New in 24R3 Limited Release

Limited Release Dates: August 23, 2024 (24R2.2); September 27, 2024 (24R2.3); October 18, 2024 (24R2.4) | General Release Date: December 6, 2024

The following applications may have different release dates: Safety, RegulatoryOne, and Veeva Claims.

We are pleased to bring you new functionality with each limited release. These release notes are updated with upcoming new features one week before the limited release date. See the following explanations for enablement options:

• Auto-on: Automatically activated and no configuration is required before using the feature; 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. 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.

Platform

Documents

Migrate Document Usage Object to Raw ObjectAuto-on24R2.2

With this release, the Document Usage object will be migrated from a standard volume object to a raw object to provide improved scalability performance.

The Document Usage object tracks each of the following actions on steady-state documents:

• View
• Download Source
• Download Rendition
• Make a Copy

Moving this object to a raw object will help provide performance stability, as the number of records created for Document Usage can be in the millions. As this is a raw object, any filters applied on Document Usage records must be case sensitive. For reports using the Contains operator, we recommend ensuring that the filters use the appropriate case.

Additionally, if the Document Usage object is exposed in the Business Admin menu, the search bar only searches the Name field. Users with access must use filters on other fields instead of the search bar:

Learn more about the Document Usage object and raw objects.

Vault File Manager: File Staging Download ImprovementsAuto-on24R2.2

When using Vault File Manager to download content from File Staging, Admins will now see two changes that will reduce potential issues that may occur with longer filepaths.

First, Vault File Manager will display a new tooltip when hovering on the status if the filepath is longer than the Windows maximum. Prior to 24R3, hovering over the status would attempt to show the full filepath rather than note specifically that the filepath length is the issue to address. After 24R3, hovering over status will show:

Second, Vault File Manager will use a shorter naming convention for folder names when folders are downloaded to reduce the potential of hitting the Windows filepath limit. Prior to 24R3, the format was “VaultID_{VaultID}_File_Staging_Download_{Datestamp}”. After 24R3, the format will be “{VaultID}_VFM_{Datestamp}”. As an example, “VaultID_1000008_File_Staging_Download 2024-05-14 16-54-29-485” will shorten to “1000008_VFM_24-05-14 16-54-29-485” after 24R3 (reducing characters from 61 to 35).

Windows has a standard limit of 256 characters for filepath length and these enhancements will help reduce the potential of downloads exceeding that and will provide clearer information to users when the filepath is exceeded.

Learn more about using Vault File Manager to work with File Staging.

Lifecycle & Workflow

Workflow Tasks Prompt for ParticipantsConfiguration24R2.2

Admins can now configure workflow tasks to prompt the task owner to select a workflow participant as part of task completion. When defining a workflow participant in the workflow Start step, Admins can now select Allow workflow task owners to select participants. This option adds the workflow Participant control as a prompt when configuring a workflow task.

You can prompt for participants as part of the task, or even as part of a specific verdict (if using the Single Verdict option), which means you can now build an optional flow whereby, for example, the user can choose to send the item for a secondary review.

Workflow Participant controls configured in this way do not show to the Workflow Initiator when starting a workflow, and the prompt can contain up to 10 Participant controls per task or verdict. You cannot select the participant group assigned for the task you’re currently configuring. This feature is available for both document and object workflows.

This feature is not available for tasks completed on Vault Mobile.

Workflow uses User Reference Fields as ParticipantsConfiguration24R2.2

With the ability to designate specific users in fields on object records, it is common to see an assignee or process owner selected, who may not have a specific Role in the record’s Sharing Settings. It is now possible to assign tasks to users selected in user reference fields, along with sending them notifications, or adding them to roles via Update Sharing Settings workflow steps.

When configuring a workflow Participant on a workflow Start step, Admins can now select Use user reference field as participant, which allows you to select one of the user reference fields on the object.

Similar to Use roles as participants, this type of workflow Participant is not displayed in the Start step to the Workflow Initiator because Vault already knows who the user is in that field.

Typically, Vault works out who is in a workflow Participant Group when the workflow initiates. However, for these user reference participants, they are not resolved until the workflow step that uses them executes (task created, notification sent, sharing settings updated, etc.) This allows for processes where that user reference field is set earlier in the workflow, and then used as a task owner, for example, later in the workflow.

Another key aspect of this functionality is that you can configure the workflow Participant to reference another user reference field on the User object, for a specific user reference field on the object defined in the workflow, such as the Manager field:

Workflow uses Groups as ParticipantsConfiguration24R2.2

Many customers utilize manual User Groups (along with automatically-managed groups created through custom and matching sharing rules) to share documents and data, and assign workflow tasks. In 24R3, when configuring a workflow and defining a workflow participant in the Start step, Admins can now default users from a User Group (limit of 1) by selecting Use Vault user groups as participants. When the workflow begins, Vault adds any users in that User Group at that point in time to the Workflow Participant Group (subsequently used for assigning tasks, updating sharing settings, sending notifications, etc.)

The new Use Vault user group as participants option supports System Managed, Custom, and Manager groups (if enabled for the Vault), but not auto-managed groups created through Dynamic Access Control. It works much in the same way as today’s Use roles as participants option, where that Workflow Participant field is not displayed in the Start step to the Workflow Initiator because Vault handles all the user selection.

Objects

Yes/No Checkbox Field EnhancementAuto-on24R2.2

While Yes/No fields on objects have always supported a null value, Yes/No fields configured as checkboxes have not. A Yes/No field is null if the user has not actively selected Yes or No. In 24R3, Yes/No checkbox fields also support null values, which impacts how records are created and updated.

Impact on New Record Creation and Vault Configuration

• When creating new records, if the user doesn’t make a selection, the checkbox will save as null if the field is not configured with a default value. Prior to 24R3, Vault saved the field as No and cleared the checkbox.

• If a Yes/No checkbox field is null, it displays the same as a checbox set to No or cleared. However, a tooltip hover identifies the checkbox as null.

• Changing a Yes/No field to a checkbox field no longer updates null Yes/No fields on records (to set them instead as No), because Yes/No checkbox fields now support null values.

• Creating new Yes/No checkbox fields on objects or object types no longer causes updates to existing records. This happens because Yes/No checkbox fields now support null values, which is the case for records that already exist.

Automatic Configuration Update on Release Night to Preserve Behavior

Veeva will automatically preserve today’s behavior via a release-night automatic upgrade of existing configuration. Any existing custom Yes/No checkbox fields that do not have a default value configured will now have a default value of No. This matches the Create and Update record behavior prior to 24R3, where if no selection was made, Vault saved the field as No and cleared the checkbox.

Integrations and Custom SDK Code

The API now supports clearing a Yes/No checkbox field by passing in a null value via the API or SDK. Integrations and custom SDK code should be reviewed in case written with the expectation that Yes/No checkbox fields can never be null. For example:

• You are creating a record but not setting an explicit value for a Yes/No checkbox field, and expecting a No value once created.

• You are setting a Yes/No checkbox field to null in your code, intending it to be false (which will now be null in 24R3).

• You are retrieving the value of a Yes/No checkbox field and evaluating its value to determine next lines of code, but you aren’t considering the possibility of it being null.

Older API versions will retain their current behavior so existing integrations should see no impact unless the API version is updated.

Best Practice for Vault Configurations Referencing Yes/No Checkbox Fields

Your existing configuration will continue to work, but as a best practice, it is important to identify formula expressions, filters, reports, dynamic role assignment, etc. to always consider the null value, which is treated the same as a blank value, in all field types, including Yes/No checkbox fields.

Attachment FieldsConfiguration24R2.2

The new Attachment object field type allows users to select and upload a file to an object record. Unlike record attachments, known as Attachment sections on object records, Attachment fields allow you to configure dedicated upload slots for specific files you need included in the record.

This feature is useful in large data migrations, where pasting content into Long Text fields may not be an option, but you still want to clearly identify the purpose of the file’s contents, as opposed to a generic attachment.

You can use Layout Rules and Validation Rules with the isBlank() function, or lifecycle state entry criteria, to ensure these fields are populated by certain points in the lifecycle (or according to the logic you configure).

Attachment fields support files up to 100 MB in size. Vault does not render these files, so you must download them in order to view them. You can control Attachment fields via Atomic Security at the Lifecycle State or Role level, and you can query these fields in VQL to retrieve the file name, MIME type, and file size. You can add files added to the file staging server to Attachment fields via Loader by referencing the file path (link to file staging server info). Finally, Vault cloning, including Sandboxing, supports Attachment fields, meaning if an object record is included in Vault clone, and it contains files in Attachment fields, those files are copied to the cloned Vault and record.

Object Type DescriptionsConfiguration24R2.2

For objects with object types enabled, Admins may need to understand the context behind each object type. With 24R3, Admins can now populate a Description field while creating or editing an object type. The object type description is included as part of its metadata.

Print Record EnhancementsAuto-on24R2.2

The Workflow Timeline section is now included in the PDF generated by Print Record if available on the layout. Only the first five rows are included. Additionally, the total page count has been added to the PDF footer.

Common UI & Search

Strict Matching AdjustmentsAuto-on24R2.2

When searching for documents or object records, Vault applies rules for how many of those terms must match for an item to be a result. In this release, we are adjusting these rules to allow more results to be returned (making it slightly less strict), without allowing so many items to match that the result set is too large to be useful.

With the new rule, 70% of search terms must match for an item to be returned as a result (rounded down). For example, if your search contains:

• 2 terms, then 1 of the 2 must match
• 3 or 4 terms, then 2 of the terms must match
• 5 terms, then 3 of the 5 terms must match
• 8 terms, then 5 of the 8 terms must match.

This is a subtle difference from the previous rules, where any search containing over 5 terms required all but 2 terms to match (which in this case would be 6).

This rule that 70% of the terms must match is easier to understand than the previous ruleset, and allows a slight increase in the number of results returned, and prevents items from being unexpectedly omitted.

Learn more about strict matching and Vault search settings.

Email to Vault: Size Limit IncreaseAuto-on24R2.2

When using Email to Vault functionality, Vault now supports emails up to 40 MB in size, increased from a prior limit of 30 MB. Prior to 24R3, if an email was between 30 and 40 MB, Vault would create an email record in the Bounced state. For emails over 40 MB, the email would not be processed by Vault and a bounce email would be sent to the sender from AWS.

With this enhancement, emails up to 40 MB can be processed by Vault accordingly and not bounced due to size. If an email is over the 40 MB size limit, there is no behavior change (no Email record is created in Vault and a bounce email is sent to the sender from AWS).

Learn more about Email to Vault.

Reporting & Expressions

Reduce Dashboard Cache and Display Last Updated TimeAuto-on24R2.2

Dashboards will now automatically refresh every 12 hours if not manually refreshed. Prior to 24R3, dashboard data cached and automatically refreshed every 36 hours, which often caused users to perform manual refreshes more frequently.

Additionally, Dashboard components now display an icon with the last updated time on each chart, making it easier for users to know how current the data is based on the last refresh.

Learn more about Dashboards.

Document Formula Fields Limited to Status and State TypeConfiguration24R2.2

When using the following document formula field functions, only the Document Status and Document State Type fields will be supported for new formula fields.

• DurationInValue()
• NumTimesInValue()
• FirstTimeInValue()
• LastTimeInValue()
• PreviousValue()

These functions are commonly used to perform cycle time calculations and are rarely utilized for fields other than Document Status. Because the fields work by querying the audit trail, focusing these functions on Document Status and Document State Type will improve the scalability of Vault’s audit trail, while still supporting the main use case for these functions.

Any existing document formula fields that are using these functions and other field types will continue to work after 24R3, but new formula fields will only be able to use Document Status and Document State Type fields.

Learn more about document formula fields.

Task Exclusion in Multi-pass Workflow ReportsAuto-on24R2.2

When using multi-pass reports that contain workflow report views, Vault will now only show multiple rows per workflow if a Task column is included in the report or if the multi-pass report type is using a Task column to join views.

Prior to 24R3, Vault would always create a row for each task within each workflow, even if the report was not using any task-related information.This would result in user confusion as it would appear that there were duplicate rows. This enhancement will help reduce the perception of duplicate rows and provide cleaner reports for users.

Learn more about Multi-Pass Reporting.

Tools

Vault Loader CLI Java 17 Support 24R2.2

In order to use the latest version of the Vault Loader CLI, developers need to ensure that Java 17 is available in the environment. Developers can continue to use older versions of Vault Loader CLI with Java 8.

Disable Audit Trail on UEM and UEIAuto-on24R2.2

Record changes for the User Exceptions Message (UEM) and User Exception Item (UEI) objects are no longer included in audit trails. These objects are used for information purposes to aid in integration management.

Sandboxing UI Warning before Vault ReleasesAuto-on24R2.2

A warning (UI Alert) will be shown to users on the Sandbox Vaults page while an infrastructure release event is ongoing. This message warns users that Sandboxing performance may be degraded, but no other functionality will be impacted by the backend maintenance.

Client Credential Support for Http Service 24R2.2

Vault now allows the creation of Client Credentials (client_crendentials__sys) type records, which can store a Client ID and an encrypted Client Secret. Previously, users could only create Connection Authorization records of the type Basic Authentication (basic_auth__sys). Developers can use these values in the Vault Java SDK together with the HTTPService.

Remove System Audit of Vault Loader ActionsAuto-on24R2.2

Vault Loader events are no longer recorded in the System Audit History. The corresponding updates to object records and documents are still recorded in the Object Record Audit History and Document Audit History, respectively.

Vault Mobile

Site Selector Support (SiteVault)Auto-on24R2.2

SiteVault users can now view and change their site context within the Vault Mobile app. A new site selector list will be available at the top of each mobile tab, which will filter the Library results to that specific site. 

SiteVault leverages a specific selector that allows users to navigate among their research organization and site(s) in SiteVault. The documents that you can access or manage are determined by the site context that’s selected. This provides a more consistent user experience between the mobile app and the web browser for SiteVault users. 

Learn more about SiteVault  

Open Binders in WebAuto-on24R2.2

Users that attempt to access a binder in the Vault Mobile app are now presented with an easy way to open that binder via a mobile browser. 

While Vault Mobile still does not fully support navigating binders within the mobile app, this enhancement removes friction and confusion for users by allowing them to immediately open the binder in a browser to perform any needed work. 

Learn more about Vault Mobile. 

Blur Content when App is in BackgroundAuto-on24R2.2

The contents of the Vault Mobile app are now blurred whenever the app is the device’s background. This enhancement provides an extra precaution to prevent any app content from being visible when a user switches between multiple apps and is consistent with how many banking and financial apps work in similar situations. 

Platform Data Model Changes

See 24R3 Platform Data Model Changes.

Vault Connections

Clinical Operations-EDC Connection

Clinical Operations-EDC - Protocol Deviations Link to CDMSAuto-on24R2.2

For Protocol Deviations managed by the Clinical Operations-EDC Connection, this feature introduces a standard link field on Protocol Deviations in Vault CTMS that leads directly to the Protocol Deviation review page in Vault EDC. Using this link, customers can quickly and easily navigate to the source Protocol Deviation when reviewing issues in Vault CTMS, similar to how Casebook Link is used for Subjects and Subject Visits.

RIM-Clinical Operations Connection

RIM-Clinical: Update to Clinical Study Field RulesConfiguration24R2.2

In 24R3, Vault Clinical Operations has added three (3) new standard fields: Type of Control, Study Type, and Study Subtype. These fields already exist in Vault RIM and customers are manually populating the information in RIM or creating custom field rules. With the addition of these standard fields in Vault Clinical Operations, the RIM - Clinical Operations Connection has added new standard field rules to enable the transfer of these field values to Vault RIM. This enhancement increases productivity and data integrity as there is no longer a need to manually populate these values.

RIM-Clinical: Enhance Study Defaulting Logic on Clinical CrosslinksAuto-on24R2.2

When cross-linking documents from RIM to Clinical Operations Vaults, the connection now respects clinical Study records on the source document and attempts to match them to Study records in the Clinical Operations Vault, even if the Study was not created in RIM by the connection (link__sys field is blank). The current crosslinking logic of the connection ignores the Study records on source documents in RIM if they are not mapped to Study records in Clinical (as per the link__sys field). This enhancement ensures that the creation of crosslinked documents will not silently fail. The connection displays an error message if the source document includes Study records that cannot be mapped to Study records in the Clinical Operations Vault.

Safety-Clinical Operations Connection

Safety-Clinical Operations Connection: CRO SupportConfiguration24R2.2

With this release, the Safety-Clinical Operations Connection now supports multiple sponsor organizations for each study, allowing contract research organizations (CROs) to utilize the connection. When users create or edit Study or Study Country records in their Clinical Operations Vault, the connection creates or updates the Study or Study Registration record in their Safety Vault. CRO users can also distribute Safety Letters using Veeva Site Connect.

Learn more about configuring CRO support for the Safety-Clinical Operations Connection.

Safety-EDC Connection

Safety-EDC Connection: Send SAE Reporter Details to SafetyAuto-on24R2.2

With this release, SAE reporter contact information transfers to Vault Safety through the Safety-EDC Connection. This enhancement facilitates direct communication between Safety users and the reporter for clarifying questions about an SAE, thereby reducing triage and processing time. EDC Admins can map reporter details directly on the Adverse Event form. In a future release, EDC Vaults will support defaulting site information to automatically set reporter details when sending SAEs to Vault Safety.

Learn more about configuring your Vaults to send SAE reporter details to Vault Safety using the Safety-EDC Connection.

Clinical Operations

Several features listed in the Vault Connections section also affect the Clinical Operations application family.

CTMS

Japanese Clinical Trial Notification Capability Requires Support to EnableAuto-on24R2.2

Enabling the Japanese Clinical Trial Notification capabilities now requires Veeva Support in order to adequately monitor resources and support for adoption.

eTMF

Multilingual ModelsAuto-on24R2.2

As clinical trials operate on a global scale, and a significant portion of TMF documents are written in languages other than English, it’s not uncommon for sponsors or CROs to have more than 50% of their TMF documents in non-English languages. To date, the TMF Bot could only train on and auto-classify documents with English text.

To significantly expand the TMF Bot’s coverage, we are introducing the Multilingual Models feature. This enhancement enables the TMF Bot to train on and automatically classify and/or detect key metadata in documents that are in non-English languages. More than 30 languages are supported.

Exclude from Metadata Extraction Studies Under Legal HoldAuto-on24R2.2

When a trial or product is involved in litigation, it is essential to preserve the integrity of related documents. In Vault, these preserved documents cannot be re-classified.

In some cases, the TMF Bot metadata extraction may detect a study that is under legal hold and set that value on the document. Since reclassification is blocked in these situations, such a metadata prediction would prevent a user from processing the document out of the inbox, thereby hindering the study’s operations and eventual archiving process.

This feature updates the metadata extraction process to address this scenario. The TMF Bot now avoids setting a Study value to any document if that Study is currently under legal hold.

Study Startup, eTMF

Auto-Manage Number Expected on EDL ItemsConfiguration24R2.2

This feature adds flexibility to the Update Requiredness, # Expected Based on EDL Matchings feature by introducing, on an item-by-item basis, whether Expected Documents should automatically sync the # Expected with the total number of matched documents. A new checkbox field on Expected Documents and Template Expected Documents called Auto-Manage # Expected (automanage_expected__v) determines the update behavior on each Expected Document. This field can be set at the template level and then managed on a study-by-study basis by leveraging the new Update Auto-Manage # Expected system action. The default value for the field is false and configuration updates are required to leverage the feature. When enabled, end users cannot manually modify the # Expected field.

Site Connect

Reason for RecallAuto-on24R2.2

To enhance clarity and transparency in the document exchange workflow process for site users, sponsors & CROs must now provide a reason (up to 255 characters) when recalling a document. Once the recall reason is saved, affected site users receive a notification detailing the recalled document, along with the reason for the recall included in the notification body.

Site Connect LicensingAuto-on24R2.2

Site Connect customers can now track Site Connect licenses on the Study Site License object in Clinical Operations Vaults. Admins can view license consumption in their Vault Settings. Users will see a warning message if consumption is over the licensed amount.

Commercial

PromoMats

Modular Content: Workflow Banner on Content Module App pageAuto-on24R2.2

With this release, reviewers can now complete workflow tasks directly on the Content Module app page instead of navigating to the VOF record. Vault only displays the workflow banner on the Content Module page if single record workflows are enabled for Content Modules.

Medical

MedComms

Statement (Source Statement + Make a Copy+Controlled Vocabulary)Auto-on24R2.2

With this release, when a user performs the Copy Record action on a Scientific Statement, the system now automatically populates the new Source Statement field on the newly created record. Vault populates the field with the ID of the Statement from which the record is copied. Additionally, a Reason for Copy field is added to the Statement, and action layouts are used to restrict the visibility of Source Statement and Reason for Copy fields to only appear during the Copy Record action.

Attribute Fulfillment Document Views & Downloads to Case Responses

This feature allows Vault to track each time an HCP opens a response package link and views or downloads a Fulfillment Document. Admins can now create reports to assemble an overview of views/downloads and their related Case Responses. This feature is deferred to a future release.

MedInquiry

Medical Inquiry Keyword Tracking: Cleanup Job & Reprocess JobAuto-on24R2.2

This release introduces a daily recurring job to delete all Case Request Medical Inquiry Keyword records for Case Requests older than three (3) years. This feature optimizes the amount of data generated in Vault by the Medical Inquiry Keyword Tracking feature.

Additionally, Admins can now configure a standard report and dashboard for Medical Inquiry Keywords in all MedInquiry Vaults.

Medical Data Model Changes

See 24R3 Medical Data Model Changes.

Training

Quality

QualityDocs

Process Navigator: Hierarchy Builder User Interface EnhancementsAuto-on24R2.2

The 24R2 Release introduced the Hierarchy Builder for Process Navigator. This feature includes several minor enhancements to the styling, spacing, process divider lines, and other visual components on the user interface of the Hierarchy Builder to further improve the page’s appearance and usability.

Document Change Control Tokens for Notification TemplatesConfiguration24R2.2

Three new tokens are available for inclusion in Document Change Control Notification Templates. These tokens allow notification recipients to view the list of documents associated with the Document Change Control and whether they are being routed for Change Authorization or are to be made Effective or Obsolete.

The new tokens are:

• ${mdccChangeAuthDocsList} displays a comma separated list of documents to be sent for Change Authorization.
• ${mdccReleaseDocsList} displays a comma separated list of documents to be made Effective.
• ${mdccObsoleteDocsList} displays a comma separated list of documents to be made Obsolete.

Support for Auto-Start Workflows in the Document Change ControlAuto-on24R2.2

If a document is assigned to both a manually-initiated workflow and one or more auto-start workflows, the Document Change Control record’s “Docs to be Made Effective with Workflows” and “Docs to be Made Obsolete with Workflows” sections will display both manual and auto-start workflows for the document in the workflow column.

QMS

Complaints Email Processor Update: Support for Complaint IntakeConfiguration24R2.2

Organizations receive complaints from consumers and healthcare practitioners. These complaints are often captured through a website or call center where they are logged in a Customer Relationship Management (CRM) system. When a complaint requires quality assurance attention, a Complaint record is created in Vault QMS. There are multiple methods of creating the QMS Complaint record:

• Automatic creation of a Complaint record via a custom-built integration with the IT system that captures incoming complaints.
• Automatic creation of a Complaint record based on an email sent to a configured Vault Email Inbox.
• Manual creation of a Complaint record by a QMS user.

The 24R2 release introduced a new option that allows QMS customers to capture potential complaints, called Complaint Intake records, to triage in Vault before making the decision to promote them to actual Complaint records. There are also multiple methods of creating potential complaints:

• Automatic creation of a Complaint Intake record via a custom-built integration with the IT system that captures incoming complaints.
• Manual creation of a Complaint Intake record by a QMS user.

Beginning in this release, system administrators can now configure a Vault Email Inbox to receive email and automatically create Complaint Intake records from the emails received. This feature is beneficial when it is not feasible to rely solely on manual creation of potential complaints, or to build a custom integration with another system to automate potential complaint creation. Vault stores the email received, and any email attachments, in the Complaint Intake record created via this feature.

If the Vault Email Inbox receives an email about a potential complaint that already exists in Vault (for example, the sender replies to the original email), the additional email and any attachments will be captured on the original Complaint Intake record.

External Collaboration: Supplier QuestionnairesConfiguration24R2.2

External Collaboration was designed to allow a customer to maintain a contact list of individuals at partner organizations that they need to interact with. With this feature, these contacts can receive a task with temporary access to Vault, complete the assigned task, and then Vault will revoke their access.

To keep a seamless stream-work with partner organizations, especially when talking about onboarding a new supplier and supplier risk management, there has been a strong business need to provide suppliers and contract manufacturers who only require temporary access to the system the possibility to complete checklists.

In 24R3 we are expanding the External Collaboration functionality to include the ability to assign an external collaborator a task to complete a checklist that was created and approved for use by your business administrator.

This feature requires step-by-step configuration to enable. Learn more on how to configure External Collaboration: Supplier Questionnaires.

Learn more about working with Checklists.

Email Body Layout Section for Complaint, Complaint Intake, & Supplier Change NotificationsConfiguration24R2.3

This release introduces a new configuration option for System Administrators: the Email Body layout section for Complaint, Complaint Intake, and Supplier Change Notification objects. The section displays the content of the email sent to a Vault Email Inbox and processed by the Create Complaint or Supplier Change Notification email processor, resulting in the creation of the object record.

We encourage System Administrators to replace the Email Body field in object layouts with the new Email Body layout section because the Email Body layout section supports the Print Record feature introduced in 24R2. The Print Record functionality enables a user to generate a downloadable PDF file containing the record’s data as shown on the record’s detail page. Replacing the Email Body field with the Email Body layout section ensures the content of the email displayed on the record is readable in the exported PDF file. The email content exported to PDF is a text version of the original email.

Download to PDF: Support for Vault QMS Specific Sections & FieldsAuto-on24R2.2

This release we’re expanding on 24r2’s Print Record feature, with a focus on functionality for QMS specific application controls. Most of the controls across QMS that were previously unsupported for Print Record are now supported:

• Quality Teams Section
• Related Events App Section
• Root Cause Analysis Tool Section
• Notification Recipients Section
• Risk Builder Section
• Risk Level Assignment
• Record Check Insights Link
• Quality Incident Configuration Data

These sections will now natively render when using the Print Record function on any record in Vault QMS. There are a few more application sections that are coming in future releases as we further push to provide native printing capabilities across the application, so stay tuned for more updates with our upcoming releases!

Action Paths: Support Change Action Templates 24R2.2

This feature enables Vault to automatically assign a new Change Action, created from a Change Action Template, to a specific Action Step on a parent Change Control, Quality Event Change Control, or Change Plan.

Prior to this feature, whenever a Change Action was created from a Change Action Template, the new Change Action was always assigned to the parent record’s Other Actions. If the Change Action belonged in a particular Action Step, a user had to manually update the Change Action to assign the desired Action Step. This feature eliminates the need for the secondary manual Change Action update.

Creators of Change Action Templates can now assign an Action Step to a Change Action Template.

When a Change Action is created from a Change Action Template, and the parent record uses the Action Path & Action Step identified in the template, Vault automatically assigns the new Change Action to that Step.

When an Action Step (e.g. Pre-Implementation) is already In Progress or Closed, users cannot create a Change Action for that Action Step. Therefore, if a user attempts to create a Change Action from a Change Action Template associated with an Action Step that is not Open, Vault does not create the Change Action, and the user receives a notification that the Change Action could not be created because the Change Action Template is associated with an Action Step that is already In Progress or Closed.

Assuming an organization already configured the Change Action Template and Action Path & Steps features, the only additional task necessary for a system administrator to enable this feature is to add the new Change Action Template Action Path & Step control to a section in the Change Action Template object layout.

A Change Action Template can only be assigned to a single Action Path & Action Step. This feature has no impact on Change Actions created from Change Action Templates when the parent record does not use an Action Path.

Station Manager

Prevent Duplicate Documents in Station ManagerAuto-on24R2.2

Previous to this release, it was possible for a Station Administrator to add the same version of a document to a Station record more than once. This feature introduces an error message and prevents a Station Administrator from adding a document version as Planned or Assigned when that document version already exists in either of these sections on the Station record.

Surveillance

eMDR: Section FConfiguration24R2.2

With 24R3, organizations acting as importers of medical devices can now submit eMDRs to the FDA. In line with the general direction of Vault Product Surveillance, the standard layout for eMDR now supports working with eMDR Section F data. Existing customers can add the Section F application section to their eMDR layouts as part of adopting this feature.

New metadata fields for capturing and supporting Section F of the eMDR form are now present in Vault Product Surveillance’s Adverse Event Reports and supporting Complaints and MedTech Complaint Details objects. This feature will require configuration to use. We strongly recommend reviewing the eMDR Standard Layout example to see how to best implement this section to the eMDR process as it includes examples of how to keep users focused, for example, by ensuring the section is only presented to users when relevant.

Validation Management

24R3 Standard App Enhancements for Vault Validation ManagementAuto-on24R2.2

In 24R3, the Validation Management application continues to enhance the standard data model and component design to help standardize the application. Examples include adding various standard date and cancellation related fields in various objects. In this release, we also have put controls in place to prevent Admins from enabling a Dynamic Access Control (DAC) attribute, like custom sharing rules or matching sharing rules, from any Vault Validation Management standard object. This was done because security is governed by the Validation Teams feature, and allowing Admins to enable DAC introduces unnecessary complexity that we want our customers to avoid. Since this change is automatically enabled, all customers must ensure they have not enabled DAC on any standard object (e.g. val_requirement_svo__v or val_activity__v) prior to the 24R3 release.

We are also introducing a new object type to help organizations manage Configuration Specifications on the Validation Requirement object (val_requirement_svo__v). Although the object type is inactive, customers must at a minimum grant Read permissions to this object type for users involved with authoring, executing, or reviewing/approving test scripts when 24R3 is released. To ensure additional guard rails are in place, we have also introduced a hard limit of 500 test steps per test script which will become effective automatically in the 24R3 release.

Optimize the Loading of Test Step Cards in the Test Authoring UIAuto-on24R2.2

With this feature, when Test Authors open the Test Authoring Interface, they see all steps in the actual size of all prompts instead of the loading icon for each step. This loading behavior eliminates the unnecessary scrolling after the data loads.

Default Requirement Burndown Filter to Approved RequirementsConfiguration24R2.2

Prior to 24R3, all requirements (user, functional, design specifications) regardless of lifecycle state appeared in the Requirements Burndown View. In 24R3, Admins can decide whether Validation Requirements in a particular lifecycle state appear by default for Test Authors from the Requirements Burndown View when authoring test scripts.

Admins now have the option to associate a lifecycle state with the Approved state type on the Validation Requirement Lifecycle. If the Approved state type is not configured, the Requirements Burndown View displays all requirements regardless of their lifecycle state. Test Authors can still modify the default filter if they wish to view requirements and specifications in other lifecycle states. This may occur in cases where scripting is taking place to get ahead while other team members are drafting requirements concurrently.

Admin Defined List Layouts for Requirement, Discrepancy, and Test Step Change Object Data GridsConfiguration24R2.2

In 24R3, Admins can define best practice list layouts for Validation Requirements, Discrepancy, and Test Step Change records. Existing users can adopt these layouts by navigating to the applicable object data grid and clicking the Restore defaults hyperlink. This restores the default configuration for columns displayed for these objects in the test authoring, pre-approval, test execution, and post-approval UIs. New users added to your Vault after 24R3 automatically inherit the Admin-defined configuration as their default list layout configuration.

Requirements Burndown Search BarAuto-on24R2.2

In 24R3, Test Authors can now search any field that exists in a user requirement, functional requirement, or design specification in the Validation Requirement object from the burndown panel. The new search bar appears in the Requirements Burndown View on the Test Authoring Interface. It helps Test Authors quickly find specific requirements while tracing them to test steps to ensure that they are challenged.

LIMS

Prevent Self Approval 24R2.2

LIMS Prevent Self Approval places users into record roles based on prescribed activity. These roles can then be configured as part of Workflows’ Segregation of Duties to disallow a particular role from participating in workflows. LIMS then does the following:

• Place users into Contributed to Test Execution role if they enter or modify a Lab Test Result or Lab Test Input
  • Sharing Settings are updated via Manual role assignment on the Lab Test, Lab Sample, and Spec Execution record
• Place users into a Contributed to Test Execution role if they contribute to Peer Review of a Lab Test
  • This requires additional workflow configuration to execute Custom Action: Cascade Contributor Roles
    • Sharing Settings can be updated via Manual role assignment on the Lab Test, Lab Sample, and Spec Execution record
• Place users into a Contributed to Stability role if they create or modify a Study, Study Time Point, or Study Action record
  • Sharing Settings can be updated via Manual role assignment on the changed record and Study if not changed record
• Place users into a Contributed to Spec Data role if they create or modify a Test Definition or child record, Sample Plan or child record, Spec Data or child record
  • Sharing Settings can be updated via manual role assignment on the changed record and Study if not changed record

To fully enable this feature, the following configuration is required:

1. Use Workflow Segregation of Duties to block Contributor roles from desired Workflows (such as Contributed to Test Execution cannot participate in a Peer Review workflow)
2. Use Custom Action on any Lab Test, Lab Sample, or Spec Execution Workflow to cascade workflow participants upward into Contributed to Test Execution

Limits of Detection & QuantificationAuto-on24R2.2

This feature introduces the ability to define Limits of Detections (LOD) and Limits of Quantification (LOQ) values for Test Definitions and Test Definition Variations. It also introduces the ability to define the calculation value to use when a result entered is needed to calculate other test result values and is below the LOD. When a test result entered is below the LOD or LOQ for that test definition, the system indicates that to the user. The system also uses the calculation value defined in its test definition/variation.

Test Definition Variation 24R2.2

This feature introduces the ability to create variations within a Test Definition based on the existing Test Definition Results and Inputs. At runtime, tests created using a Test Definition Variation have the Results and Inputs defined in the Test Definition Variation.

Three new objects are being introduced as part of this feature:

• Test Definition Variation
• Test Definition Variation Result
• Test Definition Variation Input

When a Test Definition Variation Input is created from a corresponding Test Definition Input, the following field values are copied from the Test Definition Input. The field values can be modified at the Test Definition Variation Input level, which are applied at runtime:

• Expected Amount (for consumables)
• Expected Amount Units (for consumables)
• Required

Any fields not listed above are defined based on the corresponding Test Definition Input (this includes Test Definition Step).

When a Test Definition Variation Result is created from a corresponding Test Definition Result, the following field values are copied from the Test Definition Result. The field values can be modified at the Test Definition Variation Result level, which is applied at runtime:

• Calculation Formula (for numeric type results)
  • Any applicable variables must be defined at the Test Definition Result level
• Data Class
• Data Entry Method
• External Name
• Notation (for numeric type results)
• Picklist (for picklist type results)
• Precision (for numeric type results)
• Precision Type (for numeric type results)
• Required
• Rounding Rule (for numeric type results)
• Unit of Measure (for numeric type results)

Any fields not listed above are defined based on the corresponding Test Definition Result (this includes Test Definition Step).

The table below shows an example of a Test Definition for pH analysis with 3 variations. Each variation contains the same Test Definition Inputs, but the Test Definition Results vary; the cells in gray indicate the Test Definitions Result which are not included in the Variation (and therefore will not be created as results at runtime). The calculation formula for Average pH also differs between Variation 2 and Variation 3.

Creation of a Test Definition Variation is optional. However, if a Test Definition has one or more variations, runtime tests can only be created from a variation and not the base Test Definition.

In this release only, Lab Tests with the same Test Definition Variation can be combined in a Test Set.

Stability Enhancements 24R2.2

The following changes have been made to Stability functionality to improve usability:

1. Changes to Lab Study Design and Lab Study Review pages:
   • Added Exit Overview icon to the top right corner
   • Removed the Create Design Data Copy icon
   • Removed the breadcrumb trail
   • Record name (Lab Study Design or Lab Study) is now a hyperlink
2. When generating a Lab Study record from a Lab Study Design record, the user will be prompted to input a name for the resultant Lab Study. If no name is inputted, the resultant Lab Study will be named the same as the Lab Study Design record.

1. When a Stability Spec Execution corresponding to an initial time point (for example, time zero) has the Results Spec Execution field populated (i.e., with a batch release Spec Execution) the following changes are made to the Reevaluate Criteria logic:
   • Only Lab Criteria Evaluation records which are valid (Invalid = No) within the Results Spec Execution is used when generating and evaluating the lab criteria evaluation records within the Stability Spec Execution record
   • The system ensures that there is at least one valid Lab Criteria Evaluation record match, or else an error will be presented * Any Lab Criteria Evaluation records belonging to a Criteria Set with Evaluate = “On Demand” are not generated in the Stability Spec Execution record
2. When a Stability Spec Execution is created from an initiated study time point, the following fields are added to the Spec Execution and are populated based on the corresponding value from the Study Time Point record:
   • Time Stored
   • Time Stored Units

Training

Instructor-Led Training: Support More Than 100 Learners in ClassAdmin Checkbox24R2.2

In this change, the maximum number of Learners in a single Instructor-Led Training class has been increased to allow for more than 100 Learners per class. New Custom Sharing Rules allow internal users to view classroom-related objects.

This feature enables the hosting of large-scale classes, webinars, and other sessions to support the business.

• The new maximum number of Learners per class is 1000.
• For customers using the old classroom training method prior to 22R2.2, the limit of 100 maximum Learners still applies.
• Learners and managers with access to classroom objects prior to the implementation of this feature will continue to have access to those objects.

For more details and configuration, see Instructor-Led Training.

Instructor-Led Training: Maximum Attendees and WaitlistingAdmin Checkbox24R2.2

With this change, Instructors can now set a maximum attendee count and add Learners to the waitlist for classes that are full. When roster spots open, waitlisted Learners are added to the class automatically based on the order of registration.

This change is necessary because physical classrooms and other spaces have seat limitations. Setting a maximum attendee count ensures that everyone who attends a class has a seat, and the waitlist feature ensures that no seats are wasted.

• The Registrations field on the class shows the seat capacity.
• Maximum attendees are not enforced if the field is blank.
• Training Admins can add Learners to the waitlist.
• Instructors can move waitlisted Learners to the class roster.
• Instructors can add Learners to the class roster even when it is at maximum capacity.

For more details and configuration, see Instructor-Led Training.

Quality Data Model Changes

See 24R3 Quality Data Model Changes

Regulatory

RIM Registrations

Configurable Procedure Countries for Create RegistrationsAdmin Checkbox24R2.2

This feature provides the capability to manage Procedure Type countries using configuration (with Constraints) rather than relying on a hardcoded list of countries when creating RIM Registrations in bulk. The Health Authority field set in the Constraint’s Region Specific Entry will be set for the Registration referencing that Constraint, for example Centrally Authorised Procedures (CPs) when the Health Authority should be EMA rather than the local Health Authority.

A reason for this update includes BREXIT, for which the list of countries have required updating more than once based on regulatory updates. Making this list configurable facilitates constraining country lists for currently-supported CPs, while providing future and existing support for regions that may implement procedures that behave similarly to EU CPs.

Manage Registered Details Filtering EnhancementsAuto-on24R2.2

The Manage Registered Details (MRD) wizard has additional filtering capabilities for text fields to narrow the search for records to facilitate updates. These filters support searching text values as well as blank (undefined) fields. This feature is also available in the Create Registrations wizard.

This feature increases the efficiency and ease of updating registered details by making it easier and quicker to identify, select, and update records with fewer clicks.

Support for Drug-Led Complex Combination ProductsAuto-on24R2.2

With this release, Create Registrations is enhanced to generate Registered Product records for complex products when Co-Packaged or Integral Device is set to Yes. Updates to the RIM Data Model were completed in a previous release. This enhancement completes support of the IDMP requirement that co-packaged and integral devices be included in the submission data set.

RIM Submissions

Copy Content Plan Action to Respect Use for Content Planning FieldAuto-on24R2.2

When using the Copy Content Plan action, only relationships that are used for content planning are copied onto the target Submission and Application records and target Submission Content Plan. Previously, the Copy Content Plan action copied all relationship records from the source Submission to the target Submission and its parent Application, even those designated only for use with Registrations.

If the Use for Content Planning field is not configured or is set to ‘No’ then the referenced relationship is excluded. If Use for Content Planning = Yes or is blank, the relationship is included in the target Submission. Results notifications includes a message that the indicated CP section(s) were not copied due to the relationship setting = No. Also, iIf the target Submission already has the relationship with the setting = No, that target Submission setting is respected and that relationship is not included in the target.

This enhancement reduces the cleanup effort needed in Content Plans, Submission record relationships, and Application relationships when Copy Content Plan user action is executed. This enhancement specifically impacts the Copy Content Plan action executed from the Submission record, and does not impact dragging and dropping sections directly into an existing CP. If users want all relationships in the target, including those set to Use for Content Planning = No in the source Submission, users can copy the Submission record itself rather than copying the Content Plan.

RIM Registrations, RIM Submissions

Cloning Enabled for Content Plan Item Template MappingsAuto-on24R2.2

Admins supporting Global Content Plan (GCP) customers can now include the Content Plan Item Template Mapping (CPITM) object (content_plan_item_template_mapping__v) when creating Sandbox Snapshots or cloning environments as part of a deployment. When configuring the Dispatch Global Content Plan Across Templates feature released in 24R2, the CPITM object records could only be migrated via Vault Loader or VPKs. This enhancement improves the ease and efficiency of adopting Dispatch Global Content Plan Across Templates.

RIM Submissions Archive

Submissions Archive Viewer: Filter Correspondence by Regulatory ObjectiveAuto-on24R2.2

Correspondence documents displayed in the Submissions Archive Viewer can now be filtered by their associated Regulatory Objectives. Prior to this enhancement, Correspondence could be filtered only by Application or Submission. A new Correspondence subsection with a Regulatory Objective column can be added to new or existing Saved Views. This additional filtering option allows Archive consumers to review Health Authority Correspondence related to all the Submissions in the selected Regulatory Objective, or where only a Regulatory Objective is set on the correspondence. This may be particularly useful when Correspondence documents are associated with more than one Regulatory Objective.

With this release, the Regulatory Objective association can be retrieved from either the custom Correspondence document field regulatory_objectives__c, or the standard document field regulatory_objectives__v (introduced in 24R2). A new temporary enablement option under Admin > Settings > Application Settings > Submissions Archive Features determines whether the system points to the custom or standard relationship.

RIM Vaults provisioned prior to 24R2 that are using the regulatory_objectives__c custom can immediately start using this new feature without migrating from the custom to standard document field. In a future release, this setting will be deprecated, at which time all customers will need to use the standard regulatory_objectives__v field to see this attribute in Viewer. The deprecation will be communicated via the announcements in the release notes, at a future date. By providing the temporary setting, customers will have time to migrate their document field values to the standard field while still seeing immediate benefit of the Regulatory Objective filtering.

Submissions Archive: EU eCTD v3.1 supportAuto-on24R2.2

With this release Submissions Archive is supporting importing, viewing, and exporting of European Union submissions using the EU Module 1 Specification, version 3.1, for eCTD submissions.

Import Notification UpdatesAuto-on24R2.2

In the event of a Submissions Archive Import failure, an improved notification now includes the Document ID and the field name for any required fields that were required, but not populated. If system-managed Document Types such as the Submissions Archive > Content or Submissions Archive > Structure are configured to have required fields, imports to Submissions Archive may fail. This notification provides the details needed for users or Admins to move forward with the import, such as the name of the field and from which Document Type it should be removed.

RIM Submissions, RIM Submissions Archive

Active Dossier Translation Handling UpdateAuto-on24R2.2

This enhancement to the Active Dossier generation supports more relevant translation tracking when multiple translations of the same source document are submitted in the same submission. It sets the Translation Document field on each new ADID record based on the ADID’s Country and the Vault’s Country Language records. In the case where there are multiple translations if the country has multiple languages, Vault sets the first instance on the ADID.

Active Dossier Hovercard Update: Needs SubmissionAuto-on24R2.2

The Item Detail hovercard in the Active Dossier Viewer has been updated to include the Needs Submission field. This allows users to see if a document needs to be submitted when the Global Content Plan is dispatched to the Submission Content Plan.

RIM Publishing

Publishing EU eCTD v3.1

With this release Vault Submission Publishing supports publishing and validating EU dossiers based on EMA guidance v3.1 and validation v8.0.

This capability requires template updates and updates to the Validation Criteria. These changes can be provided to customer support teams via VPK packages.

This feature has been deferred to a future release.

NeeS Canada ValidationConfiguration24R2.2

Customers publishing non-eCTD submissions (NeeS) for Health Canada can now validate the publishing output based on the HC NeeS v5.2 validation criteria. All validation rules and data model updates to support HC NeeS v5.2 can be provided to customer support teams via VPK packages.

Safety

The Safety 24R2.2 release, including all Platform features, is scheduled for tentative availability on August 29, 2024. For the latest central dictionary updates for your Safety Vault, see Safety Central Dictionary Updates.

Several features listed in the Vault Connections section also affect the Safety application family.

Safety

Sender-Based Email Inbox Item Pre-PopulationAuto-on24R2.2

With this release, Vault Safety can now automatically set the Country and Report Type fields on an Inbox Item based on the sender’s email. This feature allows Admins to pre-populate these fields for Transmission Profiles, reducing redundant data entry. Vault Safety creates Inbox Items with these mapped values, helping users triage and assign them more efficiently. This improvement accelerates the triage of inbound emails and eliminates repetitive data entry.

Although this feature is Auto-on, some components require additional configuration.

Learn More

• Enablement: Enable Sender-Based Email Attachment Handling
• User Help: Email to Inbox Item

Inbox Item Enhancements: Report Type & SeriousnessAuto-on24R2.2

In this release, Report Type and Seriousness fields are added to the Inbox Item object to support filtering and prioritization. This data is often included when Vault generates Inbox Items from structured data sourced from E2B or JSON integrations or Vault to Vault Connections (such as the EDC-Safety Connection). Report Type (Clinical versus Post-Marketing) and Seriousness impact reporting timelines. Priority and Seriousness are calculated when users add new information to an Inbox Item and can now drive the priorities of triaging Inbox Items to ensure compliance.

Although this feature is Auto-on, some components require additional configuration.

Learn More

• Enablement: Enable Inbox Items
• User Help: Inbox Item Overview

Duplicate E2B XML File DetectionAuto-on24R2.2

With this release, Vault Safety can detect E2B XML files already imported into Inbox Items. Admins can enable this setting on Transmission Profiles, and users can apply it to manually uploaded files. When a duplicate E2B XML file is detected, Vault Safety marks the Inbox Item as Duplicate and links the source document to the original. Additionally, Vault Safety retains the original file name of the ZIP file’s individual E2B XML files, enhancing traceability. This enhancement automates duplicate E2B XML file detection when importing multi-E2B files from health authorities such as MHRA and EMA.

Although this feature is Auto-on, some components require additional configuration.

Learn More

• Enablement: Enable E2B Import to Inbox Item
• User Help: Import an Inbox Item

Duplicate Inbox Item LinkingAuto-on24R2.2

When an Inbox Item is marked as a duplicate after performing duplicate detection, Vault links the matching Inbox Item record on the duplicate Inbox Item in the new Linked Inbox Item field. This feature makes it easy to identify and track duplicate Inbox Items that are associated with an existing Inbox Item.

Learn More

• User Help:
  • Inbox Item Field Reference: System Section
  • Inbox Item Follow-Up: Complete the Inbox Item to Case Compare Page

Case Access Group Security: Study Type Update for Inbox ItemsAuto-on24R2.2

When an Inbox Item does not specify a Study but does reference a Study Type, Vault now uses the Study Type as part of the criteria for assigning a Case Access Group. This enhancement supports such scenarios as postmarket studies for a partner’s study that is not set up in your Vault’s Study library. By considering the Study Type for both Inbox Items and Cases, Vault provides more consistent Case Access Group assignments.

Learn More

• Admin Help: Manage Case Access Group Security: Case Access Group Assignment Fields

Duplicate Detection during Case ProcessingConfiguration24R2.2

With this release, users can perform duplicate detection during Case processing to compare the current Case record against other Cases and Inbox Items. Case Processors can identify duplicates after data entry. This enhancement reduces manual duplicate detection effort and mitigates overreporting.

Learn More

• Enablement: Enable Duplicate Detection During Case Processing
• User Help: Duplicate Detection for Cases

Follow-Ups to Domestic Cases from Global Inbox ItemsAuto-on24R2.2

With this release, Vault Safety allows users to create Follow-ups to a Domestic Case from Global Inbox Items. Now, for Inbox Items with a Global type or blank localization, after selecting a matching Domestic Case on the Inbox Item, users can create a Follow-up Case to the Domestic Case on the Inbox Item to Case Compare page. This enhancement supports users in efficiently processing follow-ups received in English for Domestic Cases.

Learn More

• User Help: Inbox Item Follow-Up: Localized Data

Update Localized Case Narrative Language Based on Follow-Up InformationAuto-on24R2.2

With this release, when merging an Inbox Item with an updated Localization value to an existing domestic Case, Vault Safety now updates the ISO language of the Narrative document to the new value. Previously, when Localization was updated in a follow-up, Narrative documents remained linked to the Localization of the initial Case. This enhancement ensures accuracy and consistency in case documentation.

Learn More

• User Help: Inbox Item Follow-Up: Merge Behavior

MedDRA Bulk Recode Without Case UpversioningAuto-on24R2.2

With this release, when performing MedDRA Bulk Recode, Vault Safety now recodes non-current terms with current MedDRA terms as defined by your organization directly on the latest Case version, and optionally on all Case versions. Previously, Vault Safety created minor versions and reopened Cases, which users would need to close. This feature streamlines the MedDRA Bulk Recode process.

This feature is Auto-on, but you can configure your Vault to bulk recode all Cases rather than latest Cases.

Learn More

• Enablement: Enable MedDRA Bulk Recode Cases
• Admin Help: Bulk Recode MedDRA-Coded Terms on Cases

Multi-Product Selector for Study Products on CasesConfiguration24R2.2

To facilitate Study Product selection after Case promotion, the Specify Study Products action is now available on Cases, extending the feature released for Inbox Items in 23R2. Case Processors can now add multiple Study Products to a Case at once. This enhancement ensures consistency in Study Product entry across Inbox Items and Cases, improving case processing efficiency, especially for complex studies involving numerous phases or products.

Learn More

• Enablement: Enable Multi-Product Selector for Study Products on Cases
• User Help: Code and Browse Study Products

Product Browser: Product Matching ImprovementAuto-on24R2.2

When adding Company Products to Inbox Items and Cases, the Product Browser now displays all Product and Product Registration matches for the reported product. Previously, Vault displayed Product Registration records, but not Product records, if the reported product matched a Product Registration record. Product records were displayed only if Vault did not find a Product Registration match. This enhancement helps Case Processors select the correct Product Registration associated with the reported product.

This feature is Auto-on in Vaults with Faster Company Product Selection on Inbox Item or Product Browser for Faster Case Product Selection enabled.

Learn More

• User Help: Auto-Code and Browse Products: About Product Browsing

Automatically Set MedDRA Code When Product Indication is NullFlavorAuto-on24R2.2

With this release, Vault Safety automatically sets the Name (MedDRA) field to Drug use for unknown indication (10057097) when users select a nullFlavor for the Reason Omitted field on Product Indication. This enhancement ensures compliance with the business rule related to G.k.7.r.2b in the ICH E2B(R3) specifications, streamlining data entry and improving the accuracy of adverse event reporting.

Learn More

• User Help: Enter Case Data

Configurable PII and E2B Masking for NullFlavor FieldsConfiguration24R2.2

With this release, Vault Safety expands the Exceptions to PII Masking Safety rule set parameter to include nullFlavors. When users generating masked reports select Null Flavors in the Exception to PII Masking Content Protection field, Vault does not mask nullFlavor values for Personal Identifiable Information (PII) fields in generated reports. Instead, Vault populates the nullFlavor values from the Case on reports. Previously, Vault exported “MSK/Privacy” in place of nullFlavors on masked reports. This feature addresses compliance and clarity because masking a field that contains no information can imply that there is information in that field.

Learn More

• Enablement: Enable Configurable PII and E2B Masking for NullFlavor Fields
• User Help:
  • Reporting Rule Parameter Reference: Exceptions to PII Masking
  • Generate Masked Safety Reports: Exceptions to Patient Content Protection

Country Specific IMP ICSR ReportingConfiguration24R2.2

Vault now supports enhanced selection of Investigational Medicinal Products (IMPs) on a country-specific basis. When an investigational product is used exclusively in a particular study country, Vault can now evaluate reportability on a Product-Country basis. This feature introduces a new Study Product Country object and a new Study Product Role reporting rule parameter, which determine country-specific evaluations for Study Products. Previously, Vault considered any Study Product within a Case as reportable across all jurisdictions where the Study was registered. This enhancement addresses the issue of over-reporting to health authorities and ensures regulatory compliance.

Learn More

• Enablement: Enable Country Specific IMP ICSR Reporting
• Admin Help: Manage Studies: Studies with Country-Specific Investigational Medicinal Products
• User Help: Reporting Rule Parameter Reference: Study Product Role

PMDA Post-Market Reports: Filter by Local Awareness DateAuto-on24R2.2

With this release, Vault Safety supports filtering Cases on PMDA Post-Market aggregate reports by Local Awareness Date. Previously, users could filter Cases by Case Receipt Date / New Info Date or Case Approval Date only. The additional filtering option is useful when generating reports for localized Cases because the date local affiliates become aware of Cases may differ from the receipt or new information date on the global Case. This enhancement is available on all PMDA Post-Market tabulations.

Learn More

• User Help: Create PMDA Post-Market Aggregate Reports: Filter Case By

EU Convention E2B(R2)Auto-on24R2.2

With this release, Vault Safety supports the generation, submission, and distribution of EU Convention E2B(R2) individual case safety reports. This feature enables users to include regional elements required for agencies such as Swissmedic and the Therapeutic Goods Administration (TGA) of Australia, facilitating international submissions. By standardizing this functionality, Vault Safety eliminates the need for custom SDK implementations, streamlining the submission process for global agencies and partners.

Generating EU Convention E2B(R2) format reports is Auto-on. The document type is automatically available in the Document Types picklist during Transmission generation. To configure your Vault for transmitting electronic submissions to a regulatory agency, you must set up a custom Transmission Profile.

Learn More

• User Help: E2B Generation: EU Convention E2B(R2) Mapping

Additional Filters for CIOMS II Aggregate ReportAuto-on24R2.2

With this release, the CIOMS II report provides enhanced flexibility to generate a wider variety of reports with the results presented in the standard CIOMS II line listing format. The following optional filters are now available:

• Report Type
• Case Seriousness
• Case Relatedness
• Case Expectedness
• Expectedness Source
• Country inclusion and exclusion

Although this feature is Auto-on, some components require additional configuration.

Learn More

• Enablement: Enable CIOMS II Line Listings
• User Help: Create CIOMS II Reports

Safety Workbench

New Application: Vault Safety WorkbenchSupport24R2.2

The Safety 24R3 release introduces the Vault Safety Workbench application as part of the Veeva Vault Safety Suite. To use this application, a Vault Safety Workbench and a Vault Safety license are required. For information on installing and configuring Vault Safety Workbench for your Vault, contact your Veeva Representative.

Vault Safety Workbench can analyze high volumes of Vault Safety data for ad-hoc and periodic reporting. This application also allows more flexible and configurable reporting depending on your organization’s business processes. See the Vault Safety Workbench Overview to learn more.

Safety Signal

New Application: Vault Safety SignalSupport24R2.2

The Safety 24R3 release introduces the Vault Safety Signal application as part of the Veeva Vault Safety Suite. To use this application, a Vault Safety Signal and a Vault Safety license are required. For information on installing and configuring Vault Safety Signal for your Vault, contact your Veeva Representative.

Vault Safety Signal integrates with existing safety databases to detect new, unexpected adverse events or changes in existing adverse events to a medicinal product. This analysis can occur in post-marketing or during clinical trials. See the Vault Safety Signal Overview to learn more.

SafetyDocs

Update Notification Template for PSMF Periodic ReviewAuto-on24R2.2

The notification template for the PSMF Periodic Review workflow provides more information to recipients about what task they have been assigned. In order to use the new notification template, an Admin must update the workflow’s configuration. This improvement provides the user with additional context to boost productivity.

Learn More

• Enablement: Enable PSMF Periodic Reviews
• Admin Help: Configure the PSMF Periodic Review Job
• User Help: Set up PSMF Periodic Reviews

Create Inbox Items from Literature Articles in CRO VaultsConfiguration24R2.2

To better support Contract Research Organization (CRO) customers who perform literature reviews for different sponsors, Vault SafetyDocs has added an Organization field to the Literature Article and Literature Review objects. When creating an Inbox Item from a Literature Article, Vault considers the Organization field. If the field is populated on the Literature Article, Vault sets the Organization field on the Inbox Item to the same Organization value as the Literature Article it was created from. If the field is not populated on the Literature Article, then there is no change to the current behavior. These additional fields allow CRO customers with multi-sponsor Vaults to specify a separate sponsor/organization for each review and article.

Learn More

• Enablement: Enable Create Inbox Items from Literature Articles in CRO Vaults
• User Help:
  • Manage the Literature Review Process: Create a Literature Review
  • Create Inbox Items from Literature Articles: Create an Inbox Item from a Literature Article
  • Inbox Item Field Reference: Organization and Region Section

Literature Coding to Product FamilyConfiguration24R2.2

To support literature searches completed at the Product Family level, Vault SafetyDocs now supports coding Literature Articles to Product Families, Products, or both. The Product Family field has been added to the Search Term, Literature Standard Search Term, Literature Review, and Literature Article objects. By eliminating the need to select a specific Product, this feature allows for more precise coding of Literature Articles and broader signal detection.

Learn More

• Enablement: Enable Literature Coding to Product Family
• Admin Help: Create Literature Standard Search Terms
• User Help: Manage the Literature Review Process

Customize Sender Email Address for PVA Document DistributionConfiguration24R2.2

Vault SafetyDocs can be configured to send Vault emails using the customer’s email domain. Prior to this, emails sent from Vault used the domain “@veevavault.com”. In scenarios such as Pharmacovigilance Agreement (PVA) distribution where Vault sends emails to external partners, the emails may be considered suspect (and go to the spam folder) if they do not come from the customer’s email domain. The ability to configure the “From” domain addresses this challenge.

Learn More

• Enablement: Enable Customize Sender Email Address for PVA Document Distribution
• User Help:
  • Manage Pharmacovigilance Agreements: Create a PV Agreement
  • Distribute PVA Documents via Email: Use Custom Outbound Domains and Emails

Custom Translation Connections for Literature Abstracts 24R2.2

Vault now supports Literature Abstract translation through custom Translation Connections. Previously, Vault only supported Amazon Translate. Using custom Translation Connections you can connect SafetyDocs to any external translation service to meet your organizational needs.

Learn More

• User Help: Translate Literature Abstracts

Capture Additional Information for Safety InvestigationsConfiguration24R2.2

With this release, users can capture more detailed information on Safety Investigations. Users can now enter a description, track a due date, and document validation and disposition rationales for a Safety Investigation.

Safety Data Model Changes

See 24R3 Safety Data Model Changes.

QualityOne

QualityOne

Related Record Automation Enhancement for Event ActionsAuto-on24R2.2

This feature enhances the Create Related Record action to improve its performance as an event action. The Create Related Record action now runs synchronously when configured as an event action, enabling at-scale record creations to be more robust and performant.

Learn more about configuring the Create Related Record action.

QMS (QualityOne)

Generate Documents for Additional QMS ProcessesConfiguration24R2.2

This feature extends the previously introduced Generate Documents using Object Record Actions for Audits and Generate Documents for Standard QMS Processes features by adding the following objects:

• Lab Investigation
• Continuous Improvement Initiatives
• Inspection (to generate COA)

This feature allows users to generate a document from a Formatted Output or a Document Template using an Admin-configured entry or user action. By generating documents, users can leverage Vault’s full Document Management functionalities, removing dependency on manually configuring and uploading documents to the Vault Library. Generating documents using a 1-click solution also automatically generates a link between the object record and the document in the Vault Library, ensuring users retain the context of the generated document.

Learn more about generating documents and configuring Document Generation.

Periodic Reviews: APQRs for Internal FacilitiesConfiguration24R2.2

This feature enhances the end-to-end functionality of the Periodic Review feature by enabling users to conduct Annual Product Quality Reviews (APQRs) for internal facilities. Prior to this release, users were only able to conduct APQRs for supplier organizations.

Learn more about Periodic Reviews and performing APQR.

Inspection Sample Test Result Moving to Raw ObjectAuto-on24R2.2

This feature improves the scalability and performance of the Inspection Sample Test Result object by migrating it from a standard Vault object (SVO) to a raw object. Contact your Veeva Representative for more information about this change.

Learn more about setting up Inspections and defining Object Application Security.

COA Inspections: Improved COA Variant MatchingConfiguration24R2.2

This feature introduces an improved matching strategy to COA Matching Rules when extracting data from the header section of a COA file, increasing the likelihood of finding a match for fields associated with key data in COA files.

Learn more about COA Matching Rules and working with COA Inspections.

Generate HACCP Flow Diagram & Data DocumentsConfiguration24R2.2

This feature allows users to generate documents from a HACCP Plan record by running an action from the HACCP Flow Diagram. When users run the action, Vault generates a PDF rendition of the HACCP Flow Diagram and another document containing data from the associated HACCP Plan, and stores both of these documents in a binder in the Library. Admins can configure different document templates to extract specific field data from HACCP Plans, and leverage Vault’s Document Management functionality to manage generated HACCP documents.

Learn more about generating HACCP documents.

HACCP: Data Model Updates to Support TranslationAuto-on24R2.2

This feature provides additional support for the translation of HACCP Plans by adding object types to existing HACCP translation objects, ensuring accurate data mapping between HACCP library objects and their corresponding translation objects.

Learn more about working with HACCP Management.

QMS (QualityOne) & HSE

Auto-Create Proposed Audit EnhancementsAuto-on24R2.2

This feature enhances the logic for duplicate Proposed Audit creation on the Create Proposed Audits action. With this release, duplicate Proposed Audit creation is limited to the Audit Program the action runs on, rather than all Audit Programs in a Vault.

Learn more about using the Create Proposed Audits action.

HSE

Generate Documents for Standard HSE ProcessesConfiguration24R2.2

This feature makes the Generate Documents using Object Record Actions for Audits and Generate Documents for Standard QMS Processes features previously introduced in QMS available in HSE for the following objects:

• Audit
• HSE Event
• Permit to Work
• Risk Register
• Risk Study

This feature allows users to generate a document from a Formatted Output or a Document Template using an Admin-configured entry or user action. By generating documents, users can leverage Vault’s full Document Management functionalities, removing dependency on manually configuring and uploading documents to the Vault Library. Generating documents using a 1-click solution also automatically generates a link between the object record and the document in the Vault Library, ensuring users retain the context of the generated document.

Learn more about generating documents and configuring Document Generation.

QualityOne Data Model Changes

See 24R3 QualityOne Data Model Changes.

RegulatoryOne

The RegulatoryOne 24R2.2 release, including all Platform features, is scheduled for tentative availability on September 3, 2024.

RegulatoryOne

RegulatoryOne & Veeva Claims Data Model StandardizationConfiguration24R2.2

This feature introduces data model updates to RegulatoryOne and Veeva Claims applications to support evolving needs to allow for harmonization between the applications so users can leverage Veeva’s evolving best practices.

Registration & Dossier Management

Local Impact Assessment Enhancement: Multiple Registration Items in a RegistrationAuto-on24R2.2

This feature enhances the reuse of existing registration data by allowing users to run the Local Impact Assessment action regardless of the sequence of the actions they run. The action now identifies Registration Item records for the appropriate Registration and Registration Objective without having to first run the Generate Registration Data action.

Learn more about Local Impact Assessments.

Local Impact Assessment Enhancement: Ignore Cancelled & Withdrawn ObjectivesConfiguration24R2.2

This feature allows Admins to configure Cancelled and Withdrawn Registration Objectives so that the Local Impact Assessment action considers only valid Registration Objectives in specified lifecycle states, such as Active and In Progress, eliminating irrelevant data from assessments.

Learn more about configuring the Local Impact Assessment action.

RegulatoryOne Data Model Changes

See 24R3 RegulatoryOne & Veeva Claims Data Model Changes.

Veeva Claims

The Veeva Claims 24R2.2 release, including all Platform features, is scheduled for tentative availability on September 3, 2024.

Veeva Claims

Bulk Add Existing Claims to a ProjectConfiguration24R2.2

This feature allows users to add multiple existing Claim records directly from the Claims library to a new or existing Project by utilizing a bulk record action, saving users time by using a more efficient method of record creation.

Learn more about adding Claims to a Project.

Simplified Substantiations EnhancementConfiguration24R2.2

This feature enhances the existing Upload field on Substantiation records to allow users to upload a reference document after the creation of a new Substantiation record. Users can now use the field to upload a reference document when editing an existing Substantiation record.

Learn more about creating and modifying Substantiations.

RegulatoryOne & Veeva Claims Data Model StandardizationConfiguration24R2.2

See feature description.

Veeva Claims Data Model Changes

See 24R3 RegulatoryOne & Veeva Claims Data Model Changes.