New in 23R1.4

Release Date: June 30, 2023

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

Platform

Platform Data Model Changes

In addition to the data model changes done for Visual Checklist Designer in 22R1.3, the following changes were also made to ensure that, where applicable, checklist respondents are still allowed or required to attach a document for active checklists that are not completed yet:

  • For [target object] Response ([target object]_response__sys) objects, if the record is a child record of a checklist that is not in the Completed (completed_state__sys) or Inactive (inactive_state__sys) state:

    • If Documents Allowed (documents_allowed__sys) field value is null, copied the values from Attachment Allowed (Document) (doc_attachment_allowed__sys) field to Documents Allowed (documents_allowed__sys) field.
    • If Documents Required (documents_required__sys) field value is null, copied the equivalent values from Attachment Required (Document) (doc_attachment_required__sys) field to Documents Required (documents_required__sys) field.

  • Note: In Quality and QualityOne Vaults, TA Response (ta_response__sys) records for Quizzes are excluded from the data copying, as attaching documents in checklists is not officially supported by Quizzes.

Clinical Operations

Clinical EDL Template Overrides

This feature introduces a more streamlined approach to managing country intelligence. It significantly reduces the need for duplicate expected document templates and provides greater flexibility to countries to define milestone types for Study-level expected documents, making it a valuable tool for enhancing global operations and addressing the diverse regional filing practices.

The key innovation is the introduction of Override Expected Document List (EDL) templates. These templates allow for greater customization, addressing the unique challenges faced by multinational customers, especially when country-specific ethics submissions require a select number of Study-level expected documents.

The following diagram describes the way this feature works. The process begins with a standard EDL Template that applies non-country-specific global standards. It then incorporates an Override EDL Template for country-specific modifications and additions, resulting in a final EDL that combines global standards with country-specific elements.

EDL Template Overrides

Learn more about EDL Administration.

ePRO Monitoring Exports from MyVeeva

Previously, Users could only access Site ePRO data by either requesting the data directly from the site, which can cause delays, or by having access to the ePRO Module, which can cause security concerns. With this feature, Users can now download Site ePRO data directly from Vault Clinical using a new user action, Generate ePRO Survey Report, that is available on Study Sites and Monitoring Events. This action creates a zip file containing the following:

  • Full site survey data 
  • Full site adherence data
  • Aggregated compliance issues report

Notifications alert Users when the ePRO data export is ready for download or if errors were encountered. This feature is enabled through support and is available in Vaults where ePRO is enabled. Studies that have ePRO as a Connected Study Type, have the ePRO code populated, and have sites with Connected Study Agreements will have the user action visible when enabled. Users with all Object Action permissions for Study Site and Monitoring Event can run the Generate ePRO Survey Report action, but this configuration can be updated as needed. 

This feature saves time by eliminating the need to request ePRO data from sites and provides more meaningful information on survey completion and compliance. 

ePRO Monitoring Exports from MyVeeva

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 to support new features:

The following changes were made to Clinical Operations Vaults to support the Clinical EDL Template Overrides feature:

  • Added the Override Template (override_template__v) field to the EDL Template (edl_template__v) object

Commercial 

Modular Content Document Info Panel: Manual Annotation Creation

With this release, users are able to create a link annotation to a Text Asset (Claim/Reusable Text) and/or document directly from the Modular Content Document Info Panel. Content Module Assets not identified with Enhanced Suggest Links now have an ‘Add Link’ action next to them that brings the user directly into the add link annotation mode. This simplifies the process of linking Content Module Assets to areas within the promotional material that were not automatically linked, and is particularly useful when linking Content Module Assets to images on promotional material.

PPTX Video Support for CLM Auto-Publishing

CLM Auto-Publishing allows customers to manage the distribution, creation, versioning, and withdrawal of multichannel content directly from an original MLR document. Previously, when a PowerPoint slide containing a video was pushed to CLM via auto-publishing, Vault displayed a single slide showing the first frame of a video and could not play the video in CLM. As a result, Brand teams had to use the manual Create Presentation feature instead, which required the creation of a multichannel binder and slides which added to the review and approval timeline. 

This new enhancement allows Brand teams to include embedded videos in presentations delivered to CLM via the Auto-Publish feature. Reps can now play videos in CLM on auto-published presentations. This significantly streamlines the review process for getting content to CLM and reduces the duplication of content as the Create Presentation feature is no longer needed for this use case. 

While PPTX files generate a playable video, Vault does not support legacy PPT files and continues to generate the first frame PNG slide of the video. 

23R2 Commercial Data Model Changes

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

The following changes were made to PromoMats Vaults:

  • Removed the CRM Message Template Translation ( crm_message_template_translation__v) object

  • Updated the CRM Message Template (crm_message_template__v) object as follows:
    • Renamed the Global Content Template (global_content_template__v) object type to Universal Content Template (universal_content_template__v)
    • Made Universal Content Template the default object type
    • Removed the Product Content Template (product_content_template__v) object type
    • Added the Country (country__v), Language (language__v), and Text (text__v) object fields
    • Added the Country (country__v), Language (language__v), and Text (text__v) fields to the Manual Assign Content Template (manual_assign_content_template__v) object type

  • Removed the CRM Message Template CRM Product (crm_message_template_crm_product__v) object

  • Removed the CRM Message Template CRM Product Group (crm_message_template_crm_product_group__v) object

  • Removed the CRM Message Template Translations Lifecycle (crm_message_template_translations__v) and added the CRM Message Template Lifecycle (crm_message_template_lifecycle__v)

Medical

MedComms

Standard Responses for Medical Inquiry

This feature introduces a standard, object-based approach to support Standard Responses.  Standard Responses are predefined answers to Medical Inquiries commonly asked by HCPs and Patients.  They are typically the response to an FAQ.

When composing a Case Response, users can select an approved Standard Response.  The list of standard responses can be filtered to show answers to an identified FAQ.

After users select a Standard Response, Vault can populate the Case Response with the response notes, a response package, and a drafted email. Users can choose to update the response package or edit the email, or simply click to email the response.

A Standard Response typically consists of: 

  • Standard Response Notes
  • Guidelines for Use
  • The Product, Country, and Language of the response
  • A package of Fulfillment Documents
  • A Case Response Email Template
  • The FAQ to which it is an answer

This feature helps standardize responses and lessens the time required to create a response package, allowing Medical Inquiry users to manage more responses.

PPTX Video support for CLM Auto-Publishing

CLM Auto-Publishing allows customers to manage the distribution, creation, versioning, and withdrawal of multichannel content directly from an original MLR document. Previously, when a PowerPoint slide containing a video was pushed to CLM via auto-publishing, Vault displayed a single slide showing the first frame of a video and could not play the video in CLM. As a result, Brand teams had to use the manual Create Presentation feature instead, which required the creation of a multichannel binder and slides which added to the review and approval timeline. 

This new enhancement allows Brand teams to include embedded videos in presentations delivered to CLM via the Auto-Publish feature. Reps can now play videos in CLM on auto-published presentations. This significantly streamlines the review process for getting content to CLM and reduces the duplication of content as the Create Presentation feature is no longer needed for this use case. 

While PPTX files generate a playable video, Vault does not support legacy PPT files and continues to generate the first frame PNG slide of the video. 

23R2 Medical 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 Medical data model to support new features:

The following changes were made to Medical Vaults:

  • Removed the CRM Message Template Translation (crm_message_template_translation__v) object

  • Updated the CRM Message Template (crm_message_template__v) object as follows:

    • Renamed the Global Content Template (global_content_template__v) object type to Universal Content Template (universal_content_template__v)
    • Made Universal Content Template the default object type
    • Removed the Product Content Template (product_content_template__v) object type
    • Added the Country (country__v), Language (language__v), and Text (text__v) object fields
    • Added the Country (country__v), Language (language__v), and Text (text__v) fields to the Manual Assign Content Template (manual_assign_content_template__v) object type

  • Removed the CRM Message Template CRM Product (crm_message_template_crm_product__v) object

  • Removed the CRM Message Template CRM Product Group (crm_message_template_crm_product_group__v) object

  • Removed the CRM Message Template Translations Lifecycle (crm_message_template_translations__v) and added the CRM Message Template Lifecycle (crm_message_template_lifecycle__v)

Quality

QMS

Standalone Quality Events Data Model & Feature Parity

With this release, the Vault QMS data model provides standalone data models for Change Controls, Deviations, Findings, Lab Investigations, and Continuous Improvements. These objects were previously managed as object types on the Quality Event object. Due to this broad utilization of the Quality Event object, some customers were running into limit issues which impacted performance and feature expansion. The following features will be supported for the new standalone objects:

Once this feature is available, all new implementations will utilize the new standalone data model. There is no impact or action needed for customers using the current Quality Event data model.

Create Change Actions from Template Records (Standalone Change Control and Change Plan)

The Create Change Actions from Template Records feature was introduced in the 23R1.3 release with support for the Quality Event object. With 23R1.4, this functionality now extends to the standalone Change Control and Change Plan objects. 

LIMS

Test Execution & Exception Summary Enhancements

In the Test Execution and Exception Summary interfaces, there is now better contrast between the Out of Specification and Previously Out of Specification icons, an improved user flow for making Result changes, clearer error text for invalid Test Input entries, and users can now see the outcome of calculations and evaluations for the final Test Step before proceeding.

LIMS Result Exceptions Enhancements

Reopened tests show as exceptions in the Exception Summary widget, and we addressed a rare OOS scenario that could mean the user was not aware of OOS until after test completion.

LIMS Static Data Enhancements

Check Syntax formula errors are no longer included in the formula text itself.

LIMS Automation Enhancements

We have improved the notifications for initiating Batches and Samples, notifying you only in the application and not via email, and have included better support for manually progressing Lab Tests.

Quality Data Model Changes

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

The following change was made to support future Quality integration functionality:

  • Field attributes on the External Batch (external_batch_id__v) field on the Batch object have been updated as follows:

    • User must enter a value = false
    • Value must be unique = true
    • Do not copy this field in Copy Record = true

  • Field attributes on the External ID (external_id__v) field on the Material object have been updated as follows:

    • User must enter a value = false
    • Value must be unique = true
    • Do not copy this field in Copy Record = true

The following changes were made to support the Standalone Quality Events Data Model & Feature Parity feature:

New data model components:

  • Introduced new Change Control object along with the following attributes:

    • Object has the following standard types: GMP Change Control, IT Change Control, and Temporary Change Control
    • Associated Change Control Lifecycle
    • Associated join objects to align with existing Quality Event-Change Control join objects
    • Associated Change Control Sent Notification object and lifecycle and Change Control - Ext Notif Recipient object required for External Notification feature support
    • Object reference field added to Change Action and Document Change Control objects

  • Introduced new Change Plan object with the following attributes:

    • Object has types enabled
    • Associated Change Plan Lifecycle
    • Object reference field added to Change Action and Document Change Control objects

  • Introduced new Continuous Improvement object with the following attributes:

    • Object has types enabled
    • Associated Continuous Improvement Lifecycle
    • Associated join object records to align with existing Quality Event-Continuous Improvement join objects
    • Associated Continuous Improvement Sent Notification object and lifecycle and Cont. Improvement - Ext Notif Recipient object required for External Notification feature support

  • Introduced new Deviation object with the following attributes:

    • Object has the following standard types: GMP Deviation, GCP Deviation, GLP Deviation, and IT Deviation
    • Associated Deviation Lifecycle
    • Associated join object records to align with existing Quality Event-Deviation join objects
    • Associated Deviation Sent Notification object and lifecycle and Deviation - Ext Notif Recipient object required for External Notification feature support

  • Introduced new Finding object with the following attributes:

  • Object has the following standard types: Internal Finding and External Finding
    • Associated Finding Lifecycle
    • Associated join object records to align with existing Quality Event-Finding and Audit-Quality Event join objects
    • Associated Finding Sent Notification object and lifecycle and Finding - Ext Notif Recipient object required for External Notification feature support

  • Introduced new Lab Investigation object with the following attributes:

    • Object has the following standard types: Out-of Specification, Out-of-Tolerance, and Out of Trend 
    • Associated Lab Investigation Lifecycle
    • Associated join object records to align with existing Quality Event-Lab Investigation join objects
    • Associated Lab Investigation Sent Notification object and lifecycle and Lab Investigation - Ext Notif Recipient object required for External Notification feature support
    • Associated Test Plan object and lifecycle
    • Associated Related Lab Deviation object and lifecycle

Updates to existing objects in the QMS data model:

  • Related Event (related_event__v) object

    • Added the following object reference fields:

      • Source Finding
      • Related Finding
      • Source Change Control
      • Related Change Control
      • Source Continuous Improvement
      • Related Continuous Improvement
      • Source Deviation 
      • Related Deviation
      • Source Lab Investigation
      • Related Lab Investigation
      • Source Change Plan
      • Related Change Plan

    • Updated existing standard layout rules to reference new fields

    • Added new standard layout rules for new fields

    • Added the following values to the Related Event Type picklist (related_event_type__v):

      • Finding (finding__v)
      • Change Control (change_control__v)
      • Deviation (deviation__v)
      • Continuous Improvement (continuous_improvement__v)
      • Lab Investigation (lab_investigation__v)
      • Change Plan (change_plan__v)

  • Extension Request (extension_request__qdm) object

    • Added the following object reference fields:

      • Deviation
      • Change Control
      • Change Plan
      • Continuous Improvement
      • Lab Investigation
      • Finding

  • Issue Escalation (issue_escalation__v) object

    • Added the following object reference field:

      • Triggering Deviation

  • CAPA Action (capa_action__qdm) object

    • Added the following object reference fields:

      • Deviation
      • Continuous Improvement
      • Finding

  • Effectiveness Check (effectiveness_check__qdm) object

    • Added the following object reference fields:

      • Deviation
      • Continuous Improvement
      • Finding
      • Change Control
      • Change Plan

  • Impact Assessment (change_control_impact_assessment__v) object

    • Added the following object reference fields:

      • Deviation
      • Continuous Improvement
      • Change Control
      • Change Plan

    • Added the following Yes/No fields:

      • Deviation in Impact Assessment?
      • Cont. Improvement in Impact Assessment?
      • Change Control in Impact Assessment?
      • Change Plan in Impact Assessment?

  • Investigation (investigation__qdm) object

    • Added the following object reference fields:

      • Deviation
      • Lab Investigation

  • Root Cause Analysis (root_cause_analysis__v) object

    • Added the following object reference fields:

      • Deviation
      • Lab Investigation
      • Finding

  • Root Cause (root_cause__qdm) object

    • Added the following object reference fields:

      • Deviation
      • Lab Investigation
      • Finding

  • SCAR (qms_scar__v) object

    • Added the following object reference fields:

      • Deviation
      • Continuous Improvement
      • Finding

  • Quality Event Cycle Time Metric (quality_event_cycle_time_metric__v) object

    • Added the following object reference fields:

      • Deviation
      • Change Control
      • Change Plan
      • Continuous Improvement
      • Finding
      • Complaint
      • Lab Investigation

  • External Collaborator Assignment (external_collaborator_assignment__v) object

    • Added the following standard object types:

      • Deviation Collaborator Assignment
      • Change Control Collaborator Assignment
      • Finding Collaborator Assignment
      • Change Plan Collaborator Assignment

    • Added the following object reference fields:

      • Deviation
      • Change Control
      • Change Plan
      • Finding

  • Record Check Result (record_check_result__v) object

    • Added the following standard object types:

      • Change Plan
      • Finding

    • Added the following object reference fields:

      • Deviation
      • Change Control
      • Change Plan
      • Continuous Improvement
      • Finding
      • Lab Investigation

  • Record Check Match Record (record_check_match_record__v) object

    • Added the following standard object types:

      • Change Plan
      • Finding

    • Added the following object reference fields:

      • Related Deviation
      • Related Change Control
      • Related Change Plan
      • Related Continuous Improvement
      • Related Finding
      • Related Lab Investigation

Safety

Safety features are targeted for tentative availability on July 6, 2023.

Safety

Simplified Case Access Group Security Setup Configuration

In 23R1, Vault Safety introduced Case Access Group Security to provide a more straightforward way to manage access to Cases. The feature matches groups to Cases based on data such as Sponsor, Report Type, Country, and Market Segment. It also provides more granular control over unblinded and protected information.

With this release, setting up Case Access Groups is made even simpler. Optimized matching logic and the addition of a Country field on User Access Group Assignment records make setup more flexible, reducing the administrative burden of creating many Case Access Group Assignment records.

Learn More

PMDA Local Case Processing Automations Auto-on

To streamline reporting and reduce manual effort, Case Product Registrations and Case Assessments are now automatically populated for Domestic and Localized Cases that are reportable to Japan.

PMDA Automated Reportable Product Registration Retrieval
This supports the auto-population of reportable Case Product Registrations, expediting data entry for the J2 data elements of PMDA E2B(R3) reports.

PMDA Local Assessments and Expectedness
Auto-populated Case Product Registrations enable local processors to assess Expectedness more efficiently. Comprehensive Product and Assessment data supports more informed decision-making for both Domestic and Localized Cases.

Learn More

Upgrade/Downgrade Transmission State Evaluation Support

Vault Safety has the option to ignore the Transmission Lifecycle State when considering if a Case qualifies as an Upgrade or Downgrade report to a specific destination. Previously, the Upgrade and Downgrade parameters did not consider if the previous Case version was submitted. As a result, the Downgrade rule might be executed even though the initial Case was not reportable.

Learn More

Gateway Connection IP Management Support

Along with enhanced troubleshooting capabilities, Vault Safety Administrators can now create and delete entries in the IP Allowed list for AS2 Gateway Connections.

Learn More

SafetyDocs

PSMF Automated Vault Report Annexes Configuration

Vault SafetyDocs now leverages Vault Reports to automatically generate PSMF Documents. These reports can contain data such as information about marketed products, studies, and delegated tasks. Previously, every time changes were applied to a specific document, users had to manually run the relevant report, download it, upload it as a document to the relevant binder, and then approve it. This feature allows documents to be updated during PSMF generation or periodic review, making the process more efficient. Additionally, this automated process reduces the risk of errors and ensures compliance with regulatory requirements.

Learn More

Signal Management Configuration

Signal Management is now supported in Vault SafetyDocs. This new area introduces capabilities for conducting Signal Investigations, tracking emerging signals (as Product-Event combinations), and managing the overall lifecycle based on GVP Module IX.

Once configured, users are able to:

  • Track Product-Event combinations and set dispositions
  • Perform Safety Investigations using lifecycle states and workflows based on GVP Module IX
  • Link one or more Product-Events to a Safety Investigation
  • Set final verdicts and dispositions on a Safety Investigation
  • Link documents to a Product-Event combination or Safety Investigation

Using this feature will ensure compliance to Safety standards and increase user productivity.

Learn More

QualityOne

QMS

Supporting Multi-Batch Identification for COA

This feature provides Vault with additional capabilities to determine the number of batches in a single COA file during ingestion and analysis. Based on the number of identified batches, Vault will create one (1) COA Inspection record per batch. Identifying multi-batch COA files allows customers to ingest a wider range of COA formats.

Learn more about analyzing multi-batch COA files.

Training

QualityOne Training Connector: eLearning Data Model Provisioning

This feature extends the existing QualityOne Training Connector with new fields, and an integration and integration point to support E-Learning content synchronization between QualityOne and Training Vault. New fields in the Training Vault capture details from the E-Learning Source Document, while the new integration and integration point aids in the transferring of E-Learning content between the two (2) Vaults.

Learn more about the QualityOne to Training Connection.

Enablement Details

Feature Enablement Application
Platform
Platform Data Model Changes Auto-on Platform
Clinical Operations
Clinical EDL Template Overrides Auto-on Study Startup, eTMF
ePRO Monitoring Exports from MyVeeva Auto-on CTMS, ePRO, eTMF
Commercial
Modular Content Document Info Panel: Manual Annotation Creation Auto-on PromoMats
PPTX Video Support for CLM Auto-Publishing Auto-on Multichannel
Medical
Standard Responses for Medical Inquiry Configuration MedInquiry
PPTX Video support for CLM Auto-Publishing Auto-on Multichannel
Quality
Standalone Quality Events Data Model & Feature Parity Auto-on QMS
Create Change Actions from Template Records (Standalone Change Control and Change Plan) Configuration QMS
QualityOne
QualityOne Training Connector: eLearning Data Model Provisioning Auto-on QualityOne<>Training
Supporting Multi-Batch Identification for COA Configuration QualityOne QMS

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.