New in 21R1.2: RTF Renditions and more

Release Date: April 30, 2021

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

Working with Documents

Renditions for RTF Files

With this release, Vault now generates viewable renditions for Rich Text Format (RTF) files. RTF files are a popular cross-platform file type that capture information about font styles, formatting, images, and more.

Reclassified Documents Always Retain Attachments

Starting in this release, Vault always retains attachments when users reclassify documents. Previously, if a user reclassified a document to a document type that did not have attachments enabled, Vault deleted the attachments. Admins still need to enable attachments on each document type to allow users to add new attachments to that document type.

Enable Document Tags on All Vaults

Previously, the Document Tags feature was only available through Veeva Support. With this release, Admins can configure document tags in all Vaults.

Document tags allow Admins to define a set of words or phrases that Vault can automatically detect whenever new document content is added. When any of these words or phrases are found, Vault sets the defined tag on the document metadata. Users can then search and filter on the defined document tags.

Carry Forward All Document Versions

A document version can have document relationships to one or more versions of the same target document. When configured, this feature allows Vault to carry forward all related document versions when there is a new version of the source document, rather than only carrying forward the latest version of each target document.

Disable Office Online on All Vaults

Starting in this release, users can no longer check out documents to Microsoft Office Online. Users can still edit any documents that were previously checked out to Office Online, but these documents must be checked in to Vault before the 21R3 release. In 21R3, the Checkout to Office Online feature will be deprecated entirely, and any edits on documents that are not checked in will be lost.

We have been communicating this change over the past several releases. 21R2 is the last general release in which the legacy Office Online functionality will continue to work. Instead, we recommend using Collaborative Authoring, which allows users to edit documents in Microsoft Office 365 desktop applications and in browsers.

Vault Objects

We enhanced Related Object sections of objects to filter based on criteria VQL, similar to Related Document section filters. Admins can now define much more powerful and flexible filters using criteria VQL. Any existing legacy filters will be unchanged and continue to function as before. Vault will automatically convert legacy filters to criteria VQL when an Admin edits the applicable Related Object section.

Admins can also choose to apply the criteria VQL as default when new records are created by setting the Apply on Create checkbox.

Previously, Vault ignored filters that included any fields that a user did not have Read permission on. With this release, Vault applies the criteria VQL to filter the Related Object section, but users do not see any fields that they do not have Read permission on.

User Object Custom Fields Support in Validation Rules

Custom fields on the User object can now be used in Vault validation rules for object records, giving Admins much more flexibility to validate custom information added to their User objects.

Lifecycle & Workflow

Unified Workflow Access

This release brings a major step in the One Workflow initiative to our customers, with the goal of streamlining the Vault workflow creation and configuration experience. To support this initiative, we have unified access to both object and document workflows under a single configuration page located at Admin > Configuration > Workflows. In addition, single-document workflow functionality, now called legacy workflows, no longer appears on document lifecycles that do not have existing legacy workflows. Learn more about Vault workflows.

Unified Workflow Access

Vault workflows now fall under the following definitions:

Workflows

Formerly split up into Multi-Document Workflows (MDW) and Object Workflows, workflow creation and configuration is now unified under a single page. Within the page, workflows have two types:

  • Document Workflows: Formerly known as Multi-Document Workflows, this is the recommended type for workflows affecting Vault documents, whether there is only one document in the workflow or many.
  • Object Workflows: Workflows which affect object records.

On the new Workflows page, Admins can use the search bar, or filter their view by document or object workflow.

Legacy Workflows

Formerly known as single-document workflows or simply document workflows, these workflows are now labelled as legacy workflows. If a document lifecycle does not have any legacy workflows, the Legacy Workflow tab will not appear on that document lifecycle configuration page. In the 21R1.2 release, this also includes any legacy R&U workflows that were shown in the workflow tab.

Restrict Document Workflow to a Single Document

This feature allows workflow administrators to configure a document workflow (formerly multi-document workflow) to only run on one document.

When a document workflow is configured to run on a single document, users can only start the workflow from the document Actions menu using a Start Workflow user action. Users cannot start these workflows from bulk views such as Cart, Library, or Favorites.

Copy Workflow

This feature allows workflow administrators to copy an object or document workflow (formerly multi-document workflow). The copied workflow is created as Inactive, and the workflow administrator must make it Active. The workflow copy has the same type (object or document) and the same lifecycle as the source workflow.

Copy Workflow

Restrict Workflow Owner from Receiving a Task

This feature allows workflow administrators to restrict workflow owners from receiving an object workflow or document workflow (formerly multi-document workflow) task. When this option is configured on a task, the workflow owner can no longer accept or complete that task, even if the user is part of a broader participant user group that receives the task.

Prompt for Document Fields in Document Workflow Verdicts

Workflow administrators can now configure document fields as part of a document workflow (formerly multi-document workflow) task verdict. Document workflows for specific lifecycles can support all fields available to that lifecycle. Document workflows for any lifecycle can support only Base Document type fields. Fields can be optional or required. Multi-verdict tasks show existing field values for each document verdict.

Prompt for Object Reference Fields in Document Workflows

This feature allows workflow administrators to configure object reference fields inside a document workflow (formerly multi-document workflow) start step, task step, or task verdict. Vault supports both single and multi-value reference fields, and fields can be optional or required.

Support for DAC Lifecycle Role Allowed Group in Document Workflows

Workflow initiators can now select and add users in the Allowed Group of a Dynamic Access Control (DAC) lifecycle role in a specific-lifecycle document workflow (formerly multi-document workflow). This feature must be enabled on the Admin > Settings page and configured for a participant group by a workflow administrator before workflow owners can select users that are part of the allowed user group. Note that Admins cannot disable this feature after enabling it.

In addition, Vault no longer displays errors while trying to add users who are already added to the document lifecycle role using DAC. Instead, Vault simply ignores the selection.

Expression Enhancement for Update Document Field in Lifecycle & Workflow

This feature adds additional functions and operators to allow workflow administrators to build more comprehensive expressions, used for updating document fields inside a lifecycle event action, entry action, or document workflow (formerly multi-document workflow) content action step. New functions include If and Case. New operators include > (Greater Than) and < (Less Than).

Date & DateTime Fields Support in Document Workflow Decisions

Workflow administrators can now configure Date and DateTime fields in a document workflow (formerly multi-document workflow) decision step. Date or DateTime values can be within certain days, weeks, months, or years in the past or in the future.

Task Due Date Audit Updates in Document Audit Trail

This feature adds useful information to the Due Date audit event for object workflows and document workflows (formerly multi-document workflows). If a workflow automatically calculates a due date, it appears in the audit trail as performed by System. If the due date is updated by a user using a workflow action, it is listed in the audit trail as performed by a user. Each update to a user task due date is captured separately in the audit trail.

Reporting & Dashboards

Dashboard Usability Enhancements

This feature makes several aesthetic and usability enhancements to dashboards. When selecting a report, users now see a list of recent reports. When creating a chart, users now select a report prior to selecting a chart type. Additionally, charts no longer include the gray header background, and Vault displays full chart labels.

Dashboard Usability

Consistent Report URLs Across Vaults

This feature allows Admins to define web actions for accessing reports in a source Vault and migrating them successfully to a target Vault without updating the web action’s URL. URLs for the same report can now be consistent across Vaults. Users can still access reports through existing URLs, and Admins can now replace the report ID with the report’s name in URLs.

Standard Reports

This feature will allow Vault applications to introduce standard reports that cannot be deleted and that users can only allow edit in a limited capacity, if at all. Standard reports will include a Veeva tag, a Veeva logo, and the standard Vault namespace (__v) to allow users to easily distinguish them from other reports.

Note that while this feature introduces the ability for Vault applications to add standard reports, this release does not include any new standard reports in customer Vaults.

Expanded Search Enhancements

Expanded search now supports in-line editing, bulk actions, saved views, and exporting from each of the search result sections. The top of each section now displays the total number of results in that section.

Learn more about expanded search results.

Expanded Search Enhancements

Auto Claims Linking

This feature enables Auto Claims Linking to create Suggested Links and Auto Links to permalink targets in addition to version-specific documents and anchors. When enabled, a user adding references to a Claim record can select Permalink as the target type, and add one or more permalink targets as references on the Claim. Once added, the permalink record ID appears in the Reference column within the Claim record’s References section. This link always navigates to the latest version of the permalink target document.

Suggested Links to Permalink Targets

This feature is available when an Admin has enabled all of the following checkboxes in Admin > Settings:

  • Enable Copy Link and unlock Permalink Object Type
  • Enable linking to permalinks (This checkbox is only available after enabling Copy Link)
  • Enable Suggested Links

Vault File Manager

Permission Label Update: Check Out to File Manager

In this release, we have relabeled the Check Out to File Manager permission to Vault File Manager. This permission allows users to access all Vault File Manager functionality, including uploading renditions and importing submission dossiers to RIM Submissions Archive.

Administration

Display the Unclassified Document Type in Admin

This feature was postponed to a future release.

Admins Can Edit All Document Field Labels

Prior to this release, Admins could not edit the Labels on all standard document (__v) fields in the UI, even though this was possible via MDL and through bulk translation tools. This feature allows Admins to edit Labels on all document fields.

Smart Filter Enablement in Search Settings

When enabled, smart filtering automatically converts navigational search terms, such as Document Type or Status, into filters. Before this release, smart filtering was only available through Veeva Support. In this release, Admins can now enable or disable this feature on the Admin > Settings > Search Settings page.

Access Control

Automate Guest Invites to Azure AD from Vault

With this release, Admins can enable automatic invites to external users, allowing users without access to the Admin’s Vault domain to edit and collaborate on Office 365 files. When enabled, Vault automatically adds the external users as Guests using Azure AD.

Enforce Use of HTTPS When Configuring SAML & OAuth 2.0 Profiles

When configuring SAML profiles and OAuth 2.0 profiles, Admins must now use the HTTPS protocol rather than the HTTP protocol. This applies when importing SAML IdP metadata or when uploading OAuth 2.0 Authentication Server metadata. Note that this change only applies when creating new profiles or updating existing profiles.

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 following components to support the Suggested Links to Permalink Targets:

  • Added the Permalink (permalink__v) value to the Reference Type (suggestedlink_link_target_type__v) picklist.

Clinical Operations

Quality Issue Assignee Filtering By Object Type

Previously, the presence of custom VQL on the Assigned To field for any Quality Issue object type would prevent the default filtering from applying to the field on other Quality Issue object types. This updated behavior respects custom VQL on an object-type basis.

Commercial

Material ID

This feature adds a Material ID field that generates and adds a unique ID number to the document for submission to a health authority. This number can be automatically updated when the document moves from Steady State to Draft so that there is a unique ID number if a second submission is required. This allows customers to up-version documents past v1.0 while maintaining a unique ID number that can be used for each submission of a specific document.

Modular Content: Rich Text Fields

In 21R1, we added new objects to support the creation and storage of Content Modules, one of the elements of which supports storing text elements. With this release, the text fields use the new Rich Text field type, allowing basic formatting on the text. Existing unformatted text is unaffected and both the plain and rich text are accessible via the API.

eCTD Compliance Package 2253 Form Update

With this release, users can configure Vault to automatically complete line 14 on Form 2253 when generating an eCTD Compliance Package. Once configured, Vault automatically selects “Final” on line 14 of Form 2253 in Post Marketing Compliance Packages when the Center field is set to CBER – APLB. Note that the Center field is now required on the Post Marketing Compliance Package by default and is visible to users without configuration.

Create Fragment Includes Additional CRM Product Fields

With this release, the Create Fragment feature copies any standard CRM Product fields (CRM Org, CRM Product, CRM Product Detail Group) used on a source document to the generated email fragment, as part of the Veeva Approved Email functionality. This reduces the administration required when preparing fragments for use in CRM.

Data Model Change: Multi-Select CRM Product Fields

This data model change lays the foundation for a CRM feature with a planned release in Q3, which will support multiple CRM Products on CLM Presentations and Slides in Vault. With this release, Admins can update the following three (3) fields in PromoMats and MedComms to be multi select or single select:

  • CRM Product (crm_product__v)
  • CRM Product Group (crm_product_group__v)
  • CRM Detail Group (crm_detail_group__v)

These fields are single select by default.

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:

  • Added new shared document field CRM Product Group (crm_product_group__v)
  • Updated the Allow the user to select multiple values checkbox to be editable for the following shared fields:
    • CRM Product (crm_product__v)
    • CRM Product Group (crm_product_group__v)
    • CRM Detail Group (crm_detail_group__v)

    • The following components have been added to PromoMats Vaults:

  • Added the following new shared document fields:
    • Material ID (material_id__v)
    • Revision (revision__v)
    • Promotional Material ID (promotional_material_id__v)
  • Updated the shared document field Center to be required on Post Marketing Compliance Packages
  • Added new entry action and event action Update Revision & Material ID
    • Converted the Text Element Content field on the Content Module Asset object (content_module_asset_v.text_element_content_v) from long text to rich text

    Quality

    Station Manager: Capture Document Usage

    With this release, Vault is now capable of creating activity records to capture the viewing of documents in the Station Manager mobile application. These activity records provide document owners and administrators with insight into the usage of documents, such as SOPs and instructions, in manufacturing and lab environments.

    This Vault feature supports a future enhancement to the Station Manager application which will enable activity tracking and sync activity records to Vault. Learn more about setting up Station Manager.

    Health Canada Adverse Event Reporting

    Customers are now able to leverage Vault Product Surveillance to triage a complaint that is determined to be a reportable adverse event to Health Canada. This feature also adds the ability to generate formatted PDF output of the Health Canada Mandatory Medical Device Problem Reporting Form for Industry.

    Customers can use this feature to submit the PDF file manually to Health Canada. This is an extension of Adverse Event Reporting to the US FDA. Learn more about using adverse event reporting.

    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 and updated the following components to the Quality data model.

    The following changes were made to support the Health Canada Adverse Event Reporting feature:

  • Added the following to the Reportable Event object:
    • New object type: Health Canada (health_canada__v)
    • New fields added to support Adverse Event Reporting for Health Canada
  • Added the following fields to the Organization object:
    • Company Identification No (CA) (ca_company_identification__v)
    • License No (CA) (ca_license_no__v)
  • Added the VPS: Reportability Assessment (reportability_assessment__v) object with the following fields:
    • Medtech Complaint (medtech_complaint__v)
    • Type of Assessment (assessment_type__v)
    • Severity Outcome (severity_outcome__v)
    • Is Reportable? (is_reportable__v)
    • Days for Initial Report Due Date (days_reportable__v)
  • Added the Reportability Assessment Effects (reportability_assessment_effects__v) object with the following fields:
  • Reportability Assessment (reportability_assessment__v)
  • Reportable Event (reportable_event__v)
  • Operation (operation__v)
  • Justification (justification__v)

    • The following changes were made to support the Station Manager: Capture Document Usage feature:

    • Added the Station Manager Activity (station_manager_activity__v) object

    Regulatory

    Collapse Action in Content Plan Hierarchy Viewer

    With this release, a new Collapse action is available for Content Plan records in the Content Plan Hierarchy Viewer. This action allows users to collapse all descendant Content Plan and Content Plan Item records within a content plan section at once, including matched document rows.

    Collapse Action in Content Plan Hierarchy Viewer

    Correspondence in Viewer to Consider Dossier Status

    With this release, Vault now takes into account values in the Dossier Status field when displaying correspondence documents in the Submissions Archive Viewer. Submissions Publishing customers with the Correspondence in Viewer feature enabled now see submission-level correspondences in the Viewer for submissions that are not actively being published.

    Submissions Archive: Taiwan 1.0

    With this release, RIM Submissions Archive Vaults support importing and viewing eCTD submissions based on the Taiwan v1.0 DTD.

    This feature adds an additional level of granularity when users create activities from an Event record using the Create Related Records wizard. The new Activity Scope Level, Country and Application, allows users to create an Activity record for each Country record related to the impacted Application record. This feature also renames the existing Country scope to Country, Application and Product to align with its existing behavior.

    Create Related Records: Application Country Scope

    Create Related Records: Restrict Submission & Regulatory Objective Joins

    When users run the Create Related Records wizard from an Impact Assessment Report, Vault now applies validation logic before creating Submission and Regulatory Objective join records. Validation logic, which is specific to each join record type, prevents the creation of invalid join record relationships based on relevant existing relationships.

    IDMP: Registered Packaging to Medicinal Product Registration Mapping

    This feature introduces a new action that maps Registered Packaging records to the related Medicinal Product Registration record. Admins can set this up as a user action or an entry action on Registered Packaging object lifecycle states. This feature supports IDMP and extends the IDMP Accelerators feature introduced in the 21R1 release. Learn more about configuring Registered Packaging mapping.

    Quality to RIM Vault Connection Data Model Update

    With this release, the data model components supporting the Quality to RIM Vault Connection are available in all RIM Vaults. Although Admins can see these components in any RIM Vault, the Quality to RIM Vault Connection works only for RIM Vaults with the Registrations application.

    UDI Source Data Model

    This feature introduces medical device-related data model changes to allow Vault to capture UDI attributes for EUDAMED and GUDID.

    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 and updated the following components to the Regulatory data model.

    The Quality to RIM Vault Connection Data Model Update adds the data model supporting the Quality to RIM Vault Connection to all RIM Vaults, but the connection only works for Registrations Vaults.

    Added the following components to support the UDI Source Data Model Updates feature:

    • Added the following object, available to all RIM Vaults:
    • Clinical Study Product (clinical_study_product__v) with page layouts
      • Regulatory Text (regulatory_text__v) with object types and page layouts:
        • Device Description (device_description__v)
        • Device Indications for Use (device_indications_for_use__v)
        • Device Intended Use (device_intended_use__v)
        • Device Marketing Substatus Details (device_marketing_substatus_details__v)
        • Device Trade Name (device_trade_name__v)
      • Regulatory Text Translation (regulatory_text_translation__v) with object types and page layouts:
        • Device Description (device_description__v)
        • Device Indications for Use (device_indications_for_use__v)
        • Device Intended Use (device_intended_use__v)
        • Device Marketing Substatus Details (device_marketing_substatus_details__v)
        • Device Trade Name (device_trade_name__v)
      • Product Regulatory Text (product_regulatory_text__v) with object types and page layouts:
        • Device Indications for Use (device_indications_for_use__v)
        • Device Intended Use (device_intended_use__v)
      • Packaging Regulatory Text (packaging_regulatory_text__v) with object types and page layouts:
        • Device Description (device_description__v)
        • Device Marketing Substatus Details (device_marketing_substatus_details__v)
        • Device Trade Name (device_trade_name__v)
      • Submission Regulatory Text (submission_regulatory_text__v) with object types and page layouts:
        • Device Description (device_description__v)
        • Device Indications for Use (device_indications_for_use__v)
        • Device Intended Use (device_intended_use__v)
        • Device Marketing Substatus Details (device_marketing_substatus_details__v)
        • Device Trade Name (device_trade_name__v)
      • Regulatory Objective Regulatory Text (regulatory_objective_regulatory_text__v) with object types and page layouts:
        • Device Description (device_description__v)
        • Device Indications for Use (device_indications_for_use__v)
        • Device Intended Use (device_intended_use__v)
        • Device Marketing Substatus Details (device_marketing_substatus_details__v)
        • Device Trade Name (device_trade_name__v)
      • Shelf Life or Condition Translation (shelf_life_or_condition_translation__v) with page layouts
    • Added the following objects, available to Registrations Vaults:
    • Device Identifier (device_identifier__v) with object types and page layouts:
      • UDI DI (udi_di__v)
      • EUDAMED ID (eudamed_id__v)
      • Basic UDI DI (basic_udi_di__v)
      • EUDAMED DI (eudamed_di__v)
    • Registered Device Identifier (registered_device_identifier__v) with object types and page layouts:
      • UDI DI (udi_di__v)
      • EUDAMED ID (eudamed_id__v)
      • Basic UDI DI (basic_udi_di__v)
      • EUDAMED DI (eudamed_di__v)
      • UDI Submission (udi_submission__v) with object types and page layouts:
      • UDI Submission (udi_submission__v)
      • UDI Group Submission (udi_group_submission__v)
      • UDI Combined Submission (udi_combined_submission__v)
      • UDI Submission DI (udi_submission_di__v) with page layout
    • Related Registration (related_registration__v) with object types and page layouts:
      • Active Substance Registration (active_substance_registration__v)
      • Investigational Device Registration (investigational_device_registration__v)
      • Investigational Drug Registration (investigational_drug_registration__v)
      • Manufacturing Site Registration (manufacturing_site_registration__v)
      • Marketed Device Product Registration (marketed_device_product_registration__v)
      • Marketed Drug Product Registration (marketed_drug_product_registration__v)
    • Product Regulatory Authorization (product_regulatory_authorization__v) with page layout
      • Registered Authorization (registered_authorization__v) with object types and page layouts:
        • Device Certificate (device_certificate__v)
        • Device Listing (device_listing__v)
        • Device Premarket Submission (device_premarket_submission__v)
    • Regulatory Objective Authorization (regulatory_objective_authorization__v) with object types and page layouts:
      • Device Certificate (device_certificate__v)
      • Device Listing (device_listing__v)
      • Device Premarket Submission (device_premarket_submission__v)
    • Registered Regulatory Text (registered_regulatory_text__v) with object types and page layouts:
      • Device Description (device_description__v)
      • Device Indications for Use (device_indications_for_use__v)
      • Device Intended Use (device_intended_use__v)
      • Device Marketing Substatus Details (device_marketing_substatus_details__v)
      • Device Trade Name (device_trade_name__v)
      • Event Regulatory Text (event_regulatory_text__v) with object types and page layouts:
        • Device Description (device_description__v)
        • Device Indications for Use (device_indications_for_use__v)
        • Device Intended Use (device_intended_use__v)
        • Device Marketing Substatus Details (device_marketing_substatus_details__v)
        • Device Trade Name (device_trade_name__v)
    • Added the Issuing Agency (issuing_agency__v) field to the Data Carrier (data_carrier__rim) object.
    • Added the Health Authority Code (health_authority_code__v) field to the Risk Class (risk_class__v) object.
    • Added the following fields to the Product (drug_product__v) object:
      • Active Device (active_device__v)
      • Contains Animal Tissue or Cells (contains_animal_tissue_or_cells__v)
      • Contains Human Tissue or Cells (contains_human_tissue_or_cells__v)
      • Contains Human-Derived Medicinal Product (contains_humanderived_medicinal_product__v)
      • Contains Medicinal Product Substances (contains_medicinal_product_substances__v)
      • Contains Substances of Microbial Origin (contains_substances_of_microbial_origin__v)
      • Device Model or Version (device_model_or_version__v)
      • Device Name (device_name__v)
      • Implantable Device (implantable_device__v)
      • IVD Instrument (ivd_instrument__v)
      • IVD Reagent (ivd_reagent__v)
      • Measuring Device (measuring_device__v)
    • Added the following fields to the Registered Product (registered_drug_product__rim), Submission Product (submission_pharmaceutical_product__rim), and Regulatory Objective Product (regulatory_objective_drug_product__v) objects:
      • Medical Device Type (medical_device_type__v)
      • Use for UDI (use_for_udi__v)
    • Added the following fields to the Clinically Relevant Size (clinically_relevant_size__v) object:
      • Maximum Value (maximum_value__v)
      • Precision (precision__v)
      • Size Description (size_description__v)
    • Added the following fields to the Registered Product Characteristic (registered_product_characteristic__v), Submission Product Characteristic (submission_product_characteristic__v), Reg Objective Product Characteristic (reg_objective_product_characteristic__v) objects:
      • 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)
      • Product Identification Method (production_identification_method__v)
      • Reusable Surgical Instrument (reusable_surgical_instrument__v)
      • Special Device Type (special_device_type__v)
      • Use for UDI (use_for_udi__v)
    • Added the following fields to the Packaging (packaging__rim) object:
      • Catalog or Reference Number (catalog_or_reference_number__v)
      • Contains Natural Latex or Dry Rubber (contains_natural_latex_or_dry_rubber__v)
      • Device Identifier (DI) (device_identifier__v)
      • Packaging Contained Within (packaging_contained_within__v)
      • Previous DI (previous_di__v)
      • Product (product__v)
      • Product Variant (product_variant__v)
      • Quantity (quantity__v)
      • Secondary DI (secondary_di__v)
    • Smallest Salable Unit (smallest_salable_unit__v)
    • Added the following fields to the Registered Packaged Medicinal Product (registered_packaged_medicinal_product__v ) object:
      • Marketing Substatus (marketing_substatus__v)
      • Marketing Substatus Scope (marketing_substatus_scope__v)
      • Marketing Substatus Start Date (marketing_substatus_start_date__v)
      • Marketing Substatus End Date (marketing_substatus_end_date__v)
      • Medical Device Type (medical_device_type__v)
      • Smallest Salable Unit (smallest_salable_unit__v)
      • Use for UDI (use_for_udi__v)
    • Added the following fields to the Registered Packaging Characteristic (registered_packaging_characteristic__v), Submission Packaging Characteristi_c (submission_packaging_characteristic__v), and _Reg Objective Packaging Characteristic (reg_objective_packaging_characteristic__v) objects:
      • 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 Salable Unit (smallest_salable_unit__v)
      • Sterilization Method (sterilization_method__v)
      • Use for UDI (use_for_udi__v)
    • Added the EUDAMED CIV ID (eudamed_civ_id__v) field to the Clinical Study (clinical_study__v) object.
    • Added the following field to the Registered Clinical Study (registered_clinical_study__v), Submission Clinical Study (registered_clinical_study__v), Regulatory Objective Clinical Study (regulatory_objective_clinical_study__v), Registered Product Classification (registered_product_classification__v), Submission Product Classification (submission_product_classification__v), and Reg Objective Product Classification (reg_objective_product_classification__v) objects:
      • Use for UDI (use_for_udi__v)
    • Added the following fields to the Active Substance (drug_substance__v) object:
      • EC Number (ec_number__v)
      • EUDAMED INN (eudamed_inn__v)
    • Added the following fields to the Registered Active Ingredient (registered_active_ingredient__rim), Submission Active Substance (submission_active_substance__rim), and Regulatory Objective Active Substance (regulatory_objective_active_substance__v) object:
      • Substance Classification (substance_classification__v)
      • Use for UDI (use_for_udi__v)
    • Added the following fields to the Organization (organization__rim) object:
      • Address Complement (address_complement__v)
      • EUDAMED Authorised Representative SRN (eudamed_authorised_representative_srn__v)
      • EUDAMED Code (eudamed_code__v)
      • EUDAMED Importer SRN (eudamed_importer_srn__v)
      • EUDAMED Manufacturer SRN (eudamed_manufacturer_srn__v)
      • EUDAMED Notified Body SRN (eudamed_notified_body_srn__v)
      • EUDAMED SPP Producer SRN (eudamed_spp_producer_srn__v)
      • GUDID Code (gudid_code__)
      • PO Box (po_box__v)
      • Street (street__v)
      • Street Number (street_number__v)
    • Added the following fields to the Registered Site Organization (registered_site_organization__v), Submission Site Organization (submission_site_organization__v), and Regulatory Objective (regulatory_objective_site_organization__v) objects:
      • Make Contact Details Public (make_contact_details_public__v)
      • Product (product__v)
      • Use for UDI (use_for_udi__v)
    • Added the following fields to the Regulatory Authorisation (regulatory_authorisation__v) object:
      • Authorization Number (authorization_number__v)
      • Expiry Date (expiry_date__v)
      • Certificate Type (certificate_type__v)
      • Market (market__v)
      • Notified Body (notified_body__v)
      • Revision Number (revision_number__v)
      • Supplement Number (supplement_number__v)
      • Auto-name Calculation (autoname_calculation__v)
    • Added the Description (description__v) field to the Shelf Life (shelf_life__rim) object.
    • Added the following object type to the Constraint (constraint__rim) object:
      • UDI Constraint (udi_constraint__v)
    • Added the following object types to the Registered Product Characteristic (registered_product_characteristic__v), Submission Product Characteristic (submission_product_characteristic__v), Reg Objective Product Characteristic (reg_objective_product_characteristic__v) objects:
      • Device Product Characteristics (device_product_characteristics__v)
      • Device Product Variant Characteristics (device_product_variant_characteristic__v)
      • Device Non-Medical Purpose (nonmedical_purpose__v)
      • Device Clinical Size (device_clinical_size__v)
      • Device Production Identification Method (device_production_identification_meth__v)
    • Added the following object types to the Registered Packaging Characteristic (registered_packaging_characteristic__v), Submission Packaging Characteristi_c (submission_packaging_characteristic__v), and _Reg Objective Packaging Characteristic (reg_objective_packaging_characteristic__v) objects:
      • Packaged Device Characteristics (packaged_device_characteristics__v)
      • Packaged Device Sterilization Method (packaged_device_sterilization_method__v)
    • Added the following object types to the Registered Site Organization (registered_site_organization__v), Submission Site Organization (submission_site_organization__v), and Regulatory Objective (regulatory_objective_site_organization__v) objects:
      • Site Organization (site_organization__v)
      • Product Organization (product_organization__v)
    • Added the following object types to the Shelf Life (shelf_life__rim), Registered Shelf Life and Storage (registered_shelf_life_and_storage__v), Submission Shelf Life Storage (submission_shelf_life_storage__v), Regulatory Objective Shelf Life Storage (regulatory_objective_shelf_life_storage__v), and Event Shelf Life and Storage (event_shelf_life_and_storage__v) objects:
      • Device Storage and Handling Condition (device_storage_and_handling_condition__v )
      • Device Critical Warning (device_critical_warning__v)
    • Added the following object types to the Regulatory Authorisation (regulatory_authorisation__v) object:
      • Device Certificate (device_certificate__v)
      • Device Listing (device_listing__v)
      • Device Premarket Submission (device_premarket_submission__v)
    • Added the following object types to the Packaging Shelf Life (regulatory_authorisation__v) object:
      • Packaged Device Shelf Life (packaged_device_shelf_life__v)
      • Packaged Device Storage and Handling (packaged_device_storage_and_handling__v)
      • Packaged Device Critical Warning (packaged_device_critical_warning__v)
    • Enabled object types on the following objects:
      • Packaging (packaging__rim)
      • Registered Packaged Medicinal Product (registered_packaged_medicinal_product__v)
    • Added the following values to the Identifier Type (identifier_type__v) picklist:
      • UDI DI (udi_di__v)
      • EUDAMED ID (eudamed_id__v)
    • Added the following values to the Device Classification System (device_classification_system__v) picklist:
      • EAEU (eaeu__v)
      • EMDN (emdn__v)
      • NMPA (nmpa__v)
    • Added the following value to the Organization Type (organization_type__rim) picklist:
      • Issuing Agency (issuing_agency__v)
    • Added the following values to the Controlled Vocabulary Type (controlled_vocabulary_type__rim) picklist:
      • Medical Device Type (edical_device_type__v)
      • Non-Medical Purpose (nonmedical_purpose__v)
      • Clinical Size Precision (clinical_size_precision__v)
      • Production Identification Method (production_identification_method__v)
      • Certificate Type (certificate_type__v)
      • Special Device Type (special_device_type__v)
      • Substance Classification (substance_classification__v)
      • Marketing Substatus (marketing_substatus__v)
      • Marketing Substatus Scope (marketing_substatus_scope__v)
      • MRI Safety Status (mri_safety_status__v)
      • Sterilization Method (sterilization_method__v)
      • Critical Warning (critical_warning__v)
    • Added the UDI Submission Accepted by HA (udi_submission_accepted_by_ha__v) lifecycle state type.
    • Added the UDI Submission Creation Results (udi_submission_creation_results__v) notification template.
    • Added the UDI (udi__v) document type and the UDI Submission (udi_submission__v) document subtype.
    • Added the UDI (udi__v) document field layout.
    • Added the UDI Submission (udi_submission__v) document field.

    Safety

    Safety features are targeted for tentative availability on May 6, 2021.

    Local to English Language Intake Configuration

    Vault Safety now supports case intake from the local language to English through the Inbox Item, provided in the new Inbox. For example, the EMA requires English submissions. If an adverse event is reported from Holland in Dutch, you can enter the Inbox Item in Dutch while translating the data to English before promoting it to a Case.

    Learn More:

    China (NMPA) Local Fields Configuration

    Chinese local data elements required by NMPA (China regulatory authority) are now available for data entry.

    Learn More:

    Multilingual MedDRA Browser and Autocode Auto-on

    The Vault Safety MedDRA browser now offers the ability to code Adverse Events in any non-English MedDRA supported language (except Japanese). This capability also extends to auto-coding. The updated browser is available for Inbox Items during intake, and Case Adverse Events during subsequent case processing.

    Learn More: Code Multilingual MedDRA Terms

    Automatic Intake From Documents With a Viewable PDF Rendition Auto-on

    Safety.AI’s automatic PDF form intake feature is now available for all file formats supported in Vault including Word and image files. This will allow users to start the extraction process from any Vault Document with a Viewable PDF Rendition. Upon successful completion, an Inbox Item will be created with the case information extracted from the document text, fields, and checkboxes.

    New Checkbox Recognition from Documents Auto-on

    Safety.AI will automatically extract additional information from document checkboxes including Outcome, Report Type, Patient Gender, and Age Group. Adverse Event Outcome and Seriousness will be suggested from Case Outcome and Seriousness. The Source Data pane will display this information to facilitate human verification. Safety.AI will also display a value only once in the field’s dropdown menu if it was found multiple times in the source text.

    QualityOne

    QualityOne Teams

    This feature provides a mechanism to manage structured quality teams of participants that are responsible for completing specific processes within workflows assigned within Vault. QualityOne Teams can be configured to help manage change controls, audits, CAPAs, and other quality event-related processes. Learn more about configuring and working with Teams.

    Product Hierarchy Data Model for QualityOne

    The Consumer and Chemical Product industry has formulations within Quality that can form multilevel hierarchical relationships between the different quality processes. With this release, a shared standard product hierarchy data model is introduced and can be leveraged to store complex hierarchical products and their specification details to reduce reliance on customization. Learn more about QualityOne’s key data model.

    Product Hierarchy Data Model for QualityOne

    Veeva Claims

    Note that Veeva Claims features are targeted for tentative availability on May 11th.

    Auto-Create Element

    Veeva Claims’ Pack Copy module includes a reusable Element library which contains different kinds of packaging elements including Claim-type elements. Claim-type elements are existing Claim records. The current process of populating the element library can be time consuming; after marketers create and approve claims, they have to create related elements manually.

    This feature significantly reduces the time needed to populate the packaging Elements library. This feature allows the automatic creation of an Element record after the corresponding Claim reaches a defined lifecycle state. This feature provides Admins the option to configure a record action in a Claim lifecycle or workflow to enable automatic creation of a Claim-type packaging Element. Learn more about configuring Auto-Create Element.

    Enablement Details

    Name Enablement Application
    Working with Documents
    Renditions for RTF Files Auto-on Platform
    Reclassified Documents Always Retain Attachments Auto-on Platform
    Enable Document Tags on All Vaults Configuration Platform
    Carry Forward All Document Versions Auto-on Platform
    Disable Office Online on All Vaults Auto-on Platform
    Vault Objects
    Related Object Section Criteria VQL Filters Auto-on Platform
    User Object Custom Fields Support in Validation Rules Configuration Platform
    Lifecycle & Workflow
    Unified Workflow Access Configuration Platform
    Restrict Document Workflow to a Single Document Configuration Platform
    Copy Workflow Auto-on Platform
    Restrict Workflow Owner from Receiving a Task Configuration Platform
    Prompt for Document Fields in Document Workflow Verdicts Configuration Platform
    Prompt for Object Reference Fields in Document Workflows Configuration Platform
    Support for DAC Lifecycle Role Allowed Group in Document Workflows Auto-on Platform
    Expression Enhancement for Update Document Field in Lifecycle & Workflow Auto-on Platform
    Date & DateTime Fields Support in Document Workflow Decisions Auto-on Platform
    Task Due Date Audit Updates in Document Audit Trail Auto-on Platform
    Reporting & Dashboards
    Dashboard Usability Enhancements Auto-on Platform
    Consistent Report URLs Across Vaults Auto-on Platform
    Standard Reports N/A Platform
    Search
    Expanded Search Enhancements Auto-on Platform
    Auto Claims Linking
    Suggested Links to Permalink Targets Auto-on Platform
    Vault File Manager
    Permission Label Update: Check Out to File Manager Auto-on Platform
    Administration
    Display the Unclassified Document Type in Admin Auto-on Platform
    Admins Can Edit All Document Field Labels Auto-on Platform
    Smart Filter Enablement in Search Settings Auto-on Platform
    Access Control
    Automate Guest Invites to Azure AD from Vault Configuration Platform
    Enforce Use of HTTPS When Configuring SAML & OAuth 2.0 Profiles Auto-on Platform
    Platform Data Model Changes
    Platform Data Model Changes Auto-on Platform
    Clinical Operations
    Quality Issue Assignee Filtering By Object Type Auto-on Study Startup, eTMF
    Commercial
    Material ID Configuration PromoMats
    Modular Content: Rich Text Fields Auto-on PromoMats
    eCTD Compliance Package 2253 Form Update Configuration PromoMats
    Create Fragment Includes Additional CRM Product Fields Auto-on MedComms, PromoMats
    Data Model Change: Multi-Select CRM Product Fields Configuration MedComms, PromoMats
    Commercial Data Model Changes Auto-on MedComms, PromoMats
    Quality
    Station Manager: Capture Document Usage Auto-on Station Manager
    Health Canada Adverse Event Reporting Auto-on Surveillance
    Quality Data Model Changes Auto-on
    QMS, QualityDocs, Station Manager, Surveillance, Training
    Regulatory
    Collapse Action in Content Plan Hierarchy Viewer Auto-on RIM Submissions
    Correspondence in Viewer to Consider Dossier Status Auto-on RIM Submissions Archive
    Submissions Archive: Taiwan 1.0 Auto-on RIM Submissions Archive
    Create Related Records: Application Country Scope Auto-on RIM Registrations
    Create Related Records: Restrict Submission & Regulatory Objective Joins Auto-on RIM Registrations
    IDMP: Registered Packaging to Medicinal Product Registration Mapping Configuration RIM Registrations
    Quality to RIM Vault Connection Data Model Update Auto-on
    RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive
    UDI Source Data Model Auto-on RIM Registrations
    Regulatory Data Model Changes Auto-on
    RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive
    QualityOne
    QualityOne Teams Configuration QualityOne
    Product Hierarchy Data Model for QualityOne Auto-on QualityOne
    Veeva Claims
    Auto-Create Element Configuration Veeva Claims

    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.

    Known Issues

    Vault Quality (DEV-400085)

    In Limited Release Quality Vaults, a non-functional page at Admin > Configuration > Quality Record Check appears. Admins attempting to navigate to this page will encounter a server error. The Quality Record Check feature will be enabled for customers in an upcoming release.