Release Date: June 26, 2020

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

Lifecycle & Workflow

Additional Operators for Document Lifecycle State Entry Actions, User Actions & Entry Criteria

This feature adds new operators to help Admins configure conditional state entry actions, user actions, and entry criteria in document lifecycles. These operators are available for conditions based on Document Type, Subtype, or Classification:

  • The new is not equal to operator is available for conditions based on Document Type, Subtype, or Classification.
  • The new does not include operator is available for conditions based on Document Type, Subtype, or Classification, as well as all object reference fields.

Previously, with support for only is equal to and includes operators, Admins needed to list all Document Type, Subtype, or Classification rather than just the exceptions.

Atomic Security for Documents: Lifecycle User Actions

With this release, Admins have more granular control, based on lifecycle state and role, over who can perform specific lifecycle user actions like changing document state and starting a workflow. For example, the Editor role may be able to start the Review workflow, but not the Expedited Approval workflow. Previously, access to start workflows or change a state was all or nothing: roles either had access to all workflows or all state changes, or had access to none.

Immediately upon enabling Atomic Security for Documents: Lifecycle User Actions, there should be no changes to user access in your Vault. To make this possible, Vault performs the following migration actions:

  • For all configured user actions (previously controlled by Start Workflow and Change State permissions), Vault will set the State Behavior to Execute.
  • Vault will apply overrides to hide these actions for any role that did not include the controlling permission before enablement.
  • Vault will grant access to the new Multi-channel Actions permission for any roles which included Start Workflow permission.

Multi-Channel Actions Permission

In previous releases, access to certain Multichannel functionality was controlled by the Start Workflow permission. This feature introduces the new Multi-Channel Actions permission to control these actions:

  • Create Presentation
  • Send to CLM
  • Preview CLM

Administration

Default Profile Image for System User

System-owned Users such as System and Application Owner now appear with the Veeva “V” logo as a user image throughout Vault. This image will also appear in notification summary emails where a notification was sent from a System-owned User.

This feature was released in 20R1.3 without documentation.

Improvements for Long Running Jobs

Vault now clears out jobs that are stuck and do not make progress for three (3) days. Prior to this release, job instances would remain stalled in a Running state for 14 days before getting cleared out.

State Change Job Improvements

State change jobs on documents are enhanced to handle cases where there is an active workflow on the latest version of a document, and a prior Steady State document needs to change state. For example, expiring an Effective document when a newer draft is In Review. With this change, the workflow can continue on the newer version after the state change is executed on the prior version.

Working with Documents

Collaborative Authoring: Save to Vault Button Update

In the initial release of the Save to Vault feature, document owners and collaboration session starters would see a Check In button when viewing the document in Vault, with an additional option to Save to Vault in the Check In pop-up dialogue. With this release, we have made the interaction more consistent by making Save to Vault the primary button for all users, with a Check In option in a drop-down for users who have the ability to Check In. Learn more about using Using Collaborative Authoring with Microsoft Office.

Clinical Operations

Clinical Network: Rule Set Override

Rule Set Overrides allow users to constrain the set of documents transferred by the Veeva Clinical Network when an Agreement is made active. For example, the CRO may want to only send documents to the sponsor where the QA Check Completed field is set to Yes. Rule Overrides can be used to apply these constraints to any documents and records sent to the receiving Vault. Learn more about Rule Overrides.

Clinical Network: Simple Transfer

Simple Transfer provides Veeva Clinical Network users with the ability to transfer a set of study documents from the CRO to the Sponsor without requiring an extensive mapping operation. After establishing a connection between the two Vaults, the CRO can elect a study for transfer and send the approved TMF Reference Model 3.0 documents, the Study Country records, and the Study Site records to the Sponsor. Vault creates the documents as TMF Documents, a special new document type that decreases the amount of mapping required. Study Country and Study Site records are created without normal requirements. Learn more about Simple TMF Transfer.

Clinical Operations 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 Clinical Operations data model. These data model updates are automatically available on all Clinical Operations Vaults.

We have added the following components to support Simple Transfer:

  • TMF Document (tmf_document__v) document type
  • Simple Transfer Rule Set (simple_transfer_ruleset__v) field on the _Clinical Network Rule Set (_cdx_rule_set__v) object
  • Object Creation State (object_creation_state__v) field on the Clinical Network Rule (cdx_rule_v) object
  • Simple Transfer Study (simple_transfer__v) field on the following objects:
    • Study (study__v)
    • Study Country (study_country__v)
    • Study Site (site__v)
  • Added the following lifecycles:
    • TMF Exchange Document Lifecycle (tmf_exchange_document_lifecycle__v)
    • CDX Agreement (cdx_agreement_lifecycle__v)
    • CDX Issue Lifecycle (cdx_issue_lifecycle__v)
  • Added the following objects:
    • Agreement (cdx_agreement__v)
    • Agreement Activity Item (cdx_agreement_activity_item__v)
    • Clinical Network Connection User (cdx_connection_user__v)
    • Clinical Network Issue (cdx_issue__v)
    • Clinical Network Rule (cdx_rule__v)
    • _Clinical Network Rule Set (_cdx_rule_set__v)
    • Configuration Mapping (cdx_configuration_mapping__v)
    • Data Mapping (cdx_data_mapping__v)
    • Document Lifecycle State Mapping (cdx_data_mapping__v)
    • Document Type Sub-Rule (cdx_document_type_subrule__v)
    • Field Default (cdx_field_default__v)
    • Pending Scope Variable Value (cdx_pending_scope_variable_value__v)
    • Scope Variable (cdx_scope_variable__v)
    • Scope Variable Field Mapping (cdx_scope_variable field mapping__v)
    • Scope Variable Value (cdx_scope_variable_value__v)
  • New document fields:
    • Created by Clinical Network (created_by_clinical_network__v)
    • Level (level__v)
    • Source Artifact (source_artifact__v)
    • Source Create By (source_created_by__v)
    • Source Created Date (source_created_date__v)
    • Source Doc Type (source_doc_type__v)
    • Source Document Connection (source_document_connection__v)
    • Source Document Date (source_document_date__v)
    • Source Document Number (source_tmf_document_number__v)
    • Source Document Version (source_document_version__v)
    • Source Person (source_person__v)
    • Source Product (source_product__v)

We have added the following objects to support Rule Set Override:

  • Clinical Network Rule Override (cdx_rule_override__v)
  • Clinical Network Override Agreement (cdx_override_agreement__v)

We have added the following components to support Site Packages:

  • New objects:
    • Site Packages Definition (site_package_definition__v)
    • Site Package Document (site_package_document__v)
  • New fields on the Distribution Task (distribution_task__v) object:
    • Action (action__v)
    • CDX ID (cdx_id__v)
    • Complete (complete__v)
    • Completion Date (completion_date__v)
    • Cycle Time (Days) (cycle_time__v)
    • Delivery Method (delivery_method__v)
    • Document Type (doc_type_details__v)
    • Due Date (due_date__v)
    • Organization (organization__v)
    • Return Document Version (return_version__v)
    • Return Document Version (unbound) (return_version_unbound__v)
    • Source (source__v)
    • Source ID (source_id__v)

Commercial

This feature changes the enablement status of Manual Linking to Claims, a subset of the Auto Claims Linking feature, to Auto-on. To disable Manual Linking to Claims, you must contact Veeva Support. Learn more about Manual Linking to Claims.

This feature allows users with permission to preview and remove references from the References component by granting Preview: Execute and Remove: Execute permissions on Link Target: Object Action Permissions for all Standard Admin permission sets, including Business Administrator Actions, System Administrator Actions and Vault Owner Actions.

China CDN Replication Support

With this feature, Admins can configure which CRM Engage and CLM content for Chinese customers will be replicated to a China-hosted CDN, improving load times and overall performance. This Vault configuration will be used by a future CRM release.

Unified Medical Inquiry Case Intake Form

This feature introduces a single, unified form for the intake of medical inquiries in MedComms. This allows the user to enter details of the Case, Case Request and, if required, Case Response in one place, simplifying the data entry process and reducing the time it takes to create a medical inquiry. Learn more about the Case Intake Form.

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:

  • New shared document field Use China CDN (use_china_cdn__v)
  • New object field Use China CDN (use_china_cdn__v) on the Distribution (distribution__v) object

Quality

Classroom Training: Usability Enhancements

With this release, Classroom Training Assignments now have an associated auto-start workflow called View Classroom Training Assignment that provides easy access to the Classroom Training Assignment record for Learners. Once an Admin activates the View Classroom Training Assignment workflow, it is automatically started when a Classroom Training Assignment enters the Assigned state. Other enhancements to Classroom Training include:

  • In previous releases, when a Learner opened a Classroom Training Assignment record that was not yet part of a Class Roster, the Learner would see the object details page. With this release, the Learner now sees a task page.
  • When an Instructor changes a Classroom Training Assignment record’s state to Completed, the open Training Assignment workflow is automatically canceled with a configurable entry action.

Substitute Training

This feature enables Vault Training to assign an alternative, or substitute, Training Assignment to a Learner in place of a required Training Assignment using Training Admin-defined substitution rules. For example, suppose a Learner that speaks a locale-specific language is required to fulfill a Code of Conduct training requirement. A Training Admin can define a substitution rule such that the Learner is automatically assigned a substitute Training Assignment based on the Learner’s locale, Department, or Facility. When the Learner completes the substitute Training Assignment, the Learner automatically gets completion credit for the required Training Assignment.

The feature allows for the following:

  • Training Admins can mark a Training Requirement as a substitute. A Training Requirement marked in this way cannot be added to a Curriculum or have other attributes configured.
  • Training Admins can define Substitute Rules for a Training Requirement. Rules include duration, as in how long the rule is valid for, and conditions, which are based on Person, Learner Role, or Curriculum fields.
  • The Vault Training application will determine, via the nightly job and on the fly evaluation, the appropriate Training Assignment for the Learner based on the Training Requirement and its Substitute Rule definitions.

Learn more about Substitute Training Requirements.

MDCC: Banner Visibility Update

When a document is governed by a Multi-Document Change Control (MDCC), Vault displays a banner stating which Document Change Control record the document is currently governed under. With this release, Vault displays the banner to users with at least one of the Edit Document, Edit Fields, Annotate, or Version permissions. The banner is no longer displayed to users with only the Change State or Start Workflow permissions and none of the other four permissions.

Quality Data Model Changes

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

The following data model changes support the Classroom Training feature:

Added the View Classroom Training Assignment (view_classroom_training_assignment__v) workflow.

Updated the Training Assignment Lifecycle (training_assignment_lifecycle__v), adding the auto-start workflow View Classroom Training Assignment to entry actions for the Assigned state.

The following data model changes support the Substitute Training feature:

Added the following new objects:

  • Training Rule Set (training_rule_set__v)
  • Training Rule (training_rule__v)
  • Related Training Assignment (related_training_assignment__v)

Updated the following objects:

  • Training Requirement (training_requirement__v) updated with the following field:
    • Is a substitute Training Requirement (is_a_substitute_training_requirement__v)
  • Training Assignment (training_assignment__v) updated with the following field:
    • Creation Source (creation_source__v)

Added the following new object lifecycles:

  • Training Rule Set Lifecycle (training_rule_set_lifecycle__v)
  • Training Rule Lifecycle (training_rule_lifecycle__v)

Updated the Training Assignment Lifecycle (training_assignment_lifecycle__v) object lifecycle, adding the Pending Substitute Completion (pending_substitute_completion_state__v) state.

Relaxed many constraints around the editability of object and field attributes surrounding the QRM: Process FMEA Assessment Methodology Support feature:

  • For the QRM Risk Category (qrm_risk_category__v) object:
    • Lifecycle is now editable
    • Uniqueness enforcement, Maximum Length have been made editable for the field: Description
  • For the FMEA Risk Event (fmea_risk_event__v) object:
    • The ability to use object types has been made editable
    • The ability to use System Managed Naming has been made editable
    • Uniqueness enforcement has been made editable for the field: Scoring Matrix
    • Uniqueness enforcement has been made editable for the field: Process Step
    • Uniqueness enforcement, Requiredness, Maximum Length and Health Information attributes have been made editable for the field: FMEA Failure Mode
    • Uniqueness enforcement, Requiredness, Maximum Length and Health Information attributes have been made editable for the field: FMEA Failure Effect
    • Uniqueness enforcement, Requiredness, Maximum Length and Health Information attributes have been made editable for the field: FMEA Failure Cause
    • Uniqueness enforcement, Requiredness, Maximum Length and Health Information attributes have been made editable for the field: FMEA Failure Control
    • Uniqueness enforcement, Requiredness attributes have been made editable for the field: Risk Response
    • Uniqueness enforcement has been made editable for the field: Initial Severity
    • Uniqueness enforcement has been made editable for the field: Initial Occurrence
    • Uniqueness enforcement has been made editable for the field: Initial Detectability
    • Minimum Value, Maximum Value, decimal configuration attributes have been made editable for Initial RPN (initial_rpn_quantitative__v)
    • Uniqueness enforcement and Requiredness attributes have been made editable for Initial RPN (initial_rpn_qualitative__v)
    • Maximum Length has been made editable for the field: Initial RPN (initial_rpn__v)
    • Uniqueness enforcement, Requiredness attributes have been made editable for the field: Original FMEA Risk Event
  • For the FMEA Risk Event – QRM Risk Category (fmea_risk_event_qrm_risk_category__v) object
    • The ability to use System Managed Naming has been made editable
  • For the FMEA Risk Assessment (fmea_risk_assessment__v) object
    • The ability to use System Managed Naming has been made editable
    • Uniqueness enforcement, Requiredness and Maximum Length have been made editable for the field: Description
    • Uniqueness enforcement, Requiredness have been made editable for the field: Original FMEA Risk Assessment
    • Uniqueness enforcement, Requiredness have been made editable for the field: Business Process
    • Uniqueness enforcement, Requiredness have been made editable for the field: Assessment Scoring Matrix
  • For the Business Process (business_process__v) object
    • Uniqueness enforcement, Maximum Length have been made editable for the field: Description
  • For the FMEA Process Step (fmea_process_step__v) object
    • The ability to use System Managed Naming has been made editable
    • Uniqueness enforcement, Maximum Length have been made editable for the field: Description
    • Minimum & Maximum value, as well as decimal configurations have been made editable for the field: Step Order
  • For the FMEA Mitigation Action Set (fmea_mitigation_action_set__v) object
    • The ability to use System Managed Naming has been made editable
    • Uniqueness enforcement, Maximum Length have been made editable for the field: Description
    • Uniqueness enforcement, Requiredness have been made editable for the field: Original Mitigation Action Set

These changes are immediately available to Administrators, but otherwise do not affect the Vault’s function unless Admins make configuration changes.

Administrator visibility of the following components has been updated:

  • The Pending Change Control Approval State, In Change Control Approval State, and Change Control Approved State Document Lifecycle State Types are now visible in the Admin section of all Quality Vaults. These State Types are only meant for use with the Multi-Document Change Control feature in QualityDocs.
  • The Ready for Training Document Lifecycle State Type is now visible in admin in all Quality Vaults. This State Type is only meant for use with Vault Training.
  • The Recall Controlled Copies and CC: Set Change Control to Ready for Approval Entry Actions are now visible in the Admin section of all Quality Vaults. These Entry Actions will only run on QualityDocs Vaults.
  • The Update Station Document Entry Action is now visible in the Admin section of all Quality Vaults. This Entry Action will only run on Station Manager Vaults.
  • The Create Training Requirement Impact Assessment Record, Issue Training Assignments, and Retire or Assess Impact on Training Requirements Entry Actions are now visible in the Admin section of all Quality Vaults. These Entry Actions will only run on Vault Training Vaults.
  • The Download Controlled Copy User Action is now visible in the Admin section of all Quality Vaults. This User Action can only be used on QualityDocs Vaults where the Extensible Controlled Copies feature is enabled.
  • The Generate Controlled Copy User Action has been relabeled to Download Controlled Copy (Legacy) and is now visible in the Admin section of all Quality Vaults, except QualityDocs Vaults for which the Extensible Controlled Copies feature is enabled. This User Action can only be used on QualityDocs Vaults where the Extensible Controlled Copies feature is not enabled.
  • The Preview E-Learning Content and Set E-Learning Standard User Actions are now visible in the Admin section of all Quality Vaults. This User Action can only be used on Vault Training Vaults.

QualityOne

Automated Inspection of Certificate of Analysis

This feature allows users to upload a Certificate of Analysis file to a COA Inspection object which Vault analyzes to determine if the measurement values on the COA conform to Admin-configured specifications. The solution performs an OCR scan of the COA file and extracts characteristic parameters. The specifications show a comparison between the test result from the COA file and the inspection plan for the product. If all of the measurement results from the COA are within the specification limits, the COA is marked as passing the inspection. Users can manually adjust the results, if needed. Learn more about automated inspection of Certificate of Analysis.

MDCC: Banner Visibility Update

When a document is governed by a Multi-Document Change Control (MDCC), Vault displays a banner stating which Document Change Control record the document is currently governed under. With this release, Vault displays the banner to users with at least one of the Edit Document, Edit Fields, Annotate, or Version permissions. The banner is no longer displayed to users with only the Change State or Start Workflow permissions and none of the other four permissions.

Prevent Document Record Archival for Training Management

We enhanced QualityOne Training Management to account for archived documents so that documents associated with an active Training Assignment or Training Requirement cannot be archived.

This feature was released in 20R1.3.

Regulatory

Submission Import with Vault File Manager

This feature allows users in Submissions Archive Vaults to upload and import submission dossiers directly from Vault File Manager. Uploading with Vault File Manager simplifies the submission import process by eliminating the need to stage files on FTP or prepare ZIP files for import. Vault File Manager also allows users to upload and import ZIP files larger than 4 GB.

Users with the appropriate permissions can start the import process from a Submission record in Vault and select the Vault File Manager option in the Import Submission dialog. After selecting this option, Vault File Manager opens. In Vault File Manager, the user can upload the submission folder or ZIP/TAR.GZ file and track the upload progress. After the upload is complete, Vault automatically queues the files for import to the Submission record in Vault. Learn more about importing submission content with Vault File Manager.

20R2 Regulatory Data Model Updates

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

Added the following components to support the Submission Import from Vault File Manager feature:

  • Added new picklist values to the Dossier Status (dossier_status__v) picklist.
  • Added the Upload Package ID (_upload_package_id__v) field on _Submission (submission__v) object

Safety

Safety features are targeted for tentative availability on July 9, 2020.

MedDRA: Centralization Admin Checkbox

Vault Safety now hosts a centralized MedDRA dictionary that is managed and regularly updated twice a year by Veeva. This alleviates customers from their ongoing management of MedDRA. When a new dictionary version becomes available in the centralized repository, customers can choose when to transition to it.

Learn More: Manage the MedDRA Dictionary

Drug / Biologic Combination Products

Vault Safety now supports end-to-end case processing for post-marketing combination products. For combination products marketed in the US, an FDA-bound E2B (R2) Submission is generated, along with the new FDA regional E2B fields for combination products. Leverage these capabilities to remain compliant with the FDA’s PMSR requirements for combination products with or without device constituents (21 CFR Part 4), which take effect July 21, 2020.

Without Device Constituents

When a case concerning a combination product is opened, the system downloads its pre-configured constituents to the case and auto-generates Case Assessment records for them. Furthermore, Watchlists created for the Combination Product (such as AESI or IME) are applied to the case.

With Device Constituents Configuration

You can now enter additional device information during data entry, including device event problem codes, device evaluation codes, and remedial action information. The generated FDA-bound E2B (R2) Submission and the new FDA regional fields for combination products with device constituents include support for Malfunction (30-Day) and Public Health Risk (5-Day) reports.

Learn More:

DSUR Appendices (Cumulative SAR, Death Cases) and DSUR Masked Distributions Configuration

In this release, to facilitate both DSUR submissions to health authorities and distributions to partners/committees, customers will be able to generate both masked and unmasked versions of the Cumulative Tabulation of SAEs and Interval Line Listings.

Customers will also be able to generate Appendix R1 Cumulative Tabulation of SARs, and Appendix R2 List of Subjects Who Died During the Reporting Period.

Learn More: Create DSUR Aggregate Reports

XLSX Aggregate Report Templates Configuration

This release supports the use of .XLSX aggregate report table templates. This allows administrators to configure Vault Merge Fields tokens to display additional aggregate details (product family, date, etc.) on the generated Aggregate Line Listings and Cumulative reports.

Learn More: Configure Aggregate Report Templates

E2B R2 & R3 Validation Auto-on

This release contains various enhancements to inform users of validation errors when entering data and submitting E2B messages.

When a Submission E2B file is created, the system validates the XML schema and reports any errors so that the user can address validation errors before attempting to submit to the Health Authority. This feature includes support to validate the XML schema for EMA E2B (R3), FDA E2B (R2), FDA Combination Products, and Health Canada E2B (R2) files.

Vault Safety also validates specific nullFlavour values during data entry, as well as Value/Unit pair controls, and displays an icon for the invalid selections.

Learn More: Case and Submission Validation

Deprecated Controlled Vocabularies Configuration

Administrators can now deprecate non-system Controlled Vocabularies without impacting imports and Follow-Up Cases. Users will be unable to select Deprecated Controlled Vocabularies for new cases but will still be able to process older ones. This is particularly useful for migrated data.

Learn More: Configure Controlled Vocabularies: Deprecated Controlled Vocabularies

Copy Report Type and Receipt Date from AER Source Document Vault Metadata Auto-on

Report Type and Receipt Date can now be captured on documents and copied over to an AER when it is created from a document.

Learn More: Create an AER

E2B R2 Product Import Converter and Other E2B Enhancements Auto-on

When importing E2B (R2) files, Vault Safety now merges drug duplicates (B.4.k section) and creates a single Case Product, including all of its dosages and substances.

A drug is considered a duplicate when the following data points match:

  • Proprietary medicinal product name (B.4.k.2.1)
  • All active substance names (B.4.k.2.2)
  • The country where the drug was obtained (B.4.k.2.3)

The system sends a warning notification if conflicting information is found under drug duplicates.

Learn More: E2B Case Import Data Mapping

Duplicate Detection Enhancements Auto-on

Vault Safety now uses Study Arm and Site Reporter information for duplication detection. The system also returns potential matches for cases that have only one MRN field matching for Patient information. Additionally, the Potential Matches page now shows the Lifecycle state for the AER and potential matches to facilitate the review.

Learn More: Promote to Case: Overview of Duplicate Detection

Substances Configuration

Vault Safety can now track Substances and their use in individual products.

Natural Language Processing and Data Extraction for Patient Information

Safety.AI uses natural language processing and rule-based algorithms to automatically extract case information from unstructured data (text) sent through the API. This feature adds support to extract the Patient age unit, Date of Birth, and Date of Death.

AI Suggestion Generation

When Safety.AI infers case data from indirect mentions in the source text and make suggestions for the user to consider during data verification. Safety.AI clearly identifies suggestions in the user interface, along with their confidence level and rationale to make verification easy.

The system can make suggestions for the Patient Gender, and Event Country fields if the data cannot be directly extracted from the intake source. For example, if the event country is not stated but the text includes the reporter’s country, the system infers the reporter’s country may be the event country and makes a suggestion based on that data.

Simple Conflict Resolution

To make data verification easier, Safety.AI shows the confidence score for values extracted from the source text. This feature helps reduce the effort to resolve information conflicts when multiple potential values were inferred from the source text by showing the options ranked with the highest confidence score first.

Safety.AI automatically populates high confidence level predictions, while medium confidence level data is available in a drop-down menu.

Veeva Claims

Pack Copy Management

This key module introduces the ability for brand marketers to manage all packaging label content (such as claims, ingredients, logos, manufacturer addresses, usage instructions) in a structured format. Brand marketers can create pack copies organized by packaging levels (such as primary, secondary) and panels (such as front, back, top, bottom).

Note that Veeva Claims features are targeted for tentative availability on July 7th.

SiteVault Enterprise

Site Packages: SiteVault

This feature enables site users to receive and respond to regulatory document requests directly in SiteVault when working with Sponsors and CROs who are using Vault Site Connect.

Enablement Details

Name Enablement Application
Lifecycle & Workflow
Additional Operators for Document Lifecycle State Entry Actions, User Actions & Entry Criteria Configuration Platform
Atomic Security for Documents: Lifecycle User Actions Support Platform
Administration
Default Profile Image for System User Auto-on Platform
Improvements for Long Running Jobs Auto-on Platform
State Change Job Improvements Auto-on Platform
Working with Documents
Collaborative Authoring: Save to Vault Button Update Auto-on Platform
Clinical Operations
Clinical Network: Rule Set Override Auto-on Veeva Clinical Network
Clinical Network: Simple Transfer Configuration Veeva Clinical Network, eTMF
Clinical Operations Data Model Changes Auto-on CTMS, Study Startup, Vault Payments, eTMF
Commercial
Auto Claims Linking: Change Enablement of Manual Link to Claims to On by Default Auto-on PromoMats
Auto Claims Linking: Link Target Custom Actions Configuration PromoMats
China CDN Replication Support Configuration MedComms, PromoMats
Unified Medical Inquiry Case Intake Form Configuration1 MedComms
Commercial Data Model Changes Auto-on MedComms, PromoMats
Quality
Classroom Training: Usability Enhancements Configuration Training
Substitute Training Configuration Training
MDCC: Banner Visibility Update Auto-on QualityDocs
Quality Data Model Changes Auto-on QMS, QualityDocs, Station Manager, Training
QualityOne
Automated Inspection of Certificate of Analysis Admin Checkbox QualityOne
MDCC: Banner Visibility Update Auto-on QualityOne
Prevent Document Record Archival for Training Management Auto-on QualityOne
Regulatory
Submission Import with Vault File Manager Support RIM Submissions Archive
20R2 Regulatory Data Model Updates Auto-on RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive
Veeva Claims
Pack Copy Management Configuration Veeva Claims
SiteVault
Site Packages: SiteVault Auto-on SiteConnect, SiteVault Enterprise, SiteVault Free
  1. Enablement requires selecting the Admin Checkbox and configuring the feature.

See the following explanations for enablement options:

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