and post-meeting action items.

Both of these processes share common challenges which include but are not limited to:

Data extraction and identification
Scheduling, reminder, and progress updates
Data and records which come from disparate systems
Involvement of many different inputs from various stakeholders

With the APQR/QMR feature, customers will now be able to:

Manage both the APQR and QMR process within QMS
Create APQR and QMR templates for known documents that need to be collected
Once those templates have been defined, APQR or QMR records can be created from the templates and provide a consistent starting point based on various scopes, such as Country, Product, or Facility
This feature is designed to work in conjunction with the Generate Document from Report feature, which allows reports to be defined to extract key data that already resides in QMS
Once all documents have been collected, an APQR Binder can be created from the APQR record and the Generate Merged PDF document action can then be leveraged to generate the final APQR report.

Generate Document from Report: Support for APQR Item & QMR Item Lifecycles

A large portion of the data that needs to be collected for APQR final reports and QMR presentations already resides in QMS. In previous releases, the process of extracting this data was highly manual and time-consuming.

With this release, the Generate Document from Report action allows users to run a report, export that report to a predefined export format, create a document, and then associate it to the APQR Item or QMR Item record with a single user action. This greatly reduces the number of user clicks and leverages the power of Vault Reporting to easily extract this data.

Recurrence Check: UI Enhancements

With this release, the Recurrence Check interface has been improved. Once potential recurrences are returned, the Comparison and Grid views have been enhanced to allow users to view related object data referenced by the record check for both the current record and the potential duplicate. Users can click on the Compare button which to compare related object data in an easily-accessible user interface.

Generate Merged PDF Document Action

As part of the APQR process, customers are often required to produce a final report which combines summary, recommendation, and detailed report documents into a single document. In previous releases, the creation of this single document was often done manually, outside of Vault.

With this release, users can upload the individual documents into an APQR Binder and, using the Generate Merged PDF Document action, all of the documents in the APQR Binder are merged together into a single document in their binder order. The resulting document is attached to the APQR Binder through the APQR Reports document relationship and can be reviewed and approved like any other Vault document.

If any document in the APQR Binder is revised, the action can be run again. The existing Final Report document and the relationship linking it to the binder will be up-versioned and the report will include the latest content.

Generate Document for Standard QMS Processes

This feature enhances the Generate Document actions to allow execution on additional processes within QMS, and can now be configured to allow a user to generate a document from a list of available document templates, formatted outputs, or reports. This is useful when a default document is typically utilized but a different template may need to be generated based on the Country or Product of the record. Learn more about using and configuring Quality Document Generation.

Standard Cycle Time Metrics: Audit Object & Quality Event Custom Object Type Support

With this release, Vault QMS extends the capability of Standard Cycle Time Metrics to include support for all custom Quality Event object types and to automatically capture the following cycle time metrics for all standard and custom Audit object types:

Cycle Time: Duration in number of days from initiation to completion of the Audit
Audit Preparation Cycle Time: Numbers of days an Audit record is in preparation prior to the Actual Start Date.
Audit Reporting/Response Cycle Time: Number of days from the Actual End Date until completion of all post-audit or inspection activities, such as reporting, finding issuance, response, or others
Planned vs. Actual Audit Start Delta: Number of days the Actual Start Date for the Audit is before (early) or after (late) the Scheduled Start Date
Planned vs. Actual Audit Duration Delta: Actual duration of the Audit (Actual Start Date to Actual End Date) compared to planned duration (Scheduled Start Date to Scheduled End Date)

Learn more about standard cycle time metrics.

Curriculum View On Learner Homepage

Training Assignments on the Learner Homepage can now be grouped by Curriculum allowing Learners to prioritize training by Curriculum. When grouped, each Curriculum is represented as a card. The Curriculum card shows the number of Training Assignments assigned, Curriculum description, and other helpful information for Learners. From a Curriculum card, a user can navigate to a curriculum details page, which shows all Training Assignments assigned in the Curriculum, allowing the Learner to focus on a targeted list of Training Assignments. Learn more about the Learner Homepage.

Admin Alerts: Training Materials, Prerequisite Rules, & Substitute Rules

Admin Alerts inform the Training Administrator when they are about to make a change to a Training Requirement that could impact Learners’ Training Assignments. This feature explains what the impact of a change will be and how many users could be impacted. This set of auto-on alerts appear when changing Training Materials or modifying Prerequisite or Substitute rule configurations. For Training Materials, the feature also allows the Admin to adjust the settings that control impact directly from the warning message.

Admin Alerts: Quiz & Recurrence

Initial Training Due Date

This feature allows an Admin to set a duration for initial training that is different from the general duration. This means that new hires or new transfers receiving this training for the first time can have due dates that are different from a Learner who has received this training before. Learners who have received this training before (for example, those receiving the assignment via recurrence) will be given assignments with the default due date. Learn more about configuring initial training due dates.

Training Jobs: New Jobs to Process Training Assignments

This feature optimizes the performance of the Update Training Assignment job by introducing child jobs that perform the following functions alongside the parent Vault Training job:

Transition the state of Training Assignments to the target state
Cancel all Training Assignments for a Person in the Ineligible state

The child jobs allow Vault Training to assign Training Assignment records quickly and efficiently. Status and logs for the child jobs are available in a new Training Job Status page available at Admin > Configuration > Training Job Status. In addition, Training Assignments created or updated after this release have the originating Vault Training job ID written to a new field for quick troubleshooting. Learn more about Vault Training automation.

The Update Training Assignments job will no longer add the Learner and Direct Manager, if none exist, to Sharing Settings for the most recent imported Training Assignment for a Learner or Training Requirement. This change improves the overall Update Training Assignment job performance.

Updates to Cancel Training Assignments Job

The Cancel Training Assignments job, which is executed from a document lifecycle’s Cancel Training Assignments entry action, now logs the following information:

Whether Training Assignments were cancelled
Training Assignments that were cancelled
Error information, if there was an error during the job execution

Training Requirement Impact Assessment: Optional Task Assignee

The Assign Task To input for the Create Training Requirement Impact Assessment and Retire or Assess Impact on Training Requirements document entry actions is now optional. This allows configuration of workflow task participants at the Training Requirement Impact Assessment object level.

Training Requirement Impact Assessment: Action to Re-evaluate Records

This feature provides the ability for a user to re-evaluate a Training Requirement Impact Assessment record in the event that the record cannot enter the Completed state. This allows a quick way to update the record, without requiring a configuration change.

Assignment Details Creation Allowed for Imported Records

Assignment Details, a child record of Training Assignment, can now be created for imported Training Assignments. This allows historical Training Assignments to have Assignment Details, enabling reporting on Curriculum and Learner Role for historical Training Assignments.

Training Materials: Prevent Duplicate Documents

With this release, Training Admins are prevented from adding the same document multiple times to the Training Materials for a Training Requirement, regardless of whether they are attempting to add different versions of the document.

This feature allows updates to be made to the Learner Application Role in Sharing Settings for Training Assignment, Assignment Details, and other Training object records. Learners can then be added to the Learner Application Role in Sharing Settings using the Vault API.

Prevent Duplicate Assignment Detail Records

This update prevents a user or Vault from creating duplicate Assignment Details records for a given Training Assignment. A duplicate Assignment Details record is considered the same Curriculum and Learner Role for a given Training Assignment.

HVO Migration Preparation: Field Configuration Limitations

In an upcoming release, Vault Training will migrate some objects’ Data Store setting to High Volume. To prepare for this, the following fields can no longer be created on the Training Assignment or Assignment Details objects:

Field types that support field-level encryption
More than two (2) multi-value picklist fields

eMDR: Usability Enhancements

This Vault Product Surveillance feature allows Admins to add custom sections to the Adverse Event Report object page layout for the eMDR object type. It allows the users to view the information in the exact same format as it would be submitted to FDA by aggregating information from various objects and transforming it into the required format.

Quality Data Model Changes

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

The following changes were made to support the Admin Alerts: Quiz & Recurrence feature:

Impact Alert: Quiz and Impact Alert: Recurrence application control fields available for the Training Requirement object page layout selections.

The following changes were made to support the Initial Training Due Date feature:

Added the following fields to the Training Requirement object:
- Duration: Initial (initial_duration__v)
- Duration Unit: Initial (initial_duration_unit__v)

The following changes were made to support the Training Jobs: New Jobs to Process Training Assignments feature:

Added the following fields to the Training Assignment object:
- Training Job (training_job__v)
- Errors Encountered? (errors_encountered__v)
- Error Message (error_message__v)
- Training Job ID (training_job_id__v)

The following changes were made to support the Learner Homepage: Curriculum View feature:

Added the Learner Homepage Card Image (learner_homepage_card_image__v) field to the Curriculum object.

The following changes were made to support the Send Email to Non-Vault Users feature:

Added the External Notification Recipient ([object]_external_notification_recipient__v) objects with the following fields:
- Ext Notification Enabled Record (enr_enabled_record__v)
- Recipient (recipient__v)
- Distribution Group (distribution_group__v)
Added the Quality Event Sent Notification (quality_event_sent_notification__v) object with the following fields:
- Bounce Reason (bounce_reason__v)
- Distribution Group (distribution_group_recipients__v)
- Document Package (document_package__v)
- Email Message ID (email_message_id__v)
- Message ID (message_id__v)
- Message Template (message_template__v)
- Quality Event (en_enabled_record__v)
- Recipient (recipient__v)
- Reply To (reply_to)
- Role Recipients (role_recipients__v)
- Sent By User (sent_by_user__v)
- Sent Date (sent_date__v)
- Subject (subject__v)
Added the Quality Event Sent Notif Lifecycle (quality_event_sent_notif_lifecycle) with the following states:
- Delivered (delivered_state__v)
- Email Bounced (email_bounced_state__v)
- Inactive (inactive_state__v)
- Opened (opened_state__v)
- Sent (sent_state__v)
Added the Audit Sent Notification (audit_sent_notification__v) object with the following fields:
- Distribution Group (distribution_group_recipients__v)
- Document Package (document_package__v)
- Message Template (message_template__v)
- Audit (en_enabled_record__v)
- Recipient (recipient__v)
- Role Recipients (role_recipients__v)
- Sent By User (sent_by_user__v)
- Sent Date (sent_date__v)
Added the Audit Sent Notif Lifecycle (audit_sent_notif_lifecycle) with the following states:
- Sent (sent_state__v)
Added the Issue Escalation Sent Notification (issue_escalation_sent_notification__v) object with the following fields:
- Distribution Group (distribution_group_recipients__v)
- Document Package (document_package__v)
- Message Template (message_template__v)
- Issue Escalation (en_enabled_record__v)
- Recipient (recipient__v)
- Role Recipients (role_recipients__v)
- Sent By User (sent_by_user__v)
- Sent Date (sent_date__v)
Added the Issue Escalation Sent Notif Lifecycle (issue_escalation_sent_notif_lifecycle) with the following states:
- Sent (sent_state__v)
Added the Enable Reply To (enable_reply_to__v) field to the Person object.
Added the Reply To (reply_to__v) field to the following Quality Event object types: Complaint, MedTech Complaint.

The following changes were made to support the APQR/QMR feature:

Added the APQR Binder (apqr_binder__v) and Final Report (final_report__v) document types.
Added the following shared document fields:
- APQR (apqr__v)
- APQR Item (apqr_item__v)
- QMR (qmr__v)
- QMR Item (qmr_item__v)
Added the Management Review Template (content_template__v) object with the following fields:
- Country (country__v)
- Owning Facility (owning_facility__v)
- Product (product__v)
- QMR Scope (qmr_scope__v)
Added the Management Review Template Lifecycle with the following states:
- Initiated (initiated__v)
- In Approval (in_approval__v)
- Approved (approved__v)
- Retired (retired__v)
Added the Management Review Template Item (content_template_item__v) object with the following fields:
- Management Review Template (content_template__v)
- Document (document__v)
- Display Order (display_order__v)
Added the APQR (apqr__v) object with the following fields:
- Country (country__v)
- Owning Facility (owning_facility__v)
- Product (product__v)
- Management Review Template (content_template__v)
- Data Start Date (data_start_date__v)
- Data End Date (data_end_date__v)
- APQR Due Date (apqr_due_date__v)
- APQR Binder (apqr_binder__v)
Added the APQR Lifecycle with the following states:
- Approved (approved__v)
- Completed (completed__v)
- Data Preparation Completed (data_preparation_completed__v)
- In Approval (in_approval__v)
- In Data Preparation (in_data_preparation__v)
- Initiated (initiated__v)
Added the APQR Items (apqr_item__v) object with the following fields:
- APQR (apqr__v)
- Document (document__v)
- Display Order (display_order__v)
Added the APQR Item Lifecycle with the following states:
- Created (created__v)
- Initiated (created__v)
- In Progress (in_progress__v)
- Complete (complete__v)
Added the QMR Scope (qmr_scope__v) picklist.
Added the QMR (qmr__v) object with the following fields:
- QMR Scope (qmr_scope__v)
- Owning Facility (owning_facility__v)
- Data Start Date (data_start_date__v)
- Data End Date (data_end_date__v)
- QMR Due Date (qmr_due_date__v)
- Meeting Minutes (meeting_minutes__v)
- Meeting Agenda (meeting_agenda__v)
- QMR Presentation (qmr_presentation__v)
- Management Review Template (content_template__v)
Added the QMR Lifecycle (qmr_lifecycle__v) with the following states:
- Initiated (initiated__v)
- In Data Preparation (in_data_preparation__v)
- Data Preparation Completed (data_preparation_completed)
- In Approval (in_approval__v)
- Approved (approved__v)
- Meeting in Progress (meeting_in_progress__v)
- Completed (completed__v)
Added the QMR User Task (qmr_task__v) object with the following fields:
- QMR (qmr__v)
Added the QMR Item (qmr_item__v) object with the following fields:
- QMR (qmr__v)
- Document (document__v)
Added the QMR Item Lifecycle (qmr_item_lifecycle__v) with the following states:
- Created (created__v)
- Initiated (created__v)
- In Progress (in_progress__v)
- Complete (complete__v)
Added the Related QMR (related_qmr__v) field to the Quality Event object.

The following changes were made to support the High Volume Object Preparation: Field Configuration Limitations feature:

The following field configuration limitations now apply to Training Assignment and Assignment Details objects:
- Field types that support field-level encryption
- More than two (2) multi-value picklist fields

The following changes were made to support the Standard Cycle Time Metrics: Audit Object & Quality Event Custom Object Type Support feature:

Added the Audit Cycle Time Metric (audit_cycle_time_metric__v) object with the following fields:
- Audit (audit__v)
- Cycle Time Start Date (cycle_time_start_date__v)
- Scheduled Start Date (scheduled_start_date__v)
- Scheduled End Date (scheduled_end_date__v)
- Actual Start Date (actual_start_date__v)
- Actual End Date (actual_end_date__v)
- Cycle Time Stop Date (cycle_time_stop_date__v)
- Cycle Time (cycle_time__v)
- Audit Preparation Cycle Time (audit_preparation_cycle_time__v)
- Audit Reporting/Response Cycle Time (audit_reporting_response_cycle_time__v)
- Planned vs. Actual Audit Start Delta (planned_actual_audit_start_delta__v)
- Planned vs. Actual Audit Duration Delta (planned_actual_audit_duration_delta__v)
Added the Custom (custom__v) object type to the Quality Event Cycle Time Metric object.

Regulatory

Matched Document Ordering

This feature allows users to set a specific order for matched documents in the Content Plan hierarchy viewer when multiple documents are matched to a single Content Plan Item. By default, matched documents are sorted in ascending alphanumeric name order on a Content Plan Item when no specific order is set.

Users can also drag and drop documents to match to a specific matched document position under the Content Plan Item. Existing content plan actions including splitting, binder creation, copy content plan, and starting workflow from hierarchy viewer are also updated to utilize the matched document order.

Submission Wizard

A new wizard is available from the Application, Regulatory Objective, and Submission to simplify creation of Submissions, Regulatory Objectives, and their relationships as well as improve data consistency and integrity.

Users can select from a controlled list of relationships within the wizard, which are defined using new Application relationship objects to manage metadata at the application level. New options are available in the RIM Maintenance tab to extract and load a zip of loader sheets for suggested Application relationships based on the current set of Submission relationships in the Vault.

Global Content Plan

With this release, users can create and update a Content Plan directly from an Event record, where Vault generates a Global Submission and builds the Global Content Plan structure based on the Event’s Activities and other relationships. Users can also view the Global Content Plan directly from the Event or Activity, where viewing from the Activity filters the Global Content Plan based on the content relevant to the Activity. Once finalized, the Global Content Plan can be copied in bulk to multiple submissions using a new dispatch action.

Select Section in Add to Active Dossier Dialog

When adding a single document to Active Dossier in the Active Dossier Editor, users are now able to select and change the section in which to add the document via the Add to Active Dossier dialog.

Show Only Pending Toggle in Active Dossier Editor

With this release, a new toggle between ‘Show Only Pending’ and ‘Show All’ in the Active Dossier Editor allows users to quickly switch between viewing all Active Dossier Item Detail records and those with a Pending-type status, for example Pending Current.

Pull Objective Data Enhancements

With this release, the Pull Objective Data action can create Submission details with a mix of object types when the internal names of the object types on the source and target objects match. Pull Objective Data also adds the following details to Regulatory Objectives and Submissions: Authorizations such as certificates, Regulatory Text such as device trade names and descriptions, and Product Organizations such as authorised representatives. Support is also added for copying additional standard fields that were added to the data model in previous releases.

With this release, Create Related Records can create Regulatory Objective and Submission details with a mix of object types when the internal names of the object types on the source and target objects match. Create Related Records also adds the following details to Regulatory Objectives and Submissions: Authorizations such as certificates, Regulatory Text such as device trade names and descriptions, and Product Organizations such as authorised representatives. Support is also added for copying additional standard fields that were added to the data model in previous releases. Finally, Create Related Records will now always create relationships between the source Event and any resulting Submissions and Regulatory Objectives.

China XSD 1.0 eCTD Publishing & Validation

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

Asynchronous FDA Gateway Support

With this release, Admins can configure a Gateway profile for US FDA submissions to send the Mail Delivery Notification (MDN) asynchronously.

Resubmission of Previously Transmitted Submissions

With this release, users can resubmit submissions that were already sent to the Health Authority and a technical rejection was received.

Providing Additional Data in the Publishing Progress Indicator

With this release, additional information is added to the Publishing Progress Indictor’s download CSV to enable better understanding and troubleshooting of publishing-related issues.

Content Plan Creation & Copy Notification Token

A new token, ${templateConstraints}, is now supported for the Content Plan Creation and Copy notifications, providing end-users visibility into whether records were created as Inactive or Excluded due to template constraints.

Generic Token Support for Submission Pharmaceutical Form

With this release, content plans now support tokens for text and object reference fields within the Submission Pharmaceutical Form object.

RIM Data Model Changes

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

Added or updated the following components to support the Create Related Records Enhancements feature:

Added the Event Authorization (event_authorization__v) object with the following object types:
- Device Certificate (device_certificate__v)
- Device Listing (device_listing__v)
- Device Premarket Submission (device_premarket_submission__v)
Added the following components to the Event Site Organization (event_site_organization__v) object:
- Fields:
  - Product (product__v)
  - Make Contact Details Public (make_contact_details_public__v)
- Object Types:
  - Product Organization (product_organization__v)
  - Site Organization (site_organization__v)
Added the following components to the Event Product Characteristic (event_product_characteristic__v) object:
- Fields:
  - Administers or Removes Medicinal Product (administers_or_removes_medicinal_product__v)
  - Clinical Size (clinical_size__v)
  - Companion Diagnostic (companion_diagnostic__v)
  - Device is a Combination Product (device_is_a_combination_product__v)
  - Device is a Kit (device_is_a_kit__v)
  - Device Model or Version (device_model_or_version__v)
  - Device Name (device_name__v)
  - Exempt from Direct Marking (exempt_from_direct_marking__v)
  - Exempt from Premarket Submission (exempt_from_premarket_submission__v)
  - For Near-Patient Testing (for_nearpatient_testing__v)
  - For Patient Self-Testing (for_patient_selftesting__v)
  - For Professional Testing (for_professional_testing__v)
  - For Single-Use (for_singleuse__v)
  - Implantable IIb Exception (implantable_iib_exception__v)
  - Maximum Number of Reuses (maximum_number_of_reuses__v)
  - New Device According to EU IVDR (new_device_according_to_eu_ivdr__v)
  - Non-Medical Purpose (nonmedical_purpose__v)
  - Over the Counter (over_the_counter__v)
  - Prescription Use (prescription_use__v)
  - Product Information URL (product_information_url__v)
  - Production Identification Method (production_identification_method__v)
  - Reusable Surgical Instrument (reusable_surgical_instrument__v)
  - Special Device Type (special_device_type__v)
- Object Types:
  - Device Clinical Size (device_clinical_size__v)
  - Device Non-Medical Purpose (nonmedical_purpose__v)
  - Device Product Characteristics (device_product_characteristics__v)
  - Device Product Variant Characteristics (device_product_variant_characteristic__v)
  - Device Product Identification Method (dev`ice_production_identification_meth__v)
Updated the Event Product Characteristic (event_product_characteristic__v) object field Characteristic Value (characteristic_value__v) to allow configuration as a required field.
Added the following components to the Event Packaging Characteristic (event_packaging_characteristic__v) object:
- Fields:
  - Labeled as Not Made With Natural Latex (labeled_as_not_made_with_natural_latex__v)
  - MRI Safety Status (mri_safety_status__v)
  - Package Type (package_type__v)
  - Packaged as Sterile (packaged_as_sterile__v)
  - Reprocessed Single-Use Device (reprocessed_singleuse_device__v)
  - Requires Sterilization Prior to Use (requires_sterilization_prior_to_use__v)
  - Smallest Saleable Unit (smallest_salable_unit__v)
  - Sterilization Method (sterilization_method__v)
- Object Types:
  - Packaged Device Characteristics (packaged_device_characteristics__v)
  - Packaged Device Sterilization Method (packaged_device_sterilization_method__v)
Updated the Event Packaging Characteristic (event_packaging_characteristic__v) object field Characteristic Value (characteristic_value__v) to allow configuration as a required field.
Added the Substance Classification (substance_classification__v) field to the Event Active Substance (event_active_substance__rim) object.
Added the Medical Device Type (medical_device_type__v) field to the Event Product (event_drug_product__rim) object.

Added the following components to support the Submission Wizard feature:

Objects:
- Application Active Substance (application_active_substance__v)
- Application Product (application_pharmaceutical_product__v)
- Application Inactive Ingredient (application_inactive_ingredient__v)
- Application Packaging (application_packaging__v)
- Application Clinical Study (application_clinical_study__v)
- Application Nonclinical Study (application_nonclinical_study__v)
- Application Contact (application_contact__v)
- Application Packaging Characteristic (application_packaging_characteristic__v)
- Application Product Characteristic (application_product_characteristic__v)
- Application Product Classification (application_product_classification__v)
- Application Site Contact (application_site_contact__v)
- Application Organization (application_site_organization__v)
- Application Site Role (application_site_role__v)
- Application Regulatory Text (application_regulatory_text__v)
- Application Shelf Life or Condition (application_shelf_life_storage__v)
- Application Authorization (application_authorization__v)
Added the Application Source (application_source__v) field to the following Submission join objects:
- Submission Active Substance (submission_active_substance__rim)
- Submission Product (submission_pharmaceutical_product__rim)
- Submission Inactive Ingredient (submission_inactive_ingredient__rim)
- Submission Packaging (submission_packaging__rim)
- Submission Indication (submission_indication__rim)
- Submission Clinical Study (submission_clinical_study__rim)
- Submission Nonclinical Study (submission_nonclinical_study__rim)
- Submission Contact (submission_contact__rim)
- Submission Packaging Characteristic (submission_packaging_characterisstic__v)
- Submission Product Characteristic (submission_product_characteristic__v)
- Submission Product Classification (submission_product_classification__v)
- Submission Site Contact (submission_site_contact__rim)
- Submission Organization (submission_site_organization__v)
- Submission Site Role (submission_site_role__v)
- Submission Regulatory Text (submission_regulatory_text__v)
- Submission Shelf Life or Condition (submission_shelf_life_storage__v)
- Submission Authorization (submission_authorization__v)
Added the Application Source (application_source__v) field to the following Regulatory Objective join objects:
- Regulatory Objective Active Substance (regulatory_objective_active_substance__v)
- Regulatory Objective Clinical Study (regulatory_objective_clinical_study__v)
- Regulatory Objective Inactive Ingredient (regulatory_objective_inactive_ingredient__v)
- Regulatory Objective Indication (regulatory_objective_indication__v)
- Regulatory Objective Nonclinical Study (regulatory_objective_nonclinical_study__v)
- Regulatory Objective Packaging (regulatory_objective_packaging__v)
- Regulatory Objective Product (regulatory_objective_drug_product__v)
- Regulatory Objective Regulatory Text (regulatory_objective_regulatory_text__v)
- Regulatory Objective ShelfLife Condition (regulatory_objective_shelf_life_storage__v)
- Regulatory Objective Site Contact (regulatory_objective_site_contact__v)
- Regulatory Objective Organization (regulatory_objective_site_organization__v)
- Regulatory Objective Site Role (regulatory_objective_site_role__v)
- Reg Objective Packaging Characteristic (reg_objective_packaging_characteristic__v)
- Reg Objective Product Characteristic (reg_objective_product_characteristic__v)
- Reg Objective Product Classification (reg_objective_product_classification__v)
- Regulatory Objective Authorization (regulatory_objective_authorization__v)
Added the Use for Content Planning (use_for_content_planning__v) field to the Application Pharmaceutical Form object (application_pharmaceutical_form__v) object
Added the Regulatory Objective Product (regulatory_objective_product__v) field to the Regulatory Objective Inactive Ingredient (regulatory_objective_inactive_ingredient__v) object
Added the Regulatory Objective Indication (regulatory_objective_indication__v) field to the Regulatory Objective Clinical Study (regulatory_objective_clinical_study__v) object
Unlocked the Object Type Mapping (object_type_mapping__v) object for all RIM applications.

The following component updates also support the Submission Wizard feature:

Updated the Application Country (application_country__rim) object per the below. Note: At the 22R1 General Release, the data model changes described will only be applied to Vaults where Relate Multiple Records is not already enabled. System managed naming will be enabled only in Vaults where Values must be unique is enabled on the Name. Additionally, Name value formats will not be set if one is already defined.
- Added object fields:
  - XML Country Code (xml_country_code__v)
  - Use for Content Planning (use_for_content_planning__v)
- Enabled the Relate Multiple Records object configuration option.
- Updated the Name (name__v) field to be system-managed (System manages field value configuration option) with Value Format set to {country_rimr.name_v}-{##}.
Updated the Application Indication (application_indication__rim) object per the below. Note: At the 22R1 General Release, the data model changes described will only be applied to Vaults where Relate Multiple Records is not already enabled. System managed naming will be enabled only in Vaults where Values must be unique is enabled on the Name. Additionally, Name value formats will not be set if one is already defined.
- Added object fields:
  - XML Indication (xml_indication__v)
  - Use for Content Planning (use_for_content_planning__v)
- Enabled the Relate Multiple Records object configuration option.
- Updated the Name (name__v) field to be system-managed (System manages field value configuration option) with Value Format set to {therapeutic_indication_rimr.name_v}-{##}.

Added the following components to support the Global Content Plan feature:

Added the Event Pharmaceutical Form (event_pharmaceutical_form__v) object
Added the Global Application (application__v.global_application__v) object type to the Application (application__v) object
Added the Global Submission (submission__v.global_submission__v) object type to the Submission (submission__v) object
Added the Submission Grouping (submission_grouping__v) field to the following objects:
- Activity (activity__rim)
- Country (country__v)
- Content Plan Item (edl_item__v)
Added the Use for Content Planning (use_for_content_planning__v) field to the following objects:
- Event Active Substance (event_active_substance__rim)
- Event Clinical Study (event_clinical_study__v)
- Event Indication (event_indication__rim)
- Event Product (event_drug_product__rim)
- Event Inactive Ingredient (event_inactive_ingredient__rim)
- Event Nonclinical Study (event_nonclinical_study__v)
Added the Event Source (event_source__v) field to the following objects:
- Submission Active Substance (submission_active_substance__rim)
- Submission Clinical Study (submission_clinical_study__rim)
- Submission Indication (submission_indication__rim)
- Submission Product (submission_pharmaceutical_product__rim)
- Submission Inactive Ingredient (submission_inactive_ingredient__rim)
- Submission Nonclinical Study (submission_nonclinical_study__rim)
- Submission Pharmaceutical Form (submission_pharmaceutical_form__v)
Added the following fields to the Event (event__rim) object:
- Global Content Plan (global_content_plan__v)
- Content Plan Template (content_plan_template__v)
- Global Application (global_application__v)
- Global Submission (global_submission__v)
- Event Complete Date (event_complete_date__v)
- Initial Dispatch Date (initial_dispatch_date__v)
- Last Dispatch Date (last_dispatch_date__v)
Added the following fields to the Content Plan Item Template (edl_item_template__v) object:
- Active Dossier Template (active_dossier_template__v)
- Exclude Match from Active Dossier (exclude_match_from_active_dossier__v)
Added the Event Indication (event_indication__v) field to the Event Clinical Study(event_clinical_study__v) object
Added the Event Product (event_product__v) field to the Event Inactive Ingredient(event_inactive_ingredient__rim) object

The below components were added or updated to support data model changes for RIM Vaults in 22R1:

If Common Application Countries (EU and GCC) do not exist, Country records for these countries will not be created by the Automatic creation of Application Country records RIM Setting.
Updated component security as follows:
- Contact (contact__rim) object field QPPV Code (qppv_code__v) values must be unique
- Shelf Life (shelf_life__rim) object fields Shelf Life Period (shelf_life_period__rim) and Shelf Life Unit of Measurement (shelf_life_unit_of_measurement__v) are required
- Hierarchical copy is allowed for the following object fields (relationships):
  - Application Country (application_country__rim) on the Application (application__rim) object
  - Application Regulatory Objective (application_regulatory_objective__v) on the Application (application__rim) and Regulatory Objective (regulatory_objective__v) objects
  - Submission Regulatory Objective (submission_regulatory_objective__v) on the Regulatory Objective (regulatory_objective__v) object
  - Submission Language (submission_language__rim) on the Submission (submission__rim) object
Increased the maximum number of characters on the following fields:
- XML Clinical Study Title (xml_nonclinical_study_title__v) increased to 1000 (Object: Submission Nonclinical Study (submission_nonclinical_study__rim))
- XML Nonclinical Study Title (xml_nonclinical_study_title__v) increased to 1000 (Object: Submission Nonclinical Study (submission_nonclinical_study__rim)
- External ID (external_id__v) increased from 50 to 60 (Object: Submission (submission__v))
- Description of Change (description_of_change__rim) increased from 200 to 1500 (Object: Regulatory Objective (regulatory_objective__rim))
- Related Change Control Number (related_change_control_number__rim) increased from 128 to 260 (Object: Event (event__rim))
- Invented Name (invented_name__rim) increased to 250 (Object: Registration (registration__rim))
Added the following fields to the Registration (registration__rim) object:
- Expiration Date (expiration_date__v)
- Renewal Due Date (renewal_due_date__v)
- Sunset Clause Date (sunset_clause_date__v)
The Registration (registration__rim) object rimobjectconfiguraton is updated to allow the following fields to be editable within the Manage Registered Details wizard:
- Expiration Date (expiration_date__v)
- Renewal Due Date (renewal_due_date__v)
- Sunset Clause Date (sunset_clause_date__v)
Added the Full Commitment Text (full_commitment_text__v) field to the Commitment (commitment__rim) object.
Added the following fields to the Health Authority Question (health_authority_question__rim) object:
- Full Question (full_question__v)
- Full Response (full_response__v)
- Product (drug_product__rim)
Added the Report Component Type (report_component_type__v) picklist with picklist values:
- Legacy Study Report (legacy_study_report__c)
- Synopsis (synopsis__c)
- Study Report Body (study_report_body__c)
- Protocol or Amendment (protocol_or_amendment__c)
- Sample Case Report Form (sample_case_report_form__c)
- IEC IRB Consent Form List (iec_irb_consent_form_list__c)
- List Description Investigator Site (list_description_investigator_site__c)
- Signatures Investigators (signatures_investigators__c)
- List Patients with Batches (list_patients_with_batches__c)
- Randomsation Scheme (randomisation_scheme__c)
- Audit Certificates Report (audit_certificates_report__c)
- Statistical Methods Interim Analysis Plan (statistical_methods_interim_analysis_pla__c)
- Inter-Laboratory Standardisation Methods Quality Assurance (interlaboratory_standardisation_methods__c)
- Publications Based on Study (publications_based_on_study__c)
- Publications Referenced in Report (publications_referenced_in_report__c)
- Discontinued Patients (discontinued_patients__c)
- Protocol Deviations (protocol_deviations__c)
- Patients Excluded from Efficacy Analysis (patients_excluded_from_efficacy_analysis__c)
- Demographic Data (demographic_data__c)
- Compliance and Drug Concentration Data (compliance_and_drug_concentration_data__c)
- Individual Efficacy Response Data (individual_efficacy_response_data__c)
- Listing Individual Laboratory Measurements by Patient (listing_individual_laboratory_measuremen__c)
- Case Report Forms (case_report_forms__c)

Safety

Safety features are targeted for tentative availability on February 16, 2022.

Automated Case Promotion to Initial and Follow-Up Case Configuration

Vault Safety now supports automated Inbox Item promotion to an Initial or Follow-Up Case for E2B transmissions received via AS2 Gateway from external systems that have their own case processing workflows. The system verifies whether Case promotion is valid, leverages Case Identifier matching, and has selectable merging methods based on seriousness.

Learn More

Enablement: Enable Automated Case Promotion
Admin Help: Configure the Case Promotion Settings Page
User Help: Automated Case Promotion
Developer Documentation:
- Intake Inbox Item API Reference
- Intake JSON API Reference

Merge Inbox Item to In-Flight Case Admin Checkbox

Vault Safety now supports merging information received in Inbox Item into the latest Case version. When merged, source documents will also be added to the latest Case version. To facilitate parallel processing, Intake users can now alert the case processor that there is new case information by marking an Inbox Item as a follow-up to the latest case. Inbox Items marked as follow-up can either be merged into the latest Case version or can be used to create a Follow-Up Case.

Learn More

Enablement: Enable Merge to In-Flight Case
Admin Help: Configure the Case Promotion Settings Page
User Help: Merge to In-Flight Case

Promote to Multiple Cases Configuration

Vault Safety can now promote a single Inbox Item to up to 100 cases. The cases will be related and contain all the information from the Inbox Item, including source documents. This functionality is primarily intended for the intake of literature and legal cases. This feature is not supported for E2B imported Inbox Items.

Learn More

Enablement: Promote an Inbox Item to Multiple Cases
User Help: Promote to Multiple Cases

Follow-Up with Any Matching UID Configuration

Admins can now configure Vault Safety to allow Inbox Items to be promoted to a Follow-Up Case when the Worldwide UID does not match but matches another UID, such as an External System UID or a Case Identifier.

Learn More

Admin Help: Configure the Case Promotion Settings Page: Enable Duplicate Detection for Mismatching WWUID

Import Product Matching by Company Product Substance, Trade Name, and Alias Configuration

This release enhances product matching when importing Inbox Items or AERs from E2B and JSON files by supporting product generic names, trade names, product aliases, and substance aliases.

Learn More

Admin Help: Manage Products: Create Product and Substance Aliases
User Help: Inbox Item Study and Product Matching: E2B Import Study and Product Matching

Conditional Expectedness Configuration

This feature brings multiple enhancements to the configuration and evaluation of Datasheets for auto-expectedness. When configuring Datasheets, administrators can now specify seriousness criteria conditions, which define when a listed term is unexpected. Seriousness criteria can be configured at both the Datasheet and MedDRA Criteria (listed term) level. Admins can also now configure precise expectedness on Datasheets, which prevents the system from marking terms as unexpected if they are not listed on the Datasheet. Additionally, a new Expectedness MedDRA Criteria setting allows you to specify unexpected terms on a Datasheet.

Learn More

Enablement: Enable Conditional Expectedness
Admin Help: Manage Datasheets and Auto-Expectedness

Case Nullification Configuration

Vault Safety now supports the ability to void a case, including the option to nullify previous Transmissions using a configurable user action at the Case-level. You must specify a reason for nullification when you run the action, which will auto-populate in new system-generated transmission records related to the case. Additionally, upon initiating the voiding process, the system automatically cancels any in-progress workflows.

Learn More

Enablement: Enable Case Nullification
User Help:
- Case Processing Overview: Voiding
- Suppress, Nullify, or Amend a Safety Report: Void a Case

Case Validations: Control Workflow Transitions Configuration

Vault Safety can now calculate the worst validation result for a case and transmission to be used in entry criteria and prevent lifecycle state changes. The system will also prevent gateway submissions for any transmissions with Hard Failures.

Learn More

Enablement: Enable Control Workflow Transitions for Case Validations
User Help: Enter Case Data (Validation Status field)

MedDRA Hierarchy for CMQ and Vault Reporting Configuration

Admins can now download the full active MedDRA version from the central dictionary to your vault instead of uploading dictionary .zip files. Admins can also perform a deep copy of MedDRA queries and associated records, as well as update the MedDRA hierarchy with higher-level terms associated with all LLT terms in your vault.

Additionally, Vault Safety now supports creating Custom MedDRA Queries (CMQs) using any level of the MedDRA hierarchy (SOCs, HLGTs, HLTs, PTs, and LLTs). Previously, MedDRA Queries could only be constructed using LLTs. The MedDRA Queries with non-LLTs will be supported through standard Vault Reporting and Dashboarding.

Learn More

Enablement: Enable MedDRA Hierarchy Updates for CMQ and Vault Reporting
Admin Help:
- Manage the MedDRA Dictionary
- Use MedDRA Queries

This release includes enhancements to E2B generation for precise inclusion of age-related elements (B.1 / D.2) and medical confirmation by a health professional (A.1.14 / E.i.8). This change impacts all standard E2B(R2) and (R3) formats that Vault Safety generates. The following table describes the impacted data elements:

Element Name	E2B(R2)	E2B(R3)	Changes
Medically Confirmed by Healthcare Professional	A.1.14	E.i.8	Now only transmitted when the primary Reporter is not a health professional.
Patient Date of Birth	B.1.2.1	D.2.1	Now only transmitted when a full date is entered in the corresponding Vault Safety field (CCYYMMDD), except for PMDA where the Date of Birth is always masked if provided.
Date of Birth of Parent	B.1.10.2.1	D.10.2.1	Now only transmitted when a full date is entered in the corresponding Vault Safety field (CCYYMMDD).
Age at Time of Onset	B.1.2.2	D.2.2	Now only transmitted if the Date of Birth (D.2.1 / B.1.2.1) is not transmitted. For example, Date of Birth is partial or Masked.
Age Group	B.1.2.3	D.2.3	Now only transmitted when both the Patient Date of Birth (B.1.2.1 / D.2.1) and Age at Onset (B.1.2.2 / D.2.2) are not transmitted. For example, Date of Birth is partial or Masked.

Learn More

User Help: E2B Generation Data Mapping

E2B(R2) Enhancements Auto-on

This release includes the following E2B(R2) enhancements for all E2B(R2) report formats (ICH, FDA, HC):

When “Drug Not Administered” is selected for a Product Drug Role, include drug characterization with “Suspect” (B.4.k.1)
Importing and exporting the < safetyreportversion > tag
Collating seriousness from all Case Adverse Events when transmitting Case Seriousness criteria (A.1.5.2)
Masking E2B(R2) elements with “PRIVACY” for masked distributions

Learn More

Enablement: Enable Safety Report Version Customization
User Help:
- E2B Generation Data Mapping
- Generate Masked Safety Reports

E2B(R2) Partial Dates for Combination Product Expiration Date Support

Vault Safety now accepts partial dates in the Case Product “Expiration Date” field. For FDA E2B(R2) combination product reports, partial dates are exported to Expiration Date elements B.4.k.2.4.FDA.1a-b using the appropriate date format code.

Learn More

Enablement: Contact Veeva Support to enable this feature. Once enabled, an admin must replace the existing “Expiration Date” field with the new Expiration Date control on the Product and Case Product page layouts. Note: If you enable this feature, you must manually migrate any existing Expiration Date data after adding the new control.
User Help:
- Enter Case Data (Expiration Date field)
- E2B Generation Data Mapping

Reporter Masking for Post-Market Non-Literature Cases Admin Checkbox

Vault Safety provides a system-level setting to support masking reporter information in all outbound Submissions and Distribution for post-market non-literature Cases (E2B(R2), E2B(R3), CIOMS I, MedWatch3500A). If an admin enables this setting, reporter masking applies to all post-market non-literature Cases.

Learn More

Enablement: Enable Reporter Masking System Setting
User Help: Reporter Masking for Postmarket Non-Literature Cases

Transmission Product Types Configuration

This feature enables products to be registered as different product types in different markets. For example, a product may be registered as a combination product with the FDA, and a drug with the EMA. This feature is controlled by a new Transmission Product Type setting, which can be set on a Transmission or at the Product or Study Registration level by an admin.

One scenario this feature supports is omitting device constituents from combination product E2B Reports. Because certain jurisdictions do not accept combination product submissions, you can exclude Device-type product constituents from E2B files generated for Combination Product reports. Unless this feature is enabled, E2B files generated for a Combination Product Case continue to include both Device-type and Drug-type Product Constituents.

Learn More

Enablement: Exclude Device Constituents from E2B Exports: Prerequisites
Admin Help: Manage Combination Products: Exclude Device Constituents from E2B Exports
User Help: Create a Submission

Health Canada Transmission Profiles and Message Types Auto-on

Vault Safety now supports the Health Canada gateway for electronic submissions of clinical and post-market cases. A valid Health Canada E2B(R2) file with correct header information is also generated.

Learn More

Enablement: Configure Health Canada Gateway: Prerequisites
Admin Help: Configure Health Canada Gateway
User Help:
- E2B Generation Data Mapping: Health Canada
- Standard Agency ICSR Submissions: Health Canada

PHI Masking on Foreign Submissions Configuration

Vault Safety can now generate safety reports with PHI masking for Submissions. Masking can be configured at the reporting rule level to apply to all cases or only foreign cases.

Learn More

Enablement:
- To allow users to manually select masking for a Submission, an admin can add the “Patient Content Protection” and “Exceptions to Patient Content Protection” fields to the Submission Page Layout.
- To automatically apply masking with reporting rules, an admin can configure the Mask PII rule parameter.
Admin Help: Reporting Rule Parameter Reference
User Help:
- Create a Submission
- Generate Masked Safety Reports

Configurable Validation Criteria Configuration

Vault Safety now supports additional custom validation criteria using the standard validation criteria syntax, which will run as part of the Case validations. In addition, the Vault Safety validation engine now supports E2B(R2) formats.

Learn More

For assistance in configuring custom validation criteria, contact Veeva Services.

Safety Rule Version Management Admin Checkbox

Admins can now configure an Active Version of the system-provided standard rulesets. When new rules are introduced into a standard ruleset (for example, FDA, EMA, and PMDA) as part of a release, admins can set the rule version to allow for adoption of the most recent version of a standard ruleset on a configurable basis.

Learn More

Enablement: Manage Reporting Rule Versions: Prerequisites
Admin Help: Manage Reporting Rule Versions

Automated Cross Reporting Configuration

In this release, Vault Safety extends the evaluation of reporting obligations to include cross-reporting (investigational to marketing registration) scenarios. Vault Safety evaluates the investigational and marketing registrations of study products, then identifies any additional reporting destinations for products and studies. Administrators can also specify destination overrides on product licenses.

Learn More

Enablement: Enable Automated Cross Reporting
Admin Help:

Identifiable Patient Definition Ruleset Parameter Configuration

In this release, Vault Safety allows submission rules to evaluate the Identifiable Patient Definition ruleset parameter to determine whether or not a case contains an Identifiable Patient as defined by E2D (ICH standard), or less strict “Patient Known to Exists” - a newly introduced case field. This allows greater specificity in submission to health authority and partners with less strict definitions of patient (i.e. FDA) while minimizing the potential for over reporting to destinations that have more strict definitions of patient (i.e. EMA).

Learn More

Enablement: To leverage the “Patient Known to Exist” field, an admin can add the field to the Case and Imported Case page layouts.
Admin Help: Reporting Rule Parameter Reference
User Help: Enter Case Data (Patient Known to Exist field)

Bulk Unblind Configuration

Vault Safety can now bulk unblind multiple cases in a given study. This includes both the removal of blind protection for previously unblinded cases and snapshotting study arm product information for blinded cases. Cases currently in workflow will not be modified by this action.

Learn More

Enablement: Enable Bulk Unblind
Admin Help: Bulk Unblind a Study

Organized Data Collection of Reports from Patient Support Programs and Market Research Programs Configuration

Vault Safety now supports organized data collection of reports from PSPs (Patient Support Programs) and MRPs (Market Research Programs). Admins can create Study placeholders for Studies with unspecified products and intake users can select Company Products as Suspect Products. Upon case promotion, reporting obligations are evaluated using Product Registrations for the suspect Company Products.

Learn More

Enablement: Enable Organized Data Collection
Admin Help: Create a Study with Unspecified Products

SiteVault

User Administration with Multiple Security Policies

For SiteVaults that have more than one active security policy (for example, basic Vault authentication and a single sign-on provider), this feature allows the user administrator to select a security policy when creating or editing a user. This feature only pertains to vaults with multiple security policies and the Extensible SiteVault Permissions feature enabled.

Support eConsent Simple Signatures

This feature adds support to enable study participants and other signatories to complete eConsent forms without creating a MyVeeva for Patients account. In SiteVault, site staff can send eConsent forms without required contact information. This feature is tentatively scheduled to be generally available with the Vault 22R1 release.

Veeva eConsent: Additional Signatory Enhancements

This feature includes general enhancements to the Veeva eConsent Additional Signatories feature, including making it even easier to create and manage Signatory records and providing users more flexibility in sending eConsent forms to signatories.

Veeva eConsent: Contact Information Update Request

With this feature, when a patient or signatory on a study updates their contact information in MyVeeva for Patients, their contact information is also updated in SiteVault. Site Administrator users receive a notification that alerts them to the changes. This feature is tentatively scheduled to be generally available with the Vault 22R1 release.

Connected Study Details User Action

SiteVault users working on Connected Studies can now use the Connected Study Details user action to access more details regarding a document’s exchange with a Sponsor/CRO. This action opens a dialog box that displays tracking information as well as the document comment history with the Sponsor/CRO.

Sponsor/CRO Information on Documents

With this feature, SiteVault users working on Connected Studies can now see details regarding whether a document version has been sent to Sponsor/CRO, the date it was initially sent, and the last sent date directly in the document’s metadata.

New Exchangeable Document Type on Connected Studies

This feature adds support to transfer documents of type IP Excursions to a Sponsor/CRO’s vault for a Connected Study.

SiteVault Data Model Changes

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

Added the User Account Login Method (user_account_login_method__v) and User Account Federated ID (user_account_federated_id__v) fields to the User (person__sys) object to support the User Administration with Multiple Security Policies feature
Added the Middle Name (middle_name__v) field to the Signatory (signatory__v) object to support the Veeva eConsent: Additional Signatory Enhancements feature
Added the Patient Update Request (patient_update_request__v) and Signatory Update Request (signatory_update_request__v) objects to support the Veeva eConsent: Contact Information Update Request feature
Added the following document fields to support the Sponsor/CRO Information on Documents feature:
- Last Sent to Sponsor/CRO Date (last_sent_to_sponsor_date__v)
- Received from Sponsor/CRO Date (received_from_sponsor_date__v)
- Sent to Sponsor/CRO (sent_to_sponsor__v)

In addition to the changes supporting new features, we added or updated the following components:

Added the Originating User (originating_user__v) field to the Distribution Task (distribution_task__v) object
Updated the Research Organization (research_organization__v) and Site (research_site__v) fields on the User Access Assignment (user_access_assignment__v) object to lookup fields
If not already granted, all permission sets for the Study Team security profile are updated to grant Read permissions to the User (sys) (user__sys) object
If not already enabled, the Use Action Security to Control Sharing Settings option is enabled for the Participant (subject__v) object
If not already granted, view access to the Patients (patient__c) tab is added to the eConsent permission set
Added the following permission sets to the Research Organization Administrator (org_admin__c) and Regulatory (regulatory__c) security profiles:
- Budgets & Contracts (budgets_contracts__c)
- Objects: Create & Edit Profile Data (objects_create_edit_profile_data__c)
- Patients & Recruiting (patients_recruiting__c)
- If not already updated, the Veeva Admin (veeva_admin__c) tab is updated to the Admin (site_vault_admin__v) tab with the following subtabs:
  - Research Organizations (org__v)
  - Sites (research_site__v)
  - Users (sys) (user_sys__v)
  - User Role Setup (user_role_setup__v)
  - Access Assignments (access_type__v)
The default security on the Global ID (global_id__sys) document field on the Base Document (base_document__v) is updated to read-only
If present, updated the name of the following document atomic security components to remove the number 1:
- draft_to_current_draft1__c
- draft_to_current_received_from_spons1__c
- draft_to_final_draft1__c
- draft_to_final_received_from_spons1__c
- organization_profile_draft1__c
- person_profile_draft1__c
- organization_profile_received_from_spon1__c

QualityOne

External Collaboration Management on CAR

This feature allows internal users to manage the creation, activation, and inactivation of user accounts for third-party organizations. External Collaborators (third-party users) can respond to CARs (SCARs) in Vault using the External User license assigned. Internal users manage a “contact list” of persons associated with the third-party organizations, tagging CARs (SCARs) 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 CAR (SCAR) process. This feature enables Admins to utilize and configure a pool of shared External User licenses to facilitate this process using the External Collaborator User Template. Learn more about External Collaboration Management.

QualityOne Team Enhancements

This feature extends the QualityOne Team capability to allow Admins the flexibility of configuring Team roles and members. Learn more about QualityOne Teams.

Manage Invalid Users with Tasks

Admins can now control invalid users when managing QualityOne Teams. For a given Team, if any user in that Team is invalid, users can choose to remove the invalid user from the team or to replace them with an alternative, valid user. When invalid users are replaced, Vault automatically handles task reassignment by moving open tasks assigned to the replaced user.

Role Restriction & Child Object Team Enablement

Admins can now restrict a team member to a particular role, similar to a workflow’s participant group role restriction. . Team Roles are restricted by declaring the role as Exclusive: if a user is a team member of an exclusive Team Role, that user cannot also be a member of any other role for that record. Additionally, Admins can now create a Team on child objects.

Display Key Team Roles for Filtering & Reporting

Users can now surface key Team Role assignments as User fields, displaying and using the key in related lists, searches, filters on library views, and reports, allowing team membership changes to synchronize with the record’s field.

COA Ingestion Enhancements

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

Additional Matching Options for Component Matching Variants

This feature adds additional matching options for Admins to choose from when defining a COA Component Matching Rule on a Component Matching Variant. The new COA Component Matching Rules are:

Contains
Starts With
Ends With

If a Component Matching Variant does not have a COA Component Matching Rule defined, Vault uses an Exact Match criteria when evaluating a Component Matching Rule’s validity.

Additional Matching Options for Matching Rule Variants

This feature adds additional matching options for Admins to choose from when defining a Variant Type on a Matching Rule Variant. The new Variant Types are:

Contains
Starts With
Ends With

Improved COA Analysis Job Logging

This feature allows Admins to access debugging information related to COA ingestion via a Job Log. The Job Logs can be accessed by navigating to Admin > Operations > Job Status. A summary of the ingestion analysis is provided in the Job Log to give Admins the necessary information needed to quickly triage and resolve COA ingestion-related issues.

Note: This feature is currently available only to early adopters. Contact your Customer Success Manager for more information.

Risk Management: Detectability Support for Qualitative & Quantitative Risk Matrices

This feature adds support for modeling Detectability as another axis of the Risk Matrix. Adding the Detectability axis supports assessment methodologies such as the FMEA (Failure Mode and Effects Analysis) Risk Assessment, which requires the Detectability attribute of an identified risk. QualityOne customers can create 3D risk matrices (Severity x Occurrence x Detectability) within their Vaults with this feature. Learn more about Risk Management.

Product Hierarchy Data Model Extension for Packaging & Materials

This feature provisions new objects (Packaging, Product-Packaging, Material, Material-Organization) in QualityOne to extend the standard product hierarchy data model. Customers can leverage Material-related ERP (Enterprise Resource Planning) data to use with QualityOne.

Inspections Compatibility with Extended Product Hierarchy Data Model

This feature updates QualityOne Inspection Management functionality to align with the newly-provisioned Material (material__v) object that supports the Extended Product Hierarchy Data Model.

Update View 5 Whys Analysis Action

This feature offers a new record action “View 5 Whys Analysis” to launch the 5 Whys diagram, replacing the original “View 5 Whys Analysis” user action. The “View 5 Whys Analysis” user action is renamed to “View 5 Whys Analysis (Legacy)” and is targeted for removal in a future release. Learn more about the new 5 Whys Analysis record action.

RegulatoryOne

RegulatoryOne features are targeted for tentative availability on February 22.

Formulation Questionnaires

Using checklists, this feature allows regulatory users to send targeted questionnaires, such as raw material questionnaires (RMQs), via email to contacts at external organizations, such as suppliers, and enables those contacts to respond securely via public access links (PALs) without logging into Vault. Learn more about Formulation Questionnaires.

Local Impact Assessment

This feature helps users assess whether a new Registration Item’s objective can be accomplished by amending an existing registration or if a new registration is needed. Vault uses Admin-defined Regulated Category Attribute Impacts to search active registrations and identify the records that match the Registration Item. Vault also indicates to users if the matched registrations need to be amended. Lastly, Vault starts the appropriate registration process based on the user’s selection of a registration. Learn more about Local Impact Assessments.

Create Dossier Binder

This feature gives users the ability to create a binder with a list of locked steady state expected documents for a requirement while maintaining the requirement hierarchy as a hierarchy of sections. Admins can configure the new Create Dossier Binder action on the Registration Item Requirement object to allow users to create Dossier Binders from a parent record. Learn more about Dossier Binders.

Generate Requirements for Registration Objective

This feature allows Admins to configure the Generate Requirements action on the Registration Objective, allowing users to generate requirements for a collection of Registration Items. This may be helpful when multiple products, such as shaded products, can be registered together through the submission of a single dossier. Learn more about generating requirements.

Registration Item Hierarchy Viewer

When configured, this feature allows users to view multiple related Registration Items in a hierarchical view. Users can identify related Registration Items and any dependencies between them all in one viewer, improving the user experience by limiting the need to navigate to multiple other pages. Learn more about the Registration Item Hierarchy Viewer.

Split Registration Items Enhancement: Recursion

This feature enhances the Split Registration Items feature and gives users the flexibility to view generated Registration Items in an output structure that preserves the hierarchical relationship between them in addition to viewing the records in a flat list. Customers can utilize the Registration Item Hierarchy Viewer to easily visualize the output when several multi-level records are generated from the Split Registration Items action on a Registration Item with a Split Rule linked to a recursive relational token. Learn more about configuring Split Registration Items.

Track Authority Questions

This feature unlocks the standard Regulatory Request object in Registration & Dossier Management Vaults, giving users the ability to track authority questions.

Enable Checklists in RegulatoryOne

This feature enables Checklists in all RegulatoryOne Vaults, including Veeva Claims.

Product Hierarchy Data Model Extension for Packaging

Consumer and cosmetic products often come inside product packaging that can form multilevel hierarchical relationships. With this release, we are expanding the shared standard product hierarchy data model to include product packaging data (Packaging, Product Packaging, and Packaging Composition objects) to reduce reliance on customization.

These data model changes are automatically included in RegulatoryOne, but Admins must make configuration changes to make them available.

Note this feature is also available for Veeva Claims.

Veeva Claims

Veeva Claims features are targeted for tentative availability on February 22.

Project Hierarchy Viewer

When configured, this feature enables users to navigate through a large data set of Claims and Local Adaptations within a project with ease. Users can filter the list of Claims and Local Adaptations in the project to narrow down their scope. Through a hierarchy navigator, users can jump easily between different levels of a Project. Users can view and add related sections for Claims and Local Adaptation objects while maintaining the context of the Project. Learn more about configuring the project hierarchy viewer.

Dynamic Deep Copy Project

This feature improves the speed of starting new Claims projects. When configured, this feature gives users control over the copy Project record behavior by allowing users to specify which related sections of Claim and Local Adaptation records they want to copy over to the new Project record. Learn more about configuring dynamic deep copy project.

Claims UX Enhancement

This feature enhances the UX for Claims users. The feature primarily enhances the search and list experience in the Selectively Create Claims dialog and the Generate Local Adaptations dialog.

Product Hierarchy Data Model Extension for Packaging

See: feature description.

Enable Checklists in RegulatoryOne

See: feature description.

Enablement Details

See the following explanations for enablement options:

Feature	Enablement	Application
Working with Documents
Caption Bookmark Exclusions	Configuration	Platform
Annotate Usability Improvements	Auto-on	Platform
Text Indexing and Combination Enhancements	N/A	Platform
Collaborative Authoring Troubleshooting Page	Auto-on	Platform
Google Drive Integration: Create New Document	Auto-on	Platform
Enhanced Bulk Document Update: Validation Behavior Changes	Auto-on	Platform
Legacy Feature Enablement Updates	Auto-on	Platform
EDLs: Configurable States for Document Version Locking	Configuration	Platform
Vault Objects
High Volume Object Multi-Value Picklist Field	Auto-on	Platform
Lifecycle & Workflow
Consistent Steps Across Workflows	Auto-on	Platform
Populate Object Reference Fields with Workflows & Lifecycles	Configuration	Platform
Enhanced Stages Chevron Card for Workflows	Auto-on	Platform
Show More on Tasks in Home Pages	Auto-on	Platform
Remove Default Task Link in Label	Configuration	Platform
Bulk Actions on Record Actions	N/A	Platform
Reporting & Dashboards
In Operator for Name Report Filters	Auto-on	Platform
Optional Prompts	Auto-on	Platform
Additional Document Field Support in Report	Auto-on	Platform
Usability & UI Updates
Breadcrumb Enhancements for Object Tabs	Auto-on	Platform
Notifications: View Full Content in Panel	Auto-on	Platform
Notifications: Email Burst Threshold	Configuration	Platform
Email to Vault: Create Records for Bounced Emails	Auto-on	Platform
Updated UI Style on Users & Groups Pages	Auto-on	Platform
Workflow Action Menu for Objects: Drop-Down Behavior Update	Auto-on	Platform
Rich Text/Long Text Pop-up Window Size Update	Auto-on	Platform
Auditing
Audit Trail Enhancements to Track Lookup Field Changes in Object Records	Auto-on	Platform
Administration
Scheduled Data Exports: Initial Full Data Export	Configuration	Platform
Scheduled Data Exports: Escaping Characters in CSV Output	Auto-on	Platform
Scheduled Data Exports: Including Inactive Document Fields by Default	Auto-on	Platform
Scheduled Data Exports: Increased Precision on Field Values	Auto-on	Platform
Scheduled Data Exports: Uploading CSV Files to S3 with Bucket Owner Full Control ACL	Auto-on	Platform
Object and Document Field Types for Integration Field Rules	Auto-on	Platform
Configuration Management
Configuration Management: Allow Outbound & Inbound Packages enabled by default on Align Vaults	Auto-on	Platform
Data VPK: Validate VQL in Dataset Filter	Auto-on	Platform
Access Control
Object Control Security	Configuration	Platform
Search
Expanded Search with Related Records	Configuration	Platform
Field Centric Strict Matching	Auto-on	Platform
Checklists
Checklists: Add Reference Documents to Questions	Configuration	Platform
Checklists: Dependent Sections	Configuration	Platform
Checklists: Hide Unseen Questions on Review Page	Auto-on	Platform
Auto Claims Linking
Auto Claims Linking: View Claim Details from Select Claims Dialog	Configuration	Platform
Auto Claims Linking: Ignore Superscript and Subscript Characters When Matching to Claims	N/A	Platform
Vault Formulas
Workdays & Holidays	Auto-on	Platform
RecordByLabel() Function in Expressions	Configuration	Platform
Significant Figures in Expressions	Auto-on	Platform
Vault File Manager
VFM Download Rendition Usability Enhancements	Auto-on	Platform
Pause & Resume Uploads & Downloads with Vault File Manager	Auto-on	Platform
Vault Loader
Vault Loader: Return Updated Roles in Success Log	Auto-on	Platform
Vault Loader: Log Skipped Lines in Failure Log	Auto-on	Platform
Vault Loader: Disabling Workflow System Objects from Load or Extract Requests	Auto-on	Platform
Vault Java SDK
Enhancements to Reference Lookups	Auto-on	Platform
Object and Document Field Types for Integration Field Rules	Auto-on	Platform
SDK Runtime Logs	Auto-on	Platform
Vault Tokens	Auto-on	Platform
Platform Data Model Changes	Auto-on	Platform
Vault Connections
PromoMats/RIM: Conditional Transfer Support Using Query Object Rules (QORs)	Configuration	Promomats<>RIM
Clinical Operations
Milestone Roll Up Enhancements	Admin Checkbox	CTMS, Site Connect, Study Startup, Vault Payments, eTMF
Support to Identify Non-enrolling Sites	Auto-on	CTMS
Non-User Viewing of Documents in Surveys	Configuration	Study Startup
Restrict Doc Study to Single Value	Admin Checkbox	CTMS, Clinical Operations - All, Site Connect, Study Startup, eTMF
Automate Milestone State Changes: Additional Date Field Triggers	Auto-on	CTMS, Clinical Operations - All, Study Startup, eTMF
Site Document Exchange Section	Admin Checkbox	Site Connect
Monitoring Schedule Planning	Configuration	CTMS
Site Payment Holdbacks	Configuration	Vault Payments
Subject Payment Tracking Rules	Configuration	Vault Payments
Site Overhead Calculations	Configuration	Vault Payments
Transfer CSV Reports for TMF Transfer	Auto-on	eTMF
TMF Bot - Auto-classification Customer Feedback (22R1)	Auto-on	eTMF
Site Connect: Additional Vault Clinical Docs Support	Configuration	Site Connect
Site Information on Documents	Configuration	Site Connect
Cancel Site Connect Agreement Invitation	Configuration	Site Connect
Mark Site Connect document as Rescinded	Configuration	Site Connect
Site Connect Details User Action	Configuration	Site Connect
Clinical Operations Data Model Changes	Auto-on	CTMS, Site Connect, Study Startup, Vault Payments, eTMF
Commercial
Document Notifications: Support for "Based On" Relationship	Configuration	PromoMats
Modular Content Approval Document Enhancements	Auto-on	PromoMats
External Viewer: Number Of Views	Configuration	MedComms, PromoMats
Medical Inquiry UI: Admin Page	Auto-on	MedComms
Medical Inquiry UI: Case Contact Section	Configuration	MedComms
Allow Case Response Emails to be Deleted	Configuration	MedComms
CRM Data Sharing: Support Merged CRM Accounts	Admin Checkbox	MedComms
Automated Image Rendition: Include Source Document Name	Configuration	PromoMats
eCTD Binder Generation Failure Notifications	Auto-on	PromoMats
Commercial Data Model Changes	Auto-on	MedComms, PromoMats
Quality
Send Email to Non-Vault Users	Configuration	QMS
APQR/QMR	Configuration	QMS
Generate Document from Report: Support for APQR Item & QMR Item Lifecycles	Configuration	QMS
Recurrence Check: UI Enhancements	Auto-on	QMS
Generate Merged PDF Document Action	Configuration	QMS
Generate Document for Standard QMS Processes	Configuration	QMS
Standard Cycle Time Metrics: Audit Object & Quality Event Custom Object Type Support	Configuration	QMS
Curriculum View on Learner Homepage	Auto-on	Training
Admin Alerts: Training Materials, Prerequisite Rules, & Substitute Rules	Auto-on	Training
Admin Alerts: Quiz & Recurrence	Configuration	Training
Initial Training Due Date	Configuration	Training
Training Jobs: New Jobs to Process Training Assignments	Auto-on	Training
Imported Training Assignments: Sharing Settings Not Updated	Auto-on	Training
Updates to Cancel Training Assignments Job	Auto-on	Training
Training Requirement Impact Assessment: Optional Task Assignee	Auto-on	Training
Training Requirement Impact Assessment: Action to Re-Evaluate Records	Configuration	Training
Assignment Details Creation Allowed for Imported Records	Auto-on	Training
Training Materials: Prevent Duplicate Documents	Auto-on	Training
Learner Application Role Updates in Sharing Settings	Auto-on	Training
Prevent Duplicate Assignment Detail Records	Auto-on	Training
HVO Migration Preparation: Field Configuration Limitations	Auto-on	Training
eMDR: Usability Enhancements	Configuration	Surveillance
Quality Data Model Changes	Auto-on	QMS, QualityDocs, Station Manager, Surveillance, Training
Regulatory
Matched Document Ordering	Auto-on	RIM Submissions
Submission Wizard	Configuration	RIM Submissions
Global Content Plan	Configuration	RIM Submissions
Select Section in Add to Active Dossier Dialog	Auto-on	RIM Submissions, RIM Submissions Archive
Show Only Pending Toggle in Active Dossier Editor	Auto-on	RIM Submissions, RIM Submissions Archive
Pull Objective Data Enhancements	Auto-on	RIM Registrations
Create Related Records Enhancements	Auto-on	RIM Registrations
China XSD 1.0 eCTD Publishing & Validation	Configuration	RIM Publishing
Asynchronous FDA Gateway Support	Configuration	RIM Publishing
Resubmission of Previously Transmitted Submissions	Configuration	RIM Publishing
Providing Additional Data in the Publishing Progress Indicator	Auto-on	RIM Publishing
Content Plan Creation & Copy Notification Token	Configuration	RIM Submissions, RIM Submissions Archive
Generic Token Support for Submission Pharmaceutical Form	Auto-on	RIM Submissions
22R1 RIM Data Model Changes	Auto-on	RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive
SiteVault
User Administration with Multiple Security Policies	Auto-on	SiteVault Enterprise, SiteVault Free
Support eConsent Simple Signatures	Auto-on	SiteVault Enterprise, SiteVault Free
Veeva eConsent: Additional Signatory Enhancements	Auto-on	SiteVault Enterprise, SiteVault Free
Veeva eConsent: Contact Information Update Request	Auto-on	SiteVault Enterprise, SiteVault Free
Connected Study Details User Action	Configuration	Site Connect, SiteVault Enterprise, SiteVault Free
Sponsor/CRO Information on Documents	Configuration	Site Connect, SiteVault Enterprise, SiteVault Free
New Exchangeable Document Type on Connected Studies	Configuration	Site Connect, SiteVault Enterprise, SiteVault Free
SiteVault Data Model Changes	Auto-on	Site Connect, SiteVault Enterprise, SiteVault Free
QualityOne
External Collaboration Management on CAR	Configuration	QualityOne
QualityOne Team Enhancements	Configuration	QualityOne
Manage Invalid Users with Tasks	Configuration	QualityOne
Role Restriction & Child Object Team Enablement	Configuration	QualityOne
Display Key Team Roles for Filtering & Reporting	Configuration	QualityOne
COA Ingestion Enhancements	Auto-on	QualityOne
Additional Matching Options for Component Matching Variants	Auto-on	QualityOne
Additional Matching Options for Matching Rule Variants	Auto-on	QualityOne
Improved COA Analysis Job Logging	Auto-on	QualityOne
Risk Management: Detectability Support for Qualitative & Quantitative Risk Matrices	Configuration	QualityOne
Product Hierarchy Data Model Extension for Packaging & Materials	Configuration	QualityOne
Inspections Compatibility with Extended Product Hierarchy Data Model	Configuration	QualityOne
Update View 5 Whys Analysis Action	Configuration	QualityOne
RegulatoryOne
Formulation Questionnaires	Configuration	RegulatoryOne Compliance Management
Local Impact Assessment	Configuration	RegulatoryOne Registration & Dossier Management
Create Dossier Binder	Configuration	RegulatoryOne Registration & Dossier Management
Generate Requirements for Registration Objective	Configuration	RegulatoryOne Registration & Dossier Management
Registration Item Hierarchy Viewer	Configuration	RegulatoryOne Registration & Dossier Management
Split Registration Items Enhancement: Recursion	Configuration	RegulatoryOne Registration & Dossier Management
Track Authority Questions	Configuration	RegulatoryOne Registration & Dossier Management
Enable Checklists in RegulatoryOne	Auto-on	RegulatoryOne Compliance Management, RegulatoryOne Registration & Dossier Management, RegulatoryOne Regulatory Documents
Product Hierarchy Data Model Extension for Packaging	Configuration	RegulatoryOne Compliance Management, RegulatoryOne Registration & Dossier Management, RegulatoryOne Regulatory Documents
Veeva Claims
Project Hierarchy Viewer	Configuration	Veeva Claims
Dynamic Deep Copy Project	Configuration	Veeva Claims
Claims UX Enhancement	Auto-on	Veeva Claims
Product Hierarchy Data Model Extension for Packaging	Configuration	Veeva Claims
Enable Checklists in RegulatoryOne	Auto-on	Veeva Claims

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.

Working with Documents

Caption Bookmark Exclusions

Annotate Usability Improvements

Text Indexing & Combination Enhancements

Collaborative Authoring Troubleshooting Page

Google Drive Integration: Create New Document

Enhanced Bulk Document Update: Validation Behavior Changes

Legacy Feature Enablement Updates

EDLs: Configurable States for Document Version Locking

Vault Objects

High Volume Object Multi-Value Picklist Field

Lifecycle & Workflow

Consistent Steps Across Workflows

Populate Object Reference Fields with Workflows & Lifecycles

Enhanced Stages Chevron Card for Workflows

Show More on Tasks in Home Pages

Remove Default Task Link in Label

Bulk Actions on Record Actions

Reporting & Dashboards

In Operator for Name Report Filters

Optional Prompts

Additional Document Field Support in Report

Usability & UI Updates

Breadcrumb Enhancements for Object Tabs

Notifications: View Full Content in Panel

Notifications: Email Burst Threshold

Email to Vault: Create Records for Bounced Emails

Updated UI Style on Users & Groups Pages

Workflow Action Menu for Documents: Drop-Down Behavior Update

Rich Text/Long Text Pop-up Window Size Update

Auditing

Audit Trail Enhancements to Track Lookup Field Changes in Object Records

Administration

Scheduled Data Exports: Initial Full Data Export

Scheduled Data Exports: Escaping characters in CSV Output

Scheduled Data Exports: Including Inactive Document Fields by Default

Scheduled Data Exports: Increased precision on field values

Scheduled Data Exports: Uploading CSV Files to S3 with Bucket Owner Full Control ACL

Object and Document Field Types for Integration Field Rules

Configuration Management

Configuration Management: Allow Outbound & Inbound Packages enabled by default on Align Vaults

Data VPK: Validate VQL in Dataset Filter

Access Control

Object Control Security

Search

Expanded Search with Related Records

Field Centric Strict Matching

Checklists

Checklists: Add Reference Documents to Questions

Checklists: Dependent Sections

Checklists: Hide Unseen Questions on Review Page

Auto Claims Linking

Auto Claims Linking: View Claim Details from Select Claims Dialog

Auto Claims Linking: Ignore Superscript & Subscript Characters When Matching to Claims

Vault Formulas

Workdays & Holidays

RecordByLabel() Function in Expressions

Significant Figures in Expressions

Vault File Manager

VFM Download Rendition Usability Enhancements

Pause & Resume Uploads & Downloads with Vault File Manager

Vault Loader

Vault Loader: Return Updated Roles in Success Log

Vault Loader: Log Skipped Lines in Failure Log

Vault Loader: Disabling Workflow System Objects from Load or Extract Requests

Vault Java SDK

Enhancements to Reference Lookups

Object and Document Field Types for Integration Field Rules

SDK Runtime Logs

Vault Tokens

Platform Data Model Changes

Vault Connections

PromoMats/RIM: Conditional Transfer Support Using Query Object Rules (QORs)

Clinical Operations

Milestone Roll Up Enhancements

Support to Identify Non-enrolling Sites

Non-User Viewing of Documents in Surveys

Restrict Doc Study to Single Value

Automate Milestone State Changes: Additional Date Field Triggers

CTMS/CDMS: Single Study Refresh

Import Product Matching by Company Product Substance, Trade Name, and Alias Configuration