New in 20R1.3: Auto-Place Brought Forward Image Annotations and more

Release Date: June 5, 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

Auto-Place Brought Forward Image Annotations

With this release, brought forward annotations on images and text can be automatically placed based on the page and coordinates in the source version. If the coordinates or page do not exist in the new version, Vault places the annotations at the page level.

Restore Resizing to Annotation Comments Field

The ability to manually resize the Comment field in Create Annotation and Edit Annotation dialogs was removed in a prior release. This feature restores that ability and makes minor improvements. Now, users can resize the Comment field vertically to make it taller or shorter. Users cannot resize the field to make it wider. When users resize the field, the entire dialog increases to accommodate the new field size. This allows the author to view significantly more entered text at once.

Save Version to Vault Without Ending Collaboration Session

Users participating in a collaborative authoring session can now save the latest “Edit Version” to Vault without ending the collaborative authoring session for themselves or other users. The same file remains checked out to Microsoft Office 365, allowing collaborative editing to continue.

As in 20R1, the only users who can check in and end the collaboration session are the Check Out User, the document Owner, and Vault Owners. These users have the ability to Save To Vault, in addition to Check In. Learn more about collaborative authoring.

Shared Lookup Fields for Documents

Admins can now create Lookup type document fields as shared fields. It is also possible to convert existing lookup fields into shared fields. In order to share a lookup field with a document type, an Admin must ensure the Lookup Object Field is on the same document type or inherited from a parent document type.

Update to Archived Document Security Enhancements

This feature updates permissions related to the Archive tab. To view the Archive tab, users must have the Tab: Archive and View Archive permissions. Users with the Manage Archive permission automatically have View Archive permission.

Unified Navigation Behavior when Clicking Object References in Document Fields

In previous releases, clicking on an object record in a document field would take the user to a custom tab, the business admin page, or to a standalone object details page, depending on the user’s access. This feature makes the behavior more consistent. With this release, Vault always takes the user to a standalone object detail page for the object record, even if the user has access to a custom tab or the Business Admin page.

Vault Objects

This feature allows users to change the object type of related object records using the Actions menu within related record sections on an object record details page.

This feature allows users to copy a related object record directly from the Actions menu within related record sections on an object record details page. Copy Record is available for all types of related lists except simple many-to-many related lists.

Full EDL Job Match

In this release, the Match EDL Items to Documents job is optimized to run more efficiently. As a result, the first time that Vault runs the Match EDL Items to Documents job after the release, every document in a customer’s Vault will be evaluated for matches against all active EDL Item records. It is possible that Vault will match or unmatch older EDL Items and documents because the Match EDL Items to Documents job has only been doing incremental updates prior to this release. After the job runs fully once, it will return to incremental updates. Learn more about the Match EDL Items to Documents job.

Link (link__sys) is a system field on all objects that is used for integrations, including Spark Messaging integrations. In past releases, this field allowed up to 1,500 characters. This release reduces the maximum field length to 255 characters.

Lifecycle & Workflow

Variables for Multi-Document & Object Workflows

This feature supports the creation of workflows with more branching options. Admins can define a variable (text, picklist, or yes/no) when configuring a workflow and then use the variable value as the basis for a decision step. For example, a workflow could prompt at the start for whether training is required. Based on the Workflow Initiator’s response, the workflow could follow a branch that includes a training task. Learn more in Configuring Multi-Document Workflows and Configuring Object Workflows.

Atomic Security for Documents: Active Workflow Actions

With this release, Admins have more granular control over who can perform actions like Cancel Workflow, Add Participant, Reassign Task, and Cancel Task on an active workflow. Previously, access to these actions was granted at the permission set level and the Workflow Initiator had automatic access. Admins can now define access to each of these actions by document lifecycle state and document lifecycle role. For example, users in the Editor role may only be able to Cancel Task while a document is in certain lifecycle states.

When enabled, the Workflow Initiator / Workflow Owner no longer receives automatic access to these actions. Admins will need to ensure that users who start workflows are also in document lifecycle roles with access to manage their active workflows if this is needed.

Reporting

Or Filter Logic

This feature allows users to determine whether AND or OR logic should apply between two filters or prompts in reports. Users can also add parentheses to group certain filters together.

Support Priority Multi-Document Workflow Fields in Reports

This feature adds support for the Task Verdict Comment and Task Verdict Reason fields for multi-document workflows in Workflow with Document reports. Additionally, Task Verdict Comments has been added as a default field to the Workflow History Report. Learn more about workflow fields.

This feature offers a CJK Optimized setting on Vaults with Chinese, Japanese, or Korean text in object record fields. When this setting is enabled, Vault will split all CJK phrases into words on object record text fields when users search so that field values are easier to find.

Vault Formulas

Updates to Object Workflow & Lifecycle Formula UI

This feature updates the formula editor for object lifecycles and workflows. The formula editor is now consistent with the editor available when configuring objects.

Usability & UI Updates

Localize Vault to Hungarian

The Veeva Vault UI now supports Hungarian. Users can update the language Vault displays for them by changing the language settings on the User Profile page. Vault also supports setting Hungarian translations for labels in user-configurable data such as document types, fields, picklist values, and lifecycle names. Learn more about supported languages and localization settings.

Enablement Change: Localize Vault to Dutch

In past releases, the Veeva Vault UI supported Dutch for customers that requested it through Veeva Support. Now, Dutch is available automatically. Users can update the language Vault displays for them by changing the language settings on the User Profile page. Vault also supports setting Dutch translations for labels in user-configurable data such as document types, fields, picklist values, and lifecycle names. Learn more about supported languages and localization settings.

Administration

Inbound Component Dependency Validation

This feature enhances the Review & Deploy process for Configuration Migration packages by showing information regarding component relationships. In addition to component comparison information, Vault now provides component dependencies, identifying whether they are required and whether they exist in the inbound package or the target Vault. In case any steps are not ordered correctly for deployment, users will be able to reorder them prior to deployment. Learn more about Inbound Component Dependency Validation.

Document Migration Mode for Vault Loader

In Vault Loader, the Object Type Create action for Document Renditions, Document Versions, and Documents, Versions, Roles can now be used without placing the entire Vault in Migration Mode. In order to use this feature, the user must have the new Document Migration permission and enable the Document Migration Mode checkbox in the Vault Loader UI or use the -documentmigrationmode parameter in the Vault Loader Command Line tool. Learn more about Document Migration Mode.

Notification Preferences

With this release, notification preferences can be configured to help users manage emails coming from Vault. Admins can configure the following notification types:

  • Task Notifications
  • User Mentions
  • Send as Link
  • Shared Views

By default, Vault sends an email notification for every occurrence of user tasks, user mentions, send as link, and shared views. If a notification type is set to Summary, messages of this type will be held until the next scheduled email. Vault will collate summary notifications together and send them as a single email. Vault sends Shared View-type notifications when a user shares a search view. Learn more about email & messages.

Custom Job Processors with the Vault Java SDK

In this release, the Vault Java SDK now provides the ability to create custom job processors. After creating a custom job processor and deploying it to your Vault, SDK Job will appear as a selectable Type when creating a new job definition from Admin > Operations > Job Definitions. In addition, Vault extensions such as triggers or actions can execute job processors without a job definition.

Spark Integration Rules UI

With this release, Admins can now configure Spark Messaging integration rules in the Vault UI. Previously, integration rule configuration was only available through MDL. With this feature, Admins can configure integrations much more quickly and easily.

Rename Permission for Mobile Applications

With this release, the Enable App Store Configuration permission is relabeled to Enable Direct Installation. The new label and associated help text better reflect the behavior of this permission for Vault mobile applications. Learn more about permission sets.

Domain Users: Add Vaults in CSV Export

When a Domain Admin filters on All Users or Current Domain on the Domain Users page and exports the list of users to CSV, the exported file now includes a list of Vaults to which each user is assigned. Learn more about the Domain Users page.

Authentication & Security

Separate SAML SSO Configuration for Login & eSignature

Vault now supports a new type of SAML profile, eSignature Profile, specifically for electronically signing documents and object records via SAML. As part of this feature, we also renamed SAML Profiles to Single Sign-on Profiles. Using eSignature Profile is optional: if not configured, Single Sign-on Profile is used for both SSO login and eSignatures. One Single Sign-on Profile and one eSignature Profile can be associated with a Security Policy. Learn more about Configuring SAML Profiles.

Vault File Manager

Vault File Manager: Check In & Check Out Enhancements

With this release, Vault no longer opens new browser tabs when checking out to and in from Vault File Manager.

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 made the following changes to the Platform data model:

  • Added the Annotations (Auto Links) (annotations_auto__v) document field. In PromoMats, these are links that Vault creates automatically when there are exact matches. In all other Vaults, this field exists to support future functionality.
  • Added the following new picklist fields to the User (user__sys) object:
    • Tasks (tasks__sys)
    • User Mentions (user_mentions__sys)
    • Shared Views (shared_views__sys)
    • Send as Link (send_as_link__sys)

Clinical Operations

EDL Automation for Study Personnel, Organizations & Products

This feature allows users to apply EDL Item Templates to specific roles for a Study Person, Study Organization, and Study Product in a given study. Vault automatically creates EDL Items that match on a Person, Organization, or Product when those are added to a study, and it links the new EDL Items to open milestones based on template configuration. This feature is available for configuration in Vaults with the Clinical EDL Template Refactor and Person & Organization Migration features enabled. Learn more about working with EDLs.

RBSM: Clinical Risk Assessments

This feature allows users to curate a library of selectable risks, create re-usable risk assessment templates, and generate study-specific risk assessments. By tracking impact, probability, and detectability on study-specific risks, along with an overall risk score on the study-specific risk assessment, users can understand specific areas of risk and how this study compares to the risk of other studies. Learn more about Risk Based Study Management.

Archive TMF

Archive TMF User Action & Snapshot

This feature introduces a user action to archive a study, its documents, and its related records in a single automated job. The Initiate Study Archival action moves study documents into the Vault platform archive, moves the study, its countries, and its sites into the Archived lifecycle state, and inactivates related records such as EDLs, Milestones, and CTMS objects. For documents used across multiple studies, the action creates a study-specific copy, or snapshot, of the document and archives that copy. Learn more about archiving studies with lifecycles.

This feature ensures that CrossLink documents are protected from further changes when a study is archived. At the moment of archival, the system automatically creates snapshots of all CrossLink documents to ensure their immutability, while allowing the original CrossLink documents to live on for future use.

Archive TMF Security

This feature enables study team assignments and new document upload for archived studies. Access to the newly available capabilities for archived studies is controlled by the Manage Archive permission. Learn more about managing archived studies.

Pre-Save Field Defaulting

This feature improves defaulting behavior for document metadata field values populated by Vault based on values in other fields. Previously, the controlled field did not update until after saving. Now, the controlled field values update dynamically to reflect changes to the controlling field in real-time while the user is editing.

Yuzu: CTN Enhancements

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

  • CTN Site IP Name is now selectable from a list on Study Country records
  • Improved error handling for XML validation
  • User action to trigger the Change Log job immediately
  • JIS Level 1 and 2 character sets validation for CTN data
  • Format improvements for generated documents

Learn more about Clinical Trial Notifications.

Milestone Evolution & Standard Metrics

With this feature, Veeva has defined industry-standard Global Milestone Types, and Global Milestone Offsets to measure key cycle times between milestones. Users can map custom milestone types to these standards and Vault calculates Cycle Times between completed milestones on a daily basis and recalculates Cycle Times to support historical data. This feature is available for Admin configuration in Study Startup Vaults. Learn more about Global Milestone Types and Cycle Times.

Investigator Initiated Studies in Vault Clinical Operations

This feature allows users to track the internal processes of Investigator Initiated Studies, including proposal review and approval, study planning and execution, publication tracking, and document tracking. Learn more about Investigator Initiated Studies.

Vault Clinical Docs Update

This feature adds new artifact records to the Vault Clinical Docs Model so that users can map certain document types with more granularity.

Clinical Operations Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Clinical Operations data model. These data model updates are automatically available on all Clinical Operations Vaults.

We have made the following changes in support of Archive TMF:

  • The Archive study lifecycle state is an active state instead of archived.
  • In previous releases, archiving a study switched the record to Inactive status. In the current release, records in the Archived lifecycle state have Active status.

  • Setting a study to Archived cascades the archived status to the country and site. In previous releases, the status cascaded to site only.

  • We have added the following components to support EDL Automation for Study Personnel, Organizations, & Products:

    • Added the following values to the EDL Matching Field (edl_matching_field__v) picklist:
      • Person (person__v)
      • Organization (organization__v)
      • Product (product__v)
    • Added the following object types to the Template EDL (edl_template__v) object:
      • Person (person__v)
      • Organization (organization__v)
      • Product (product__v)
    • Added the following object types to the Template Expected Document (edl_item_template__v) object:
      • Person (person__v)
      • Organization (organization__v)
      • Product (product__v)
    • Added the following fields to the Template Expected Document (edl_item_template__v) object:
      • Application Role and Study Team Role (team_role__v)
      • Study Organization Role (study_organization_role__v)
      • Study Product Role (study_product_role__v)
    • Added the following object types to the Template EDL (edl_item__v):
      • Person (person__v)
      • Organization (organization__v)
      • Product (product__v)
    • Added the following fields to the Template EDL (edl_item__v):
      • Person (person__v)
      • Study Person (study_person__v)
      • Organization (organization__v)
      • Study Organization (study_organization__v)
      • Product (product__v)
      • Study Product (study_product__v)
    • Added the Selected Study Organization Role Lifecycle (selected_organization_role_lifecycle__v) lifecycle to the Selected Study Organization Role (selected_organization role__v) object.

We have added the following components to support Milestone Evolution and Standard Metrics:

  • New objects:
    • Global Milestone Type (global_milestone_type__v)
    • Global Milestone Offset (global_milestone_offset__v)
    • Global Milestone Mapping (global_milestone_mapping__v)
    • Cycle Time (cycle_time__v)
  • Added Point in Time (point_in_time__v) object type to the following objects:
    • Milestone (milestone__v)
    • Template Milestone (milestone_template__v)
  • New fields on Milestone Dependency (milestone_dependency__v) object:
    • Previous Template Milestone (previous_milestone_type__v)
    • Next Template Milestone (next_milestone_type__v)
    • Baseline Finish-to-Finish (Days) (baseline_finishtofinish_days__v)
    • Actual Finish-to-Finish (Days) (actual_finishtofinish_days__v)
    • Planned Finish-to-Finish (Days) (planned_finishtofinish_days__v)
  • New fields on the Template Milestone Dependency (milestone_dependency_template__v) object:
    • Previous Template Milestone (previous_milestone_type__v)
    • Next Template Milestone (next_milestone_type__v)
  • Added Block Automatic Updates (block_automatic_updates__v) field to the Milestone (milestone__v) object.

We have added the following components to support Investigator Initiated Research:

  • Investigator Initiated Study (investigator_initiated_study__v) object
  • Investigator Initiated Study Lifecycle (investigator_initiated_study_lifecycle__v) lifecycle
  • Investigator Initiated Study Documents (investigator_initiated_Study_documents__v) document type
  • Investigator Initiated Study (investigator_initiated_study__v) field
  • Added the following picklists:
    • Publication Type (publication_type__v)
    • Type of Support Requested (type_of_support_requested__v)

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

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

We have added the following components to support RBSM: Clinical Risk Assessments:

  • New objects:
    • Risk (risk__v)
    • Risk Category (risk_category__v)
    • Risk Template (risk_template__v)
    • Risk Assessment Template (risk_assessment_template__v)
    • Study Risk (study_risk__v)
    • Study Risk Category (study_risk_category__v)
    • Study Risk Assessment (study_risk_assessment__v)
  • New picklists:
    • Impact (impact__v)
    • Probability (probability__v)
    • Detectability (detectability__v)
    • Response Type (response_type__v)
  • New lifecycles:
    • Risk Assessment Template Lifecycle (risk_assessment_template_lifecycle__v)
    • Risk Assessment Template Lifecycle (study_risk_assessment_lifecycle__v)
    • Study Risk Category Lifecycle (study_risk_category_lifecycle__v)
    • Study Risk Lifecycle (study_risk_lifecycle__v)

We have made the following changes to support Yuzu: Japanese Clinical Trial Notification Generation:

  • Added the CTN IP Name / 治験薬名称 (ctn_ip_name__v) object
  • Removed the IP Name / 治験薬名称 (ip_name__v)field
  • Added the Clinical Trial Notification / 治験届 (ctn__v) shared document field
  • Added the Original CTN (original_ctn__v) field on the Clinical Trial Notification / 治験届 (ctn__v) object
  • Added CTN Data Change Logs / 変更履歴 section to the Clinical Trial Notification / 治験届 Detail Page Layout (clinical_trial_notification_detail__c) on the Clinical Trial Notification / 治験届 (ctn__v) object
  • Added the Hide Change Log (hide_change_log__c) layout rule to the Clinical Trial Notification / 治験届 Detail Page Layout on the Clinical Trial Notification / 治験届 (ctn__v) object
  • The Number of Amendment / 変更回数 (amendment_count\__v) field has been removed from the following object types on the Clinical Trial Notification / 治験届 (ctn__v) object:
    • Trial Completion Notification / 治験終了届 (trial_completion_notification__v)
    • Trial Termination Notification / 治験中止届 (trial_termination_notification__v)
    • Protocol Notification / 治験計画届 (protocol_notification__v)
  • Added the External ID (external_id__v) field to the CTN Data / 治験届関連情報 (ctn_data__v) object and all object types
  • Added the CTN Data Lifecycle (ctn_data_lifecycle__v) lifecycle to the CTN Data / 治験届 関連情報 (ctn_data__v) object
  • Added the following page layouts to the CTN Data / 治験届関連情報 (ctn_data__v) _o_bject:
    • Organization Detail Page Layout (ctn_data_org_detail_layout__c)
    • Person Detail Page Layout (ctn_data_person_detail_layout__c)
    • Product Detail Page Layout (ctn_data_product_detail_layout__c)
    • Study Organization Detail Page Layout (ctn_data_study_org_detail_layout__c)
    • Study Person Detail Page Layout (ctn_data_study_person_layout__c)
    • Study Site Detail Page Layout (ctn_data_site_layout__c)
  • Added the following fields to the CTN Data (ctn_data__v) object:
    • Study Organization Name (study_organization_name__v)
    • Study Organization Site (study_organization_site__v)
    • Study Person Name (study_person_name_v)
    • Study Person Role (study_person_role__v )
    • Study Person Site (study_person_site__v)
  • Added the following fields to the Study Person (_study_person__v) object type for the _CTN Data / 治験届関連情報 (ctn_data__v) object:
    • Study Person Name (study_person_name__v)
    • Study Person Role (study_person_role__v)
    • Study Person Site (study_person_site__v)
  • Added the following fields to the Study Organization (study_organization__v) object type for the CTN Data / 治験届関連情報 (ctn_data__v) object:
    • Study Organization Name (study_organization_name__v)
    • Study Organization Site (study_organization_site__v)
  • Added the CTN Data Change Log Lifecycle (ctn_data_change_log_lifecycle__v) lifecycle to the CTN Data Change Log (ctn_data_change_log__v) object
  • Added the CTN Site IP Lifecycle (ctn_site_ip_lifecycle__v) lifecycle to the CTN Site IP/ 治験施設治験薬情報 (ctn_site_ip__v) object

We have added the following Artifact (hierarchy__v) records to support Vault Clinical Docs Update:

  • Operational Procedure Manual
  • Expedited Safety Report
  • Pre-Study Visit Follow Up Letter
  • Pre-Study Visit Confirmation Letter
  • Site Initiation Visit Confirmation Letter
  • Site Initiation Visit Follow Up Letter
  • Interim Monitoring Visit Confirmation Letter
  • Interim Monitoring Visit Follow Up Letter
  • Close-Out Visit Confirmation Letter
  • Close-Out Visit Follow Up Letter
  • Remote Monitoring Visit Confirmation Letter
  • Remote Monitoring Visit Follow Up Letter

We have removed the following object types from the Study Organization (study_organization__v) object in support of Person & Organization Migration:

  • Study Organization (study_organization__v)
  • Study Country Organization (study_country_organization__v)
  • Study Site Organization (study_site_organization__v)

We have added the following lifecycles and assigned them to the corresponding objects unless a custom lifecycle is already assigned to that object:

  • Location Lifecycle (location_lifecycle__v) to the Location (location__v) object
  • Organization Lifecycle (organization_lifecycle__v) to the Organization (organization__v) object

We have added the Pending Decision (pending_decision_v) value to the EDL Requiredness (edl_item_requiredness__v) picklist.

Commercial

Auto Claims Linking: Manually Target Claims

When enabled, this feature allows users to select an Approved Claim when manually creating link annotations on documents with non-text content if the Suggest Links action is enabled for the document type. Selecting a Claim record results in a Claim Link: a manually created link annotation with non-editable links to the references defined in the selected Claim.

After selecting the link tool, users with permission see a link type selector in the toolbar. When the user selects Claims, then selects image or text content, Vault opens the record picker dialog containing all Approved Claims that the user has permission to view.

This enhancement allows users to leverage the approved Claims Library when manually referencing content, including creating links to approved references on images and pseudo-text, which cannot be linked by the Suggest Links action. Claim links are not available in Video Annotations. Learn more about manually adding claim links.

When a user performs the Suggest Links action, and a Claim or Match Text Variation matches the content exactly (without wildcards), Vault bypasses the Review & Approve step and creates a pre-approved link annotation known as an Auto Link. By comparison, when a user manually Accepts a Suggested Link, the result is known as an Approved Link. Once created, Auto Links can be removed in bulk by the Remove Suggested Links button, which removes both Suggested Links and Auto Links (but not Approved Links). Users can also delete their own Auto Links manually.

To opt out of Auto Linking, contact Veeva Support. Learn more about Auto Links.

This feature provides greater focus and efficiency when reviewing references by allowing users to control the visibility of manual and auto links on a document. Manual Links include standard, manually created link annotations, as well as Claim Links. Auto Links include both Approved Links and Auto Links (if enabled). The new Manual Links and Auto Links filters replace the existing Links filter, and do not impact the visibility of pending Suggested Links, which are filtered separately. Manual Links, Auto Links and Suggested Links filters are only visible in Vaults with Suggest Links enabled. Learn more about filtering by link type.

When the Suggest Links action is initiated, Vault displays a Generating suggested links… message. Vault now updates this message to notify the user when the action is completed successfully, or fails, or when the Suggest Links action takes longer than three (3) minutes. This timeout period was incorrectly identified as 60 seconds in a previous version of these release notes.

Vault Digital Publishing Security Update

This feature enhances Vault Digital Publishing configuration to prevent inappropriate configurations and provide configuration validation. When configuring digital publishing, an additional step is required to ensure appropriate access to the S3 buckets that are in use. The feature is on automatically, and existing Vaults with Digital Publishing in a working state do not need to make configuration changes unless any of the CloudFront or S3 configuration is changed. Learn more about configuring Vault Digital Publishing.

Standard Metrics: Make Mandatory

Standard Metrics was turned on for all PromoMats Vaults in 20R1 with three user input fields: Global Content Type, Content Creation Currency, and Content Creation Cost. This feature makes these fields mandatory on all documents and adds four new currencies to the Content Creation Currency field: Swiss Franc, Canadian Dollars, Chinese Yuan, and Australian Dollars. Standard Metrics fields cannot be hidden, but can be configured with default values.

For more information, visit the Vault PromoMats Standard Metrics resource center.

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:

  • Updated the following fields to be mandatory on all documents:
    • Content Creation Cost (content_creation_cost__v)
    • Content Creation Currency (content_creation_currency__v)
    • Global Content Type (global_content_type__v)
  • Added the following new document fields:
    • Annotations (Claim Links) (annotations_claim__v)
    • Annotations (Auto Links) (annotations_auto__v)

Quality

QRM: Process FMEA Assessment Methodology Support

This enhancement to Vault Quality’s Risk Management (QRM) feature suite introduces the ability to model Process FMEA (pFMEA) risk assessments within your Vault. These are separate from Risk Registers, but function similarly, so if users are already familiar with Risk Registers within QRM, the details of this new feature set will be easy to learn.

Organizations can now create pFMEA risk assessment records to model risk assessments of processes within the business. Processes require a set of steps to be identified, such that the events within a pFMEA assessment are tied to individual steps, supporting a procedural approach to risk identification, analysis and mitigation. FMEA Risk Assessments contain FMEA Risk Events which represent unique combinations of failure mode, effect, cause and control within a step of a process. Users can tag specific FMEA Risk Events with more general Risk Categories for trending and reporting. These FMEA Risk Events are scored with pre- and post-assessment fields to capture Severity, probability of Occurrence, and Detectability scores, combined in an overall Risk Priority Number for the event. FMEA Risk Assessments make use of the existing Risk Matrix, Risk Matrix Setup and Risk Level functions of Vault QRM to model the qualitative and quantitative scoring systems for your organization’s assessments. For details on the new data model elements introduced with pFMEA support, see the Quality Data Model Updates section of these release notes.

In addition to modeling your pFMEA Risk Assessments, events and process steps, this new feature set introduces the ability to duplicate a completed or in progress FMEA assessment. This action allows users to re-assess a process without changing your original assessment. This FMEA Assessment-specific action clones the Assessment, Step, Risk Event and Mitigation Action Set records and their field data into a new set of records, then restarts the lifecycles for those records. Copying the records and their field values allows for a clean re-assessment, including the removal or addition of new Risk Events in the new assessment. In this release, the copy action will not duplicate inbound relationships for any of the records copied. However, records copied in this way will maintain a reference to the record they were copied from, allowing for traceability of assessments in the system. Note that this functionality assumes the process itself has not changed between assessments. For processes which have had their steps changed, we recommend creating a new FMEA assessment to account for accurate modeling of Risk Events against process steps.

For existing QMS customers, this new feature set will require configuration by an Admin.

Lastly, based on feedback from our customers, this feature also introduces the ability for QRM Risk Matrices and their component configurations to be cloned between environments for easier deployment and sandboxing. Learn more about Process FMEA Risk Assessments.

Facilitated Training

This feature enables a Training Admin, or a user with proper access, to give completion credit for Training Assignments on behalf of Learners. This allows completion of Training Assignments for Learners that may not have access to Vault. For example, in some organizations, users could be contractors, external employees, temporary employees, or otherwise outside the primary organization.

The Facilitated Training feature allows organizations to have Learners that do not reference a user account. Vault Training automation still issues Training Assignments, but does not assign a workflow task. After training is held, a Training Admin can create a Facilitated Training Request record and select the Training Assignments for which to give completion credit. After completing the Facilitated Training Request process, the linked Training Assignments are moved to the Completed state. Learn more about Facilitated Training.

Training Nightly Job Performance & Robustness Improvements

This feature improves the performance and robustness of the Update Training Assignments job which drives Vault Training automation. In addition to internal improvements, the job can now more gracefully handle issues encountered while processing Training Assignments. In previous releases, the job would stop upon encountering an issue on one training path. With this release, the job now continues to issue Training Assignment records even if an issue is encountered, skipping paths which have issues. Learn more about Vault Training automation.

Assignment Details Lifecycle State No Longer Updated

To improve accurate reporting and searching, the Assignment Details lifecycle state is no longer updated. In previous releases, the Assignment Details lifecycle state changed when the Training Assignment entered the Assigned, Completed, or Cancelled states.

With this release, there is now a lookup field on Assignment Details records that references the parent Training Assignment record’s lifecycle state. This provides a real-time indication of the Training Assignment lifecycle state. This change also improves the performance of the Update Training Assignment job by negating the need to change the Assignment Details lifecycle state.

Note that if there are reports, filters, or views that use Assignment Detail lifecycle state, customers should update those items to instead use the Training Assignment Lifecycle State lookup field. The Assignment Details lifecycle state is no longer in sync with the Training Assignment’s lifecycle state. Learn more about Training Assignments and Assignment Details.

Training Assignment Lifecycle User Actions

With this release, Admins can now edit user actions on the Training Assignment Lifecycle. This feature is only intended to support the Download Formatted Output user action. Avoid configuring other actions to this lifecycle, such as the Change State to or Start Workflow user actions, as this may cause issues, such as duplicate Training Assignments or preventing the completion of active Training Assignments. Learn more about configuring Vault Training.

Updated Training Requirement Document Picker Dialog

The dialog box when selecting documents in a Training Requirement or Training Requirement Impact Assessment has been updated to match the checkbox-style document picker introduced in the 20R1 Vault release.

Include Purpose for eSignatures Cascaded from MDCCs to Documents

This feature allows adding purposes when cascading eSignatures from Document Change Controls to Documents to be made Effective and Obsolete. On the signatures page with a new token for purposes, users will now be able to differentiate between eSignatures for release and eSignatures for obsolescence. This ensures that if a user approves the release of a document, then later approves the obsolescence of that same version, this activity is recorded as two separate signatures.

Admins can set purpose values in the workflow steps for cascading eSignatures system actions, and include the signature purpose token in the eSignature template. Once the values are set, the purposes are also manifested in the document’s audit trail. If an Admin does not set purpose values in the workflow steps, all behaviors remain as-is. Learn more about cascading eSignatures.

Auto-Close Completed MDCCs: Job Logging, Label & Field Updates

The following enhancements have been made to the Auto-Close Completed MDCCs feature:

  • The “Close Multi-Document Change Control” entry action is relabeled to “Check and Close Document Change Control”.
  • Logging for the Close Document Change Control job includes information about the document version whose state transition started the job.
  • The Closure System Details field can no longer be modified by users (only by the system).

Learn more about configuring Multi-Document Change Control.

Enablement Change: QMS to Registrations Spark Connection

Enablement of the QMS to Registrations Spark Connection for Change Control & Variation Management no longer requires a Support request to activate. Use of this feature still requires configuration. Learn more about the configuring the QMS to Registrations Spark connection.

Quality Data Model Changes

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

Added the following data model changes to support the QRM: Process FMEA Assessment Methodology Support feature:

  • The Business Process (business_process__v) object has been added to all QMS Vaults, for the purpose of acting as an identifier for which process is being assessed in an FMEA’s scope. This object includes standard fields for use with the FMEA feature set.
  • The FMEA Risk Assessment (fmea_risk_assessment__v) object has been added to all QMS Vaults, for the purpose of modeling a business processes’ risk assessment following the FMEA methodology. This object includes standard fields for use with the FMEA feature set.
  • The FMEA Risk Assessment Lifecycle (fmea_risk_assessment_lifecycle__v) and relevant standard states have been added to all QMS Vaults, for the purpose of modeling the lifecycle of Vault QRM’s FMEA Risk Assessment object.
  • The FMEA Process Step (fmea_process_step__v) object has been added to all QMS Vaults, for the purpose of identifying the individual steps of a process being assessed in an FMEA’s scope. This object includes standard fields for use with the FMEA feature set.
  • The FMEA Risk Event (fmea_risk_event__v) object has been added to all QMS Vaults, for the purpose of modeling a business processes’ risks, as identified by process step, failure mode, failure effect, failure cause and failure controls. This object includes standard fields for use with the FMEA feature set regarding Risk Matrix definition, FMEA specific data elements and Risk Priority Number calculation.
  • The FMEA Risk Event Lifecycle (fmea_risk_event_lifecycle__v) and relevant standard states have been added to all QMS Vaults, for the purpose of modeling the lifecycle of Vault QRM’s FMEA Risk Event object.
  • The QRM Risk Category (qrm_risk_category__v) object has been added to all QMS Vaults, for the purpose of acting as information for the categorization of individual risks identified by the customer’s organization. This object includes standard fields for use with the FMEA feature set.
  • The FMEA Risk Event – QRM Risk Category (fmea_risk_event_risk_category__v) object has been added to all QMS Vaults, for the purpose of linking identified risks in assessments with higher-level categorizations described by the QRM Risk Category object. This object includes standard fields for use with the FMEA feature set.
  • The FMEA Mitigation Action Set (fmea_mitigation_action_set__v) object has been added to all QMS Vaults, for the purpose of modeling a summary of actions taken to mitigate a particular Failure Mode, Effect & Cause. This object includes standard fields for use with the FMEA feature set.
  • The FMEA Risk Mitigation Action Lifecycle (fmea_mitigation_action_lifecycle__v) and relevant standard states have been added to all QMS Vaults, for the purpose of modeling the lifecycle of Vault QRM’s FMEA Mitigation Action Set object.

These changes will not immediately affect end-users, and must be configured (fields added to types of the described objects and, if applicable, Risk Priority Number (RPN) field formulas updated to account for detectability scores on risk events, etc.) before they will modify system behavior.

The following data model changes support the Facilitated Training feature:

  • Added the following new objects:
    • Facilitated Training Request (facilitated_training_request__v)
    • Facilitated Training Request-Training Assignment (facilitated_training_request_training_assignment__v)
  • Added the following new object lifecycles:
    • Facilitated Training Request Lifecycle (facilitated_training_request_lc__v)
  • Updated the following objects:
    • Training Assignment (training_assignment_v) updated with the following fields:
      • Completion Source (completion_source__v)
      • Facilitated Training Request (facilitated_training_request__v)
    • Person (person__sys) object updated with the following field:
      • Person is not a Vault user (person_is_not_a_vault_user__v)
  • Updated the following lifecycles:
    • Training Assignment Lifecycle (training_assignment_lifecycle__v)
      • Added the ‘Person is not a Vault user is No’ condition to Entry Action for the Assigned state

The following data model change supports the Training Assignment Lifecycle User Actions feature:

  • Updated the Training Assignment Lifecycle (training_assignment_lifecycle__v):
    • User actions are now editable for any lifecycle state

The following data model changes support the Assignment Details Lifecycle State No Longer Updated feature:

  • Updated the Assignment Details (assignment_details__v) object with the following field:
    • Training Assignment Lifecycle State (training_assignment_lifecycle_state__v)
  • Updated the Training Assignment Lifecycle (training_assignment_lifecycle__v) object lifecycle:
    • Removed the Change Related Object Lifecycle State entry action for the Assignment Details object for the Assigned, Completed, Cancelled states

Added the following data model change to support the QMS application:

  • The Name field on the Regulatory Impacted Country object is now editable to support auto-naming using the System Managed Field attribute for usage of the object when it is not being automatically named from the RIM Integration.

The following data model changes in QMS were added to support MedTech and Medical Devices utilizing QMS in future releases:

  • Quality Event (quality_event__qdm) object:
    • Fields added for Medical Devices and their processes
    • Quality Event object types added:
      • Nonconformance (nonconformance__v)
      • Medtech Complaints (mt_complaint__v)
  • Context object:
    • Fields added for Medical Devices
    • Context object type added:
      • Parts/Component (part__v)
  • New objects added:
    • Correction (correction__v)
    • Product Return (product_return__v)
    • Containment (containment__v)

QualityOne

Supplier Portal Phase I

This feature offers a simple and easy to use interface that empowers the supplier to effectively collaborate with the buyers when participating in the QMS processes starting with the supplier nonconformance process. Suppliers can review, update, and create nonconformance details, such as reviewing objective photo evidence and creating action items. Admins can configure the supplier portal to include instruction text and a link to sample documentation or guidelines where needed so that users have a clear indication of what is required of them. Learn more about configuring Supplier Portal.

Regulatory

Matched Document Version Locking Entry Criteria

A new Matched Documents are Version Locked entry criteria option is available for Admin configuration on the Content Plan Item object lifecycle. This entry criteria requires that all documents matched to a Content Plan Item record are locked to a Steady state version. Configuring this will help prevent content plans from progressing to a final state when matched documents are not version locked and ensure that content plans contain the correct document version. Learn more about managing content plans with a lifecycle.

Enablement Change: Content Plan Hierarchy Viewer

This release introduces an enablement change for the Content Plan Hierarchy Viewer. In 20R1, an organization needed to contact Veeva Support to request this feature. Now, this updated Hierarchy Viewer is available automatically on any Vaults that do not contain existing Content Plan records. On Vaults that contain Content Plan records already, an Admin can enable this feature from the Settings > Application Settings page.

Expand Content Plan Section to View Descendant Records in Viewer

With this release, a new Expand action is available on Content Plan records in the Content Plan Hierarchy Viewer. This action allows users to expand and view all descendant Content Plan and Content Plan Item records within a content plan section at once, up to the 2,000-record limit. Selecting this action will not expand matched documents in the Hierarchy Viewer. Users will need to expand Content Plan Item records manually to see matched documents.

The Expand action is automatically available for users whose permission sets include the All Object Actions: Execute permission on the Content Plan object. Admins will have to add the Expand: Execute object action permission on the Content Plan object to make this action available to other users.

Additional Content Plan Hierarchy Viewer UI Enhancements

This release includes several minor improvements to the Content Plan Hierarchy Viewer UI:

  • Matched document rows now include a gray document icon to help users more easily differentiate them from Content Plan and Content Plan Item records.
  • When users have active content plan workflow tasks, the task banner now displays below the root Content Plan record name.
  • Users can select additional document fields to display as Matched Document columns, including standard RIM fields and custom fields.

Merge PDF Error Handling

This enhancement provides additional details in the Vault notification message when Vault encounters errors while merging content as part of report level content plan publishing. The CSV file in the notification message now includes a user-friendly message for each document that encounters errors. Any errors, such as encrypted files, files in XFA format, or files exceeding a page limit, cause the PDF merge to fail.

This feature also introduces a new Exclude from Post Processing on Failure checkbox field on the Publishing Validation Criteria object. Admins can choose to set this field on Publishing Validation Criteria records to prevent documents that encounter this error from merging. Learn more about merging published documents into a PDF.

This feature, when configured for a submission, allows documents to be auto-matched to Content Plan Item records of submissions within the same application. This option removes the need for users to manually match documents in cases when they need to reference previously matched documents. Learn more about configuring a submission to allow auto-matching of previously matched documents.

Submissions Archive Switzerland (CH) 1.5 Support

With this release, RIM Submissions Archive Vaults support importing and viewing Switzerland 1.5 DTD submissions.

Thailand eCTD DTD 1.0 Publishing & Validation

With this release, RIM Publishing Vaults support the Thailand v1.0 (DTD 1.0) specification. Users can now create content plans and generate submissions that are compliant with Thailand v1.0 specifications. Vault validates these submissions based on the corresponding Thailand v1.0/01 Validation Criteria. Learn more about working with Thai regulatory submissions.

South Africa eCTD DTD 2.1 Publishing & Validation

With this release, RIM Publishing Vaults support the South Africa v3.0 (DTD 2.1) specification. Users can now create content plans and generate submissions that are compliant with South Africa v3.0 specifications. Vault validates these submissions based on the corresponding South Africa v2.1 Validation Criteria. Learn more about working with South African regulatory submissions.

Switzerland eCTD DTD 1.5 Publishing & Validation

With this release, RIM Publishing Vaults support the Switzerland 1.5 (DTD 1.5) specification. Users can now create content plans and generate submissions that are compliant with Switzerland v 1.5 specifications. Vault validates these submissions based on the corresponding Switzerland v1.5 Validation Criteria. Learn more about working with Swiss regulatory submissions.

Registration History View

This feature allows users to extract audit trail data for registrations and registered details, grouped by the regulatory objective that originated the change. Vault exports the Registration History Report to Microsoft Excel™. Users can extract a report for a set of Registration records across a specific date range or for a single Registration’s entire history. This report supports health authority reporting requirements, such as a history of changes to registration data required for Pharmacovigilance Master File (PSMF) maintenance. Learn more about generating the Registration History Report.

Verification of Registration Data

This feature allows Admins to configure a workflow to run at the end of the update process for registration and registered detail data. This optional enhancement to the Manage Registered Details process starts a workflow to allow users to review proposed changes before Vault commits the updates to existing object records or creates new records. Vault sends data verification tasks to users in Admin-defined roles to allow for a multi-user review of any changes to the data. Once the reviewers confirm changes in accordance with the workflow, Vault updates the registration and registered detail records. Learn more about the verification workflow for registration data.

Manage Registered Details for Medical Devices

Customers using the Regulatory Objective object as the source of data for the Manage Registered Details wizard can now use the wizard to update and add related registration details for medical devices. Customers that have both drug and device registrations can create Object Type Mapping records to ensure that Vault adds new registered details using the appropriate object types. Learn more about managing registered details.

IDMP Phase 1: Algorithms

This feature introduces an aggregation algorithm that will recurse through RIM Registrations data to compile submission data in new IDMP objects. The full IDMP feature set will be delivered across multiple releases. Learn more about generating IDMP data.

Contact Veeva Support to enable the IDMP algorithm and the Generate IDMP Elements user action in your Vault. RIM Registrations Vaults include all IDMP objects automatically.

Enablement Change: QMS to Registrations Spark Connection

As part of the 20R2 release, customers who wish to enable the QMS to Registrations Spark Connection can do so through configuration, without contacting Vault Support to request the feature. This does not automatically enable the feature, but makes the configuration options available to Admins. Learn more about configuring the QMS to Registrations Spark connection.

20R2 Regulatory Data Model Updates

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

Added the following components to support the TH v1.0 eCTD Publishing feature:

  • Added the Licensee Type (licensee_type__v) field to the Application (application__v) object.

Added the following components to support the South Africa eCTD DTD 2.1 Publishing & Validation feature:

  • Added the Submission Efficacy Data Type (sub_eff_data_type__v) value to the Controlled Vocabulary Type (controlled_vocabulary_type__rim) picklist.

Added the following components to support the Merge PDF Error Handling feature:

  • Added the Exclude from Post Processing on Failure (exclude_from_post_processing_on_failure__v) field on the Publishing Validation Criteria (publishing_validation_criteria__v) object.

Added the following components to support the Registration History View feature:

  • Added the Registered Markets (registered_markets__v) field to the Product (drug_product__v).
  • Added the Registered Markets (registered_markets__v) picklist.

Added the following components to support the Verification of Registration Data feature:

  • Added the Unverified Registration Data (unverified_registration_data__v) object with object type:
    • Unverified Data (unverified_registration_data__v.unverified_data\_v)_
    • Summary of Changes (unverified_registration_data__v.summary_of_changes__v)
  • Added the Registration Data Verification (registration_data_verification__v ) object workflows with notifications.
  • Added the Action Type (action_type__v) picklist.
  • Added the Impacted Record (impacted_record__v) picklist.

Added the following components to support the Auto-Match Previously Matched Documents to Multiple Submissions Related to the Same Application feature:

  • Added the Include Previously Matched Documents (include_previously_matched_documents__v) field to the Submission (submission__v) object.

Added the following components to support the IDMP Phase 1: Algorithms feature:

  • Added the IDMP Product Data Submission (idmp_product_data_submission__v) object.
  • Added the IDMP Element (idmp_element__v) object.
  • Added the IDMP Attachment (idmp_attachment__v) object.
  • Added the IDMP Classification System (idmp_classification_system__v) object with object types:
    • ATC Code (idmp_classification_system__v.anatomical_therapeutic_classification__v)
    • Legal Basis (idmp_classification_system__v.legal_basis\__v)
    • Medicinal Product Category (idmp_classification_system__v.medicinal_product_category__v)
    • Paediatric Use (idmp_classification_system__v.paediatric_use\__v)
    • XEVMPD Product Type Information (idmp_classification_system__v.xevmpd_product_type_information\__v)
  • Added the IDMP Master File (idmp_master_file__v) object.
  • Added the IDMP Medicinal Product Element (idmp_medicinal_product_element__v) object.
  • Added the IDMP Medicinal Product Full Name (idmp_medicinal_product_full_name__v) object.
  • Added the IDMP Name Part (idmp_name_part__v) object.
  • Added the IDMP Pharmaceutical Product Element (idmp_pharmaceutical_product_element__v) object.
  • Added the IDMP Product Cross Reference (idmp_product_cross_reference__v) object.
  • Added the IDMP Regulatory Authorisation (idmp_regulatory_authorisation__v) object with object type:
    • Orphan Designation (idmp_regulatory_authorisation__v.orphan_designation\_v)_
  • Added the IDMP Route of Administration (idmp_route_of_administration__v) object.
  • Added the Product Cross Reference (product_cross_reference__v) object.
  • Added the Medical Device Type (medical_device_type__v) field to the Administered Product (administered_product__rim) object.
  • Added the following fields to the Application (application__v) object:
    • Domain (domain__v)
    • Procedure Date End (procedure_date_end__v)
    • Procedure Date Start (procedure_date_start__v)
  • Added the following fields to the Classification System (classification_system__rim) object:
    • ATC (atc__v); also added this field to the ATC object type
    • Medicinal Product Category (medicinal_product_category__v)
    • Paediatric Use Indication (paediatric_use_indication__v); also added this field to the Paediatric Use object type
  • Added the Medicinal Product Category (classification_system\_rim.medicinal_product_category__v) object type to the _Classification System (classification_system__rim) object.
  • Added the following fields to the Active Substance (drug_substance__v) object:
    • Ingredient Role (ingredient_role__v)
    • EU PSUR Single Assessment Procedure Num (eu_psur_single_assessment_procedure_num__v)
  • Added the Contact Subtype (contact_subtype__v) field to the Contact (contact__rim) object.
  • Added the SPOR Referential ID (spor_referential_id__v) field to the Language (language__rim) object.
  • Added the following fields to the Medicinal Product (medicinal_product__rim) object:
    • EURD ID (eurd_id__v)
    • Authorisation Type (authorisation_type__v)
    • PMS ID (pms_id__v)
  • Added the Name Part Type (IDMP) (name_part_type_idmp__v) field to the Medicinal Product Part Name (medicinal_product_name_part__rim) object.
  • Added the Master File Type (master_file_type__v) field to the Organization (organization__rim) object.
  • Added the Orphan Designation (orphan_designation__v) field to the Registered Indication (registered_indication__rim) object.
  • Added the Regulatory Authorisation (regulatory_authorisation__v) object with object type:
    • Orphan Designation (regulatory_authorisation\_v.orphan_designation\_v)
  • Added new values to the Controlled Vocabulary Type (controlled_vocabulary_type__rim) picklist.
  • Added the following shared document fields:
    • IDMP Document Type (idmp_document_type__v)
    • IDMP Effective Date (idmp_effective_date__v)
    • IDMP File Type (idmp_file_type__v)
    • IDMP PMS ID (idmp_pms_id__v)

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

  • Added the Country Language (country_language__v) object.
  • Added the Product Type Jurisdiction (constraint__rim.product_type_jurisdiction__v) object type to the Constraint (constraint__v) object.
  • Added the Organization (organization__v) field to the Health Authority (health_authority__rim) object.
  • Added the Product Type Jurisdiction (product_type_jurisdiction__v) value to the Constraint Scope (constraint_scope__v) picklist.
  • Updated the Description on the Correspondence Event (correspondence_event__v) object.

This release also expands Enhanced Configurability to additional components in RIM Vaults. Enhanced Configurability offers the ability for applications to determine which field attributes in a standard object’s configuration an Admin should be able to edit. Depending on your Vault application’s data model, Admins may be able to edit additional settings, such as system-managed naming or if the field is required, or editing may be blocked on some of these attributes.

  • Added the ability for Admins to enable system-managed naming for the Name (name__v) field on the following objects:
    • Container (container__rim)
    • Application Pharmaceutical Form (application_pharmaceutical_form__v)
    • Submission Pharmaceutical Form (submission_pharmaceutical_form__v)
  • Added the ability for Admins to enable the attribute Audit data changes in this object for the objects:
    • Controlled Vocabulary (controlled_vocabulary__rim)
    • Application Pharmaceutical Form (application_pharmaceutical_form__v)
    • Submission Pharmaceutical Form (submission_pharmaceutical_form__v)
  • Added the ability for Admins to enable the attribute Allow hierarchical copy for the following object fields:
    • Submission (submission__v) field on the Submission Packaging Characteristic (submission_packaging_characteristic__v) object
    • Submission (submission__v) field on the Submission Product Characteristic (submission_product_characteristic__v) object
    • Submission (submission__v) field on the Submission Product Classification (submission_product_classification__v) object
    • Submission (submission__v) field on the Submission Regulatory Objective (submission_regulatory_objective__v) object
    • Submission (submission__rim) field on the Submission Pharmaceutical Product (submission_pharmaceutical_product__rim) object
    • Submission (submission__rim) field on the Submission Active Substance (submission_active_substance__rim) object
    • Submission (submission__rim) field on the Submission Inactive Ingredient (submission_inactive_ingredient__rim) object
    • Submission (submission__rim) field on the Submission Clinical Study (submission_clinical_study__rim) object
    • Submission (submission__rim) field on the Submission Contact (submission_contact__rim) object
    • Submission (submission__v) field on the Submission Pharmaceutical Form (submission_pharmaceutical_form__v) object
    • Application (application__v) field on the Application Pharmaceutical Form (application_pharmaceutical_form__v) object
  • Added the ability for Admins to configure the attribute Allow user to select multiple values for the following object fields:
    • Assigned Department (assigned_department__rim) field on the Health Authority Question (health_authority_question__rim) object
    • Organization Type (organization_type__rim) field on the Organization (organization__rim) object
  • Added the ability for Admins to configure the attribute User must always enter a value (required) for the following object fields:
    • The Manufactured Dosage Form (manufactured_dosage_form__rim) field on the Product Variant (product_detail__v) object
    • The following fields on the Clinical Study (clinical_study__v) object:
      • Product (product__v)
      • Clinical Study Description (clinical_study_description__rim)
      • Study Type (study_type__rim)
      • Study Subtype (study_subtype__rim)
    • The following fields on the Nonclinical Study (nonclinical_study__v) object:
      • Product (product__v)
      • Nonclinical Study Description (nonclinical_study_description__rim)
      • Study Type (study_type__rim)
      • Study Subtype (study_subtype__rim)
    • The Date Received (date_received__v) field on the Health Authority Question (health_authority_question__rim) object
    • The Initial Submission Date (initial_submission_date__rim) on the Regulatory Objective (regulatory_objective__rim) object
    • The Manufacturer (manufacturer__v) field on the Regulatory Objective Active Ingredient (regulatory_objective_active_substance__v) object
    • The Manufacturer (manufacturer__v) field on the Regulatory Objective Drug Product (regulatory_objective_drug_product__v) object
    • The Manufacturer (manufacturer__v) field on the Regulatory Objective Inactive Ingredient (regulatory_objective_inactive_ingredient__v) object
    • The Manufacturer (manufacturer__rim) field on the Registered Drug Product (registered_drug_product__rim) object
    • The Manufacturer (manufacturer__rim) field on the Submission Active Substance (submission_active_substance__rim) object
    • The Manufacturer (manufacturer__rim) field on the Submission Pharmaceutical Product (submission_pharmaceutical_product__rim) object
    • The Manufacturer (manufacturer__rim) field on the _Submission Inactive Ingredient (_submission_inactive_ingredient__rim) object
    • The Related Manufacturer (related_manufacturer__rim) field on the Registered Active Ingredient registered_active_ingredient__rim object
    • The Related Manufacturer (related_manufacturer__rim) field on the Registered Inactive Ingredient (registered_inactive_ingredient__rim) object
    • The following fields on the Submission Nonclinical Study (submission_nonclinical_study__rim) object
      • Nonclinical Study Type (nonclinical_study_type__rim)
      • Nonclinical Study Subtype (nonclinical_study_subtype__rim)
    • The Commitment Due Date (commitment_due_date__rim) field on the Commitment (commitment__rim) object
    • The Pharmaceutical Form Translation (pharmaceutical_form_translation__v) field on the Application Pharmaceutical Form (application_pharmaceutical_form__v) object

Safety

Safety features are targeted for tentative availability on June 11, 2020.

Medical Review Timeline Configuration

Vault Safety now has the ability to display certain case-related events on a visual timeline to help medical reviewers view the progression of events. The system currently supports displaying Case Adverse Events, Case Products, including individual doses, Case Test Result, Case Drug History, and Case Medical History.

Users can toggle individual series on and off and adjust the zoom (amount of time shown). The timeline infers dates from other available information when full dates are not present. Inferred dates are approximate and the underlying data should always be verified before making a final determination.

Learn More: Perform Medical Review

MedDRA Browser Hierarchy Tree View Auto-on

Vault Safety now allows users to browse through MedDRA in the Tree View hierarchy and to refine their searches to a specific MedDRA level to find terms.

Learn More: Code MedDRA Terms: Browse for a MedDRA Term

Optimized Submissions: Local Datasheets & Primary Expectedness Auto-on

This release introduces further enhancements to submissions. Vault Safety will now generate submissions on assessment level expectedness which will be based on a product registration’s country and product. Auto-expectedness will also now calculate only the primary case assessment.

Learn More:

E2B R2 Product Import Converter and Enhancements Auto-on

When importing E2B(R2) files, Vault Safety now merges drug duplicates (B.4.k) and creates a single Case Product, including all of its dosages and substances. The system sends a warning notification if conflicting information is found under drug duplicates.

Learn More: E2B Case Import Data Mapping

Automated Intake API Integration

Vault Safety.AI integrates with Vault API to introduce a publicly accessible endpoint for high-volume case intake.

The Intake API can be used to import new cases from a JSON file. The source JSON file can contain both structured and unstructured data. After a successful operation, the system extracts the data using AI and Natural Language Processing to create an Inbox Item for verification.

The Vault Developer Portal provides more information on the Intake AI endpoint.

Manual Intake and Data Entry

Users can manually create Inbox Items, as an alternative to automated intake through the API. Users can also manually create and remove Case Product and Case Adverse Event child records from Inbox Items.

Natural Language Processing and Data Extraction

Safety.AI uses Natural Language Processing and rule-based algorithms to automatically extract case information from unstructured data (text) sent through the API. This information is then merged with other unstructured and structured data to create an Inbox Item.

Data Verification

The user interface has been designed for Safety.AI to streamline high-volume case intake. The system seamlessly guides users through their verification and data entry tasks on the Inbox Item page, with the ability to edit multiple records at once and verify data extracted through the API while reviewing source data side-by-side.

Safety.AI guides users to review and verify information extracted from unstructured data, such as case narratives. To provide context during data verification, the system shows a snippet of the relevant unstructured data and highlights the extracted value. You can expand and collapse blocks of unstructured data for additional context.

During data verification, users can assign ranks to repeated sections (Case Adverse Event, Product, and Reporter). Sections assigned a rank are listed in descending order.

Create AER for Case Processing

After verifying the data of an Inbox Item, users can create an AER to proceed with case processing. This feature includes section validation to ensure field values are E2B (R3)-compliant.

Duplicate AER Detection

Prior to sending the AER to an external system or promoting it to a Vault Safety Case, Safety.AI compares the current AER against all other AERs in the system to find all potential matches.

Send AER to External System or Promote to Vault Safety

Safety.AI integrates seamlessly with Vault Safety. Customers with the full Vault Safety Suite can promote their AER to a Vault Safety Case and continue with case processing.

For customers using an external system for case processing, Safety.AI transmits AERs through an AS2 Gateway using the ICH-compliant E2B (R3) format.

RegulatoryOne

Product Raw Material Ingredient Rollup

This feature provides users with an action to calculate the ingredients in a product and their concentrations based on the product variant’s raw material concentrations and the raw material’s ingredient concentrations. This capability removes the need for customers to calculate a formula’s ingredient concentration manually.

This feature, when configured for a submission, allows documents to be auto-matched to Content Plan Item records of submissions within the same application. This option removes the need for users to manually match documents in cases when they need to reference previously matched documents. Learn more about configuring a submission to allow auto-matching of previously matched documents.

SiteVault Enterprise

Site Field is System-Managed

Users no longer need to manually update the Site field on documents in SiteVault Enterprise. Now, when an update is made to a document’s Study field, the site for any added studies is also added to the document’s Site field.

Enablement Details

Name Enablement Application
Working with Documents
Auto-Place Brought Forward Image Annotations Auto-on Platform
Restore Resizing to Annotation Comments Field Auto-on Platform
Save Version to Vault Without Ending Collaboration Session Auto-on Platform
Shared Lookup Fields for Documents Configuration Platform
Update to Archived Document Security Enhancements Auto-on Platform
Unified Navigation Behavior when Clicking Object References in Document Fields Auto-on Platform
Vault Objects
Add Change Type Action to Related Record Auto-on Platform
Add Copy Record Action to Related Record Auto-on Platform
Full EDL Job Match Auto-on Platform
Change to Maximum Length for Link Field Auto-on Platform
Lifecycle & Workflow
Variables for Multi-Document & Object Workflows Configuration Platform
Atomic Security for Documents: Active Workflow Actions Support Platform
Reporting
Or Filter Logic Auto-on Platform
Support Priority Multi-Document Workflow Fields in Reports Auto-on Platform
Search
CJK Optimized Record Search Support Platform
Vault Formulas
Updates to Object Workflow & Lifecycle Formula UI Auto-on Platform
Usability & UI Updates
Localize Vault to Hungarian Auto-on Platform
Enablement Change: Localize Vault to Dutch Auto-on Platform
Administration
Inbound Component Dependency Validation Auto-on Platform
Document Migration Mode for Vault Loader Auto-on Platform
Notification Preferences Configuration Platform
Custom Job Processors with the Vault Java SDK Configuration Platform
Spark Integration Rules UI Auto-on Platform
Rename Permission for Mobile Applications Auto-on Platform
Domain Users: Add Vaults in CSV Export Auto-on Platform
Authentication & Security
Separate SAML SSO Configuration for Login & eSignature Configuration Platform
Vault File Manager
Vault File Manager: Check In & Check Out Enhancements Auto-on Platform
Platform Data Model Changes
Platform Data Model Changes Auto-on Platform
Clinical Operations
EDL Automation for Study Personnel, Organizations & Products Configuration1 CTMS, Study Startup, eTMF
RBSM: Clinical Risk Assessments Configuration CTMS
Archive TMF User Action & Snapshot Support eTMF
Archive: Snapshot Crosslink Documents Support eTMF
Archive TMF Security Support eTMF
Pre-Save Field Defaulting Auto-on CTMS, Study Startup, Vault Payments, eTMF
Yuzu: CTN Enhancements Support CTMS
Milestone Evolution & Standard Metrics Configuration Study Startup
Investigator Initiated Studies in Vault Clinical Operations Configuration CTMS, Study Startup, Vault Payments, eTMF
Vault Clinical Docs Update Auto-on CTMS, SiteConnect, eTMF, Study Startup, Vault Payments
Clinical Operations Data Model Changes Auto-on CTMS, Study Startup, Vault Payments, eTMF
Commercial
Auto Claims Linking: Manually Target Claims Support PromoMats
Auto Claims Linking: Option to Auto Link Auto-on PromoMats
Auto Claims Linking: Filter by Link Type Auto-on PromoMats
Auto Claims Linking: Notify User When Suggest Links Completes Auto-on PromoMats
Vault Digital Publishing Security Update Auto-on PromoMats
Standard Metrics: Make Mandatory Auto-on PromoMats
Commercial Data Model Changes Auto-on MedComms, PromoMats
Quality
QRM: Process FMEA Assessment Methodology Support Configuration QMS
Facilitated Training Configuration Training
Training Nightly Job Performance & Robustness Improvements Auto-on Training
Assignment Details Lifecycle State No Longer Updated Auto-on Training
Training Assignment Lifecycle User Actions Auto-on Training
Updated Training Requirement Document Picker Dialog Auto-on Training
Include Purpose for eSignatures Cascaded from MDCCs to Documents Configuration QualityDocs
Auto-Close Completed MDCCs: Job Logging, Label & Field Updates Configuration QualityDocs
Enablement Change: QMS to Registrations Spark Connection Configuration QMS
Quality Data Model Changes Auto-on QMS, QualityDocs, Station Manager, Training
QualityOne
Supplier Portal Phase I Support QualityOne
Regulatory
Matched Document Version Locking Entry Criteria Configuration RIM Submissions
Enablement Change: Content Plan Hierarchy Viewer Auto-on2 RIM Submissions
Expand Content Plan Section to View Descendant Records in Viewer Auto-on3 RIM Submissions
Additional Content Plan Hierarchy Viewer UI Enhancements Auto-on4 RIM Submissions
Merge PDF Error Handling Auto-on RIM Submissions
Auto-Match Previously Matched Documents to Multiple Submissions Related to the Same Application Configuration RIM Submissions
Submissions Archive Switzerland (CH) 1.5 Support Auto-on RIM Submissions Archive
Thailand eCTD DTD 1.0 Publishing & Validation Configuration RIM Publishing
South Africa eCTD DTD 2.1 Publishing & Validation Configuration RIM Publishing
Switzerland eCTD DTD 1.5 Publishing & Validation Configuration RIM Publishing
Registration History View Configuration RIM Registrations
Verification of Registration Data Configuration RIM Registrations
Manage Registered Details for Medical Devices Auto-on5 RIM Registrations
IDMP Phase 1: Algorithms Support RIM Registrations
Enablement Change: QMS to Registrations Spark Connection Configuration RIM Registrations
20R2 Regulatory Data Model Updates Auto-on RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive
RegulatoryOne
Product Raw Material Ingredient Rollup Configuration RegulatoryOne
Auto-Match Previously Matched Documents to Multiple Submissions Related to the Same Application Configuration RegulatoryOne
SiteVault
Site Field is System-Managed Auto-on SiteVault Enterprise
  1. On Vaults with the Clinical EDL Template Refactor and Person & Organization Migration features enabled.
  2. On Vaults that don’t contain existing Content Plan records. Admins can enable this feature from the Application Settings page on other Vaults.
  3. On Vaults with the Content Plan Hierarchy Viewer enabled and for users with the All Object Actions: Execute permission on the Content Plan object.
  4. On Vaults with the Content Plan Hierarchy Viewer enabled.
  5. On Vaults with object type mapping 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.