New in 25R1 Limited Release

Limited Release Dates: December 18, 2024 (24R3.2); February 7, 2025 (24R3.4); February 28, 2025 (24R3.5) | General Release Date: April 11, 2025

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 Highlights

Word Formatted OutputsAuto-on24R3.2

Admins can now define formatted outputs for objects using Microsoft Word. Admins can use Vault-specific syntax and tokens in the Microsoft Word file to control how the data is outputted, while also managing general formatting in a much easier and user-friendly way. 

Prior to 24R3, defining formatted outputs required the use of Adobe products such as LiveCycle or EAM Forms Designer, both of which are costly and require extensive knowledge to use. Moving to Microsoft Word streamlines the process for creating and maintaining formatted outputs, and allows customers more flexibility to manage their own templates.

The key syntax items that users can leverage are:

• Rowset(...): This syntax can contain the relationship name and any necessary VQL criteria, and sets the context for the table. For example, ${Rowset(user__sysr WHERE status__v = 'Active')} permits a table to print information from related users on the template

• RepeatRow(), RepeatTable(): Allows a specific row or table to be repeated for each record that was retrieved in a Rowset

• HideRowIf(...), HideTableIf(...): Allows a specific row or table to be hidden based on an expression. For example, ${HideRowIf(state__v = 'Inactive')} hides the given row based on the value of the state__v field.

• #define: An existing function in Vault formulas that can be used in Word formatted outputs to simplify the syntax and maintain the document’s readability

You must wrap each syntax in the following notation brackets when adding them to your template: ${..}. For example, ${HideRowIf(state__v = 'Inactive')} is a valid syntax. Once the template is validated and executed, Vault deletes the notation brackets from the document.

When creating new Word formatted output templates in Vault, Admins can also download a data model CSV file by clicking Download Data Model. This file allows them to easily identify available relationships and fields. The CSV also provides the relevant token syntax to leverage in the Microsoft Word template.

Admins can also choose PDF or Word as the output for the new Microsoft Word formatted output template. A PDF formatted output takes longer to generate than a Microsoft Word formatted output. 

Admins can also easily test their uploaded templates by using a new Download Preview button and selecting an existing record in the system.

With 25R1, new formatted outputs can use either Microsoft Word or Adobe as input files; however, in 25R2, you must create new formatted outputs using Microsoft Word (no new Adobe formatted outputs can be created in a Vault). Though, you can still edit and use any existing Adobe formatted outputs.

Enhanced Formatting Options for Signature Page TemplatesAuto-on24R3.2

With this release, Admins can now customize page format, adjust the font styling, select text alignment, and add logos when creating Standard Signature/Cover Page templates that will apply to viewable renditions upon download. These new options will be based on using an intuitive rich text editor for the Header, Signature Block and Footer. 

In addition to standard rich text editor options, Signature/Cover Pages also include options for adding logo(s) (based on logos added in Admin > Settings > Branding Settings), adding tables, and accessing tokens. 

Admins will also have a Download Preview option to be able to preview the formatted Signature/Cover page:

Prior to 25R1, customers needed to leverage XFA templates to apply customizations like these to their signature page templates. Adding new formatting options allows Admins to create customized signature pages without relying upon external software. 

For existing Signature Pages, no change will occur as part of the 25R1 deployment. Once an existing Signature Page template has been edited and saved, the new template will apply going forward. 

With 25R1, all new Signature Pages created in Vault will leverage this new functionality and no new XFA-based Signature templates can be created (though existing XFA templates can still be edited). 

Learn more about Managing Document eSignature Templates. 

Roll-up FieldsAuto-on24R3.2

Roll-up fields offer a powerful way to aggregate values from child records associated with a parent object via a parent-child object relationship. Roll-up fields deliver these calculated values, such as calculated expenses in an expense report, over time without manual effort. You can define up to 25 Roll-up fields on parent objects to derive a value (count, sum, max, or min) from related child records. The derived value is calculated when a child record is created, updated, or deleted. You can also use a filter expression to determine which child records to include in the roll-up function. Roll-up fields do not support multiple levels of aggregation (roll-ups of roll-ups).Parent objects with 100 or fewer child records calculate Roll-up fields synchronously, upon child record changes.

Parent objects with over 100 child records calculate Roll-up fields asynchronously, for performance considerations. We do not recommend using Roll-up fields in criteria or conditions that are enforced as part of a record save operation, such as validation or layout rules. Similar to all system-driven calculations that execute on record save, the more Roll-up fields on a parent object, the longer it may take the record to save. We recommend taking careful consideration before creating Roll-up fields.

Admins will now see a new Roll-up field type for parent objects that exist within a parent-child object relationship. Once selected, Vault prompts Admins to specify the specific child relationship, roll-up function, and field before saving. 

Updates to Roll-up fields on parent records are considered a change on the record (captured as System on behalf of the user who caused the roll-up calculation, or System, in the case of synchronous and asynchronous calculations respectively within the Object Record Audit History. The Last Modified By field displays the value System in both of these scenarios. In addition, the Last Modified Date and Audit Trail will update accordingly; however, it will not cause Vault Java SDK triggers to execute.

Roll-up fields are best for use cases where point-in-time calculation of a derived consistent value is required (when records from this specific child relationship are created, updated or deleted, calculate the value), rather than use cases that require a different value based on something dynamic, such as the current date or current user.

Lastly, there are situations where an Admin may need to recalculate all Roll-up fields on all records in an object. One such situation is when you add a new Roll-up field to an object, as this will only calculate values on a go-forward basis when adding, updating, or deleting child records in the specified child relationship. If you need historical records to populate the roll-up value, use the Recalculate Roll-Up Fields button on the object’s Details tab. Alternatively, you can write values to Roll-up fields in record migration mode. In all other instances, Roll-up fields are read-only.

User Experience

Keyboard Shortcut Hints 24R3.2

Actions that have keyboard shortcuts assigned will now show the keyboard shortcut combination in the Actions menu, and also when hovering over actions in the Action Bar, making it easier to discover keyboard shortcuts for everyday actions.

Identifiable Browser TabsAuto-on24R3.2

Browser tabs for Vault are now named in a more meaningful way that makes it easier for users to identify which tabs are open. Browser tabs are named from most specific to least specific. For instance, when viewing a specific record in the system, the browser tab will now be formatted to show the record name first, followed by the object label. When viewing a specific document, the tab will show the document name.

Prior to 25R1, all browser tabs for Vault began with “Veeva Vault”, which made it difficult to identify tabs when multiple tabs were open.

Access Vault Information from User Profile MenuAuto-on24R3.2

A new About this Vault option is available from the User Profile menu. This option opens a dialog containing information about the Vault such as the Vault Name, Vault ID, URL, Version, Applications, Domain Name, and POD. This is particularly helpful when providing Vault information to Veeva’s Product Support team.

Managing Data

Enhanced Picklist AdministrationAuto-on24R3.2

This release includes many UI updates for picklists, including the ability to add and manage picklist values directly from the field using the picklist, the ability to search for values, picklist value pagination, improved reordering, and inline editing capabilities.

Picklist Administration

Improved UI with picklist value search: 

Create new picklist values directly from the field using this picklist: 

Pressing the Enter key in the Create Picklist Value dialog executes the Save + Create create, allowing efficient entry of multiple values.

Manage, reorder, and inline edit picklist values directly from the field using this picklist: 

Dependent Picklists

Prior to this release, dependencies between picklist values could only be specified on the fields that leverage picklist. Because these dependencies exist on the field (not picklist), there could be differing dependencies between two fields that leverage the same picklist.

As part of this release, standard picklists can now possess dependencies defined on the picklist, as opposed to the field. Picklist dependencies will therefore be consistent across all fields that leverage them.

When reusing a dependent picklist, Vault requires you to select the controlling field (which must be using the controlling picklist). For example, if you reuse the new State (state_cda__v) picklist in a field, you must have another field on the object referencing the controlling Country (country_cda__v) picklist:

Picklist dependencies can be viewed within a new dependencies interface accessible from the picklist Admin UI (Business Admin > Picklists):

A given picklist field may only be governed by a single set of dependencies, and as a result picklists that possess dependencies may not be leveraged in conjunction with field dependencies. Picklist dependencies are only available for standard picklists, delivered by Platform and Vault application teams and cannot be created by customers.

These changes improve the picklist administration experience, and help support picklists that contain larger sets of values. For large picklists, the new administrative interface will provide pagination in increments of 200 values. As part of these enhancements, and to ensure optimal performance, picklists with over 200 values may only be reordered via API.

Ignore Locked Objects During Deep CopyAuto-on24R3.2

When performing a deep copy on an object record (for parent-child relationships), Vault now ignores any locked child objects. Before, deep copy was not allowed on parent objects with locked child objects.Locked objects are those that are disabled in Vault, which is typically based on which Vault Applications are enabled in the Vault.

Analytics

Skip All Optional PromptsAuto-on24R3.2

When a report or dashboard contains multiple optional prompts, users can now use Skip Optional Filters to skip all prompts.

For reports and dashboards that may contain a lot of optional prompts, this provides users an easy option to skip all prompts and see the full report results without having to click to skip each prompt individually.

Learn more about Optional Prompts.

Dashboard Prompt EnhancementsAuto-on24R3.2

Dashboard prompts will now be shown as a pop-up dialog similar to report prompts, and users will be able to hover over prompts to easily identify which charts a prompt is associated with. This is supported on the filter dialog when entering the value, as well as read-only filters once the dashboard is updated.

Report PDF Export EnhancementAuto-on24R3.2

When exporting a report to PDF that contains long text or rich text fields, and the report is set to fit PDF to page, Vault will overflow text onto additional pages as needed to ensure that all information is appropriately included in the PDF output. Prior to 25R1, there could be instances where report PDFs truncated long text or rich text fields in the output, but this enhancement ensures this truncation does not occur.

This enhancement specifically applies when a report includes columns for long text or rich text fields, has the Fit PDF export columns to one page option checked in Advanced Options, and has Include full text for rich text fields or Include full text long text fields checked.

Learn more about Exporting Reports.

Support for Additional Fields on Object Types in Formula ExpressionsAuto-on24R3.2

With 25R1, you can reference the API Name (api_name__v) and ID of an Object Type in formula expressions, and whether it is the default Object Type (default_type__v). Prior to this release, you could only reference the label of an Object Type. 

This update is available everywhere that uses formulas, including formula fields in objects, field defaults, validation rules, and expression-based conditions on lifecycle and workflow configuration.

Admin Experience

Layout Profiles: Save As ActionConfiguration24R3.2

You can now create copies of existing layout profiles by using the new Save As action. This is helpful for creating variations of layout profiles that already have many layouts selected across many objects, allowing for efficient administration. This new action is not available for the All Layouts layout profile.

Migration Package Deployment EnhancementsAuto-on24R3.2

We have changed the way Migration Package (VPK) logs are attached to a package. Previously, each log file was a separate attachment. From this release, there is a single attachment, with each new log added as a new version.

Additionally, the Retrieve Package Deploy Results API now includes a URL to download a ZIP file containing all data deployment success and failure logs.

Document Migration Mode Support for Document RelationshipsAuto-on24R3.2

In order to support Similarity Scores in PromoMats (a new feature coming in 25R1), Document Migration Mode now supports creating Document Relationships using Vault Loader or the API. 

In PromoMats Vaults, enabling Document Migration Mode when loading Document Relationships allows Vault to skip creating Content Similarity records, if needed. This allows for faster bulk creation when migrating Created From relationships that don’t require leveraging the Similarity Scores feature. 

Performance & Availability

Picklist Limit UpdatesAuto-on24R3.2

In multi-value picklist fields on objects, users can select a maximum of 100 values. Prior to this change, users could select more than 1,000 values, which resulted in a less optimal user experience and performance. 

For existing object records with more than 100 values selected, users can still edit those records and the values in that field, as long as the number of values selected is less than or equal to the quantity currently selected.This limit will also be applied to picklist fields on documents in a future release. 

While limited to 100 values on a given record, the overall limit for the number of possible entries that can exist in a picklist (whether applied to objects or documents) has been raised from 1,204 to 2,000. 

Email to Vault: Increase Inbound Email Address LimitAuto-on24R3.2

When leveraging Email to Vault functionality, which allows Vault to receive email directly, a single Vault can now have up to 250 inbound email addresses configured. Prior to 25R1, the limit per Vault was 50. While this is a change to the overall Platform limit, the main use case for this limit change is to enable MedInquiry use cases, where a separate address is needed per Country.

Learn more about Configuring Email to Vault.

Document Usage Storage PolicyAuto-on24R3.2

To improve overall performance, Vault automatically deletes records from the Document Usage object after 36 months. In addition, Vault deletes any Document Usage records that reference deleted documents, even if they are newer than 36 months. Any deleted Document Usage records will not be recoverable. This deletion occurs on the first day of each month.The Document Usage object is a system-managed object that automatically tracks when a user views, downloads (either the source or rendition), or copies a steady-state document. Over time, this has resulted in tens of millions of records, which can impact search performance. 

For customers that regularly report on document usage, any existing reports that are not already constrained by a time period will now only pull records for the previous 36 months. 

Learn more about Document Usage. 

Limit Increases for ObjectsAuto-on24R3.2

Vault Admins can now create more custom fields across all objects, including a higher number of custom unique fields, custom long and rich text fields, custom formula fields, along with more custom object types per object.

Per Object Limit	Old Limit	New Limit
Custom Fields	500	800
Unique Fields	10	25
Long / Rich Text	10	50
Formula Fields	25	50
Object Types	30	50

These limit increases are necessary as the needs of our customers grow, but configuring close to the maximum comes with performance costs. Special attention should be paid to any Vault Java SDK that interacts with these components, as unoptimized code could now have a greater impact on system and UI performance.

Minor Enhancements

Document Reference: Document Moves to Steady StateAuto-on24R3.2

If a document reference field is set to track the latest steady state of a document, it will always update whenever the document enters a steady state. This happens even if the document’s state changes without creating a new version.

Change Owner on Unclassified DocumentsAuto-on24R3.2

When working with unclassified documents or documents in the Staged lifecycle state, users with the Change Owner permission can now replace the document Owner on documents prior to classifying them. 

This allows users to make an Owner change prior to classification without needing to use the API. 

Learn more about Unclassified Documents. 

Make a Copy Dialog Indicates That Autonaming is EnabledAuto-on24R3.2

Vault will no longer prompt users for a new document name when using the Make a Copy action if the document name will be auto-named by the system. Prior to 24R3, the Make a Copy dialog box always allowed a user to input a new document name, though if auto-naming was enabled, any entry a user made would be disregarded.

This change reduces user confusion and effort by ensuring they are only asked to input a new document name when auto-naming is disabled for a given document type.

Learn more about Copying Documents. 

Platform Data Model Changes

See 25R1 Platform Data Model Changes.

Vault Connections

EDC, Safety

Safety-EDC: Support Custom Mappings to Standard Safety FieldsConfiguration24R3.2

With this release, the Safety-EDC connection supports custom field mapping to standard fields. Admins can create and map custom fields across safety-related form types in EDC to standard Safety fields. When transferring SAEs without custom fields, Vault looks for the applicable standard field, optimizing operational efficiency and data integrity.

RIM Submissions, eTMF

RIM-Clinical: Respect Archived Studies on Clinical CrossLinksAuto-on24R3.2

When a source document in Vault Submissions is associated with an archived Clinical Study in Vault eTMF, the archived study is not populated on the Study field of the CrossLinked document. This update respects eTMF’s study association logic and prevents errors when saving the CrossLinked document.

Clinical Operations

CTMS, Vault Payments

Global Procedure DefinitionsConfiguration24R3.2

This feature streamlines procedure management in Vault by allowing for a Vault-level library of global Procedure Definitions that you can use to create Procedure Templates. A new user action on the Study object lifecycle allows customers to quickly and easily populate Procedure Definitions in a Study by selecting either a Procedure Template or by copying from an existing study. Triggers prevent duplicate Procedure Definitions within a Study. By using global Procedure Definitions, customers can perform cross-study comparisons and gain additional insights into procedure costs.

eTMF

Filter Obsolete on TMF Homepage Unapproved DocsAuto-on24R3.2

TMF Managers rely on the TMF Homepage to get an overview of their studies’ status and identify areas that may require attention in the TMF. The current Unapproved Documents report is misleading because it includes Obsolete documents, which should not be categorized as unapproved.

The updated Unapproved Documents chart on the TMF Homepage now excludes any documents categorized as Superseded or Obsolete from the count. This adjustment ensures the chart accurately reflects the intent to see a count of In Progress documents.

Study Training

Cross-Sponsor GCP Certification TransfersAuto-on24R3.2

In this change, Vault will allow Learners linked to VeevaID users to complete the GCP training for one Sponsor in Study Training and use that as evidence of completion with other Sponsors so that the Learner does not have to retake the course or submit redundant evidence.

For a Training Requirement marked for GCP transfer, Vault tracks the Learners’ completion across all Vaults and automatically creates an Exemption Request for new assignments when a Learner has already completed the training. As a result, a new Training Assignment is automatically marked as completed, and the completion certificate is transferred from the Vault where the GCP training was originally completed.

Prior to this change, if multiple customer Vaults required a Learner to submit a GCP training, the Learner would have to submit for all Vaults separately.

Clinical Operations Data Model Changes

See 25R1 Clinical Operations Data Model Changes.

Commercial

PromoMats

eCTD: Redline AnnotationsAdmin Checkbox24R3.2

With this release, redline annotations required for some FDA submissions can be automatically created on eCTD annotated materials during compliance package generation, using Vault link annotations on the promotional piece. Previously, redline annotated versions needed to be created manually and then added to compliance packages.

To enable this feature, select the Add Annotations from Vault Links checkbox in Admin > Settings > Application Settings and set Include Linked References to Yes in the compliance package binder’s metadata.

Preview Content Module EnhancementsAuto-on24R3.2

To enhance the preview experience for Content Modules, we have made several enhancements to the user flow, including updating the record action label and button to Generate Preview.

Standard Document Type DescriptionsAuto-on24R3.2

With this release, we have added descriptions to the Material (material__v), Component (component__v), and Reference (reference__v) document types. Previously, these document types did not have a description.

Additional Controlled VocabulariesAuto-on24R3.2

This feature introduces ANSM Classifications and new Health Authority Submission values to the Controlled Vocabulary object.

MLR Commenting on Content ModulesAuto-on24R3.2

To improve the user experience when reviewing content modules, the comments and replies are now displayed with the most recent comments appearing first.

Medical

MedComms

Auto-On Auto Linking: MedicalAuto-on24R3.2

Auto-Linking is now the default for linking Scientific Statements in MedComms Vaults. When initiated, Auto-Linking runs in the background to provide a better matching experience for Scientific Statements, including non-exact text matches.

MedInquiry

MedInquiry Email Intake: Forwarded Email ProcessorConfiguration24R3.2

This feature enables MedInquiry to match Case Contacts that are manually forwarded to Vault, where the original sender of the email is correctly identified as the Case Contact instead of the last person who forwarded the email.

The Forwarded Email Processor addresses the use case where customers need to run a manual selection of inquiries that will be forwarded from their Medical Inquiry email inbox to Vault MedInquiry for further processing.

Telephony Support: Error NotificationsAuto-on24R3.2

With this release, Vault notifies System Administrators and Vault Owners of errors related to OmniConnect Connections (telephony integrations).

Quality

Batch Release

Batch Release Plan Variation (Parent Plans)Configuration24R3.2

Batch Disposition Plan Variation improves the efficiency of managing hundreds or thousands of plans by allowing material-specific child plans to inherit the settings and Check Requirements from a parent plan. This feature is enabled by referencing the parent plan in the new Parent Plan field on a Batch Disposition Plan. A child plan can have only one (1) parent plan; users cannot enter a plan in the Parent Plan field if the selected plan already has a child or parent plan associated. When a setting or field on a child plan is blank, the setting or field value from the parent plan is used instead.

Evaluate "Impact Batch?" fieldAuto-on24R3.2

Currently, a Batch Disposition Item is closed when its related Deviation or Lab Investigation is closed. With the new Impact Batch? field on the Batch - Deviation and Batch - Lab Investigation join objects, a Batch Disposition Item now is closed only when the related Deviation or Lab Investigation is in a Closed state and the Impact Batch? field is False.

QMS

Execute Root Cause Analysis from InvestigationConfiguration24R3.2

The addition of the 5 Whys Analysis to Vault QMS provided a flexible and integrated tool to maximize efficiency, consistency, and compliance when users perform a root cause analysis.

In this release, we are enabling customers to launch and link to a Root Cause Analysis record directly from an Investigation record instead of navigating to the parent Quality Event record to perform the analysis. Once root cause analysis is complete, the resulting Root Cause records are linked to both the Investigation and parent Quality Event records.

You can learn more about configuring Root Cause Analysis from Investigation in Vault Help.

5 Whys Analysis: Save Button on Why CardAuto-on24R3.2

In this release, we are adding a Save button to the Why? box in the 5 Whys Root Cause Analysis Tool to save any changes made to a record, instead of saves being determined by Vault via clicking outside the panel to trigger a save. This change will make it much more apparent to users which data has been affected by a Save action while working with the 5 Whys Root Cause Analysis Tool’s cards.

The Save action is required on any new or changed card in the Root Cause Analysis Tool before any data is saved in Vault. This change in behavior will be automatically enabled in all Vaults that use the 5 Whys Root Cause Analysis Tool.

Audit Room: Auto AssignmentConfiguration24R3.2

With this release, use of the Audit Room capability of Vault QMS has become faster and easier. Vault now can automatically assign fulfillers to new Inspection Requests. As the audit response team sets up, members of the Fulfiller role on the Inspection record can be granted Inspection Request Auto Assignment records, which allows the team to split up how they will own and respond to inquiries during planning and setup for the audit itself. These default assignments are made per audit and can be reassigned manually during an audit as needed.

Setting up automatic assignments for Inspection Requests does take a small amount of configuration before it is available to your business teams. You can learn more about setting up and using Automatic Assignments for Inspection Requests in Vault Help.

External Collaboration: Impact Assessments & Change ActionsConfiguration24R3.2

Vault QMS enables organizations to provide business partners with temporary, short-term, streamlined access to certain records for the purpose of completing specific tasks within quality business processes. This release expands the External Collaboration feature’s supported quality business processes to include Impact Assessments and Change Actions.

Customers can create Organization records to identify external business partner companies and Person records to identify the individuals in these organizations who can receive external collaboration tasks.

Internal users can assign an external individual’s Person record to a Change Action or Impact Assessment.

When the Change Action or Impact Assessment reaches a particular state, Vault can automatically:

• Provision an External User account for the individual identified in the Person record.
• Send a specialized email message to the external user that provides information about how to log in and complete the task.
• Provide the external user with streamlined access to Vault to complete a workflow task.
• Provide the external user with the minimum required access to the Change Action or Impact Assessment record in order to provide the required information.

When the external collaboration task is completed, Vault can automatically:

• Inactivate the External User account.
• Send an email message to the external individual indicating that the task is finished and access to Vault is no longer available.

System Admins must configure this feature before use. You can learn more about configuring External Collaboration for Impact Assessments and Change Actions in Vault Help.

Field Actions: Related Event AutomationConfiguration24R3.2

Continuing our investments into the new Field Corrective Vault, QMS has expanded the Quality Relationship Automation feature to allow Field Corrective Actions and Health Hazard Evaluations to link to Quality Events (either in the Quality Event object or the standalone Event records). Once configured, users may link Event records to Field Corrective Actions or Health Hazard Evaluations via the Related Events section on their records details pages, and the reverse relationships are established automatically for them.

Surveillance

VPS: Regulatory Updates EnhancementsAuto-on24R3.2

With this release, Vault Product Surveillance (VPS) has added support for the generation and management of Adverse Event Reports for health authorities that aren’t currently supported with a standardized health authority form, including any reportable event where no configured Report Type is listed for the Country. In these instances, Vault now either properly creates and moves to Draft or properly creates a follow-up for an Adverse Event Report (AER) of type Other with a populated due date, based on whether an AER already exists (and what state it’s in) for that event within the system.

Lastly, given recent FDA guidance, eMDR validations also have been updated to add additional data enforcements. These enforcements cover scenarios like requiring Weight Units when Weights are recorded and requiring all adverse event codes to be in initial MDRs with code entry requirements when Report Submitters are either Blank, Manufacturer, or Importer.

Validation Management

Improved Navigation to Application PagesAdmin Checkbox24R3.2

In 25R1, Vault Validation Management will redirect users to the applicable authoring, execution, or review UI when they click the link for a Test Script record from a list view or object reference field. The feature must be enabled in the application settings and configured by an Admin.

Quick Create for Requirements and SpecificationsConfiguration24R3.2

In 25R1, Vault Validation Management will streamline how user requirements, functional requirements, design specifications, and configuration specifications are created by reducing the number of clicks involved to create a new record. Users now can create records directly from an Entity Version without having to click Create from a separate Add dialog, which reduces the number of clicks from four (4) to one (1). 

This feature also enhances the Requirement Entity Version control on the Entity Version object to include filters for each column displayed and provides the ability to remove one (1) or more requirements or specifications from the Entity Version.

Comment Design Enhancements for Dry RunAuto-on24R3.2

In 25R1, customers who have configured and enabled Dry Run for Test Scripts will see several enhancements to comments. The Add Comment and Edit Comment forms have been optimized to provide a better user experience. Comments in the Comment panel display the category, groups are updated with simpler labels, and more direct interaction is available for selecting and expanding comments. Resolve and Reject actions for Authors are displayed when users hover over a comment, but only if the user has permissions assigned. This feature is auto-on for customers who have enabled Dry Run for Test Scripts, released in 24R3.

LIMS

Design Data Portability 24R3.2

This feature allows organizations to easily move design data records between Vaults in a fast and efficient way. Design Data records (Sample Plan, Test Definition, and Specification Data) can each be exported to a ZIP file, and then the file is imported to the target Vault. This eliminates the need to build complex loader files to transfer design data.

Stability Study: Data ExportConfiguration24R3.2

Authorized users can now export stability data to an Excel or CSV format. The data is in a table format grouped by Storage Condition and Orientation. For each Condition and Orientation combination, tests and results are exported across timepoints.

LIMS 25R1 Data Model StandardizationAuto-on24R3.2

Vault LIMS adds a number of standard components to support evolving needs around major business processes.

LIMS-Quality Connection: Lab InvestigationConfiguration24R3.2

With this feature, authorized users can initiate Lab Investigations from Vault LIMS. During exception review, an authorized user can request a Lab Investigation for any exception. The Lab Investigation is created in QMS for investigation and closure. As the Lab Investigation is processed in QMS, Vault LIMS is aware of the key milestones and can integrate Lab Investigation status into LIMS workflows.

LIMS 25R1 Standard Metrics & KPIsConfiguration24R3.2

This feature introduces standard components to the LIMS data model to support the measurement of operational excellence.

Quality Data Model Changes

See 25R1 Quality Data Model Changes

Regulatory

RIM Publishing

Allow Dosage Form Envelope Attribute for ZA Submissions to be OverriddenAuto-on24R3.2

This feature will allow users to override the Dosage Form when updating Submission Administrative Information. The overridden value is carried forward to future Submissions in the Application.

Allow Product Name Envelope Attribute for WHO Submissions to be OverriddenAuto-on24R3.2

This feature will allow users to override the Product Name when updating Submission Administrative Information.The overridden value is carried forward to future Submissions in the Application.

Activate Validation Results Archival Job on all VaultsAuto-on24R3.2

The Validation Results Archival Job has been made Active on all RIM Vaults. The job runs daily to clean up Submissions that have an Actual Submission Date with Open Validation Results greater than 90 days old. The job will create an attachment ZIP file of all open results.

This is a follow up to the 24R3 announcement Validation Results Archival Job Activation in 25R1

Remove Control Characters from Published Output Location Upon PublishingAuto-on24R3.2

ASCII control characters (except for spaces) will be automatically removed from the Published Output Location (POL) field upon publishing, ensuring the folder or file path remains valid. Previously, if a POL contained a control character (such as Tab or a carriage return), folder or file paths could have errors upon ZIP file export or Gateway dispatch. If a POL is manually updated to include a control character while publishing of the Content Plan Item is underway, the most recently completed action (manual or System) will take precedence.

RIM Registrations

Create Related Records: Optional PreviewAuto-on24R3.2

This feature will make Create Related Records preview optional, where it is currently enabled. Users will now be able to skip directly to record creation on the last step if they do not wish to preview data.

Enablement: Will be Auto-On when the Preview is enabled. Admin setting to Disable Confirmation Pop-up when Skipping Review.

Create Related Records: Validation EnhancementsAuto-on24R3.2

This feature allows customers who are not currently using Create and Manage Event Details to take advantage of the enhanced Create Related Records validation logic introduced in 24R3. Vault will use pre-existing validation logic when the Related Change Type is blank, but customers will still benefit from the updates to inactive and multi-match handling as long as the Enable Application Relationships and Enable dynamic validation for Create Related Records and Bundling application settings are enabled.

Enablement: Auto-On when Enable Application Relationships and Enable dynamic validation for Create Related Records and Bundling application settings are enabled.

RIM Submissions

Multi-Record Workflows From Content Plan ViewerAuto-on24R3.2

Content Plan users can now initiate multi-record object workflows directly from the Content Plan Viewer. Similar to the initiation of document workflows when the Content Plan Viewer includes matched documents, object workflows can be initiated on single or multiple (up to 100) Content Plan or Content Plan Item (CPI) records. Workflows may only be initiated on like objects. For example, a group of Content Plan records can be selected, or a group of Content Plan Item records can be included in one Workflow.

The existing Start Workflow action is relabeled to Start Document Workflow and users will see a new Start Object Workflow action. If records have not been filtered to a single object prior to initiating the action, users will be prompted to first select the object to send on the workflow. The available workflows will then depend on the workflows configured for the object records’ lifecycle states and the user’s permissions.

Content Plan Creation Support for ASMF/APIMFConfiguration24R3.2

This feature supports the creation of Submission Content Plans for markets that distinguish between the Open/Applicant’s Part and the Restricted Part for the Active Substance section in the CTD structure. This is applicable, for example, for EU ASMFs and WHO APIMFs.

A new Information Classification picklist is introduced with the following picklist entries: ASMF Applicant Part, ASMF Restricted Part, APIMF Open Part, APIMF Restricted Part.

Enablement: Configuration.

• Expose the Information Classification picklist field on page layouts for the following objects: Application Active Substance, Regulatory Objective Active Substance, Submission Active Substance, Content Plan Template (Module 2 & 3 Object Types), Content Plan Item Template (Module 2 & 3 Object Types), Content Plan (Module 2 & 3 Object Types), Content Plan Item (Module 2 & 3 Object Types).
• Update the Application, Regulatory Objective, and Submission Active Substance object page layouts to expose the Information Classification picklist field in the section for Active Substance relationships.
• Update the CTD Content Plan Template to include ASMF Applicants & Restricted Part sections, tagged with the correct Information Classification picklist values.
• Update the CTD Content Plan Template to include APIMF Open & Restricted Part sections, tagged with the correct Information Classification picklist values.

Drag & Drop from Desktop to Content Plan Items With No Document TypeAuto-on24R3.2

Users can now drag and drop documents from a desktop directly onto a Content Plan Item (CPI), even if the CPI does not have a full Document Type assigned. Previously, the drag and drop option would fail and an error message would be displayed. With this enhancement, users will instead be prompted with a dialog to classify documents now and populate document metadata.

Additionally, the toast for tracking document upload & match progress is updated to better distinguish between documents that are newly created vs. existing documents that are matched as a result of Duplicate Content Detection being enabled on the Vault. Newly created documents are denoted by the existing icon () while existing documents that are matched use a new icon ().

Global Content Plan Updates for Region & Country HandlingAuto-on24R3.2

Global Content Plans can now include Content Plans and Content Plan Items that are tagged with the global Submission’s Lead Market Country value, which is typically Global. When dispatching the structure, Region and Country filtering will continue to exclude the Global Content Plans and Content Plan Items. However, dispatching documents only will include documents matched to Global Content Plan Items and attempt to map them into target Submission structures. This feature better supports the Global Content Plan dispatch of Module 1 structure and documents to target Submission Content Plans.

Submissions: Increase Mini-Browser Window SizeAuto-on24R3.2

When opening documents using the pop-out button in Vault Submissions, such as from the Content Plan Viewer, the default width of the mini-browser window has been increased to also display the Document Information Pane and Action Menu. Users will no longer have to resize the mini-browser to initiate document actions or to view or edit document details.

Singapore (SG) eCTD v1.0Auto-on24R3.2

With this release Submissions Archive is supporting importing, viewing, and exporting of Singapore eCTD v1.0 submissions.

Australia (AU) eCTD v3.2Auto-on24R3.2

With this release Submissions Archive is supporting importing, viewing, and exporting of Australian eCTD v3.2 submissions.

Submissions Archive Viewer: Mini-Browser To FrontAuto-on24R3.2

This enhancement returns the mini-browser to the forefront if it has been obscured by other Vault windows or browser windows, or by other system applications. Selecting the pop-out button will bring forward the mini-browser window with a single click.

Job Label Update: Submissions Archive CleanupAuto-on24R3.2

The system-managed job that removes temporary files generated during the Submissions Archive import process is renamed to Submissions Archive Cleanup. This is not a functional change, and is aimed at improving clarity for the Job Title visible to Admins in Operations > Job Status.

RIM Submissions, RIM Submissions Archive

Approval Type support in Active Dossier LoaderAuto-on24R3.2

With this release the Active Dossier Loader will support the Approval Type field. This field was recently released on Active Dossier Item Detail as part of the Additional Status Tracking feature in 24R3.

Move Saved View Selector in Active Dossier ViewerAuto-on24R3.2

With this release the location of the Saved View selector in the Active Dossier Viewer has changed to be in a more logical position next to the Save View button in the header. There is no change to the saved view functionality.

Safety

The Safety 24R3.2 release, including all Platform features, is scheduled for tentative availability on January 2, 2025. 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

Duplicate Detection Search UpdatesAuto-on24R3.2

This release introduces several updates to enhance the duplicate detection in Vault Safety:

• Case Identifier matching: Vault now prioritizes WWUID matching for more reliable identification of duplicates.
• Patient matching: Vault excludes keywords such as “unknown” and “privacy” from Patient ID matching, reducing false positives in potential match results.
• Adverse Event field matching: Vault no longer considers partially matching reported and coded Adverse Event terms when detecting duplicates.
• Updated filtering criteria: When a Study on an imported Inbox Item does not match a Study from the Study library, the filtering of potential matches will now be based on the source Study Type.

Inactivate Products and StudiesConfiguration24R3.2

With this release, Vault Safety enables setting Products and Studies to the Deprecated lifecycle state so the Safety Rule Engine no longer considers them when determining the reportability of a Case. When a Product or Study is deprecated, Vault deprecates all related Product Registrations or Study Registrations as well. Where deprecated Products or Studies appear on or are added to Inbox Items and Cases, Vault adds a Deprecated tag beside the applicable field, indicating to the user the status of the record. Previously, Products and Studies were transitioned to the Inactive lifecycle state, which caused issues in follow-up situations. This new Product and Study capability facilitates more precise downstream ICSR reporting.

Regions for CountriesAuto-on24R3.2

Vault Safety now includes standard regions for grouping countries. This feature includes the data structure, which Business Admins can revise. Future enhancements will leverage this data structure.

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

Data Model for Korea Drug DictionaryAuto-on24R3.2

With this release, Vault Safety introduces data model changes to support coding external products to Korea Drug Dictionary codes. This feature provides a foundation for future coding dictionary capabilities in Vault Safety.

Updated Cross Reporting Logic for Non-Company Sponsored StudiesAuto-on24R3.2

Vault Safety supports additional requirements around the reporting approach taken for non-company Products. Vault now uses the following reporting rule engine logic for Company Sponsored and non-Company Sponsored Studies:

• Company Studies or Non-Company Studies with Registrations: Vault evaluates reporting for each registration destination.
• Company Studies: Vault evaluates general reporting and cross reporting.
• Non-Company Sponsored Studies with No Registrations: Vault does not evaluate reporting for such Studies.
• Non-Company Sponsored Studies with Registrations: Vault evaluates general reporting only based on the registrations. Vault does not evaluate cross reporting for such Studies.

These changes ensure that the reporting approach aligns with each Study’s sponsorship and registration status for more compliant downstream ICSR reporting and avoidance of over-Submission in certain scenarios.

Auxiliary Medicinal Product SupportConfiguration24R3.2

With this release, Vault Safety enhances the Development Safety Update Report (DSUR) to meet new regulatory requirements from the EMA regarding Auxiliary Medicinal Products (AxMPs). This feature introduces a report-level Submission Format picklist for Annual Safety Report formatting, allowing users to choose between the standard DSUR and the CTIS Annual Safety Report. When a user selects CTIS Annual Safety Report for this field value, Vault generates DSUR aggregate reports with the following criteria:

• Unauthorized AxMPs included in the DSUR SAR line listings.
• Subject IDs hidden in the DSUR SAR line listings and the DSUR list of patient deaths.

This feature also includes formatting updates to align data in rows when a suspect drug has multiple values of Daily Dose Route Formulation and Dates of Treatment Treatment Duration.

Safety Workbench

Use Registrations from Submissions for Workbench PADERsSupport24R3.2

This release improves Workbench Periodic Adverse Drug Experience Report (PADER) reporting by generating a Cases Submitted under other NDA’s report instead of the Non-Primary Suspect Product Report PADER tabulation to capture all Cases containing a suspect Product but where the report was filed to another new drug application (NDA). With this release, Safety Workbench includes Cases in the appropriate reports using the Product Registration that triggers the Transmission. This feature ensures tighter FDA compliance and greater accuracy for categorizing Cases with multiple products into reports.

Safety Signal

Signal Alert Rule EngineConfiguration24R3.2

With this release, Vault Safety Signal introduces the Signal Alert Rule Engine to identify Statistical Data records that meet predefined thresholds. This feature allows Admins to create flexible alert rules for different groups of Products using standard operators and mathematical expressions. The alert criteria support custom business logic and industry-standard rules, for example, when the Product-Event Combination (PEC) is unlisted and when EB05 is greater than or equal to two (2). When a Statistical Data record meets the alert criteria, Safety Signal flags it and allows users to manually review the data. This feature enhances signal detection in compliance with industry standards and custom business criteria. Signal alerts can also run against high volumes of Statistical Data records and support faster signal detection workflows.

SafetyDocs

Risk Management EnhancementsAuto-on24R3.2

With this release, Vault SafetyDocs has made several enhancements to Risk Management:

• For Local Risk Measures, Admins can configure the Target Date field on the RMP Risk Measure Tracking object as required or optional.
• The Copy to New Version and Create Local Implementations actions have been modified so that no documents will be created or upversioned.

These enhancements provide additional flexibility and better align with Risk Management processes.

Safety Data Model Changes

See 25R1 Safety Data Model Changes.

QualityOne

QualityOne

Print Record for TeamsAuto-on24R3.2

This feature enhances the Platform Print Record functionality in QualityOne. With this update, the PDF file output of the Print Record functionality now includes a Team section if it appears on object records, along with Team Role assignments such as Reviewers and Approvers. This enhancement ensures that important Team Role information is included and clearly visible in the PDF output, making the printed document more consistent with the on-screen view and improving overall clarity and completeness.

Related Record Automation Enhancement for Entry & User ActionsConfiguration24R3.2

This feature improves the performance of the Create Related Record action, both for user and entry actions. With this release, the action runs synchronously when there are no Related Child Record Setup records in the corresponding Related Record Setup, and asynchronously when Related Child Record Setup records are present. This enhancement boosts the efficiency and scalability of record creation, ensuring better performance during large-scale operations.

QualityOne Data Model Changes

See 25R1 QualityOne Data Model Changes.

RegulatoryOne

The RegulatoryOne 24R3.2 release, including all Platform features, is scheduled for tentative availability on January 7, 2025.

Compliance Management

Formulation Questionnaires: Change PAL ExpirationConfiguration24R3.2

This feature allows Admins to increase the public access links (PALs) expiration duration Vault generates for FQ Checklists, giving suppliers more time to respond to questionnaires.

RegulatoryOne Data Model Changes

See 25R1 RegulatoryOne & Veeva Claims Data Model Changes.

Veeva Claims

The Veeva Claims 24R3.2 release, including all Platform features, is scheduled for tentative availability on January 7, 2025.

Veeva Claims

25R1 Claims EnhancementsAuto-on24R3.2

This feature enables users with non-English Vault language settings to view picklist values for the Packaging Level, Pack Type and Panel fields in their specified language setting.

Veeva Claims Data Model Changes

See 25R1 RegulatoryOne & Veeva Claims Data Model Changes.