Release Date: October 14, 2022

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

Platform

Working with Documents

Glossary Terms | Editable Search Terms and Other Enhancements

With this release, Vault makes the following enhancements to the Glossary feature:

  • Users can enter or edit search text in the Glossary panel.
  • Vault presents exact matches in search results in bold text.
  • A progress indicator appears in the Glossary panel while search is in progress.
  • Any full-path URLs in Definition Text fields display as hypertext in the Glossary panel search results.

Improved Error Handling for Signature Page Generation

With this release, Vault validates the template layout of Advanced Templates upon downloading a signature page to ensure all signatures can be manifested. Templates configured with a maximum row count on the signature blocks that exceed the number of expected signatures trigger an error, prompting an Admin to address the issue.

Reporting & Dashboards

HVO Lookup Field Support in Reports

With this feature, customers can filter on searchable HVO lookup fields in reports. All searchable and non-searchable lookup fields are available to be added as a column in reports. All fields can also be used to to group the standard report. Additionally, there are no restrictions in Multi-Pass reports.

Formulas

Currency Formula Fields

This feature introduces the formula field type, currency, to object formula fields. Currency formula fields return numerical data formatted as a corporate or local currency.

Saved Views on Dynamic Tabs

When using the “Show in Tab” option on a related list, users are now able to save their search criteria to a view within that dynamic tab. These views can be shared with other users who can access the same related list.

UI & Usability Updates

What’s New Page Content Update for 22R3

The content of the What’s New in 22R3.0 Page has been updated to highlight a few features that help make using Vault easier and faster.

Checklists

Checklists: Ad-hoc Sections

With this feature, admins can configure checklists so that respondents can add sections to runtime checklists on an ad hoc basis.

Administration

30-minute Upgrade

Production Vaults will be unavailable for approximately 30-minutes while being upgraded. Immediately prior to the Vault being unavailable, active users will be notified and have time to complete their work. Once a Vault has been upgraded, users will see a “What’s New” notification in the notifications area. An email will be sent to users subscribed to Service Availability Notifications. Sandbox Vaults will continue to be unavailable for the duration of the maintenance window.

OCR Extended Language Support - Language Override

This feature allows users to override the initial OCR language selection.

Platform Data Model Changes

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

  • Added the Ad Hoc Sections Allowed (ad_hoc_sections_allowed__sys) system field.

Vault Connections

Safety/Clinops: Studies

The Safety to Clinical Operations Vault Connection transfers Study and Study Countries records across Vaults. When users create or edit Study or Study Country records in Clinical Operations Vault, Vault creates or updates the Study record or Study Registration record in the Safety Vault.

Vault CRM to PromoMats Connection

Vault PromoMats now supports a standard connection with Vault CRM. When configured on a document type via a new document type group, this connection automatically sends approved documents from PromoMats to Vault CRM.

Clinical Operations to Medical CRM Connection: Activity Deletion Support

The Clinical Operations to Medical CRM Connection now indicates when transferred activities or interactions are deleted in the source system.

Clinical Operations to Medical CRM Connection: Standard Field Mappings

This feature introduces standard Field Rules for the Integration Rules applicable to the Clinical Operations to Medical CRM Connection.

Clinical Operations

Study Startup, eTMF

Increment # Expected from Matched Documents

This feature introduces triggers on EDL Item that updates the Requiredness field if it is not equal to “Required” and increments the # Expected field based on EDL Item matching.

Vault Mobile: TMF Bot Support

Adding support for Vault Mobile, allowing TMF Bot to auto-classify Inbox Documents uploaded to Vault eTMF.

CTMS

Yuzu: CTN Change Log Enhancements

This feature improves the automated tracking and support for CTN (Clinical Trial Notification) Data Change Logs used with the Yuzu capabilities for CTMS. CTN Data Change Logs related to CTNs that are created after the CTN Document is generated are now automatically brought forward via the Create Subsequent CTN action.

Clinical Operations Data Model Changes

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

The following changes were made to Clinical Operations Vaults to support the Yuzu Change Log Enhancements feature:

  • Added new fields to the CTN (ctn__v) object:
    • Generate CTN Change Log / 治験届作成変更履歴 (generate_ctn_change_log__v)
    • CTN Document Generation Datetime / 治験届作成日時 (ctn_document_generation_datetime__v)

The following changes were made to Clinical Operations Vaults to support the Safety to Clinical Operations Vault Connection feature:

  • Added new fields to the Study (study__v) object:
    • Masking (masking__v)
    • Study Start Date (study_start_date__v)
    • Study Name (study_name__v)

The following change was made to Clinical Operations Vaults to support the Clinical Operations to Medical CRM: Activity Deletion Support feature:

  • Added the new standard local connection Clinical Operations Local Connection (clinops_local_connection__v)

The following change was made to Clinical Operations Vaults to support the Clinical Operations to Medical CRM: Standard Field Mappings feature:

  • Added new field rules on the CRM/Clinical Operations Connection (crm_clinops_connection__v) for standard fields included in transfer

Commercial

PromoMats

eCTD Submission Package

This feature adds the new eCTD Submission Package rendition type. Once configured, users can upload a ZIP file containing many materials, such as audio and video files, to the rendition type. While generating an eCTD Compliance Package, Vault unzips the contents of the rendition type and adds them to the package as Clean Material. Vault does not rename or convert the contents of the ZIP file to PDF.

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 change was made to PromoMats Vaults to support the eCTD Submission Package feature:

  • Added the eCTD Submission Package rendition type
  • Added the Submission Ready Copy Type document field and picklist

The following change was made to PromoMats Vaults to support the Vault CRM to PromoMats Connection feature:

  • Added the Vault CRM to PromoMats Connection document type group

Medical

MedComms

Define MedComms & MedInquiry Applications in Vault Medical

The existing MedComms Vault will be renamed to Vault Medical. Within Vault Medical, two independently licensable applications will be available: MedComms and MedInquiry.

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 change was made to MedInquiry Vaults:

  • Added the Source CRM Org (source_crm_org__v) field to the Case (case__v) object

Quality

QMS

Duplicate Detection Check

With this feature, Vault QMS replaces the complex manual process of identifying a duplicate Complaint with an intelligent search functionality and user experience. The existing Quality Record Check functionality is enhanced to allow Admins to configure new Duplicate Check record check types for the standalone Complaints object and the Complaints and MedTech Complaint object types on Quality Event.

The Duplicate Check record check feature has the following key capabilities:

  • A search capability to identify potential duplicates based on duplicate check rules that utilize exact match fields, similar match fields, and related object exact match fields
  • A purpose-built UI to view potential duplicates and review those that are provided a verdict before completing the process
  • An asynchronous job automatically relates duplicates and follow-ups to the main record and performs a state change on the duplicates or follow-ups to an appropriate lifecycle state

Learn more about configuring duplicate detection checks.

Vault Validation Management

Validation Test Script Authoring UI

In Vaults with Validation Management enabled, this feature provides an intuitive user interface to help validation professionals author, review, and pre-approve test scripts before they can be executed. Test script authors can add, copy, and delete setup steps and execution steps to ensure that applicable requirements are challenged effectively. User requirements, functional requirements, and design specifications can be linked to test steps or test scripts which helps with automatic creation of the requirements traceability matrix. Validation Management is only available to customers participating in the early adopter program. Learn more about test script authoring in Validation Management.

Vault LIMS

Vault LIMS continues to expand its available features in this release, including the following additional functionality:

  • New capabilities supporting making revisions to a Lab Result after the Lab Test has been evaluated against the specification criteria.
  • New capabilities for reviewing a Lab Test Set, Lab Sample, & Batch with a focus on reviewing any exceptions.

Learn more about Vault LIMS.

Quality Data Model Changes

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

The following components were added to Quality Vaults to support the Lab Test Set, Lab Sample, & Batch Review as well as the Making Revisions to Lab Results feature in Vault LIMS:

  • Added new fields to the Lab Result object:
    • Actual Data Entry Method
    • Change Reason
    • Revisions
    • Out of Specification
    • Previously Out of Specification
    • Out of Control
    • Change Reason
    • Revisions
  • Added new fields to the Lab Test object:
    • Revisions
    • Out of Specification
    • Previously Out of Specification
    • Out of Control
    • Override
  • Added new fields to the Lab Sample object:
    • Revisions
    • Out of Specification
    • Previously Out of Specification
    • Out of Control
    • Override
    • Additions
    • Disposed of Date
  • Added new fields to the Batch object:
    • Override
    • Revisions
    • Out of Specification
    • Previously Out of Specification
    • Out of Control
    • Override
    • Actual Data Entry Method
    • Additions
  • Added new objects:
    • Lab Result History (lims_result_history__v)
    • Lab Result Signature (lims_result_sig__sys)
  • Added new standard lifecycle for Lab Result History object:
    • Lab Result History Lifecycle (lims_result_history_lifecycle__v)
  • Added new picklists:
    • Lab Result Signature Type (lims_result_sig_type__sys)
    • Lab Result Change Reason (lab_result_change_reason__v)
  • Added new state types:
    • Committed (committed_state_type__v)
    • In Review (in_review_state_type__v)
    • Reviewed (reviewed_state_type__v)
  • Added new standard workflow:
    • Lab Result Change (lims_lab_result_change__v)

Regulatory

RIM Submissions Archive

New Submissions Archive Viewer

In this release, a new Submissions Archive Viewer has been added. The new user interface streamlines the review process with advanced searching, filtering, and document viewing capabilities.

The New Submissions Archive Viewer setting is configurable in Application Settings in 22R2.4, however the new viewer’s full functionality will be available in 22R3.0.

RIM Registrations

DADI Output Report

With this release, a new action on the regulatory objective has been created. When executed, a series of reports will be generated. This supports the population of the DADI form, required for EU submissions starting in 2023.

RIM 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 or updated the following components to the Regulatory data model:

  • Added the Shelf Life (shelf_life__rim) field to the Application Packaging (application_packaging__v) object.
  • Added the Types of Changes (types_of_changes__v) picklist field to the Regulatory Objective (regulatory_objective__rim) object and its Worksharing (worksharing__v) object type to support the DADI Output Report feature.
  • Added the following fields to the Submission Metadata (submission_metadata__v) object to support the New Submissions Archive Viewer feature:
    • Hierarchy Level (hierarchy_level__v)
    • Hierarchy Path (hierarchy_path__v)
    • Parent (parent__v)

RegulatoryOne

RegulatoryOne features are targeted for tentative availability on October 25th.

Compliance Management

Relabel Compliance Assessment Object to Qualitative Assessment

This feature changes the label of the compliance_assessment__v object from “Compliance Assessment” to “Qualitative Assessment” in Vaults created after the 22R3 release. We recommend Admins update this label in their Vaults.

Enablement Details

Feature Enablement Application
Working with Documents
Glossary Terms | Editable Search Terms and Other Enhancements Admin Checkbox Platform
Improved Error Handling for Signature Page Generation Auto-on Platform
Reporting & Dashboards
HVO Lookup Field Support in Reports Auto-on Platform
Formulas
Currency Formula Fields Auto-on Platform
Search
Saved Views on Dynamic Tabs Auto-on Platform
Usability & UI Updates
What's New Page Content Update for 22R3 Auto-on Platform
Checklists
Checklists: Ad-hoc Sections Configuration Platform
Administration
30-minute Upgrade Auto-on Platform
OCR Extended Language Support - Language Override Auto-on Platform
Vault Connections
Safety/Clinops: Studies Configuration Safety<>ClinOps
Vault CRM to PromoMats Connection Configuration PromoMats
Clinical Operations to Medical CRM Connection: Activity Deletion Support Auto-on CTMS
Clinical Operations to Medical CRM Connection: Standard Field Mappings Auto-on CTMS
Data Agnostic Vault Medical to CRM Connection for Medical Inquiry: Push Status Back to CRM Auto-on MedComms
Clinical Operations
Increment # Expected from Matched Documents Configuration Study Startup, eTMF
Vault Mobile: TMF Bot Support Auto-on eTMF
Yuzu: CTN Change Log Enhancements Auto-on CTMS
Commercial
eCTD Submission Package Configuration PromoMats
Medical
Define MedComms & MedInquiry Applications in Vault Medical Auto-on MedComms
Quality
Duplicate Detection Check Configuration QMS
Validation Test Script Authoring UI Configuration Validation Management
Regulatory
New Submissions Archive Viewer Admin Checkbox RIM Submissions Archive
DADI Output Report Configuration RIM Registrations
RegulatoryOne
Relabel Compliance Assessment Object to Qualitative Assessment N/A RegulatoryOne Compliance Management

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.