New in 20R3.2: Audio & Video Renditions for CrossLinks and more

Release Date: December 11, 2020

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

Working with Documents

Audio & Video Renditions for CrossLinks

With this release, CrossLinks support audio and video renditions, allowing users to easily review CrossLinks where the source document is an audio or video file.

Video Playback Speed Controller

With this feature, users can modify the playback speed of videos in Vault by clicking on a minus (–) icon to slow down, or a plus (+) icon to speed up, within a set of defined speeds:

  • 0.25x
  • 0.5x
  • 0.75x
  • 1x (default)
  • 1.25x
  • 1.5x
  • 2x

Vault displays the selected speed next to the control.

Note that speed control is not supported for Android devices, and is not available on audio-only source files.

Learn more about video playback controls.

Document Owner Can Undo Checkout for All Check Out Types

In past releases, the only user who could cancel or undo a checkout session was the user who checked out the document. This feature extends this capability to the Document Owner, as long as they have a document role with the Edit Document permission. This change makes the ability to cancel checkouts more consistent across all checkout types.

Enabled Field for Document Type Detail Object

This feature introduces the Enabled field on the Document Type Detail object, which reflects the active or inactive status of its associated document type, subtype, or classification. When configuring controlled document templates, Admins can now create a reference constraint on the Template Document Type field using the Enabled field to display only active document types. Learn more about controlled document templates.

Document Auto-Naming: Excluded Characters

With this feature, Vault excludes curly bracket characters when auto-naming documents as these can cause issues when resolving document field tokens.

Admin Field Layout Matches Doc Info

With this release, the order of sections that users see on the Doc Info page always matches the section order on the Field Layout page. Previously, the order of these sections may not have matched if an Admin imported new sections to the Vault using a Configuration Migration Package, or if Veeva provisioned a new section as part of a new release.

Vault Objects

With this feature, Admins now have the ability to control whether users can add new related documents directly in the Related Document section of the object page layout.

Lifecycle & Workflow

Enablement Change: Atomic Security for Document Lifecycles

In past releases, Atomic Security for document lifecycles was only available to customers who requested it from Veeva Support. In this release, Atomic Security for document lifecycles is available for all Vaults.

With Atomic Security, Admins have more granular control, based on lifecycle state and role, over who can perform specific lifecycle user actions in the Atomic Security tab, such as changing a document’s state and starting a workflow, and active workflow actions, such as Cancel Workflow and Add Participant. Each action is individually listed in the Atomic Security tab, allowing fine control over access. Workflow Initiators and users in the Coordinator role will continue to have automatic access to active workflow actions.

Learn more about Atomic Security for Document Lifecycles and the impact of this enablement change.

Multi-Document Workflow: Short Circuit Tasks

With this feature, Admins can advance multi-document workflows without waiting for every task to be completed by automatically canceling workflow tasks with matching tags. Vault cancels all tasks with any matching tag, including parallel tasks, when a short circuit verdict is provided.

Admins can configure short circuit verdicts on both single-verdict and multi-verdict tasks and on both Any Lifecycle and Specific Lifecycle multi-document workflows. Learn more about short-circuiting tasks in multi-document workflows.

Object & Multi-Document Workflow: Send Notification Based on Roles

Vault can now send notifications based on roles in an object or multi-document workflow. Workflow Admins can select one role per notification step.

In multi-document workflows, Vault sends the notification to users who are in that role on every document in that workflow. For object workflows, Vault sends the notification to users who are in that role in the object record’s sharing settings. Learn more about configuring notification steps for object and multi-document workflows.

Object & Multi-Document Workflow: Conditional Controls on Start Step

This feature allows Workflow Admins to hide some controls from the workflow start dialog based on the value of a Yes/No (boolean) expression configured at the start step of a workflow. Conditional start step controls are available for both object and multi-document workflows. Controls that can be hidden include Participant, Date, or Field controls. Learn more about configuring start steps for object and multi-document workflows.

Object Lifecycle & Workflow Expression Enhancement

With this feature, expressions in object workflow configuration and lifecycle configuration support additional fields, functions, and operators. These items were already available in other expression-based features in Vault object configuration. The additional items are supported in expressions within Event Actions and Entry Actions in lifecycles, and within Update Record Field and Update Related Record Field steps of workflows.

For example, these areas now support functions such as If and Case, and operators such as >= (greater than or equal to) and <= (less than or equal to).

Learn more about expression support across Vault in the Vault Formula Reference Guide.

Reporting

Column Sorting in Reports is Consistent with Library

With this release, column sorting in Vault reports is consistent with what users see in the Library and other lists within Vault. Sorting is now case insensitive, which means that text beginning with the same characters appear next to each other regardless of capitalization. In addition, blank cells no longer appear at the top when users select ascending, and instead appear below cells with values for both ascending and descending.

Increase Maximum Number of Objects for Standard Report Type

This feature increases the default maximum number of objects that can be included in a standard report type to ten (10).

Object Formula Field Enhancements for Reports

This feature allows Admins to define report formula fields on objects directly in a Report View. In addition, users can now include Picklist field types when defining formula fields in reports.

Search & Filter

Contains Operator for Advanced Filtering

This feature adds a new contains operator to the advanced filtering options for Picklist and Object Reference field types. This operator returns any documents or object records that match any portion of the search string.

For example, when users filter on the Country field using the contains operator and enter the term United, Vault returns all search results with United States, United Kingdom, or United Arab Emirates in the Country field. Learn more about advanced filtering.

In past releases, when related object filters were configured on object tabs, they were only available in the Advanced Search dialog. Now, users can add these related object filters in the Filters section of the tab sidebar. For example, users can add a Country Decision Detail filter within the Regulatory Objective object tab on RIM Vaults. Learn more about applying related object filters.

Checklists

Checklist: Ad Hoc Questions

Admins can configure Checklists to allow respondents to add questions to checklist instances on an ad hoc basis. Learn more about ad hoc questions.

Auto Claims Linking

Auto Claims Linking: Prevent Duplicate Records

This enhancement prevents users from saving new and updated Claim records if doing so would create an exact duplicate of an existing record. Duplicates are defined as Claims with identical Match Text and matching field values. Note that, for the purpose of duplicate validation, Vault treats wildcards as plain text, and ignores excluded characters, trailing periods, and trailing exclamation points.

Auto Claims Linking: Preview & Create Anchor from Claims

With this feature, users with the appropriate permissions can preview, select, and create anchor annotations while defining references on Claim records.

Learn more about previewing and creating anchors.

Administration

Rendition Status

This feature introduces the Rendition Status page, which provides Admins with the ability to view the status of a rendition and troubleshoot rendering issues with source documents. The Rendition Status page provides Admins with clear and actionable information on specific rendering failures and errors.

From the Rendition Status page, Admins can apply filters to find specific renditions statuses.

Job API Enhancements

To make the UI and API consistent, the Instance ID label has been updated to Job ID on the Admin > Job Status page.

Vault Loader

Vault Loader Export Usability Enhancements

This feature enhances column selection filtering and Where Clause token help for Vault Loader Document, Document Relationship, Document Version, Object, and Legacy User extractions. Learn more about extracting metadata and files with Vault Loader.

Vault Loader Bulk Document Attachment Enhancements

Vault Loader now supports the creation and deletion of document attachments. In addition, this feature adds support for the extraction of document attachment relationships. Learn more about managing document attachments with Vault Loader.

Vault Loader Bulk Object Attachments Support

Vault Loader now supports the creation and deletion of object attachments. Learn more about managing object attachments with Vault Loader.

File Staging for Vault Loader CLI: View Remote Server & Create Folders

With this feature, users can view directories and files, create new folders, or delete existing folders on their Vault’s file staging server using the Vault Loader Command Line tool (CLI). Learn more about file staging for Vault Loader CLI.

Vault Java SDK

SDK Job Queues

Admins can now create custom SDK job queues for use with Vault Java SDK integrations from Admin > Operations > SDK Job Queues. Prior to this release, it was not possible to create custom job queues and only the default System queues were available. This feature also completes the SDK Jobs UI Enhancement in the last release by separating the SDK Job Queues from the Spark queues.

Learn more about SDK Job Queues.

Move Spark Queues to the Connection Tab

Admins can now access Spark Queues under the Connection tab alongside the other Spark components. This enhancement streamlines UI navigation when creating Spark integrations, and separates Spark Queues from SDK Job Queues.

Spark Integration Rule Support for Object Relationships

Spark Integration Rules, which fetch and map data in Vault to Vault integrations, now support object relationships from the source Vault. This allows the Spark integration to retrieve data based on the configured relationship from the source Vault.

For example, there is a Spark integration which needs to retrieve a Product’s Manufacturer’s Incident Phone Number, where Manufacturer is represented as an object relationship field on the Product object. With this feature, integration rules can map the relationship between Product and Manufacturer. For example, the Vaccine product has a Manufacturer field with the value VeePharm, where VeePharm is a Manufacturer object record which has a text field labelled Incident Phone Number. Given the Vaccine product, this Spark integration can quickly grab the Incident Phone Number on the related VeePharm record.

Learn more about the primary query object, which enables object relationships for your integration rules.

Field Default Prompts in Field Rule UI

With this feature, Admins can easily configure field rule defaults for their Spark integrations with prompts specific to the target field. For example, if the target field is a Yes/No (boolean) field, Vault prompt for a value of True or False. If the target field is a Date field, a date selector calendar UI appears. Previously, these values were entered manually which may have left room for error.

Vault Java SDK Service Account

A new Java SDK Service Account user appears in the Users & Groups tab. This system-managed, read-only user will support future Vault functionality. Vault does not include this user in license counts.

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 Enabled field on the Document Type Detail (doc_type_detail__v) object.
  • Added an additional value to the Check Out Types (checkout_types__sys) picklist.
  • Added additional values to the Link Status (link_status__v) picklist.

Added the following components to support the Checklist: Ad Hoc Questions feature:

  • Added the Ad Hoc (ad_hoc__v) field to the Response (response__sys) object.
  • Added the Ad Hoc Questions Allowed (ad_hoc_questions_allowed__sys) field to the Checklist Design (checklist_design__sys) object.

Clinical Operations

Site Connect Enhancements

This feature provides a number of enhancements to the Veeva Site Connect application. This includes support for transferring additional Vault Clinical Artifacts and a new standard Site Connect rendition type. Learn more about Veeva Site Connect.

Site Connect: Additional Vault Clinical Docs Support

With this release comes support for transferring additional document types via Veeva Site Connect. Document types mapped to the following Vault Clinical Docs artifacts can now be exchanged between Clinical Operations Vaults and SiteVault Vaults:

  • Data Privacy Agreement
  • Investigators Agreement (Device)
  • Investigator Newsletter
  • Investigator Regulatory Agreement
  • Note to File
  • Other Financial Agreement
  • Other Site Staff Medical License
  • Site Signature Sheet
  • Visit Log

Yuzu: CTN Enhancements

With this release, we’ve made various enhancements to Yuzu Clinical Trial Notifications, including:

  • Option to keep old organization- and person-related information for the designated Study Organization and Study Person identified on CTNs
  • Track changes made to CTN Remarks records

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 and updated the following components to the Clinical Operations data model.

Added the following components to support the Site Connect Enhancements feature:

  • Added the Site Connect Rendition (site_connect_rendition1__c) Rendition Type to all Vaults with Vault Site Connect enabled

Added the following components to support the Site Connect: Additional Vault Clinical Docs Support feature:

  • Added the following Artifact (hierarchy__v) records:
    • Investigator Newsletter
    • Note to File
    • Other Site Staff Medical License
    • Subject Log
    • Visit Log

Added the following components to support the Yuzu: CTN Enhancements feature:

  • Added the Use Study Specific Info / 試験固有の情報を使用 (use_local_info__v) field to the CTN Data / 治験届関連情報(ctn_data__v) object for the following object types:
    • Study Site (study_site__v)
    • Study Organization (study_organization__v)
    • Study Person (study_person__v)
  • Added the Include in CTN / 届出書記載 (include_in_ctn__v) field to the CTN Remarks / 備考 (ctn_remarks__v) object
  • Added the CTN Remarks / 備考 (ctn_remarks__v) field to the CTN Data Change Log (ctn_data_change_log__v) object
  • Added the Study Site (site__v) field to Study Organization (study_organization__v) and Study Person (study_person_v) types of CTN Data / 治験届関連情報 (ctn_data__v) objects

Commercial

Embedded Source Document Metadata

This feature was postponed to a future release.

In the 20R3 release, we added the eCTD Compliance Package feature, which automatically creates the compliance package, generates submission-ready copies of documents, and converts Vault link annotations to relative PDF links for both Post Marketing and Pre Clearance Compliance Packages. Previously, users would need to export the compliance package and open the ZIP file to check the relative PDF links.

With this release, relative PDF links open in PromoMats, and users no longer need to export the compliance package to open the links. Note that relative PDF links can still be opened after exporting the compliance package.

Quality

Maximum Attempts for Quizzes

With this Vault Training feature, learners can retry a training assignment’s quiz a specified number of times. Once a learner exceeds the maximum attempts for a quiz, Vault locks the quiz and notifies training admins or managers. While the quiz is locked, the training assignment is still accessible so that the learner can continue to review material within the assignment.

Once locked, quizzes can be unlocked by training admins or managers. If configured with a lockout period, the quiz will be auto-unlocked after a preset period of time. Learn more about creating quizzes for training assignments.

Station Manager: Record Based Categorization

This feature allows customers to manage categories for Station Manager using object records and use Vault’s access controls to restrict which users can manage categories and the assignment of categories to Station Documents. Object-based categories are flexible and enable scoping, by Facility for example, to allow each site to manage their own list of categories.

This feature will be supported by future versions of the Vault Station Manager mobile applications. Learn more about setting up document categorization.

QMS to Registrations Update & Resync Enhancements

This feature extends the QMS to Registrations Spark Connection to allow updates to data in both the QMS Vault and the Registrations Vault after the initial regulatory Event has been created. These enhancements support the following scenarios:

  • Users can resend updates to the impacted product scope in the QMS Vault to the Registrations Vault manually, which updates the Event record with additional impacted product information.
  • If the initial impact scope changes and new impacted countries are added in the Registrations Vault, users can send these to the QMS Vault.
  • New Activity lifecycle state types represent when the filing has been submitted and when the filing type indicates an implicit approval, for example, when a change is able to be implemented immediately in a given market.

Learn more about configuring and using the QMS to Registrations Spark Connection.

US FDA eMDR Enhancements

This feature was postponed to a future release.

EU MIR Data Model Updates

This feature was postponed to a future release.

Updates to Cloning Rules for Vault Training Objects

With this release, when a Vault is cloned, the following Vault Training objects are not cloned:

  • Learner Role (learner_role__v)
  • Curriculum (curriculum__v)
  • Training Requirement (training_requirement__v)
  • Curriculum-Learner Role (curriculum_learner_role__v)
  • Training Requirement-Curriculum (training_requirement_curriculum__v)

Users can use Vault Loader to move data from these objects to a target Vault.

Quality Teams: Team Role Attribute Label Change

To support future functionality, the Quality Teams Team Role attribute Constraining Role label has been updated to Constraining Application Role.

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 Station Manager: Record Based Categorization feature:

  • Added the Station Manager Category (station_manager_category__v) object with the following fields:
    • Category Label (name__v)
  • Added the Station Document Categorization (station_document_categorization__v) object with the following fields:
    • Station Document (station_document__v)
    • Station Manager Category (station_manager_category__v)
  • Added the Station Manager Category Lifecycle (station_manager_category_lifecycle__v) object lifecycle with the following states:
    • Approved (approved__v)
    • Inactive (inactive__v)
  • Added the Station Document Categorization LC (station_document_categorization_lc__v) object lifecycle with the following states:
    • Approved (approved__v)
    • Inactive (inactive__v)

The following changes were made to support the Updates to Cloning Rules for Vault Training Objects feature:

The following objects are no longer cloned:

  • Learner Role (learner_role__v)
  • Curriculum (curriculum__v)
  • Training Requirement (training_requirement__v)
  • Curriculum-Learner Role (curriculum_learner_role__v)
  • Training Requirement-Curriculum (training_requirement_curriculum__v)

The following changes were made to support the Maximum Attempts for Quizzes feature:

  • Added the Unlock Quiz User Input (unlock_quiz_user_input__v) object with the following fields:
    • Name (name__v)
    • Quiz Unlock User Input Type (object_type__v)
    • Additional Attempts (additional_attempts__v)
    • New Due Date (new_due_date__v)
  • Added the following fields to the Checklist Design (checklist_design__sys) object and enabled on Quiz Checklist Design (vdta_checklist_design__sys) object type:
    • Max Attempts Required? (max_attempts_required__v)
    • Max Attempts (max_attempts__v)
    • Auto Unlock? (auto_unlock__v)
    • Lockout Period (Days) (lockout_period_days__v)
    • Auto Update Due Date? (auto_update_due_date__v)
    • Extended Due Date Duration (extended_due_date_duration__v)
  • Added the following fields to the Training Assignment (training_assignment__v) object and enabled on Vault Document Training Assignment (vault_document_training_assignment__v) and External Training Assignment (external_training_assignment__v) object type:
    • Max Attempts Required? (max_attempts_required__v)
    • Max Attempts (max_attempts__v)
    • Attempts Remaining (attempts_remaining__v)
    • Total Attempts (total_attempts__v)
    • Auto Unlock? (auto_unlock__v)
    • Lockout Period (Days) (lockout_period_days__v)
    • Quiz Locked On (quiz_locked_on__v)
    • Quiz Unlock Date/Time (quiz_unlock_datetime__v)
    • Auto Update Due Date? (auto_update_due_date__v)
    • Extended Due Date Duration (extended_due_date_duration__v)
    • Quiz Locked (quiz_locked__v)
  • Added the following field to the TA Checklist (ta_checklist__sys) object:
    • Last Attempt? (last_attempt__v)

The following changes were made to support the Vault Product Surveillance application:

  • Added a new lifecycle: Reportable Event Lifecycle (reportable_event_lifecycle__v)

The following changes were made for the EU MIR: Data Model Changes feature, to support future functionality:

  • Added Health Authority (health_authority__v) object type to Organization (qms_organization__qdm)
  • Added the following fields to the Organization (qms_organization_qdm) object:
    • NCA EUDAMED # (nca_eudamed_no__v)
    • Notified Body Id # (notified_body_id__v)
    • Health Authority Type (health_authority_type__v)
  • Added the following object type to the Person (person_sys) object:
    • Contact (contact__v)
  • Inactivated the following objects:
    • Reporter (reporter__v)
    • Contacts (contact__v)
  • Added following object type to Reportable Event (reportablre_event__v) object with new data fields:
    • EU MIR (eu_mir__v)
  • Added following new objects with associated data fields:
    • Single Registration Number (single_registration_number__v)
      • Organization (organization__v)
      • Organization Capacity (org_capacity__v)
      • Single Registration Number (srn__v)
      • Country (country__v)
    • Person – Organization (person_organization__v)
      • Organization (organization__v)
      • Person (person__v)
    • Contact Information (contact_information__v)
      • Organization (organization__v
      • Person (person__v)
      • Contact Type (contact_type__v)
      • Unit (unit__v)
      • Street Name (street_name__v)
      • Street Number (street_number__v)
      • Address Details (address_details__v)
      • Additional Address Info (additional_address_info__v)
      • City (city__v)
      • Postal Code (postal_code__v)
      • Zip Code (zip_code__v)
      • Zip Extension (zip_extension__v)
      • PO Box (po_box__v)
      • State (state_address__v)
      • Country (country__v)
      • Primary Email (primary_email__v)
      • Email 2 (email_2__v)
      • Email 3 (email_3__v)
      • Primary Phone (primary_phone__v)
      • Phone 2 (phone_2__v)
      • Phone 3 (phone_3__v)
      • Primary Fax (primary_fax__v)
      • Fax 2 (fax_2__v)
      • Fax 3 (fax_3__v)
      • Website (website__v)
    • Notified Body Product (notified_body_product__v)
      • Notified Body Name (notified_body_name__v)
      • Notified Body (NB) Certificate Number (nb_cert_num__v)
      • Product (product__v)
    • Multi Device Reportable Event (multi_device_reportable_event__v)
      • Reportable Event (reportable_event__v)
      • Multi Device -NCA Reference # (nca_ref_multi_dev__v)
      • Multi Device -EUDAMED Reference # (eudamed_ref_multi_dev__v)
      • Multi Device -Manufacturer Reference # (mfr_ref_multi_dev__v)
    • FSCA Reportable Event (fsca_reportable_event__v)
      • Reportable Event (reportable_event__v)
      • FSCA NCA Reference # (nca_ref_fsca__v)
      • FSCA EUDAMED Reference # (eudamed_ref_fsca__v)
      • FSCA Manufacturer Reference # (mfr_ref_fsca__v)
    • PSR (psr__v)
      • Reportable Event (reportable_event__v)
      • PSR ID (psr_id__v)
    • PMCF/PMPF (pmcf_pmpf__v)
      • Reportable Event (reportable_event__v)
      • PMCF/PMPF EUDAMED Id (pmcf_pmpf_eudamed_id__v)
    • Similar Incidents (similar_incidents__v)
      • Reportable Event (reportable_event__v)
      • Region (region__v)
      • Period (period__v)
      • Start Date (start_date__v)
      • End Date (end_date__v)
      • Similar Incidents (similar_incidents__v)
      • No. of Devices (no_of_devices__v)

Regulatory

Publishing Progress Indicator

A new Publishing Status field displays the current state of submissions publishing and report level publishing, providing a visual indicator to let users know if Vault is still processing publishing jobs. When configured, users can view Publishing Status on Submission, Report Level Content Plan, Content Plan, and Content Plan Item object records. Learn more about viewing publishing progress.

Documents Matched to Inactive Content Plan Items

In the Content Plan Hierarchy Viewer, documents matched to inactive Content Plan Item records now display struck through document icons. This icon allows users to differentiate these from documents matched to active Content Plan Item records when filtering matched documents in the viewer.

Content Plan Tokens Create Sections Alphabetically

When Content Plan Template hierarchies include Content Plan section tokens, Vault now creates new repeating sections in alphabetical name order. This change aligns with the default display order of Submission relationship records.

Save Import Results as Attachments

With this release, if attachments are enabled on the Submission object, Vault automatically saves the import results as an attachment on the Submission record if an error or warning occurs during import. Vault up-versions the attachment with subsequent imports to the same Submission record. Learn more about accessing submission import results.

Create & Update Dossier Details

With this release, Vault automatically creates and updates Dossier Detail records at submission import with the import status, the number of files in the imported dossier, and the imported dossier size. To leverage this feature, the Dossier Details and Dossier Status fields must be assigned to the Submission record’s object type.

Allow Imports to Proceed with Invalid XML

A new setting on the Admin > Settings > Application Settings page allows users to import eCTD dossiers that are invalid according to the DTD or XSD. Vault will display a warning but won’t block the submission import. The dossier must contain util-related files and folders for the import to proceed. Learn more about enabling submission imports with invalid XMLs.

Dynamic Sorting in Submissions Archive Viewer

With this release, Admins can choose to order documents and sections in the Submissions Archive Viewer dynamically. When enabled, Vault reorders submissions within the Viewer based on the Actual Submissions Date on the Submission record, even if the date is populated after an import has already taken place. If no date is available, Vault defaults to the Ordering Date Time field on the Submission Metadata object record. This enhancement also corrects the order of sections that were not placed in the correct order at the time of import. Learn more about dynamic sorting.

Display Sequence ID

Vault now uses the Sequence ID (xml_submission_id__v) field to display a leaf’s operation lifecycle within the Submissions Archive Viewer, Historical Leaf Lifecycle dialog, Cumulative View dialog, and within the Dossier Panel. If the field is not populated on the Submission record, Vault will continue to display the Submission record’s Name field.

Detect Source from Content Plan

RIM Submissions Archive Vaults now leverage the matched documents within a submission content plan to identify the source document of imported content. If an active Content Plan Item record in the submission content plan has a Published Output Location that corresponds to a file location in the current import, Vault uses the matched document as the source for the Submissions Archive-type document as well.

UI Updates in Bundling & Splitting Wizards

This feature adds the following enhancements to the record grid pages in the Activity and Regulatory Objective bundling wizards as well as the Regulatory Objective splitting wizard:

  • Bundling grids now display 50 records per page, increased from 10 records per page, to better accommodate customers with large datasets
  • Searching or applying filters in the grids no longer clears any previously-selected records
  • Every grid page now includes a clear indicator displaying the total number of selected records selected for any given step of the bundling or splitting process, regardless of the filters or search settings applied

Pull Objective Data for Medical Devices & Manufacturing Sites

The Pull Objective Data user action now supports pulling additional medical device- and manufacturing site-related data from a Regulatory Objective record’s details into a Submission record’s details. Additionally, this action now supports object type mappings to create Submission details with the appropriate object types for drug submissions or medical device submissions. Learn more about configuring and using the Pull Objective Data user action.

Include New IDMP Relationships in Manage Registered Details Wizard

This feature updates the scope of the Manage Registered Details wizard to support new registered detail objects added for IDMP functionality. Users can now:

  • Create and update additional Registered Indication fields
  • Create and update Registered Shelf Life and Storage and Registered Site Role records
  • Update includes Registered Packaged Medicinal Product records

All new records are subject to verification workflows and registration history reporting based on your Vault’s settings.

QMS to Registrations Update & Resync Enhancements

This feature extends the QMS to Registrations Spark Connection to allow updates to data in both the QMS Vault and the Registrations Vault after the initial regulatory Event has been created. These enhancements support the following scenarios:

  • Users can resend updates to the impacted product scope in the QMS Vault to the Registrations Vault manually, which updates the Event record with additional impacted product information.
  • If the initial impact scope changes and new impacted countries are added in the Registrations Vault, users can send these to the QMS Vault.
  • New Activity lifecycle state types represent when the filing has been submitted and when the filing type indicates an implicit approval, for example, when a change is able to be implemented immediately in a given market.

Learn more about configuring and using the QMS to Registrations Spark Connection.

IDMP: Integration with RMS

This feature integrates Vault RIM with the EMA’s Referentials Management System (RMS) using the EMA’s public REST-based API. The structured data from RMS will populate values of the Controlled Vocabulary records relevant to IDMP, for example, route of administration, dosage form, and units of measurement. Learn more about configuring the EMA RMS integration.

XEVMPD Enhancements

This feature improves the overall XEVMPD submission process by providing targeted updates to validation results and acknowledgement handling. Additionally, this feature updates submission document handling to accommodate multiple languages and introduces tracking for traffic through the EMA gateway. Learn more about XEVMPD gateway submission.

Regulatory 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 the following components to support the Include New IDMP Relationships in Manage Registered Details Wizard feature:

  • Added the Submission Shelf Life and Storage (submission_shelf_life_and_storage__v)* object.
  • Added the Regulatory Objective (regulatory_objective__v) field to the following objects:
    • Registered Shelf Life and Storage (registered_shelf_life_and_storage__v)
    • Registered Packaged Medicinal Product (registered_packaged_medicinal_product__v)
  • Added the following fields to Regulatory Objective Indication (regulatory_objective_indication__v) object:
    • Full Indication Text (full_indication_text__v)
    • Indication Translations (indication_translation__v)
    • Orphan Designation (orphan_designation__v)
  • Added the following values to the Impacted Record (impacted_record__v ) picklist:
    • Registered Shelf Life and Storage (registered_shelf_life_storage__v)
    • Registered Packaged Medicinal Product (registered_packaged_medicinal_product__v)

* Admins must create an object lifecycle for this object to use the feature.

Added the following components to support the XEVMPD Enhancements feature:

  • Added the XEVMPD Acknowledgement (xevmpd_acknowledgement__v) object with object types and object page layouts:
    • XEVMPD Level 1 (xevmpd_level_1__v)
    • XEVMPD Level 2 (xevmpd_level_2__v) with additional fields:
      • Attachment EV Code (attachment_ev_code__v)
      • Document EV Code (document_ev_code__v)
      • Local Number (local_number__v)
    • XEVMPD Level 3 (xevmpd_level_3__v)

Added the following components to support the QMS to Registrations Update & Resync Enhancements feature:

  • Added the following lifecycle state types to all RIM Vaults:
    • Submitted (submitted__v)
    • Implicit Approval (implicit_approval__v)

Added the following components to support the Dynamic Sorting in Submissions Archive Viewer feature:

  • Added the Ordering Date Time (ordering_date_time__v) field on Submission Metadata (submission_metadata__v) object.

Added the following components to support the Publishing Progress Indicator feature:

  • Added the Publishing Status (publishing_status__v) field, available when configuring the object page layouts on the following objects:
    • Submission (submission__v)
    • Content Plan (edl__v)
    • Content Plan Item (edl_item__v)
    • Report Level Content Plan (report_level_content_plan__v)

Added the following components to support the IDMP: Integration with RMS feature:

  • Added the following fields to the Controlled Vocabulary (controlled_vocabulary__rim) object:
    • SPOR Domain (spor_domain__v)
    • SPOR List ID (spor_list_id__v)
    • SPOR List Name (spor_list_name__v)
    • SPOR Term (spor_term__v)
    • SPOR Version (spor_version__v)
  • Added the following fields to the Language (language__rim) and Country (country__v) objects:
    • SPOR Domain (spor_domain__v)
    • SPOR List ID (spor_list_id__v)
    • SPOR List Name (spor_list_name__v)
    • SPOR Status (spor_status__v)
    • SPOR Term (spor_term__v)
    • SPOR Version (spor_version__v)
    • Valid as Of (valid_as_of__v)
  • Added additional values to the Controlled Vocabulary Type (controlled_vocabulary_type__rim) picklist.

Safety

Safety features are targeted for tentative availability on December 17, 2020.

Recode Badge for MedDRA Terms Auto-on

Users are now made aware with a visible indicator if a term MedDRA version is out of sync with the Case MedDRA version.

Learn More: Recode a MedDRA Term

Drug/Biologic/Vaccine-Led Combination Product Intake Auto-on

Safety.AI will support intake for Drug, Biologic, and Vaccine Combination Products on the Inbox Item. On case promotion the combo product information will be mapped to the product constituents and product constituents’ information will be downloaded from the library.

Learn More: Manage Combination Products

MedDRA Coding on Inbox Item Auto-on

Safety.AI now leverages the Vault Safety Central Medical Dictionary for Regulatory Activities (MedDRA) to code terms for Adverse Events, Medical History, and Case Product Indication on the Inbox Item.

Learn More:

RegulatoryOne

Obsolete Features

The following RegulatoryOne features will no longer be available:

  • Formula Insights by Internal & Regulatory Agency Standards
  • Ingredient Lists
  • Generate Submission Ingredients
  • Product Raw Material Ingredient Rollup

Veeva Claims

Note that Veeva Claims features are targeted for tentative availability on December 22nd.

Claim Creation Uniqueness Check

This feature prevents duplicate Claim record creation when users create records manually or by copying records. Vault checks if a Claim record already exists with the same claim Statement and Product combination, and avoids duplicate record creation. This uniqueness check increases the efficiency and accuracy of the Claims approval process.

SiteVault

Research Organization Defaulting for Documents & Objects

This new standard behavior allows customers to meet information security requirements with less manual work. Vault automatically populates the Research Organization field on new documents and object records. If the user creating the document or record is assigned to a Site, Vault also populates the Research Site field.

Enablement Details

Name Enablement Application
Working with Documents
Audio & Video Renditions for CrossLinks Auto-on Platform
Video Playback Speed Controller Auto-on Platform
Document Owner Can Undo Checkout for All Check Out Types Auto-on Platform
Enabled Field for Document Type Detail Object Auto-on Platform
Document Auto-Naming: Excluded Characters Auto-on Platform
Admin Field Layout Matches Doc Info Auto-on Platform
Vault Objects
Prevent Document Add in Related Document Section Configuration Platform
Lifecycle & Workflow
Enablement Change: Atomic Security for Document Lifecycles Auto-on Platform
Multi-Document Workflow: Short Circuit Tasks Configuration Platform
Object & Multi-Document Workflow: Send Notification Based on Roles Configuration Platform
Object and Multi-Document Workflow: Conditional Controls on Start Step Configuration Platform
Object Lifecycle & Workflow Expression Enhancement Configuration Platform
Reporting
Column Sorting in Reports is Consistent with Library Auto-on Platform
Increase Maximum Number of Objects for Standard Report Type Auto-on Platform
Object Formula Field Enhancements for Reports Auto-on Platform
Search & Filter
Contains Operator for Advanced Filtering Auto-on Platform
Related Object Filter Updates Auto-on Platform
Checklists
Checklist: Ad Hoc Questions Configuration Platform
Auto Claims Linking
Auto Claims Linking: Prevent Duplicate Records Auto-on1 Platform
Auto Claims Linking: Preview & Create Anchor from Claims Auto-on1 Platform
Administration
Rendition Status Auto-on Platform
Job API Enhancements Auto-on Platform
Vault Loader
Vault Loader Export Usability Enhancements Auto-on Platform
Vault Loader Bulk Document Attachment Enhancements Auto-on Platform
Vault Loader Bulk Object Attachments Support Auto-on Platform
File Staging for Vault Loader CLI: View Remote Server & Create Folders Auto-on Platform
Vault Java SDK
SDK Job Queues Auto-on Platform
Move Spark Queues to the Connection Tab Auto-on Platform
Spark Integration Rule Support for Object Relationships Auto-on Platform
Field Default Prompts in Field Rule UI Auto-on Platform
Vault Java SDK Service Account Auto-on Platform
Platform Data Model Changes
Platform Data Model Changes Auto-on Platform
Clinical Operations
Site Connect Enhancements Auto-on SiteConnect
Site Connect: Additional Vault Clinical Docs Support Auto-on SiteConnect
Yuzu: CTN Enhancements Support CTMS
Clinical Operations Data Model Changes Auto-on CTMS, SiteConnect, Study Startup, Vault Payments, eTMF
Commercial
eCTD Compliance Package: Relative PDF Links Work in PromoMats Auto-on PromoMats
Quality
Maximum Attempts for Quizzes Configuration Training
Station Manager: Record Based Categorization Configuration Station Manager
QMS to Registrations Update & Resync Enhancements Configuration QMS
US FDA eMDR Enhancements Auto-on Surveillance
EU MIR Data Model Updates Auto-on Surveillance
Updates to Cloning Rules for Vault Training Objects Auto-on Training
Quality Teams: Team Role Attribute Label Change Auto-on QMS
Quality Data Model Changes Auto-on QMS, QualityDocs, Station Manager, Surveillance, Training
Regulatory
Publishing Progress Indicator Configuration RIM Publishing
Documents Matched to Inactive Content Plan Items Auto-on RIM Submissions
Content Plan Tokens Create Sections Alphabetically Auto-on RIM Submissions
Save Import Results as Attachments Auto-on RIM Submissions Archive
Create & Update Dossier Details Configuration RIM Submissions Archive
Allow Imports to Proceed with Invalid XML Admin Checkbox RIM Submissions Archive
Dynamic Sorting in Submissions Archive Viewer Admin Checkbox RIM Submissions Archive
Display Sequence ID Auto-on RIM Submissions Archive
Detect Source from Content Plan Auto-on RIM Submissions Archive
UI Updates in Bundling & Splitting Wizards Auto-on RIM Registrations
Pull Objective Data for Medical Devices & Manufacturing Sites Auto-on RIM Registrations
Include New IDMP Relationships in Manage Registered Details Wizard Configuration RIM Registrations
QMS to Registrations Update & Resync Enhancements Configuration RIM Registrations
IDMP: Integration with RMS Configuration RIM Registrations
XEVMPD Enhancements Auto-on2 RIM Registrations
Regulatory Data Model Changes Auto-on RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive
RegulatoryOne
Obsolete Features Auto-on RegulatoryOne
Veeva Claims
Claim Creation Uniqueness Check Auto-on Veeva Claims
SiteVault
Research Organization Defaulting for Documents & Objects Auto-on SiteVault Enterprise, SiteVault Free
  1. Auto-on in PromoMats and MedComms Vaults. This feature is currently unavailable in other Vaults.
  2. Auto-on in Vaults with XEVMPD configured.

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.