New in 22R3.4: Object Lifecycle Conditions enhancements and more

Release Date: February 10, 2023

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

Save Link Type Selection as a User Preference

With this release, when a user creates a link annotation on a document, Vault now pre-selects their most recently selected link type in Vaults where more than one link type is available. Link types can include Document (linking directly to document versions and anchor annotations), Permalink (linking to permalink targets), and Claim (linking to Claim records, PromoMats only). Vault applies this saved user preference across browsers and sessions. Users can change the saved preference by selecting a different link type. 

Glossary Usability Enhancements

Vault now includes the user’s name when recording activity in Glossary Event object records. This enables content administrators to follow up with specific users when working to expand and improve the Glossary’s library of definitions. This feature also enables the Glossary on video documents, allowing users to manually search for terms that may appear visually or audibly in video content. 

Prevent Re-Render of Documents with Manual Renditions

With this release, users must delete an existing manually uploaded rendition prior to re-rendering.

Signature Page Generation Enhancements

With this release, Vault generates a signature page when the document enters its steady state. Users can also regenerate signature pages through a configurable user action. Previously, Vault generated signature pages when viewed for the first time and after a new signature is captured. 

File Size Reduction for Viewable Rendition Downloads

With this release, Vault optimizes downloaded viewable renditions configured with overlays by removing duplicate fonts, images, and other elements, resulting in a smaller PDF file.

Improved Rendering Status Reporting

Vault now provides more insight into the process and restrictions of creating viewable renditions. If Vault does not return a viewable rendition, it provides users with an explanation and, if applicable, troubleshooting steps.

Upload Documents UI Enhancements

With this release, we have updated the icons and typography when uploading documents to clearly indicate to users whether a document uploaded successfully, with warnings, or unsuccessfully. 

Updated Download Icon for Source File

The Download icon for source files has been updated to an icon that is more intuitive for the action that it represents.

Search for Document Number in “Search Current Binder”

In addition to document names, the “Search Current Binder” box now searches for document numbers.

Add a File to a Placeholder via Drag & Drop

With this release, you can now add a file to a placeholder via drag & drop. 

Reporting & Dashboards

Object Reference Fields in Reports Formulas

This feature adds support for object reference fields in report formula fields. When defining a report formula field, users may now wrap an object reference field in the Text() function to retrieve its label, or the ID() function to retrieve its ID as text. Users may also return an object reference field directly if a function accepts that datatype, such as NetWorkdays(). 

Advanced Filter Logic for Multi-Pass Reports Enhancements

This feature allows users to add OR filter logic across different objects and views in a multi-pass ladder report, making reports more flexible. Users can also add custom logic expressions between filters.

Vault Objects

Person Object: Duplicate Person Record Enhancements

When users attempt to create Person records from object reference fields on a document or object record, they can now select an existing record when duplicate records are found.

Country Object: Add Code field

A Code field is now available on the Country object to facilitate easy transfer of Country records in future Vault Connections.

Lifecycle & Workflow

Object Lifecycle Entry Criteria: State of Related Record Rule Can Validate Multiple States

The Object Lifecycle Entry Criteria validation rule for validating the state of related records now supports the includes operator, allowing Admins to configure the rule to validate multiple states.

Object Lifecycle Conditions: Evaluating Related Object Field Values

Admins can now configure conditions in User Actions, Entry Actions, and Entry Criteria to evaluate fields and values on related objects, providing more options to determine when actions and rules are performed on records within states.

Multi-Record Object Workflows: Action Step for Automatically Removing eSignatures

Admins can now configure action steps in multi-record object workflows to automatically remove eSignatures from the records based on specific task verdicts that were captured during the workflow. 

Multi-Record Object Workflows: Limiting Roles Allowed to Participate for Workflow Initiator Selected Participant Groups

Admins can now configure start steps in multi-record object workflows to limit the roles allowed to participate when a workflow initiator selects the users for a participant group. This ensures the workflow initiator only selects users from a specific role in sharing settings.

Workflow Details on Active Workflows & Timeline

For workflows on the Active Workflows home page, the workflow start date and workflow version are now visible. For object workflows, the workflow version is now visible in the workflow timeline on the object record page. This helps workflow owners and administrators understand which version of the configuration is being used for the active workflow.

Workflow Participant Selection Actions Support Search by Email Address

Start Step participant controls, the add participant action, and the re-assign task action on workflows for documents and objects now support searching users by entering an email address. 

UI & Usability Updates

Tab Collection Updates

Admins can enable the new Hide the All Tabs option in Tab Collections Menu setting from Settings > General Settings > User Interface Options. When enabled, Vault hides the All Tabs item in the Tab Collections menu, so users cannot select and see all tabs available to them. Users see only the tab collections available to them. Before enabling this setting, we strongly recommend configuring and assigning Preferred Tab Collections to users.  

This feature increases the limit for the number of custom tabs from 20 to 60. However, the limit on subtabs remains at 20 per menu tab.

Search

Later Version Available Indicator

Document search results will now display an icon indicating when a document version that matches their search criteria has progressed to a later version and is available for them to view by one of their other roles on the document. Clicking this icon will tell the user which version is the latest available to them and the roles they have on the document that caused the earlier version to be included in the results.   

Include Search Criteria when Exporting Results to Excel

Administrators now have an option to add search criteria when exporting search results to Excel. When this is enabled, a second sheet will be added to the Excel workbook containing the tab that the results were exported from, all of the applied filters and search terms, and the user who created the export with a timestamp. For standard tabs, a clickable link back to the search results in Vault is available.  

Checklists

Checklists: Batch Saving Responses

This release improves the performance of the checklist respondent UI by batch saving responses instead of saving each response individually.

Checklists: Increased Limit for Maximum Answers per Question

With this release, the maximum number of answers per question is increased to 20. Prior to this release, Vault limited each question to 10 answers.

Vault Authentication

New Certificate for SAML SSO & Spark Messaging Connection

Vault is scheduled to rollover the signing certificate used to sign SAML Single Sign-on requests and Spark messaging connections. There is no expected downtime.

Release Dates:

• New Certificate Testing Period: February 3, 2023 7:00 pm PT (February 4, 2023 03:00:00 UTC) - March 3, 2023 6:00 pm PT (March 4, 2023 02:00:00 UTC)
• New Certificate Rollover Event: March 3, 2023 6:00 pm PT (March 4, 2023 02:00:00 UTC)
• Support for New and Old Certificate: March 3, 2023 6:00 pm PT (March 4, 2023 02:00:00 UTC) - March 24, 2023 6:00 pm PT (March 25, 2023 01:00:00 UTC)
• Final Certificate Rollover: March 24, 2023 6:00 pm PT (March 25, 2023 01:00:00 UTC)

Your IT organization must ensure that the new certificate is configured on your Enterprise Identity Provider system prior to the New Certificate Rollover Event on Friday, March 3 2023. Learn more about the action required for the certificate rollover process.

Administration

Email Suppression List

With this release, Vault automatically adds email addresses that produce a hard bounce to the Email Suppression List, minimizing the number of emails Vault may send to invalid email addresses. Admins can manually remove an email address from the suppression list. Learn more about the Email Suppression list.

Notifications: Add Annotation Replies to Summary Emails

This feature allows Admins to set the email notification preference for annotation replies. By default, Vault sends notifications for annotation replies in Summary emails. Admins can configure Vault to send these notifications on each occurrence or not at all. If this setting is visible on the User Profile page, users can also change this notification preference.

Sandbox Snapshots Upgrades

This feature allows Admins to upgrade a Snapshot on an older release to the current release of Vault. This feature has been moved to a later release.

Configuration Report: Atomic Security Enhancement

Previously, Vault Configuration Reports only included atomic security on fields, controls, actions, and relationships if there are overrides. In this release, Vault Configuration Reports now include non-overridden default values.

Document Templates Limit in Sandboxing

To prevent sandbox cloning timeouts due to a large number of document templates being included in the clone, Vault no longer includes document templates in the clone when the total size of the document templates exceeds 5GB.

Vault File Manager

VFM Resumable Upload & Download for Check Out & Check In

With this release, if a document check out/in process via Vault File Manager is interrupted, users can resume the process where the interruption occurred. Prior to this release, if a check out/in was interrupted, all progress was lost, and users needed to restart the download process from the beginning. 

Support 500GB File Size

Source files up to 500 GB in size can now be uploaded using Vault File Manager. Prior to this release, the source file size limit with Vault File Manager was 100 GB.

Download Source Files Using Vault File Manager

When downloading source files from Vault, users can now download using Vault File Manager. Vault File Manager now includes auto-resumable download capabilities, ensuring reliable and successful source file downloads.

This feature was released in 22R3.2 without documentation.

Vault Loader

Vault Loader Support for Record Migration Mode Update & Upsert

Users of Vault Loader can now leverage Record Migration Mode to update and upsert records in non-initial state while bypassing reference constraints and validation rules.

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 Annotation Replies (annotation_replies__sys) picklist field to the User (user__sys) object
• Added the Suppressed Email Address (suppressed_email_address__sys) object

Clinical Operations

CTMS

Trip Report Question Branching: Show & Hide Dependent Questions

This feature allows CRAs to choose whether to show or hide uneditable Trip Report questions during monitoring. Users can toggle the view mode within a Trip Report Question Section with dependent questions. *Auto-on with Trip Report Question Branching enabled

Trip Report Question Branching: Review Comments on Dependent Questions

This feature allows Reviewer Comments to be logged on dependent Trip Report questions. *Auto-on with Trip Report Question Branching enabled.

Clinical Operations to Medical CRM Connection: Study & Study Site Transfer

This feature enables Clinical Operations to transfer Studies and Study Sites from Clinical Operations to Medical CRM. This allows Study data to be included in the Activity transfer between Clinical Operations and Medical CRM.

Support for Tracking EUCT Number & OMS ID in Vault Clinical EU CTR Data Model Support

This feature introduces text fields to capture EU Clinical Trial (EUCT) Number on Study and Organization Management Service (OMS) ID on Global Directory objects, Organization and Location. Admins will need to configure page layouts to fully utilize these fields.

eTMF

Study Person Field Validation Check

Vault will now prevent the Person, Study Team Role, Study, Study Country, and Study Site fields on Study Person from being edited when the record is used to grant security permissions and Grant Access to Related Records is true/yes.

Limit for Study Team Roles

With this release, Vault prevents Admins from adding more than 300 Study Team Role records.

Vault Payments

Automate Site Fee Generation

This feature enables the generation of Site Fee records in Vault Payments when milestones are completed in Clinical Operations.

Users can identify the Milestone that they expect to trigger a Site Fee in the Site Fee Definition and when Milestones with the corresponding Milestone Type value are completed at a Site, corresponding Site Fee records are generated. The Site Fee is linked to the corresponding Milestone record and will update if the completion date or completion status is updated.

Populate Site Fee Definitions

With this feature, Vault Payments customers can now easily create Site Fee Definitions for a study. Customers can create Site Fee Templates and a set of associated Site Fee Definitions as a reference set.  

Users can add Site Fee Definitions from either other studies or Site Fee Templates via the Populate Site Fee Definition user action.

Fee Schedule & Template Copy

Users can now copy a Fee Schedule and related Fees via a single action. This will result in a new Fee Schedule with corresponding record data and a set of matching Fees for the original Fee Schedule.

Users can also now copy a Fee Schedule Template and related Fee Templates via a single action. This will result in a new Fee Schedule Template with corresponding record data and a set of matching Fee Templates for the original Fee Schedule Template.

Copy Fees From Template Enhancement

The Copy Fees From Template user action now works on Fee Schedules that have existing Fees. The user action will create new Fees for any Fee Templates in the related Fee Schedule Template that do not have matching names in the destination Fee Schedule. Fees with matching names are not updated as part of this action. 

Veeva Site Connect

Safety Distribution Gap Pack

With this feature, Site Connect customers can now automatically send designated gap pack Safety Distribution documents when a Study Site moves into a particular lifecycle state (for example, Active). This feature allows customers to easily manage their gap packs across Products and Line Listings so that the appropriate safety documents can automatically be sent to recently onboarded sites.

Safety Distribution Document List Token

With this feature, Site Connect customers can now include a list of the specific safety documents being sent to each site contact in the body of the email. The list contains the documents that are viewable when accessing the special link contained in each safety email. The list can be added to the Safety Distribution Email template using the custom app token ${Custom.safetyDocList}.

Safety Distribution Types

Site Connect customers can now create multiple Safety Distribution Types in order to have multiple sets of distribution defaults per document type. Rather than creating many document types to accommodate the need for a variety of distribution rules, a single document type can now be used in combination with multiple Safety Distribution Types.

Study Training: Vault Connections with Clinical Operations

Customers can now automatically send data from their Clinical Operations Vault to their Study Training Vault. The connection between Study Training and Clinical Operations Vaults simplifies the management of studies and related data and documents. When a Study, Study Country, Study Site, Study Person, or document is created or updated in the Clinical Operations Vault, data is automatically created or updated in the Study Training Vault.

Track Study Site ISF Location

With the addition of this standard field, Clinical Operations customers can now track where an individual Study Site is storing its Investigator Site File (ISF). This field is beneficial for Site Connect customers looking to better flag which Sites are using SiteVault as their ISF.

Clinical 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:

Click here to expand this section

Commercial

PromoMats

Modular Content Document Info Panel

This release introduces the Modular Content Document Info Panel. This doc info panel allows users to visualize where their Content Modules and individual Content Module Assets are located within documents by using a combination of Suggested Link and manual link annotations. The Modular Content Document Info Panel also enables users to find previously approved content within their documents by allowing users to interact with the annotations directly from the panel. 

Enhanced Suggest Links within Content Modules

Admins can now configure Enhanced Suggest Links to only match Text Assets contained within Content Modules linked to your content. This action can be configured as both a Lifecycle State Entry Action and a Lifecycle State User Action.

Brand Portal Refresh for Users & Portal Administrators

This release includes significant improvements to the Portal user interface. 

Portal users can experience the new homepage, which provides a modernized look and feel. The Portal refresh provides a more intuitive experience allowing users to find their content quicker. Admins benefit from a refreshed administration interface, allowing multi-document select, rich text support, further customization options, and other subtle yet essential enhancements.

This improvement is currently an opt-in experience and will be auto-on for all customers in 23R3. Learn more about the updated Brand Portal.

Product & Country Become Shared Fields

With this release, the standard Product and Country document fields become shared fields. This enhancement provides greater flexibility for document field configuration. 

Standard Metrics Track Duration

Document Lifecycle States can now be mapped to standard business process groups on a new Configuration page called Standard Metrics State Mappings. Pulse uses these mappings to determine how long a document spent in each process. The standard processes are: Time in Content Creation, Time in Quality Check, Time in Review and Approval, and Time in Regulatory Submission. This data is not currently available through reports and dashboards.

Increased Matching Flexibility with Enhanced Suggest Links

In this release, Enhanced Suggest Links is more flexible in how it searches and matches for Text Assets. This increases the amount of suggested link annotations and matches when performing Enhanced Suggest Links on your content.

Enhanced Suggest Links Leverages Search Synonyms

With this release, Enhanced Suggest Links leverages Search Synonyms within Vault. Enhanced Suggest Links can now look to match synonym entries when searching and matching content to your Text Assets.

This feature has been postponed to a future release.

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:

• Converted the Product (product__v) and Country (country__v) document fields to shared fields
• Values for the Application Number (application_number__v) field on the Application (pm_application__v) object are no longer required to be unique by default.

Medical

MedInquiry

Response Package: Download Source Document

With this release, Medical Inquiry users can allow HCPs to download source documents when receiving a response to a Medical Inquiry they have made.

Email Templates for Medical Inquiry Case Responses

When constructing an email response, Medical Inquiry users can now use a predefined template. Via a user action or state change, Vault can populate the email subject and body on the Case Response from the template.

Include Attachments in E2B(R3) Generation in Vault MedInquiry

With this release, users can add files associated with Adverse Events to records as object record attachments, allowing them to share the files with a safety team. Vault then encodes these files when generating an E2B(R3) file.

Add Country to Cover Letter Generation Action

With this release, when a user runs the Generate Cover Letter action, Vault populates the cover letter’s Country field with the Country from the Case Response object if present. This provides better support to multinational organizations, who require the ability to control which documents a user can see by region.

MedComms

Medical Portal Refresh for Users and Portal Administrators

This release includes significant improvements to the Portal user interface.

Portal users can experience the new homepage, which provides a modernized look and feel. The Portal refresh provides a more intuitive experience allowing users to find their content quicker. Admins benefit from a refreshed administration interface, allowing multi-document select, rich text support, further customization options, and other subtle yet essential enhancements.

This improvement is currently an opt-in experience and will be auto-on for all customers in 23R3. Learn more about the updated Medical Portal.

MedComms & Multichannel as Apps

With this release, we have separated Multichannel functionality from MedComms. Vaults that were previously Multichannel now appear as Medical Vaults with only Multichannel functionality enabled. 

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 to support the Email Templates for Medical Inquiry Case Responses and Response Package: Download Source Document features:

• Added the following fields to the Case Response object:
  • To (email_to__v)
  • Subject (email_subject__v)
  • Body (email_body__v)
  • Email Template (email_template__v)
  • Allow Source Document Download (allow_source_document_download__v)
• Added the following lookup fields to the Case Response object:
  • Country (country__v)
  • Language (language__v)

• Added the Case Response Email Template (case_response_email_template__v) object

• Added the following join objects:
  • Case Response Email Template Product (case_response_email_template_product__v)
  • Case Response Email Template Country (case_response_email_template_country__v)
• Added the following fields to the Case object:
  • Country (country__v)
  • Language (language__v)
• Added the Case Response Email Template lifecycle

The following changes were also made to Medical Vaults:

• Added the following fields to the Country (country__v) object:
  • Vault Medical UUID (medical_uuid__v)
  • Country Code (country_code__v)

• Added the following objects:

  • Language (language__v)
  • Country Language (country_language__v)

Training

Study Training receives functionality and data model updates in parallel with the Quality Suite: Vault Training application.

Study Training

Study Training: Vault Connections with Clinical Operations

Customers can now automatically send data from their Clinical Operations Vault to their Study Training Vault. The connection between Study Training and Clinical Operations Vaults simplifies the management of studies and related data and documents. When a Study, Study Country, Study Site, Study Person, or document is created or updated in the Clinical Operations Vault, data is automatically created or updated in the Study Training Vault.

Quality

QMS

5 Whys Analysis

Vault QMS now supports the ability for a user to perform and document a 5 Whys Analysis within Vault as a tool to assist in determining the true root cause of a Quality Event or Complaint. For this feature, 5 Whys Analysis will be supported for any standard or custom Quality Event and Complaint object types.

The 5 Whys Analysis is one of several cause-effect techniques that are used to perform root cause analysis as part of a Quality Management System. The general approach is to start with your problem statement and iteratively ask “why” with each answer forming the basis of the new “why” until the root cause is clearly identified. The number 5 has been a general observation on the number of times “why” is asked to get to the true root cause and is a rule of thumb rather than a requirement. Learn more about setting up 5 Whys analysis.

Auto-Create Proposed Audits

When an Audit Program record is created, Vault now provides the ability to automatically create the associated Proposed Audit records from Organization records based on the Planned Start Date and Planned End Date of the Audit Program as well as the configured date field on the applicable Organization records, in addition to specific optional metadata that is configured in the user action. Learn more about setting up Proposed Audit auto-creation.

Supplier Change Notifications

QMS now supports the ability for customers to send Supplier Change Notifications that originate via an email to a Vault Email Inbox configured with the new Create Supplier Change Notification email processor. 

Once the email is received and processed by the email processor, Vault creates a Supplier Change Notification record, impacted sites can be identified, and impact assessments can be performed to determine if a Change Control is required. If a Change Control is required, it can easily be created directly from the Supplier Change Notification, linking the two records together. Learn more about configuring supplier change notifications.

Extend Recurrence Check to Support Custom Object Types on Quality Event

The existing Recurrence Check capability in QMS now supports all custom object types on the Quality Event object. Customers can now configure a recurrence check to identify similar, recurring events for custom object types and drastically reduce the manual effort of identifying recurrences. 

QRM Risk Builder

This feature adds a purpose built interface to make it easier for users to enter risk data into the system. Users can add new risks by clicking the Add Row button or by pressing the <Ctrl> + <Enter> keys on the last row. Users can also use keyboard short-cuts such as arrow keys, <Tab>, <Shift> + <Tab> to move around the grid. Users will also be able to copy and delete risk rows easily. This feature significantly improves the user experience and usability of Quality Risk Management. Learn more about the Risk Builder tool.

Surveillance

eMDR Update: Auto Generate Manufacturer Report  Number

This feature automates the generation of Manufacturer Report Number for eMDR. System auto-generates the Manufacturer Report Number as per the FDA’s format when the user generates the required XML file for FDA eMDR submission. The system also automatically restarts the report number sequence to 00001 at the beginning of the new year. Learn more about auto-generating manufacturer report numbers.

Standalone MedTech CAPA & Nonconformance Objects

With this feature, QMS now supports the CAPA (for MedTech) and Nonconformance process as a standalone data model separate from Quality Events. This will allow customers to manage their Lifecycle separate from the Quality Event Lifecycle for these processes.

New implementations are encouraged to utilize the standalone CAPA (for MedTech) and Nonconformance data model. Customers who are already live or in the process of implementing the existing CAPA (for MedTech) and Nonconformance object type on Quality Event are strongly encouraged to continue leveraging their existing configuration. There will be no functional differences between the two models and there is no need or functional requirement to move to the standalone CAPA (for MedTech) and Nonconformance data model if already leveraging the existing CAPA (for MedTech) and Nonconformance object type on Quality Event.

Reporting Enhancements

With this feature, we have made a few enhancements to eMDR and EU MIR reporting. eMDR now supports MDR Contact Office and MDR Contact Information for section G1. It also separates the Manufacturer Report Number for eMDR and EU MIR, so that you can assign different numbers for both health authorities.

Standalone Complaints: VPS Support

With this feature, Vault Product Surveillance now supports the Standalone Complaints data model (released in 22R3) VPS supports eMDR and EU MIR reporting on Standalone Complaints process in the 23R1 release. 

Training

Learner Homepage Usability Enhancements

The following updates were made to the Learner Homepage to make it more intuitive for a Learner to use:

• In the Curriculum View, the curriculum card’s View button has been updated to Begin Training. This button now takes the user to the first Training Assignment for the Curriculum.
• Each curriculum card now includes a separate view button to take the user to the Curriculum’s detail page.
• On Training Assignment cards, the Curriculum is hyperlinked and takes the Learner to the Curriculum’s detail page.
• The Learner’s Homepage now remembers these view preferences when navigating away and back to the page: Group By, Tab, and Card vs. List

Add Participant Action Available for All Training Workflows

With this update, the Add Participant workflow action is available for all Training Assignment workflows. This allows an authorized user to add additional participants to a workflow, especially useful in evaluation (on-the-job) workflows where participants may be added at the last minute.

Tag Reason for Training Assignment Creation

Training Assignments created via the training matrix after this release now capture the reason in a new picklist field Creation Reason. The possible values are: Matrix Updates, Document Updates, and Recurrence. Previously, this information was only available in a text field, which was not helpful in searching or reporting. Now, the information can be used in trending reports. 

Complete Training Tasks on Vault Mobile

This feature allows the user to complete training tasks from the 23R1 version of the Vault Mobile app. Training tasks assigned to the Learner are displayed in a new My Learning mobile tab. The Learner can view the task, view associated documents, and complete the task. This feature will be available with the 23R1 release of Vault Mobile.

LIMS

Capture Instruments & Consumables in Test Execution

With this release, we add the functionality to record instruments and consumables used during test execution. These records are associated with the samples and tests so that it is possible to trace which instruments and consumables were used in preparation and analysis. This can replace the recording of this information in laboratory notebooks.

Lab Test Reopening, Retesting, Canceling & Rejecting

In the typical laboratory workflow, completed and reviewed sample testing records are sometimes revisited to allow for corrections found by QA or management review. With this release, we add the ability to reopen completed lab tests to allow for controlled and tracked changes to the test data. 

Lab Hazards & Special Instructions

Samples in laboratories require specific handling and storage precautions for safety and stability reasons.These precautions are based on the material that has been sampled. This applies to samples being tested in the laboratory as well as to reagents and other consumables that are used during the testing process. Capturing this information is a prerequisite step to enabling label design and generation for sample and consumable identification and management purposes.

This feature adds a Precautions object to store a lookup table of common safety, handling and storage precautions, and a join object to connect many Precautions to a single Material, and to use a single Precaution across many Materials.

The join includes an elaboration field which allows the user to specify additional clarifying information that may be material-specific. For example, a precaution might be “Do Not Swallow”; an elaboration for that precaution might be, “In case of ingestion, induce vomiting immediately and seek medical attention.”

Validation Management

Test Protocol Review

With this release, Vault Validation Management allows executors to view narrative content associated with a test protocol to be accessed from the Test Execution UI and Test Protocol Review UI app pages. Users can access the narrative content from a document mini-browser icon action. Clicking the icon opens the test protocol narrative content linked from QualityDocs.

This feature also supports the approval experience whereby all independently-reviewed test scripts that are part of the protocol will be available for approvers to review, provide their verdict, and complete their final approval task for the test protocol. Learn more about reviewing test protocols.

Test Authoring with Requirements Burndown

With this release, Vault Validation Management allows authors of test scripts to easily identify and challenge requirements. Available requirements can be dragged and dropped onto a test step which will update the traceability matrix automatically. Included is the ability to easily search and filter requirements so that they can be linked with test steps based on available attributes such as risk, category, etc.

This feature helps to ensure that all necessary requirements are challenged as part of a validation activity while reducing the burden on validation and qualification professionals that manually maintain the trace matrix today. Learn more about authoring test scripts with the requirements burndown view.

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:

Click here to expand this section

Regulatory

RIM Publishing

Support Sequence ID Updates in Continuous Publishing

With this release, Vault Submissions Publishing will trigger continuous publishing when the Sequence ID is updated on the Submission record and Enable Continuous Publishing is enabled. This updates the folder structure without needing to republish all items.

Workgrouping Support for Australia eCTD

Vault Submissions Publishing now supports the ability to add multiple Submission Types and Submission Subtypes to Work-grouping submissions in Australia.

RIM Submissions

Additional Granularity for Content Plan Template Constraints

This release introduces a new Template Constraint Type picklist field on the Submission, Event, and Constraint objects. The field is leveraged in loading and applying Content Plan Template Constraints at an additional level beyond the Region, Country, Application Type, Submission Type, Submission Subtype, and Supplement Effective Date Type for Submission Content Plans. For Events, the field is leveraged in loading and applying Content Plan Template Constraints for different types of Global Content Plans.

Content Plan & Content Plan Template: Exclude from Auto-Matching

The Content Plan and Content Plan Template field Exclude from Auto-Matching is added in this release to allow auto-matching only for specific sections in a Content Plan Template. This field is intended to be configured as a conditional entry action in the Content Plan object lifecycle, so that Vault only updates the Match Documents field to Yes when Exclude from Auto-Matching is de-selected.

Copy Report Level Content Plan

With this release, a new Report Level Content Plan workflow system action is available to support creating a Content Plan for a Report Level Content Plan by copying from an existing Report Level Content Plan’s Content Plan. The system action copies both the Content Plan and Content Plan Item records and matched documents. While a new workflow must be configured to enable this feature, a new Copy Content Plan field is automatically added to all Report Level Content Plan object types to support the feature.

Update Content Plan Study Section

With this release, a new Update Content Plan Study Section action is available for the Submission Clinical Study and Submission Nonclinical Study objects. Once configured, the action moves valid study sections related to the Submission Clinical Study or Submission Nonclinical Study within the Submission Content Plan to the new location when the Clinical Study Type or Nonclinical Study Type (or Subtype) fields are updated.

For example, a Submission Clinical Study was originally created in Section 5.3.1.1 of the eCTD content plan with its Clinical Study Type and Clinical Study Subtype values set to Biopharmaceutical and Bioavailability (BA), respectively. To move the record to Section 5.3.1.2 (Comparative BA and Bioequivalence (BE) Study Reports), users can update the Clinical Study Type and Clinical Study Subtype values to Comparative BA and Bioequivalence (BE), then run the new action (instead of deleting Section 5.3.1.1 and re-creating in Section 5.3.1.2).

In addition to reparenting the study section, the new action also updates additional fields on the Content Plan and Content Plan Item records in that section, including the Published Output Location, Source Content Plan Template, and Source Content Plan Item Template.

RIM Registrations

FHIR Message Handling in IDMP Viewer

This feature extends the IDMP viewer functionality to render FHIR messages in a human-readable format. Initial support will render FHIR messages generated using HL7 FHIR version 4.6.0 to support viewing the XML output from the eAF form. 

UPD Data Model Updates

This feature extends the Registrations data model to include data points specific to animal health products, such as species and withdrawal period. These data points are captured in new Registrations object types, but require an Admin to create additional custom object types. See 23R1 RIM Data Model Changes below and UPD Configuration for more information.

IDMP Data Model Updates

With this release, the Registrations data model is updated to support EU IDMP IG V2.1.1. This includes updates to source and output data points as well as the IDMP data aggregation algorithm. Additionally, a new Pending Withdrawal state type is added to allow the algorithm to skip creation of output records in the lifecycle state assigned to the state type.

Multi-Record Registration Verification

This feature updates the Registration Verification workflow to accommodate both single and multi-record workflows.  

RIM Submissions Archive

Add Submission Fields as Selectable Columns in the New Viewer

Users navigating the new Submissions Archive Viewer have the option to select, view, and filter on the Submission object fields Lifecycle State, Sequence ID, and Actual Submission Date as part of the final dossier review process.

Display Inactive Applications and Submissions in the New Viewer

With this release, the new Submissions Archive Viewer will support previously-existing functionality of allowing users to select and view inactive Applications and Submissions.

Empty Section Indicator in the New Viewer

With this release, the new Submissions Archive Viewer will support previously-existing functionality of pre-calculating and displaying a visual indicator on empty sections, based on the delete lifecycle operation.

Leaf Source File Path Auto-Correction

RIM Vault Admin users are now able to initiate a system process to correct the Submissions Archive metadata of previously imported or published Submissions after the Application folder name is changed. This feature is not included in the 22R3.4 release. It will be released in 23R1.0.

New Submissions Archive Viewer Automatic Enablement

Submissions Archive Vault users are automatically guided to the new Submissions Archive Viewer as it is the default and only RIM Archive viewer supported by Veeva. As such, the related Submissions Archive Feature (New Submissions Archive Viewer) is removed from Admin > Settings > Application Settings.

Save View in the New Submissions Archive Viewer

This feature is a continuation of enhancements to the new Submissions Archive Viewer, providing users with a way to save and share views.

Submission Based Viewer Filters Automatic Enablement

Users are now automatically able to filter by Submission related objects within the new Submissions Archive Viewer. As such, the related legacy Submissions Archive Viewer settings in Admin > Settings > Application Settings are impacted as follows:

• Enable Submission based Viewer Filter is removed.
• Show eCTD Metadata Mapping to users on submission import is removed from Vaults where Enable Submission based Viewer Filter has been configured.

Enforce Submissions Archive User License

The new Submissions Archive Viewer now supports previously-existing functionality enforcing Submissions Archive application licensing, blocking RIM Vault users without a Full User application license from accessing any Submissions Archive functionality.

RIM Submissions, RIM Publishing

Document Merging on Publish

To support authoring at a lower level of granularity, Vault will merge multiple documents assigned to a single Content Plan Item at the time of publishing. This functionality is available when using Report Level Content Plan publishing or Submission publishing.

Vault Link Annotations: Multiple Target Destination Support

To support document reuse across multiple regions, Vault now supports Vault Link Annotations that target multiple destinations. When multiple destinations are defined, the publishing process determines the destination best suited for the current submission or report. This functionality is available when using Report Level Content Plan publishing or Submission publishing.

RIM Submissions, RIM Submissions Archive

Active Dossier Loader

With this release, a new Active Dossier Loader object supports active dossier record migration. When users create an Active Dossier Loader record, Vault creates or updates Active Dossier Structure, Active Dossier Item, and Active Dossier Item Detail records based on the corresponding Active Dossier Loader record metadata.

Active Dossier Template Update

With this release, several new records have been added to the Active Dossier Template and RIM Reference Model objects for all RIM Vaults to add support for 3.2.P.9 Product Interchangeability Equivalence Evidence for ACTD and the granular 3.2.P.2 Pharmaceutical Development components.

23R1 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 the below Registration (registration__rim) object types in all RIM Vaults. See 23R1 Announcements for more information.

• Investigational Vet Device Registration (investigational_vet_device_registrati__v)
• Investigational Vet Drug Registration (investigational_vet_drug_registration__v)
• Marketed Vet Device (marketed_vet_device_registration__v)
• Marketed Vet Drug (marketed_vet_drug_registration__v)

Click here to expand this section for additional feature- and application-specific Regulatory data model changes

Safety

Safety features are targeted for tentative availability on February 16, 2023.

Safety

Configurable Inbox Item Sections and Custom Case Fields for Manual Intake Configuration

Admins can now configure the list and order of Inbox Item fields for the Details, Patient, Contact, Medical Events, and Products sections. Admins can also hide Medical History and Drug History in the Medical Event and Products sections. Finally, Admins can select custom Case fields for the Inbox Item Details and Patient sections. Users can then manually enter values for the selected fields during intake and the system can copy these values to Case upon promotion.

Learn More

• Admin Help: Customize the Inbox Item Page Layout

Local Case Import to Inbox Item Admin Checkbox

Vault Safety can now import local language text to the Inbox Item localized fields to facilitate translation to English in the global fields. When enabled, the system imports the text values to the localized or global fields based on the set Localization.

Learn More

• Enablement: Enable Local Case Import
• User Help: Import an Inbox Item: Local Inbox Item Import

Local Intake Auto-Translation Framework Configuration

With this release, Vault Safety can now use the Amazon Translate Connection to translate local text fields to English to allow for global Case processing. In other words, you can now use a third-party service to translate Inbox Item text fields from the reporter’s local language to English during Case intake.

Admins can enable translations by configuring a user action. Admins can also configure the localizations, fields, and volume limits for translations.

Learn More

• Enablement: Enable the Local Intake Auto-Translation Framework
• User Help: Send Translation Requests Through the Auto-Translation Framework

Pregnancy Case Intake Configuration

Intake users can now mark an Inbox Item as Pregnancy Case to track pregnancy exposure or to report an Adverse Event suffered by the mother. Upon Case promotion, Child Information placeholders and Case Test Results will be automatically created to facilitate data entry.

Learn More

• Enablement: Enable Pregnancy Case Intake
• User Help: About Pregnancy Case Intake

Record Selection Usability Enhancements for Inbox Items Auto-on

With this release, searching and selecting records from the Study, Country, and Product Registration dropdown fields during Inbox Item data entry is made easier by displaying recently used values at the top of the list. These fields also now include a binoculars icon for browsing and filtering the available options. In addition, searching and selecting records in picklist fields (for example, Dose Form and Patient RoA) is made easier by displaying exact matches at the top as you type.

Generate Assessments Record Action Support

Vault Safety now gives Case Processors the ability to generate Assessments, Assessment Results, and Expectedness records for all serious and non-serious Adverse Events on a Case. Completed in a single action, this feature improves Case processing efficiency by removing the need to generate each required record manually.

Learn More

• Enablement: Enable Generate Assessments Record Action
• User Help: Generate Assessments

Record Selection Usability Enhancements for Cases Auto-on

With this release, searching and selecting records from picklist fields during Case data entry is made easier by displaying exact matches at the top as you type.

Domestic Case Edit Enhancements Auto-on

With this release, global Case Processors can view and edit global information in dual-text app controls, even while the localized Case is still generating.

Case Locking User Interface Enhancements Auto-on

This feature introduces enhancements to manual and strict Case locking. If another user applies manual or strict Case locking, the relevant user actions will not be displayed or available for you to run in the All Actions menu. This improvement affects only the user interface and contains no functionality changes.

Automatic MedDRA Hierarchy Updates Auto-on

Vault Safety now enables downloading the latest central MedDRA dictionary version as soon as it becomes available. With the download complete, when you update the active version in your Vault, all of the global and localized terms, as well as any hierarchy changes, are automatically applied to MedDRA terms referenced on Cases. This means that you can immediately start the required verifications. In addition, it reduces the manual effort of bulk recoding, enabling MedDRA Admins and Medical Coders to focus on currency status changes, policy, and best practices.

Learn More

• Enablement: (Optional) Update the MedDRA Dictionary Page Layout
• Admin Help: Manage the MedDRA Dictionary
• User Help: Code MedDRA Terms

Smart MedDRA Coding Configuration

Vault Safety Smart MedDRA Coding offers advanced coding of MedDRA terms that aren’t an exact match to the active dictionary or your synonym list. Using AI and automation, this feature overcomes common problems such as alternate and incorrect spelling, abbreviations, and multiple reported terms. For Case Processors, this means less time spent on manual MedDRA coding.

For Admins, configuring Smart MedDRA Coding reduces the manual effort of maintaining the MedDRA Synonym list. As terms are coded, they are automatically added to the synonym candidate list, making coding more streamlined and consistent over time.

Learn More

• Enablement: Enable Smart MedDRA Coding
• User Help: Code MedDRA Terms

IMDRF Bulk Snapshotting Configuration

With this release, when an IMDRF Dictionary version is updated, the system now downloads the full dictionary. Admins can choose when to transition to a new version and receive notifications when updating and downloading are complete.

Learn More

• Admin Help: Manage the IMDRF Dictionary

Enhanced Eligible Products Selection for Cross Reporting Support

With this release, Vault Safety uses improved logic to determine the product driving ICSR reporting requirements in cross reporting scenarios. Contact Veeva Support to enable this feature in your Vault.

Additionally, Admins can modify the behavior of the Product and Study rule parameters when evaluating cross reporting scenarios. Admins can configure this behavior only after Support has enabled the improved logic feature.

Learn More

• User Help:
  • Cross Reporting
  • Configure Reporting Rules Product Selection
  • Reporting Rule Parameter Reference

Parameter Driven Assessment Selection for Rules Engine Support

Previously, the most conservative product and assessment rule parameter evaluation strictly relied on Case Seriousness, Expectedness, and Relatedness being defined in the Distribution Rules. This can lead to under-reporting for common rule sets. Vault Safety can now employ a more tolerant rule parameter evaluation based on the configuration of relevant reporting rules.

Learn More

• User Help:
  • Reporting Rule Parameter Reference
  • Configure Reporting Rules Product Selection

Support for New Company Products Type in Safety Data Exchange Configuration

Vault Safety Data Exchange now supports the new Company Product product types, such as Cosmetics and Nutritional. In addition, the Vault Safety rule engine now supports rules based on product type. For example, you can configure FDA Submission rules specific to OTC Drugs so that this product type won’t be subject to the same Submission rules as prescription drugs.

Learn More

• Admin Help: Configure Support for Company Product Type
• User Help:
  • Reporting Rule Parameter Reference
  • Manage Partner Distribution Lists
  • Cross Reporting

Generate E2B Formats for Migrated Cases Auto-on

With this release, preview generation of E2B(R3) files and Transmission generation of all E2B formats are now available for migrated Cases.

Learn More

• User Help: Migrate External Cases

New Info Date for PADER Line Listings Support

For PADER Line Listings, previously, the Initial Report Date and a Transmission Date represented the date the FDA first received the Case. With this release, a New Info Date column will be added to the Interval Line Listings and to the Non-Primary Suspect Drug Report, which will be populated from the Case. When you filter the PADER data on the New Info/Receipt Date, you can see what date was used as the inclusion criteria for the report.

The Transmission Date has been added to the log of the 15-Day and Non-15 Day report and the log of the Summary of Adverse Events Report to assist in troubleshooting.

Essentially, all four (4) PADER reports now have both the Receipt/New Info Date and the Transmission Date.

Learn More

• Enablement: Enable PADER Authoring and Table Generation
• User Help:
  • Create PADER Aggregate Report
  • Configure Aggregate Report Templates

Feature Enablement Changes

Note the following features with enablement changes in this release:

Feature	Previous Enablement	New Enablement
Deep Duplicate Search Note: If you are still using the old Inbox (AER), this change will not affect you.	Support (22R3)	Auto-on (22R3.4)
EDQM Dose Forms and Routes of Administration	Admin Checkbox (22R2)	Auto-on (22R3.4)

Read more about these features:

• Deep Duplicate Search: What’s New in 22R3
• EDQM Dose Forms and Routes of Administration: What’s New in 22R2

SafetyDocs

PSMF Binder Approvals Auto-on

Vault SafetyDocs can now manifest approval pages on generated PSMF PDFs.

Learn More

• User Help:
  • Review and Approve PSMF Binders

PSMF Binder Table of Contents Configuration

Vault SafetyDocs can now automatically generate a table of contents for PSMF Binders when merging to PDF.

Learn More

• Enablement: PSMF Table of Contents Template
• User Help: PSMF Table of Contents

PSMF Logbook Format Enhancements Auto-on

The PSMF Logbook in SafetyDocs has been enhanced to have a clearer format. The new Excel template is automatically available in all Vaults. To use this feature, you must first remove any previously generated logbooks in your existing PSMF binders.

Learn More

• User Help: PSMF Logbook

Literature Process Management Configuration

Vault SafetyDocs now supports the management of literature articles and article reviews. This feature includes the data structure and document types necessary for Literature Management. Future enhancements will leverage this data structure.

Learn More

• Enablement: Enable Literature Review Process Management
• User Help: Manage the Literature Review Process

PVA Document and Obligation Management Configuration

Vault SafetyDocs now supports the management of pharmacovigilance agreements (PVAs) and Safety Data Exchange agreements (SDEAs). This feature includes the data structure and document types necessary for PVA Management. Future enhancements will leverage this data structure.

Learn More

• Enablement: Enable PVA Management
• User Help: Manage Pharmacovigilance Agreements

QualityOne

QualityOne

Independently Licensable Applications in QualityOne

Within Vault QualityOne, three independently licensable applications will be available. Admins can now specify different license types for different users. There is no impact to features or functionality and no action is required.

QMS & Doc Control Applications for QualityOne

With this release users can be independently licensed to QMS and Doc Control. There is no impact to features or functionality and no action is required.

HSE Application for QualityOne

With this release HSE can be licensed independently from QMS and Doc Control. There is no impact to features or functionality and no action is required. Learn more about the HSE application.

Conditional Role Exclusivity for Teams

This feature enables users to define conditional exclusivity for each role within the Team. This allows greater flexibility so that a user can be selected for more than one (1) role on a team while simultaneously providing exclusivity to another role where it is required. Learn more about conditional role exclusivity for Teams.

Displaying Team Assignment Users in Audit Logs

This feature enhances the Audit logs for Team assignments. Previously, the Audit logs would display “System” as the user who performed the Team assignment. Now, Audit logs will display the name of the user who performed the Team assignment with “System” acting on behalf of the user. Learn more about audit logs for Teams.

User Experience & Security Enhancements for Teams

This feature extends the Teams capabilities to enhance security, performance and user experience. Learn more about other Teams enhancements.

Restricting Creation of Teams on Related Objects

Previously, Admins could select the User Task (user_task__v), Related Quality Event (related_quality_event__qdm) objects, and High Volume objects (HVOs) for Team configuration. Since these objects would not require Teams to be enabled, Admins will now be restricted from creating Teams for these objects.

Updating Team Sharing Setting with Workflow Action

Previously, Admins were unable to update Team-governed sharing settings using the Update Sharing Settings workflow action. Now, Admins can update Team-governed sharing settings using this workflow action.

Displaying a Warning when Updating Maximum Users Retroactively

When the Maximum Users field is retroactively updated in the Team Role configuration, users should see a red exclamation mark indicating a warning for an invalid team. This allows the user to update the team assignment according to the warning.

QMS

Generate Documents using Object Record Actions for Audits

This feature allows users to generate a document from a Formatted Output or a Document Template using an entry action or user action on the Audit object record. Learn more about generating documents for Audits.

QualityOne & Training Vault Connection

This feature enables the synchronization of training documents from a QualityOne Vault to a Training Vault. After the documents are approved (or updated) in the QualityOne Vault, a CrossLink is created (or updated) in the Training Vault so that the Training Admins can create Training Requirements and assign training tasks to users. Learn more about the connection between QualityOne and Training Vaults.

Pre-populate Hazards in Material Verification Checklists by Food Category and Sub-category

This feature provides the ability to send a single material verification checklist to a supplier for all the materials that belong to one material category and sub-category. In cases where material verification is requested by a supplier that is supplying multiple materials that belong to the same material category and sub-category, the supplier will only need to submit their response once rather than completing a separate checklist for each material. Learn more about the Material Verification enhancements.

Populate HACCP Plan Enhancement

Enhancements to the Populate HACCP Plan Details feature allow the user to view all the related CCP-Hazard Analysis (ccp_hazard_analysis__v) records on the HACCP Plan page by automatically populating the HACCP Plan (haccp_plan__v) field when the CCP-Hazard Analysis record is created.

Enhancements to the Populate HACCP Plan Details action will also enable the following:

• Admins can configure the objects that will be automatically populated by the system based on the data setup.
• Automation logic will auto populate HACCP Plan Process Step Connection records in addition to the HACCP Plan Process Step records.
• Automation logic is updated to support the standard object type on the Process Step and HACCP Plan Process Step object when automatically populating the HACCP Plan Process Step record.

Learn more about the HACCP Plan enhancements.

Deep Copying Inspection Plan Requirement & Acceptable Attributes

This feature extends the Copy Record action to include related records under the Inspection Plan hierarchy. Users can choose to deep copy Inspection Plan Requirement and Acceptable Attribute records whenever an Inspection Plan is copied. Learn more about deep copying Inspection Plan Requirement and Acceptable Attributes.

Supporting Application Security Matching Rules using Facility for Inspection Sample Test Result Object

This feature extends the Application Security design for the Inspection Sample Test Result object to apply record-level access control using the Facility field. Learn more about Application Security.

Inspection Sample Test Results Enhancements

This feature improves the user experience by providing an effective way for presenting test result data. The overall responsiveness of validating test results has been improved, and users can record test result data faster in fewer columns. Learn more about Inspection Sample Test Results enhancements.

Setting Pass / Fail Value for Qualitative Inspection Sample Test Results

With this feature, users can explicitly set a passing or failing test result value for attribute test result data associated to an Inspection Sample Test Result record.

Validating Inspection Sample Test Result Record

As users enter test results of an Inspection Sample Test Result record, its value will be validated against the associated LSL and USL values (quantitative testing), or the pass and fail value (qualitative testing). The existing Analyze Inspection and Analyze Inspection Sample actions will evaluate Inspection Sample Test Results where validation has not been performed.

Recording Inspection Sample Test Result Variable & Attribute Data in a Single Column

Users can record the qualitative (attribute) and quantitative (variable) test result, along with its test result unit and data symbol, in a single test result column. These resulting values will be stored in the existing Inspection Sample Test Result data field for attribute and variable test result data.

Acceptable Attribute Remodel

This feature replaces the existing Acceptable Attribute object and its related objects with a new Attribute Test Result Variant object. This data model change will provide an improved user experience as users can now efficiently capture different variations of qualitative test results found in COA files without having to specify each attribute in the Inspection Plan Requirement record.

This also allows users to view matched text from the COA file that leads to either a “Pass” or a “Fail” verdict. Learn more about the Acceptable Attribute remodel.

COA Inspection Enhancements

These features improve organizations’ ability to report on overall ingestion accuracy, specifically, the percentage of COA documents that can processed uninterrupted (straight-through processing). Learn more about COA Inspection enhancements.

Analysis Source for Header Fields

With this feature, Admins can report holistically regarding the COA ingestion accuracy. Admins can report on fields that have Matching Rule Variants defined if they were ingested automatically or required manual intervention to be successfully extracted from a COA file.

Automatic Flagging of Problematic COA Formats

With this feature, Vault can automatically flag COA files that were not processed straight-through. Once an Inspection record enters a “Complete” lifecycle state type, Vault assesses whether the document was ingested automatically.

Document Control

Process Navigator: Visual Hierarchy Configuration Page

The Visual Hierarchy Configuration Page will allow customers to configure Process Detail pages to display different types of information about a business process. Enhancements to the Process Navigator feature will also allow users to reparent the Visual Hierarchy records in a business process without losing their associated documents, allowing for more flexibility. Learn more about the Visual Hierarchy configuration page.

RegulatoryOne

RegulatoryOne features are targeted for tentative availability on February 21, 2023.

RegulatoryOne

Turn On Audit Tracking for the Organization Object

Audit tracking is now turned on for the Organization (organization__v) object, allowing Admins to view the audit trail of changes made to all Organization records. The Audit data changes in this object attribute cannot be disabled for the Organization object.

Registration & Dossier Management

Specify Object Type for the Create Registration and Objective Action

This feature allows Admins to specify what Registration object types Vault creates when users run the Create Registration and Objective action. Learn more about configuring the Create Registration and Objective action.

Veeva Claims

Veeva Claims features are targeted for tentative availability on February 21, 2023.

Veeva Claims

Reuse Element Translations for Different Locales

This feature enables users to reuse element translations in a particular language across different geographical pack copies when that language is mapped to each geographical location. When localizing a Pack Copy, Vault can reuse existing element translations for languages mapped to multiple locations rather than creating a unique element translation for each location. Learn more about translating pack copy elements.

Bulk Add Local Adaptation Comments

This feature enables users to add a Local Adaptation comment to multiple Local Adaptations using a bulk object record action. When configured, users can select Bulk Add Comment after selecting the option to perform a bulk action from the All Actions menu and add the same comment to all selected Local Adaptation records. Users can also mention other users by entering the “@” or “+” keys in the Local Adaptation Comment. Learn more about bulk adding a comment to multiple records.

Project & Pack Copy Automation: Record Action Settings

This feature enables Admins to configure the Create Selective Local Adaptations and Localize Pack Copy actions for each lifecycle state of the Project and Pack Copy objects, respectively. For the Generate Local Adaptations action, Admins can define Instructional Text, Grid Columns, and Claims Lifecycle States for each lifecycle state. For the Localize Pack Copy action, Admins can define Instructional Text and Grid Columns for each lifecycle state. Learn more about configuring the Create Selective Local Adaptations and Localize Pack Copy actions.

23R1 Veeva Claims Enhancements

This feature enables users to select multiple Country object records when running the Bulk Create Local Adaptations and Localize Pack Copy actions. In prior releases, Vault relied on a multi-select country picklist for these actions.

Enablement Details

Feature	Enablement	Application
Working with Documents
Save Link Type Selection as a User Preference	Auto-on	Platform
Glossary Usability Enhancements	Auto-on	Platform
Prevent Re-Render of Documents with Manual Renditions	Auto-on	Platform
Signature Page Generation Enhancements	Configuration	Platform
File Size Reduction for Viewable Rendition Downloads	Auto-on	Platform
Improved Rendering Status Reporting	Auto-on	Platform
Upload Documents UI Enhancements	Auto-on	Platform
Updated Download Icon for Source File	Auto-on	Platform
Search for Document Number in “Search Current Binder”	Auto-on	Platform
Add a File to a Placeholder via Drag & Drop	Auto-on	Platform
Reporting & Dashboards
Object Reference Fields in Reports Formulas	Auto-on	Platform
Advanced Filter Logic for Multi-Pass Reports: Improved Logic Flexibility	Configuration	Platform
Vault Objects
Person Object: Duplicate Person Record Enhancements	Configuration	Platform
Country Object: Add Code Field	Auto-on	Platform
Lifecycle & Workflow
Object Lifecycle Entry Criteria: State of Related Record Rule Can Validate Multiple States	Configuration	Platform
Object Lifecycle Conditions: Evaluating Related Object Field Values	Configuration	Platform
Multi-Record Object Workflows: Action Step for Automatically Removing eSignatures	Configuration	Platform
Multi-Record Object Workflows: Limiting Roles Allowed to Participate for Workflow Initiator Selected Participant Groups	Configuration	Platform
Workflow Details on Active Workflows & Timeline	Auto-on	Platform
Workflow Participant Selection Actions Support Search by Email Address	Auto-on	Platform
Usability & UI Updates
Tab Collection Updates	Configuration	Platform
Search
Later Version Available Indicator	Auto-on	Platform
Include Search Criteria when Exporting Results to Excel	Admin Checkbox	Platform
Checklists
Checklists: Batch Saving Responses	Auto-on	Platform
Checklists: Increased Limit for Maximum Answers per Question	Auto-on	Platform
Vault Authentication
New Certificate for SAML SSO & Spark Messaging Connection	Auto-on	Platform
Administration
Email Suppression List	Auto-on	Platform
Notifications: Add Annotation Replies to Summary Emails	Auto-on	Platform
Configuration Report: Atomic Security Enhancement	Auto-on	Platform
Document Templates Limit in Sandboxing	Auto-on	Platform
Vault File Manager
VFM Resumable Upload & Download for Check Out & Check In	Auto-on	Platform
Support 500GB File Size	Support	Platform
Download Source Files Using Vault File Manager	Auto-on	Platform
Vault Loader
Vault Loader Support for Record Migration Mode Update & Upsert	Auto-on	Platform
Platform Data Model Changes	Auto-on	Platform
Clinical Operations
Trip Report Question Branching: Show & Hide Dependent Questions	Auto-on	CTMS
Trip Report Question Branching: Review Comments on Dependent Questions	Auto-on	CTMS
Clinical Operations to Medical CRM Connection: Study & Study Site Transfer	Configuration	CTMS
Support for Tracking EUCT Number & OMS ID in Vault Clinical EU CTR Data Model Support	Auto-on	Clinical Operations - All
Study Person Field Validation Check	Auto-on	CTMS, Study Startup, Vault Payments, eTMF
Limit for Study Team Roles	Auto-on	CTMS, Study Startup, Vault Payments, eTMF
Automate Site Fee Generation	Configuration	Vault Payments
Populate Site Fee Definitions	Configuration	Vault Payments
Fee Schedule & Template Copy	Auto-on	Vault Payments
Copy Fees From Template Enhancement	Auto-on	Vault Payments
Safety Distribution Gap Pack	Configuration	Site Connect
Safety Distribution Document List Token	Configuration	Site Connect
Safety Distribution Types	Configuration	Site Connect
Study Training: Vault Connections with Study Training Vault	Configuration	CTMS
Track Study Site ISF Location	Configuration	CTMS, Study Startup, Vault Payments, eTMF, Site Connect
Clinical Data Model Changes	Auto-on	CTMS, Study Startup, Vault Payments, eTMF
Commercial
Modular Content Document Info Panel	Auto-on	PromoMats
Enhanced Suggest Links within Content Modules	Configuration	PromoMats
Brand Portal Refresh for Users & Portal Administrators	Admin Checkbox	PromoMats
Product & Country Become Shared Fields	Auto-on	PromoMats
Standard Metrics Track Duration	Auto-on	PromoMats
Increased Matching Flexibility with Enhanced Suggest Links	Auto-on	PromoMats
Enhanced Suggest Links Leverages Search Synonyms	Auto-on	PromoMats
Commercial Data Model Changes	Auto-on	PromoMats
Medical
Response Package: Download Source Document	Configuration	MedComms
Email Templates for Medical Inquiry Case Responses	Configuration	MedComms
Include Attachments in E2B(R3) Generation in Vault MedInquiry	Auto-on	MedComms
Add Country to Cover Letter Generation Action	Configuration	MedComms
Medical Portal Refresh for Users and Portal Administrators	Admin Checkbox	MedComms
MedComms & Multichannel as Apps	Auto-on	MedComms, PromoMats
Medical Data Model Changes	Auto-on	MedComms
Training
Study Training: Vault Connections with Clinical Operations	Configuration	Study Training
Quality
5 Whys Analysis	Configuration	QMS
Auto-Create Proposed Audits	Configuration	QMS
Supplier Change Notifications	Configuration	QMS
Extend Recurrence Check to Support Custom Object Types on Quality Event	Configuration	QMS
QRM Risk Builder	Configuration	QMS
eMDR Update: Auto Generate Manufacturer Report Number	Auto-on	Surveillance
Standalone MedTech CAPA & Nonconformance Objects	Auto-on	Surveillance
Reporting Enhancements	Configuration	Surveillance
Standalone Complaints: VPS Support	Auto-on	Surveillance
Learner Homepage Usability Enhancements	Auto-on	Training
Add Participant Action Available for All Training Workflows	Auto-on	Training
Tag Reason for Training Assignment Creation	Auto-on	Training
Complete Training Tasks on Vault Mobile	Auto-on	Training
Capture Instruments & Consumables in Test Execution	Auto-on	LIMS
Lab Test Reopening, Retesting, Canceling & Rejecting	Auto-on	LIMS
Lab Hazards & Special Instructions	Auto-on	LIMS
Test Protocol Review	Configuration	Validation Management
Test Authoring with Requirements Burndown	Auto-on	Validation Management
Quality Data Model Changes	Auto-on	LIMS, QMS, QualityDocs, Station Manager, Surveillance, Training, Validation Management
Regulatory
Support Sequence ID Updates in Continuous Publishing	Auto-on	RIM Publishing
Workgrouping Support for Australia eCTD	Auto-on	RIM Publishing
Additional Granularity for Content Plan Template Constraints	Auto-on	RIM Submissions
Content Plan & Content Plan Template: Exclude from Auto-Matching	Auto-on	RIM Submissions
Copy Report Level Content Plan	Configuration	RIM Submissions
Update Content Plan Study Section	Configuration	RIM Submissions
FHIR Message Handling in IDMP Viewer	Configuration	RIM Registrations
UPD Data Model Updates	Auto-on	RIM Registrations
IDMP Data Model Updates	Auto-on	RIM Registrations
Multi-Record Registration Verification	Configuration	RIM Registrations
Add Submission Fields as Selectable Columns in the New Viewer	Auto-on	RIM Submissions Archive
Display Inactive Applications and Submissions in the New Viewer	Configuration	RIM Submissions Archive
Empty Section Indicator in the New Viewer	Configuration	RIM Submissions Archive
Leaf Source File Path Auto-Correction
New Submissions Archive Viewer Automatic Enablement	Auto-on	RIM Submissions Archive
Save View in the New Submissions Archive Viewer	Auto-on	RIM Submissions Archive
Submission Based Viewer Filters Automatic Enablement	Auto-on	RIM Submissions Archive
Enforce Submissions Archive User License	Auto-on	RIM Submissions Archive
Document Merging on Publish	Auto-on	RIM Publishing, RIM Submissions
Vault Link Annotations: Multiple Target Destination Support	Auto-on	RIM Publishing, RIM Submissions
Active Dossier Loader	Auto-on	RIM Submissions, RIM Submissions Archive
Active Dossier Template Update	Auto-on	RIM Submissions, RIM Submissions Archive
23R1 RIM Data Model Changes	Auto-on	RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive
QualityOne
Independently Licensable Applications in QualityOne	Auto-on	QualityOne
QMS & Doc Control Applications for QualityOne	Auto-on	QualityOne
HSE Application for QualityOne	Auto-on	QualityOne HSE
Conditional Role Exclusivity for Teams	Configuration	QualityOne
Displaying Team Assignment Users in Audit Logs	Auto-on	QualityOne
User Experience & Security Enhancements for Teams	Configuration	QualityOne
Generate Documents using Object Record Actions for Audits	Configuration	QualityOne
QualityOne & Training Vault Connection	Configuration	QualityOne
Pre-populate Hazards in Material Verification Checklists by Food Category and Sub-category	Configuration	QualityOne
Populate HACCP Plan Enhancement	Configuration	QualityOne
Deep Copying Inspection Plan Requirement & Acceptable Attributes	Auto-on	QualityOne
Supporting Application Security Matching Rules using Facility for Inspection Sample Test Result Object	Auto-on	QualityOne
Inspection Sample Test Results Enhancements	Auto-on	QualityOne
Setting Pass / Fail Value for Qualitative Inspection Sample Test Results	Auto-on	QualityOne
Validating Inspection Sample Test Result Record	Auto-on	QualityOne
Recording Inspection Sample Test Result Variable & Attribute Data in a Single Column	Auto-on	QualityOne
Acceptable Attribute Remodel	Configuration	QualityOne
COA Inspection Enhancements	Configuration	QualityOne
Analysis Source for Header Fields	Auto-on	QualityOne
Automatic Flagging of Problematic COA Formats	Auto-on	QualityOne
Process Navigator: Visual Hierarchy Configuration Page	Configuration	QualityOne
RegulatoryOne
Turn On Audit Tracking for the Organization Object	Auto-on	RegulatoryOne Compliance Management, RegulatoryOne Registration & Dossier Management, RegulatoryOne Regulatory Documents, Veeva Claims
Specify Object Type for the Create Registration and Objective Action	Configuration	RegulatoryOne Registration & Dossier Management
Veeva Claims
Bulk Add Local Adaptation Comments	Configuration	Veeva Claims
Reuse Element Translations for Different Locales	Configuration	Veeva Claims
Project & Pack Copy Automation: Record Action Settings	Configuration	Veeva Claims
23R1 Veeva Claims Enhancements	Configuration	Veeva Claims
Turn On Audit Tracking for the Organization Object	Auto-on	RegulatoryOne Compliance Management, RegulatoryOne Registration & Dossier Management, RegulatoryOne Regulatory Documents, Veeva Claims

See the following explanations for enablement options:

Enablement	Description
Auto-On	Automatically activated and no configuration is required before using the feature; note that in some cases, a new feature is dependent on another feature that must be enabled or configured.
Admin Checkbox	Admins must turn on the feature with an Admin checkbox. Note that some “Auto-On” features have a checkbox setting that hides the feature; these will show “Auto-On.”
Configuration	Admins must configure the feature (separately from an Admin checkbox) before it is available to use or is active; for example, an Admin must add document templates before users can create documents from templates.
Support	On/off option controlled by Support.