New in 24R2 Limited Release | Vault Release Notes

Limited Release Dates: ~~May 3, 2024~~ Postponed to May 9, 2024 (24R1.2); June 7, 2024 (24R1.3); June 28, 2024 (24R1.4) | General Release Date: August 9, 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

VeevaID Login Support for Vault File ManagerAuto-on24R1.2

VeevaID users will now be able to log in to Vault File Manager to perform typical functions such as check-out, download, and check-in to support document editing.

VeevaID is an Identity Provider (IdP) system for Veeva Applications (such as Study Portal, SiteVault Free, Vault Training). VeevaID allows end-users (Clinical Site Staff) to self-register, access applications they are subscribed to, and maintain their account.

Learn more about Veeva ID.

Send as Link: Limit Number of RecipientsConfiguration24R1.2

When using the Send as Link function, Vault will now limit the number of recipients in a single action to fewer than 1,000. This count is based on the total number of recipients across users, groups and external email addresses that are added. When calculating the number of targeted recipients, any individual user only counts once. For instance, if a user is targeted directly by email address, and again by membership in a targeted group, that user only counts once against the maximum threshold.

This enhancement prevents users from accidentally sending a document to a large group of recipients, which can happen if a user selects a group such as All Internal Users. This also prevents potential performance impact to email notifications being sent from Send as Link actions (for instance, if Vault needs to send over 1,000 email notifications, that can create a delay due to the volume).

Select Anchor & Permalink ImprovementsAuto-on24R1.2

When leveraging the Select or create new anchor option in the Select anchors dialog, the mini-browser that opens will now automatically filter only on anchors to allow users to more easily find and select the correct anchor for their document link.

Additionally, when creating a permalink link annotation, the Select target dialog will now include a Recent Targets view, with an option to sort by Selection Date, allowing users to more easily reuse permalink targets:

Vault will now also remember the last view that a user used in the Select target dialog and apply that the next time they perform an action to create a permalink link annotation.

Learn more about Using Link Annotations & Document Links.

Improved Directory Upload to File Staging in Vault File ManagerAuto-on24R1.2

When uploading a single directory or multiple directories to the File Staging tab within Vault File Manager, Vault File Manager now shows the upload progress of each file within the directories. If there is an error uploading a file in the directory, users will now be able to easily identify which file had an error and what the error was.

With this change, all files within the directory will be shown as a separate line. Each line notes the full file path as well as the Upload Status, Dated Added, Upload Type, Size, and Destination.

Learn more about Vault File Manager.

Clearer Reclassification WarningAuto-on24R1.2

When reclassifying documents that are matched to binders via autofiling, Vault will now display a clearer message to users indicating that the binder relationship may change: “Binder autofiling rules based on a document type may no longer be applied.” Prior to 24R2, the message Vault displayed did not clearly indicate the warning is based on autofiling rules that are based on document types.

Before 24R1, the warning would show as:

After 24R1, the warning will show as:

Learn more about Reclassifying Documents.

Clearer Error Handling when Reclassifying Documents Under Legal HoldAuto-on24R1.2

If a user is viewing a document while another user places that document under legal hold, Vault continues to display the Reclassify link until the page is refreshed. If the user attempts to click the Reclassify link, Vault will prevent the reclassification per legal hold restrictions.

With 24R2, this behavior will not change, but Vault will now also provide a message to the user making clear to them why the reclassification is not allowed: “Cannot reclassify document : Document is associated with one or more approved Legal Holds.”

Learn more about Applying & Removing Legal Holds.

Configuration Migration: Remove Document Type Filter WarningAuto-on24R1.2

Prior to 24R2, when deploying document configuration using configuration migration packages, Admins received a warning if the package contained a document type with a filter and the filter wasn’t applied to its subtypes or classifications. This warning was not actionable, so with 24R2, this warning is no longer displayed.

Google Drive Integration: List View Only in File DialogAuto-on24R1.2

For customers leveraging the standard Google Drive Integration, when adding files to Vault from Google Drive, users will no longer be able to switch between List and Grid views within the Google Drive dialog:

This change is being made based on changes to the API between Vault and Google, but users will still be able to access, search, and sort within the Google Drive dialog.

Standardized Undo Checkout PermissionsAuto-on24R1.2

Vault supports several different checkout methods for editing documents - standard checkout, checkout to Vault File Manager, Collaborative Authoring, and using Google Drive. Each method provides a mechanism to cancel/undo an existing checkout. Going forward, the permissions governing when cancellation can be performed of another’s user’s checked out document will be consistent across all checkout types.

In order for a user to cancel/undo a checkout that another user owns, users will need to have Edit Document permission in the document lifecycle state security settings, as well as one of the following:

Have the Document Owner role for the document
Have the All Document Actions permission in their Permission Set
Have the Cancel Checkout permission in their Permission Set

Ensuring that the same permissions apply across all checkout types will reduce confusion and make it easier to manage permissions and permission changes.

Error Message When Adding a Duplicate Document to a Binder SectionAuto-on24R1.2

When a user attempts to add a document to a binder section and an existing version of that document is already bound to the binder section, using the Add Existing Documents function, Vault now displays a clear message to users letting them know that the document cannot be linked twice in a single binder section.

Prior to 24R2, Vault already prevented users from adding documents to a binder section more than once, but no message was provided to users. Including this message will reduce confusion for users so they know why the document was not linked again.

Learn more about Editing Binders.

Lifecycle & Workflow

New Workflows Deployed as ActiveConfiguration24R1.2

To reduce the number of steps required when migrating workflow configurations from Sandbox to Production, Vault will now deploy new workflows as Active if all the configuration is valid. Prior to this change, only updates to existing workflows would result in the workflow becoming active, and all new workflows would deploy in the Inactive status.

Advanced Start Workflow Available from Document ReportAuto-on24R1.2

When using the Start Workflow action from the results of a document report, we have now included the new Advanced Start Workflow link. From there, you can refine your selection (if you don’t want to send all the documents in the results on the workflow), select your workflow, and even loop back through those documents multiple times using the Finish + Start Next Workflow button. This is particularly useful if you’re executing ‘taskless’ workflows on the documents; using workflows as a way to perform a series of configured actions.

Start Multi-Record Workflows from Object ReportsAuto-on24R1.2

Object reports are often designed to return a very specific set of object records that require action, often via one or more workflows. Directly from the results of an object report you can now execute a multi-record workflow, including the Advanced Start Workflow option that allows you to refine your selection before initiating one of the available workflows.

Objects

Matching Field Limit Increase Applied to User Role Setup Object TypesAuto-on24R1.2

In 24R2, the maximum number of custom matching fields on User Role Setup objects was increased from five (5) to six (6). For RIM Vaults specifically, where Vault allows for multiple Object Types on the standard User Role Setup object, the limit remains as five (5) per object type.

With 24R2, customers will now be able to add up to six (6) custom matching fields per User Role Setup Object Type.

Learn more about User Role Setup Object Types.

Object Type TranslationConfiguration24R1.2

To better support users in Vaults with multilingual labels enabled, Object Type labels can now be translated. Users who view Vault in a language other than the base language will now see translated object type labels where available in the Vault UI, including record detail pages, reports, and formula fields. If no translation is available in the user’s language, Vault displays the label in the base language.

Admins who can edit localized labels for a single language will now see additional fields for localized Label and Plural Label when viewing object types.

Common UI & Search

What's New General Release Notification: Mark as ReadAuto-on24R1.2

With each General Release, there is a What’s New notification that is automatically available to all users in the Notifications menu. This notification is pinned at the top of the notification list.

Starting with 24R2, users will be able to mark this notification as read, and once marked as read, the notification will begin to move down the list as other notifications are received.

This enhancement ensures that users are still made aware of new features, while also providing the flexibility to have the notification not remain at the top of the list.

This update does not apply to the following applications: CDMS, Align, CRM.

Object Data Grid Freeze Line Design ChangesAuto-on24R1.2

When using a grid view (either on an object tab or in the Library), we have enhanced the user experience in a couple of ways:

When freezing columns, the line indicating which column is frozen will be gray rather than blue, making it look less like something that is being actively moved.

When moving columns via drag-and-drop or moving the freeze line, Vault now shows a dotted gray line rather than a dotted blue line, in accordance with the change above.

Reporting & Expressions

Object Attachment ReportsAuto-on24R1.2

Admins can now create report types that include attachments on any object with the Allow Attachments setting enabled.

When the Attachments object is included in a report type, users can create reports that include the following standard attachment information, which users can include as report columns or use in report filters:

Reporting on attachments has been a common need from customers across Vault applications; for instance, in QMS, a customer may need to identify which Quality Event records have attachments and the details included in those attachments. Prior to 24R2, users could only obtain this information through the API.

Attachment reports are also supported as Report Views in multi-pass reports, and support pulling information on all attachment versions (though by default, attachment reports will filter for the latest version).

Learn more about Attachments and Configuring Report Types.

Expression EnhancementsConfiguration24R1.2

This release introduces some new capabilities to Vault’s expressions functionality (used in formula fields on objects, validation rules, formula fields on reports, and more).

New system variables: expressions are now able to return the Domain of the Vault, the Vault ID, and the timezone of the Vault. These can be accessed in any expressions with the following tokens: @Vault.domain, @Vault.id, @Vault.timezone
DateTimeValue: this is a new function that accepts a date, datetime, or text in the format of a date or a datetime, and returns a datetime value. Datetimes are assumed to be in GMT, but users can specify a timezone through a second parameter.
IsAppEnabled: this new function accepts the name of a Vault Application as a string and returns true or false depending on whether the app is enabled in the Vault
- See the Vault Formula Reference Guide for a list of application strings
Blank Handling: all functions in object formula fields now honor the Treat blank fields as zeros and empty strings attribute.

Security

Security Profile Limits Exclude Standard Security ProfilesAuto-on24R1.2

The number of Security Profiles that a given Vault can have is limited to 100 or less. Prior to 24R2, Standard (__v) Security Profiles were included in this count, but going forward, this limit will only be enforced on the number of custom (__c) Security Profiles.

Tools

Users No Longer Require the All Document Create Permission for Vault LoaderAuto-on24R1.2

When creating or updating documents, versions, relationships, attachments, roles, or renditions using Vault Loader, users no longer require the All Document Create permission in their permission sets. You don’t need this additional permission to do these actions in Vault, so it is no longer required for Vault Loader either.

Vault Mobile

Note: Vault Mobile does not have a Limited Release, and only releases with Vault General Releases. Features listed here will be available for testing and assessment during the pre-release period for the next General Release. Learn more about the mobile pre-release here.

Show Document Name and Latest Version Link in Doc ViewerAuto-on24R1.2

When viewing a document in Vault Mobile, users can now see the name of the document at the top, and if they are not viewing the latest version, they will also see a link to the current version. Similarly, if a user is viewing a minor version, and a steady state version exists, users will see a link to the latest steady state version.This enhancement helps ensure that it’s clear to users that they are viewing the correct document, and reduces the risk that a user might inadvertently reference an unapproved version of the document.

Platform Data Model Changes

See 24R2 Platform Data Model Changes.

Vault Connections

Quality-LIMS Connection

Quality-LIMS Connection: Reference ObjectConfiguration24R1.2

Vault LIMS continues to add functionality to support the connection between Quality and LIMS. This feature will provide new integration and integration points to support the automated syncing of reference object records from Quality Vaults to LIMS. The shared objects that are supported in the reference object syncing connection are the following: Batch, Related Batch, Material, Related Material, Product, Product Family, Product Variant, Product Marketed, Organization, Asset Family, and Asset.

RIM-PromoMats Connection

RIM-PromoMats: Configurable Action to Automate Sequence IDConfiguration24R1.2

To provide more flexibility for customers who may plan submissions far in advance of being ready to assign a Sequence ID, a new Action has been added: “Automate the Sequence ID.”

In 21R1, Veeva introduced the Admin setting to automatically populate the Sequence ID (xml_submission_id__v) field when a new Submission record is created. The Admin setting applies to all new Submission records Vault-wide, and will use the next available 4-digit sequence for that Application. The existing setting is used by the RIM-PromoMats Connection when creating 2253 Submission records; however, assigning a Sequence ID at the time of record creation is not always desirable.

With 24R1, “Automate the Sequence ID” can be configured as an Event Action or Lifecycle State Entry Action. Customers can specify when and on what Application Types/Submission Types the Sequence ID field is auto-populated. For example:

Entry Action on Submission Lifecycle In Progress state: Sequence ID will only be populated when Submission record advances to In Progress

For RIM-PromoMats Connection customers, the “Automate the Sequence ID” Action will need to be executed upon record creation, therefore:

Event Action: Update record upon Create

Submissions Publishing customers should ensure “Automate the Sequence ID” is configured to occur before any action that automatically enables Continuous Publishing to prevent failure of the Publishing job to initiate.

Safety-RIM Connection

Safety-RIM Connection: PSMF Annex H SupportAuto-on24R1.2

The Safety-RIM connection now transfers all data from RIM Vaults needed to generate Annex H of the PSMF in SafetyDocs Vaults. Additionally, with this release, SafetyDocs includes a standard report that organizations can use to generate the annex. These enhancements allow the PV team to own the Annex H document fully, streamlining the PSMF management process and compliance.

Safety-EDC Connection

Safety-EDC Connection: SAE Transfer EnhancementsConfiguration24R1.2

This release introduces enhancements to the Safety-EDC connection. If a customer has connections to both CDMS and Safety from their CTMS Clinical Operations Vault, Studies match in all Vaults based on the common Link (link_sys) values, regardless of existing matching criteria such as Study Number.

Additionally, the connection now effectively manages Case deletion scenarios from EDC. When a user clears an SAE form in EDC, Vault Safety generates an Inbox Item containing all Case details. When automated Case promotion is configured, the Inbox Item has an EDC Reason indicating that any corresponding Case must be voided or nullified.

In the event of a subject deletion in EDC, Vault Safety generates an Inbox Item for each Case associated with that subject as well as a nullification Inbox Item. The EDC Reason field on the generated Inbox Item denotes the subject’s deletion by an EDC user.

When a Case is downgraded in EDC, Vault Safety generates a new follow-up Inbox Item, allowing users to compare and observe the removal of seriousness criteria.

Clinical Operations

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

eTMF

Metadata Extraction Generally AvailableAuto-on24R1.2

The capabilities of the TMF Bot have expanded significantly over time. Beyond its initial function of automatically classifying documents, it now also possesses the ability to set metadata. Initially we focused on Study metadata (23R1) and more recently we extended to Country and Site metadata (24R1).

TMF Bot Metadata Extraction is now generally available, eliminating the need for support enablement. Customers can now independently create, test, and deploy Metadata Extraction models in their Vaults.

Country & Site Check in Document QC StepAuto-on24R1.2

TMF Bot continues its extension and enhances the Document QC Step to check Country & Site metadata. Thanks to this enhancement, TMF Bot will be able to identify, at any Document workflow step, classification and metadata issues (incorrect Study, Country or Site). Both possible issues and suggested resolutions will be presented to the end users in the same document panel. This will help our customers improve TMF documents’ quality and accelerate inspection readiness.

Study Startup, eTMF

Recurring Milestone Schedule Automated Date UpdateAuto-on24R1.2

This auto-on feature automates updates to the ‘Next Create Date’ field on the following cases:

Auto-set ‘Next Create Date’ = ‘Initial + offset’ fields on activation of ‘Recurring Milestone Schedule’ object record
Null ‘Next Create Date’ field on inactivation of ‘Recurring Milestone Schedule’ object record

When this feature was released in 24R1 populating these field values required configuration, now this automation streamlines the process and bridges this gap.

All Clinical Operations Applications

CTMS Transfer: Deletion in SourceConfiguration24R1.2

CTMS Transfer automates the daily transfer of study data from the CRO to the sponsor when both organizations utilize Vault CTMS. Over time, some of these previously transferred data may be deleted by the CRO in the Source Vault. However, until now, the Sponsor Vault lacked a mechanism to track these deletions.

Recognizing the critical importance of ensuring that changes made in the Source Vault by the CRO are accurately mirrored in the target Vault, CTMS Transfer has been enhanced to now highlight records that have been deleted in the source system thanks to a new Deleted in Source System field. This enhancement ensures that sponsors can confidently conduct thorough analyses and make informed decisions based on the most current data available.

Clinical Operations Data Model Changes

See 24R2 Clinical Operations Data Model Changes.

Commercial

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

PromoMats

Portals: Enhancements to Document CardAuto-on24R1.2

Enhancements have been made to document cards on the Portals homepage that allow users to quickly find more information on documents. Users can now see the file format for a document represented by an icon similar to other areas of the Vault UI. Additionally, the document type/classification is now visible without having to hover over a document card. The format is the same as it is today on hover (Document Type > Subtype > Classification).

Portals: Update to Portal Tab VisibilityAuto-on24R1.2

With this release, Portals Tab visibility is based solely on user permissions, meaning users with permissions can still see the tab even when no portals exist. Prior to this release, if users had access to the Portals Tab but no portals existed, the tab was hidden.

Modular Content: UI ImprovementsAuto-on24R1.2

With this enhancement, we have made usability improvements to the Modular Content UI, including surfacing the Content Module Details on the user interface, a navigation panel to the left of the modules, and a refreshed Quick Look panel.

eCTD: Change Material State on SubmissionConfiguration24R1.2

Administrators can now configure an entry action on the Submission Ready Lifecycle to change the state of the eCTD Source document when the state of the submission ready copy is updated. We recommend configuring this on the Submitted state of the Submission Ready Lifecycle to set the eCTD Source document to the Steady State state type. The action will only run on documents where the Main Promotional Material? field is equal to Yes. This is a system-managed field on the clean material submission ready copy and must be activated if not configured already.

Multichannel: New Email Preview FormatsAuto-on24R1.2

With this release, Vault includes more current email formats when previewing Approved Email content prior to publishing to field teams. This release also removes older email formats and clients.

Commercial Data Model Changes

See 24R2 Commercial Data Model Changes.

Medical

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

MedInquiry

Capture Multiple Reactions and Products under EventsConfiguration24R1.2

The new Event Reaction and Event Product objects allow structured capture of multiple reactions/events and multiple products in an Adverse Event or Product Quality Complaint. Multiple Event Reactions and Event Products generate the corresponding repeating sections in the E2B(R3) report.

MedComms

Portals: Enhancements to Document CardAuto-on24R1.2

Portals: Update to Portal Tab VisibilityAuto-on24R1.2

Multichannel: New Email Preview FormatsAuto-on24R1.2

With this release, Vault includes more current email formats when previewing Approved Email content prior to publishing to field teams. This release also removes older email formats and clients.

Commercial Data Model Changes

See 24R2 Medical Data Model Changes.

Training

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

Training

Learner Homepage History Tab: Performance ImprovementAuto-on24R1.2

Performance improvements were made to the History tab on the Learner Homepage to quickly display completed Training Assignments:

The list of field values in the filter shows up to 50 values. To locate a field out of view, users can type ahead to search more.
It is no longer possible to sort by Curriculum or Learner Role columns.
To filter on a Training Assignment object field, Learners require Read permission to that field.

Quiz UI Improvements for Mobile AppAuto-on24R1.2

While taking a quiz on the mobile app, users can navigate back to the previous page. Previously, this was not possible.

Study Training

VeevaID Invitation Based on Study Person TypeAuto-on24R1.2

The Clinical Operations Person record’s Person Type field now determines whether a Learner receives a VeevaID invitation when they are brought over to Study Training with an assigned Study Team Role.

Quality

A feature listed in the Vault Connections section also affects the Quality application family.

Vault Batch Release

Batch Release Execution App Page (Edit / Actions)Configuration24R1.2

Vault Batch Release is a new Vault Quality Suite application that offers an automated, end-to-end solution for dispositioning batches. Vault Batch Release features a dedicated page aimed at simplifying batch disposition for quality personnel post-completion of Checks containing Items. This user-friendly interface consolidates all pertinent records including Batches, Dispositions, Checks, and Items. Checks and their respective Items are displayed in a structured “tree-grid” format with visual status indicators, enhancing the visibility of completion statuses. Links to related items such as deviations and documents expedite information review and status assessment. Standard pages will cover all other application needs including list views, reports, and the administration of Disposition Plans. Material-specific Disposition Plans are used to determine what Checks need to be completed to disposition a batch.

Note: Vault Batch Release is only available to customers enrolled in the Early Adopter Program. To learn more, please contact your Account Partner or Customer Success Manager.

Batch Release Workflow IntegrationConfiguration24R1.2

With the launch of Vault Batch Release, a new workflow is available to help coordinate the review and approval of Dispositions after all their Checks have been completed.

QMS

Complaint Intake & Promote to ComplaintConfiguration24R1.2

Organizations intake information about potential product complaints, and this information must be triaged to determine if an actual product complaint process is necessary. In order to support the capture and triage of potential product complaints, this release introduces the following new objects included in the standard QMS data model:

Complaint Intake: represents a potential complaint to be triaged. If necessary, one or more actual QMS complaint records can be created and related to the source Complaint Intake record.
Reported Product: represents the product associated with a Complaint Intake record. Each Complaint Intake record can have one or more Reported Product records.
Reported Product Batch: represents the product batch associated with a Reported Product record. Each Reported Product record can have one or more Reported Product Batch records.

The data model updates support the ability to create related standalone Complaint or Quality Event Complaint records. This release also introduces two standard join objects:

Complaint Intake Complaint: joins Complaint Intake records to their related standalone Complaint records.
Complaint Intake Quality Event Complaint: joins Complaint Intake records to their related Quality Event Complaint records.

A new Promote to Complaint action for the Complaint Intake object makes it possible to create one or more complaints that are related to the source Complaint Intake record. System administrators can configure the action to be used on a Complaint Intake record’s lifecycle state in a User Action or Entry Action. The action can also be configured to execute in a workflow step within a workflow that routes a Complaint Intake record. When this action executes, information from a Complaint Intake is copied to the resulting QMS complaint record(s) created from this action, including any attachments on the Complaint Intake record. The Complaint Intake record’s related Reported Products are also copied to the QMS complaint.

The diagram below shows an example of a Complaint Intake record that includes multiple products and batches. It also shows how a single Complaint Intake record can create multiple complaint records, including the option to configure Promote to Complaint to create separate complaints by product batch.

This feature sets the stage for:

Future Release: New Vault Connections that will enable automatic creation of quality complaints in Vault QMS based on input from Medical and Safety Vaults.
Vault QMS integrations with customer applications that receive complaint information from patients and healthcare providers to create Complaint Intake records.
Enabling Vault QMS users to manually create Complaint Intake records, triage them, and create complaints as described above. Of course, QMS users will continue to have the ability to create complaint records directly, bypassing the Complaint Intake process.

Recurrence Check: Support Execution as an Entry ActionConfiguration24R1.2

Today, you can only manually execute recurrence checks with a user action configured on one or more lifecycle states. For instance, when initially reviewing a quality event before sending it for an investigation to find potential recurrences, you can configure a recurrence check to be mandatory.

In this release, the Run Quality Record Check action has been enhanced and is now available to be executed as an entry action. This allows for the recurrence check to be automatically run when entering into a specific lifecycle state, eliminating the need for users to manually run the recurrence check.

Learn more about Configuring Recurrence Check.

Duplicate Check: Enable Verdicts without Transitioning Complaint Lifecycle StateConfiguration24R1.2

The Duplicate Check feature was introduced with the 22R3 release to replace complex manual processes to identify duplicate and follow-up complaints with an intelligent search functionality.

Previously, when a Complaint has been found and a verdict to mark the record as a duplicate or follow-up needs to be provided, the lifecycle state which the duplicate or follow-up complaint will transition into is a required input. With this feature, the transition to a specific lifecycle state will no longer be required. This will solve situations when the complaint still needs to be processed to closure while ensuring that a verdict has been selected and a related event record is still created.

When configuring Duplicate Check, Admins have to select a picklist value as a verdict, but the Destination Lifecycle State is now an optional field. Additionally, the Do not transition complaints in the following lifecycle states field added in 24R1 only displays when at least one Destination Lifecycle State on at least a single verdict has a value.

Recurrence Check: Refresh Results from Comparison PageAuto-on24R1.2

When a user wants to resume a recurrence check, the system uses the data based on the last time the check was run. That could have been several days ago and additional data, such as new related records or field value changes, could now be in the system. In order to get the latest results, the user would have to use the option to discard the previous record check and then execute a new record check.

In 24R2, a Refresh button with information regarding the date and time of the latest update will be displayed in the header of the record check interface. This button allows the user to refresh the results based on the latest data added to Vault.

For any new record check executed following the release, if the Allow user to override discovered match terms option is enabled, selecting the Refresh button will also give the user the opportunity to add, edit, or remove search terms.

If a record check is executed prior to this release and is In Progress, a user will not be able to override match terms even if the Allow user to override discovered match terms option was enabled when the recurrence check was originally executed.

Learn more about Configuring Recurrence Check.

QRM: Risk Builder Enhancements Part 1Auto-on24R1.2

This release includes a series of enhancements across the Quality Risk Management (QRM) application. The following enhancements have been made to support the QRM functionality:

The Risk Builder interface now displays the Mitigation Action column regardless of whether the Risk Response is present or not. You can add this column to the Risk Builder directly from the columns selector. This feature adds additional automation = to the flow, automatically calculating both the Criticality Score and Criticality Level after the Severity & Occurrence field values have been populated.
The heat map visualization now renders the appropriate new object label in Vaults where the label of the Criticality object has been modified.

Keep an eye on the upcoming limited releases for more exciting enhancements to Vault QRM.

Surveillance

VPS: Application-Wide Optimizations Part 1Auto-on24R1.2

This release includes a series of enhancements & optimizations across the Vault Product Surveillance (VPS) application. Internal validations no longer perform unnecessary data checks while permission checks have been modified in some areas of the AER workflows to handle cases where the user lacks rights to the object storing data that should be shown on that page.

The following enhancements have been made to support the VPS application:

VPS-rendered PDFs now support showing the MDR Contact Office site and person in eMDR G1.
EUMIR: 2.4 now supports picklist dependencies to guide user value selections.
EUMIR: 4.3.1 now provides more precise validation messages.
EUMIR: Data truncation is now honored identically across the VPS UI and generated PDF & XML artifacts, with indications inline where data has been appropriately truncated in rendered PDFs.
EUMIR: 1.3.2, 1.3.3 subsections c,d, as well as 1.3.4 subsections b, c have had their validation granularity adjusted, now supporting more helpful error messages if a person, or part of a person’s definition (first name, last name) are missing from the data set.
eMDR: additional translation support has been added for Validation messages in sections A, D, and H6.

Validation Management

Enforce Valid License Types for Validation Management UsersAuto-on24R1.2

Beginning in 24R2, Vault will introduce a streamlined user management experience. The goal of this feature is to create transparency between the way licenses are displayed and managed in Vault, and the way licenses are defined contractually, reducing the effort required to reconcile Vault licenses.

System Administrators will only be able to select valid application license types for each application. The valid application license types for the Vault Validation Management application are:

Full User
External User

The impact of this change is as follows:

Application Licensing fields will no longer accept invalid values when a System Administrator creates a new user or updates an existing user.
The upgrade will not change the Application Licensing field values for existing users. System Administrators can access a summary of invalid application license assignments.
If your organization uses multiple Quality applications, and an existing user attempts to access an object or tab that is not supported by their assigned application license, Vault will show a warning message, but allow the user to access the object or tab.

LIMS

Evaluate Additional CriteriaAuto-on24R1.2

Create Spec Data Criteria Sets to group Spec Data Criteria to be evaluated to specified country conformance criteria. Used with runtime app section to generate on demand Criteria Evaluations and summary reports for additional markets.

Quality Data Model Changes

See 24R2 Quality Data Model Changes.

Regulatory

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

RIM Registrations

Enhanced Support for Parallel XEVMPD & IDMPAuto-on24R1.2

In this release, the Vault Registrations data model and aggregation algorithms are updated for XEVMPD and IDMP. This auto-on enhancement supports the continued concurrency of these transactions.

Dependent Labeling Deviation GranularityAdmin Checkbox24R1.2

Vault Registrations has added a new Skip Duplicate Check for Dependency Automation Trigger Application Setting. Prior to this release, Labeling Deviation records were required to have a unique combination of Activity and Labeling Concept. However, this uniqueness check is inconsistent with the ability to cascade Labeling Deviations to dependent countries. Additionally, more than one deviation can be captured per labeling concept. To address this, the CCDS Section picklist can be configured as multi-value. The ability to skip the duplicate check removes the requirement to have a unique combination of Activity and Labeling Concept. These enhancements support more granular Labeling Deviations as well as deviations that are cascaded to dependent markets.

Enhancement to Product-Based Activity Creation from Impact Assessment ReportAuto-on24R1.2

With this release, the Create Related Records wizard in Vault Registrations is updated to more accurately create records when running the wizard from an Impact Assessment Report (IAR) and the Activity Scope is Product-based (“Application and Product” or “Country, Application and Product”). In some cases, the Product field may be blank on the Registration records included in the IAR, for example if the Registration Scope is “Marketed Product Group’’. In this case, Vault calculates the product based on the Product field on the Registered Product records associated with the Registrations in the IAR.

RIM Registrations, RIM Submissions

Global Content Plan Creation: Support for Custom Matching FieldsAuto-on24R1.2

When generating Global Submission records and Global Content Plans, Vault will now consider custom fields on Event, Submission, Application and Regulatory object relationships when calculating and removing duplicate records. Previously, the system did not include custom fields in its calculation and would remove what it considered duplicate relationships that were identical, except for their custom field values.

This enhancement prevents the system from removing relationships that were intended by the customer to be included in the GCP. Vault can also now use the custom fields to support Automatching and Suggested Matching of documents to the GCP.

RIM Submissions

Suggested Matching Enhancements: Maintain User Context, Update to Clear All (Filters) ButtonAuto-on24R1.2

Two enhancements have been added to improve the Match Document Mode user experience. When a user enters Match Document Mode with a specific Content Plan Item selected, the Viewer will open to that specific CPI, rather than opening to the first item in the Content Plan. This prevents users from losing their place in the Viewer and reduces time spent navigating back to the CPI they want to match. Upon launching Match Document Mode, a new Clear All Filters option is available by default, reducing the number of clicks to remove the default matching filters.

Respect Uppercase Lettering in Published Output Location

Vault Submissions now respects upper case letters in the Published Output Location field when the submission record’s dossier format is set to Other. This will be respected in the following actions: Split CPI, Bulk Update Tokens from CP and Update Tokens from CPI, Create/Update/Copy CP.

~~Note that document naming based on the Published Output Location field requires Vault Submissions Publishing.~~

This feature is deferred to a future release.

Exclude "Use for Registrations" from GCP Matching RulesAuto-on24R1.2

The Use for Registrations field has been removed from being used as a matching field for Event relationships when dispatching or generating comparisons of Global Content Plans.

RIM Submissions Archive

Support for Additional Document User Actions in the ViewerAuto-on24R1.2

Submissions Archive users are now able to execute the following User Actions directly from the Submissions Archive Viewer:

Open Content Plan
Open Content Plan Item
Open Source Document

When configured, these actions support using the Viewer to review in-process submissions, and are now available in the new Archive Viewer interface.

Submissions Archive: Singapore eCTD 1.0

~~With this release, import, display and export of Singapore 1.0 DTD for eCTD submissions are now supported.~~

This feature is deferred to a future release.

EAEU latest updatesAuto-on24R1.2

With this release, the latest updates to the EAEU submission specification are now supported in the Submissions Archive. The following updates are now available:

Updated document codes to display 3.2.R.1 documents properly
- Section 1.8.2 has been updated
- Sections 1.8.2.x have been added within the structure

Submissions Archive: South Africa eCTD v3.0Auto-on24R1.2

With this release, import, display, and export of eCTD v3.0 for South Africa are now supported.

RIM Publishing

Support Canada REP Validation RulesConfiguration24R1.2

With this release, Vault Submissions Publishing supports validation of Health Canada eCTD submissions against the Health Canada validation criteria version 5.2, which now includes Regulatory Enrollment Process (REP) rules I01 - I11. Version 5.2 also includes the following updates to rules that were made available in 24R1:

Updated text (but not logic) in B32, B44, B47, B48 rules regarding PDF Analysis
- B49: Added searchable documents

Define RLCP Output Document Type for Section Level MergeAuto-on24R1.2

Report Level Content Plan users can now define the published output document type, subtype, and classification for documents produced using Section Level Merge. With 24R1, merged output was classified as a Submission Ready document. Now, users have the option to define a more useful classification to support filtering, searching, and matching into Submission Content Plans.

A new Content Plan field, RLCP Section Output Document Type, can be added to the RLCP Viewer and populated as needed. For example, when using Section Level Merge to produce a single PDF containing a Table of Contents and tables & figures, users can choose Clinical > Study Reports > Tables and Figures.

View Submission Administrative Information based on region and regional.xmlAuto-on24R1.2

When viewing Submission Administrative Information on a Submission or Submission Country record, viewing is only available when the region on the Published Output Location matches the Submission Country.

In the event that a regional.xml Published Output Location is accidentally or purposefully updated to include a different country code than the Submission Country, users will receive an error (The Regional XML is not available) when attempting to view Submission Administrative Information. For example, for a US Submission, if the regional.xml was updated to m1/za/us-regional.xml, the Submission Administrative Information would show an error.

Support Empty Published Output Location Field for Delete Lifecycle OperationsAuto-on24R1.2

When publishing a Content Plan Item with its XML Leaf Operation field set to Delete, Vault automatically clears the item’s Published Output Location (POL) field and the xlink:href within the regional or index XML. Previously, manually clearing the Published Output Location field for a Delete operation could cause Publishing issues. Now, regardless if the Published Output Location field is cleared or remains populated, Publishing will execute and Vault will clear any values in the Published Output Location field.

RIM Data Model Changes

See 24R2 RIM Data Model Changes.

Safety

The Safety 24R1.2 release, including all Platform features, is scheduled for tentative availability on ~~May 9, 2024~~ (postponed) May 17, 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 Attachment HandlingConfiguration24R1.2

With this release, Admins can now efficiently manage the handling of emails and attachments received from their PV email inboxes. This feature introduces new settings that allow Admins to associate inbound Vault emails with Transmission Profiles, providing granular control over email management. Depending on configuration, Vault generates an Inbox Item per email or attachment, streamlining organization and user accessibility. Moreover, both multi- and single-E2B ZIP and XML format attachments are automatically imported into Inbox Items, eliminating manual user intervention and enabling seamless integration of structured attachment formats. This advancement automates the handling of email attachments and facilitates touchless intake. This feature eliminates the need for manual triage and classification of email attachments.

Follow-up Parent Information Case UpdatesAuto-on24R1.2

With this release, Vault Safety creates a new version of Parent Information Cases for Global Follow-up Cases. Now, for Follow-up Cases with an associated Parent Information Case, Vault applies new information from import to the Follow-up Parent Information Case. When creating a Follow-up through the Case Compare page, Vault applies new information from the Inbox Item and copies missing information from the previous Parent Information Case. This feature improves data quality and compliance.

MedDRA Query Reporting Rule Parameter Eligibility UpdatesAuto-on24R1.2

With this release, Vault Safety enhances the logic governing the evaluation of the Include MedDRA Query and Exclude MedDRA Query reporting rule parameters to determine more precisely the reportability of cases containing Adverse Events configured within a MedDRA Query. Previously, the rule engine used an approach known as Most Conservative Product/Assessment (MCP/A) to identify the single “most reportable” Product/Assessment. However, the enhanced logic now evaluates all Case Adverse Events as a Case-level snapshot rather than at the individual Assessment level. This refined methodology provides a more efficient evaluation of reporting rules and ensures a consistent evaluation method across multiple destinations. This enhancement does not require you to change your currently configured rules, allowing you to maintain the continuity of your current workflow and processes.

Japan Domestic Case: Calculate Due Dates for Localized Case AssessmentsConfiguration24R1.2

With this release, users have the flexibility to calculate Due Dates on Localized Case Assessments without leaving the related Japan Domestic Case. The new Calculate Due Dates on Localized Case Assessments action is available on Domestic Cases when the Japan Localization is set to generate Localized Assessments for Case Product Registrations. Previously, the option to calculate Due Dates on Localized Case Assessments was available on Localized Cases only. This feature improves the Domestic Case processing experience.

PMDA E2B(R3): Export Substance Codes from JDrug CodesAuto-on24R1.2

With this release, Vault Safety improves the export of Substance codes to PMDA E2B(R3) reports. When Company Products or External Products have a Japan Product Code Type of J-Drug Code, Vault exports the first seven (7) digits of the Local Product Code or Local MPID Code, respectively, to the G.k.2.3.r.1 Substance / Specified Substance Name data element.

This feature is Auto-on in Vaults with the Japan Drug Dictionary enabled. Although this feature is Auto-on, some components require additional configuration.

PMDA E2B(R3): Prevent Export of Unsupported UCUM CodesAdmin Checkbox24R1.2

With this release, Vault Safety prevents the export of unsupported Unified Code for Units of Measure (UCUM) codes to PMDA E2B(R3) reports. In addition, Vault can automatically replace unsupported UCUM codes in PMDA Submissions. This reduces instances of Submissions being rejected for unsupported codes and eliminates the need to send Cases back to Global for correction.

Adverse Event in Jurisdiction Parameter Country DifferentiationConfiguration24R1.2

With this release, Vault Safety Admins can configure safety reporting rules to use either Primary Reporter Country or Event Country to determine if the Adverse Event occurred within the jurisdiction of a specific Agency. This allows Vault to comply more closely with regulations from global health agencies including the EMA (Europe) and the TGA (Australia).

Reporting Rule Level Control of Auto-Submit for TransmissionsConfiguration24R1.2

With this release, Vault Safety supports the configuration of automatic submissions for Transmissions generated using a specific reporting rule. This feature introduces a new Output Reporting Rule Parameter for the Auto-Submit feature which can be set on a rule-by-rule basis. This could allow, for example, only non-serious cases to be auto-submitted to a specific destination, providing enhanced control for touchless processing. Previously Auto-Submit was controlled at the Transmission Profile level. As a result, when Vault generated a Submission or Distribution to a specific destination, Vault marked that Transmission as Auto-Submit.

Reporting Family Configuration ScenariosConfiguration24R1.2

With this update, Vault Safety Admins can configure Partner Distribution Lists (Reporting Families) to include the following:

All Products stored in the Vault.
All Studies stored in the Vault.
All Products within a designated Product Family.
All Products coded to a specific Product Registration.

Previously, this functionality was limited to specific Products and Studies. This enhancement provides Admins with greater Reporting Family configurability, especially in scenarios where additional Products, Studies, or Product Family members are configured in Production.

Strict Transmission Version EnforcementAdmin Checkbox24R1.2

With this release, Vault Safety can enforce the order in which you are able to send Transmissions via Gateway and Email to all destinations except the PMDA. If set, you cannot submit a Follow-up report if the initial report for the same Case Number is not first completed. This helps ensure that Submissions are not sent out of order which can lead to downstream compliance issues.

Note: PMDA support for this feature will be provided in a future release.

Include Source Document in Email TransmissionConfiguration24R1.2

With this release, Vault Safety provides a configurable option to automatically include source documents as email attachments for distribution. The feature introduces a new Transmission Profile picklist field called Attach Source Document(s). If you have an obligation to share source documents with a certain partner, based on PVA requirements, this feature eliminates the step of manually attaching source documents during the Transmission workflow. Additionally, if you use the Auto-Submit feature, this new configuration option completely automates the process.

PBRER: Include Spontaneous Events Without AssessmentsAuto-on24R1.2

With this release, users can create PBRER reports that include spontaneous events without Case Assessments. Previously, adverse events were gathered for inclusion based on the presence of a case assessment, PBRER reports omitted any adverse event without a Case Assessment record. This enhancement aligns with ICH guidance, recognizing that spontaneous Cases imply causality and thus don’t mandate assessments or assessment results. Additionally, this feature ensures accurate aggregate reports for Cases migrated without Case Assessment records.

DSUR & PBRER: Exclude Cases with Study Products Unrelated to Products in the Reporting FamilyAuto-on24R1.2

With this release, DSUR and PBRER reports only include Cases with Products directly defined in the Reporting Family or linked to a Study defined in the Reporting Family. Previously, when a Reporting Family was set up with a Product (not a Study), DSUR and PBRER reports included Cases from the Studies of the Products in the Reporting Family. This feature streamlines reporting processes and reduces errors, improving safety monitoring and regulatory compliance.

Safety Feature Enablement Updates

Enablement updates apply to the following feature in this release:

Enablement Update: Automated Cross ReportingAuto-on24R1.2

With this release, the Cross Reporting feature is Auto-on. This feature was originally introduced in 22R1 with Configuration-enablement (see Automated Cross Reporting in What’s New in 22R1). Although this feature is Auto-on, some components require additional configuration. This enablement change primarily impacts customers using version 3 of the FDA ICSR Reporting Rule Set.

See the following articles to learn more about this feature:

Enablement: Enable Automated Cross Reporting
User Help: Cross Reporting

SafetyDocs

Order PSMF Logbook by Section/AnnexAdmin Checkbox24R1.2

With this release, Admins can choose to order logbook entries by date of entry or by section/annex. Previously, the logbook was ordered exclusively by date. This enhancement contributes to the usability of the logbook by providing additional flexibility.

PSMF Version Binding ValidationConfiguration24R1.2

Vault SafetyDocs can now specifically verify PSMF Content documents for steady-state binding when approving a PSMF binder prior to PDF generation. Previously, Vault would run steady-state verification for all documents within a binder, including obsolete documents, which should never be included in the generated PDF, and auto-generated documents such as reports, table of contents, and the PSMF Logbook. These would block approval as they may not have a steady-state version available. This enhancement ensures that no draft documents are included in the generated PDF, without considering obsolete or auto-generated documents during approval.

Update PSMF Logbook TemplateAuto-on24R1.2

The PSMF Logbook template has been updated with a wider column for Summary of Changes. This provides a clearer view of the data and a better user experience.

Code Product-Event Combinations to MedDRA QueriesConfiguration24R1.2

In this release, Vault SafetyDocs provides the ability to code Product-Event Combinations to a MedDRA query (SMQ or CMQ) rather than to a single MedDRA term. This enhancement adds more flexibility to Signal Management.

Create Safety Investigations from Product-Event DispositionsConfiguration24R1.2

In this release, Vault SafetyDocs provides a new action to create Safety Investigations directly from Product-Event Dispositions. This helps streamline the process of managing your safety investigations.

Signal Management Disposition and Reporting Period ChangesAuto-on24R1.2

This release introduces several data model changes to better support the Signal Management process:

The reporting period is now available at the Product-Event Disposition level for point-in-time reference whereas Safety Investigations are no longer tied to a reporting period.
You can now prioritize Validated Signals using the standard Safety Investigation Priority picklist.
A new lifecycle state, Monitoring, has been added to the Product-Event Disposition lifecycle.
SafetyDocs now provides several standard Checklist types to reduce the need for custom Checklist types and improve alignment.
For the Validation Outcome picklist, the “Refuted” picklist value label has been updated to “Non-Validated” to align with industry terminology.

Safety Data Model Changes

See 24R2 Safety Data Model Changes.

QualityOne

QMS (QualityOne)

External Collaboration Management on Audit Findings and Action ItemsConfiguration24R1.2

This feature extends External Collaboration Management functionality in QualityOne QMS to the Audit Finding and Action Item objects, enabling users to work with External Collaborators to complete and follow up on Audit Findings and Action Items in Vault. Internal users manage a “contact list” of persons associated with the third-party organizations, tagging Audit Finding and Action Item records with a relevant External Collaborator for Vault to automatically create, activate, or inactivate. When the user account for the External Collaborator is created, activated, or inactivated, the relevant email is sent to those persons as part of the process.

This feature automates the creation, activation, and deactivation of accounts for external collaborators such as suppliers. Users can easily bring in External Collaborators using a license from a “revolving door” pool of external licenses without needing to purchase licenses for each individual external user, and Vault automatically manages user accounts for External Collaborators with little to no need for Admins to manage user account creation, activation, and deactivation.

Previously introduced External Collaboration Management functionality includes the CAR, NCR, Change Control, Audit, and Inspection objects, as well as Document Review & Approval for Document Control users.

QualityOne Data Model Changes

See 24R2 QualityOne Data Model Changes.

RegulatoryOne

The RegulatoryOne 24R1.2 release, including all Platform features, is scheduled for tentative availability on ~~May 14, 2024~~ (postponed) May 21, 2024.

Compliance Management

Packaging Composition ViewerConfiguration24R1.2

This feature allows users to review Packaging Compositions in a hierarchical view, inclusive of related Formulations, enabling regulatory teams to easily determine the weight and percentage of recycled content in packaging for reporting to authorities.

Registration & Dossier Management

Object Mapping Enhancement: Support for Formula & Lookup FieldsAuto-on24R1.2

This feature allows Admins to create Object Mappings for non-editable source fields such as lookups and formula types of fields, supporting more flexibility when mapping fields.

24R2 Registration & Dossier Management EnhancementsAuto-on24R1.2

These enhancements ensure data correctness by validating the following conditions when users create or update records and run actions:

Dossier Binders cannot include binders.
Root dossier Requirements must reference a root Requirement Library.
Requirements must reference either a Registration Item or a Registration Objective.
Each EDL and its child EDL Items must reference the same dossier Requirement.
Users cannot select the Use Source checkbox on dossier Requirements that directly reference an active EDL.

RegulatoryOne Data Model Changes

See 24R2 RegulatoryOne & Veeva Claims Data Model Changes.

Veeva Claims

The Veeva Claims 24R1.2 release, including all Platform features, is scheduled for tentative availability on ~~May 14, 2024~~ (postponed) May 21, 2024.

Veeva Claims

Pack Copy Enhancement: All Elements ViewConfiguration24R1.2

With this release, the All Elements View is available to configure on the Pack Copy object, which gives users a consolidated view of all elements assigned to different panels of a Pack Copy record.

This feature also allows Translators to provide translations for a local Pack Copy by editing the element text field and gives them the ability to add columns of their choice, freeze columns, and click on hyperlinks to view more details of all records displayed in the viewer.

Owner Role for Clone Pack Copy & Localize Pack Copy ActionsAuto-on24R1.2

This Pack Copy enhancement sets the current user as the owner of records generated by the Clone Pack Copy and Localize Pack Copy actions when Dynamic Access Control (DAC) is configured for the Pack Copy object so that the current user can view and edit records created by them through above actions.

Veeva Claims Data Model Changes

See 24R2 RegulatoryOne & Veeva Claims Data Model Changes.