New in 20R1.2: Archived Document Security Enhancements and more

Release Date: May 1, 2020

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

Working with Documents

Archived Document Security Enhancements

This release introduces big changes to the Archived Documents functionality. These changes ensure your documents are not edited in any way once archived.

New permission for viewing archive documents

As of this release, users will need a security profile with the new View Archive permission in order to see archived documents. Like before, users will also need to be in a document role that includes the View Document permission.

Archived documents are not editable

Once documents enter the archive, Vault now prevents users from taking the following actions:

  • Editing fields
  • Adding or removing relationships
  • Adding or removing attachments
  • Adding or removing renditions
  • Deleting the document (without Power Delete permission)
  • Deleting document versions (without Power Delete permission)
  • Checking out
  • Starting a workflow
  • Executing a user action

Note that when Vaults are in document migration mode, Vault allows certain edits.

New user action to move documents in and out of the archive

Users with a security profile that grants the Manage Archive permission can now move documents into and out of the archive from an action in the document Actions menu.

Collaborative Authoring: Alert Box for Documents Being Edited

When a user views a document that is being edited by another user via Collaborative Authoring, Vault displays a message in the document viewer to indicate that what is displayed may not be the latest content. This message is dismissed when the user clicks within the viewer area.

Learn more about Using Collaborative Authoring with Microsoft Office

XML Rendering

This feature provides the ability to generate a viewable rendition for XML files. XML files are rendered in text format and can be reviewed and annotated within Vault.

Indicate When Annotations Hidden by Filters

When a user views a document with annotations that are hidden by Annotate filter settings or by the Hide button on the Info Card, Vault now displays an alert message to the user.

This message includes a count of the currently hidden annotations. This count is limited to 99, and updates whenever annotations are created, hidden, un-hidden or deleted. Learn more about Annotating Documents.

Move Merge Anchors to Create Anchor Tool

The Merge Anchors action now appears when users select the Create Anchor tool. With this change, we have also modified the required permissions. Users must now have:

  • Security Profile permission: Merge Anchors
  • Document Role permission: Annotate
  • Document Role permission: Create Anchors

In previous releases, Merge Anchors appeared when users selected the Link tool. To perform the action, users previously needed a document role that included Edit Relationships permission, but not Create Anchors permission.

Learn more about Merging Document Link Anchors.

Document Migration Mode API Header

This feature introduces a new Document Migration permission. Users with a security profile that grants this permission can include a new document migration mode header in bulk API calls that would normally require enabling Migration Mode for the entire Vault, which can disrupt auto-matching processes such as EDL and Legal Hold.

Learn more about the Document Migration Mode API Header in the Vault Developer Portal release notes.

Vault Objects

Sharing Settings UI Enhancements for Objects

In this release, we’ve streamlined the object Sharing Settings UI.

Role assignments are now displayed in one single table, rather than multiple tables. This table includes an Access column which indicates how the role is assigned, such as custom sharing rules, matching sharing rules, or manual assignment.

In the updated page, users can search for role assignments assigned to a specific user or group. The results include both directly assigned roles and implicit assignments, such as group membership.

LongText Field Enhancements

In this release, we’ve enhanced LongText fields to provide a better Admin and user experience:

  • Vault Admins can now create LongText fields from the Objects > {Object} > Fields > Create Field page.
  • Users can edit LongText fields in a pop-up dialog on the object record details page, which provides them a larger area to edit large content.
  • Users can now export the entire content of LongText fields in an object tab.

Audit Captures Source Record ID in Copy

In past releases, Vault used the same Event Description in the audit trail when users created a new object record or copied an object record. Now, Vault uses separate descriptions for these actions. When users select the Copy Record action, the Event Description in the new record’s audit trail includes the source record’s name. Learn more about copying object records.

Lifecycle & Workflow

Object & Multi-Document Workflows: Invoke Record Action via a System Action Step

This feature enables Admins to configure a System Action workflow step that invokes a Vault Java SDK Record Action as part of an Object Workflow or a Multi-document Workflow. When the workflow reaches the System Action step, Vault executes the custom Record Action logic. Learn more about using Record Actions in a System Action Step.

Auto-Number Envelope Record for Multi-Document Workflow

With this feature, Admins can configure a multi-document workflow where Vault automatically generates a name for the Envelope record. The auto-naming can use any string and a token that generates a unique number, for example, Document Review – [######] would generate names like “Document Review – 000001” and “Document Review – 000002”.

When the workflow initiator starts the workflow, the system-generated envelope name will display in the start dialog as a read-only value.

Multi-Document Workflow: Execute Entry Action & Entry Criteria When Canceling Workflows or Removing Documents

When users cancel a multi-document workflow, Vault moves the content documents to the configured Cancel Workflow State. Your organization can configure this to be either the “state in which the workflow started”, a specific state in the document’s lifecycle, or no state change.

With this enhancement, Vault also executes entry actions and entry criteria for the cancel state. This change will help customers who would like to capture information like workflow cancellation date or reset values that were set during the workflow process.

Enhanced Document Number & ID Search

This feature enhances searching for documents by document number in two ways:

  • Partial document number searches: Searching for the beginning, middle, or end of a document number now gets a match. The search engine will detect document number patterns in a search automatically to find that document with more precision than before. For example, if a user is looking for VV-123-DEF, they can search VV-123-DEF, VV123DEF, VV123, 123DEF, or 123-DEF to find that document.
  • Multiple document numbers in Advanced Search: In Advanced Search, the Document Number field now supports multiple document numbers, making it easier to search for more than one specific document.

Learn more about Enhanced Document Number & ID Search.

Minimum Match Logic: Strict Matching

When searching documents or records with multiple search terms, strict matching will require most search terms to match. Results that only have one matching term will not be considered relevant. This will return a more precise set of search results and often reduce the number of results as the number of search terms increases. This feature is Auto-on but can be turned off with an Admin checkbox in Search Settings.

Learn more about Strict Matching.

Default Search Context

When users log in for the first time or navigate to a tab that is not searchable, such as Home or Dashboards, the search box context defaults to search All Documents. Admins can now specify any document or object tab as the default search.

Learn more about Configuring the Default Search Tab.

With this feature, Vault constrains object reference field values in filter value searches on object tabs. These filters now only return values that are included in a user’s search results.

Reporting

Include Prompts with Filters in Report Builder

This feature adds prompts to the filter section of the report builder. Users can decide whether a filter should be determined at runtime by selecting a checkbox.

Auditing

Individual Audit Filters

In previous releases, individual audit trails only supported filtering by date, while admin audits supported filtering by date, event and user. With this release, users can now apply event and user filters to individual document and object audit trails. This feature allows users to more easily find specific activity of interest within individual audit trails. Learn more about filtering on individual audit trails.

Display Page X of Y & Datetime in PDF Audit Exports

This feature improves audit exports to PDF by including the total page count on each page and adding the audit name as well as the Vault name to each page. Additionally, the date currently provided on each page of a document audit trail export is now a datetime to provide more detail. These changes to PDF audit exports make them more consistent with PDF report exports. Learn more about audit exports.

Administration

Re-establish Vault to Vault Connections

Spark Vault to Vault Connections require two Vaults with configured and approved connections. If one or both of these Vaults are a sandbox Vault and you refresh the sandbox, the connection will break. Prior to 20R1.2, reconnecting a broken connection is only possible by completely reconfiguring the connections from scratch, including all integration-related components such as Integrations, Integration Points, and Integration Rules.

This feature allows you to break the connections by setting one of the connections to Pending using the new Make Connection Pending user action on the connection. From there, you can download a new connection file to reconnect and approve the connection without needing to recreate any interaction-related components.

This feature is available for both custom and standard connections.

VPK Deployment Order Dependency & Validation

This feature introduces a new Validate feature at the Inbound Package level that allows the Admin to determine if an Inbound Package has any dependencies that are blocking the deployment of the package. The Admin will be able to download a validation log that contains all component dependency information, including whether they are required and whether they exist in the package or in the target Vault.

Vault File Manager

Configure Auto-Open Safelist for Vault File Manager

In past releases, when users checked out a document’s file to Vault File Manager, the file opened automatically when the download completed. Now, organizations can configure which file extensions will automatically open when download is complete by adding VFM File Security Policy object records. If there is not an object record for a file extension, instead of the file opening automatically, the Vault File Manager client displays to the user when the file download is complete.

Learn more about Configuring the Auto-Open Safelist for Vault File Manager.

Platform Data Model Changes

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

  • Added the VFM File Security Policy (vfm_file_security_policy__v) object.

Clinical Operations

Payments: Generate Payable Items User Action

In previous releases, Vault only generated payable items when Subject Visits, Procedures, or Site Fees were updated. Vault now allows users to generate payable items for activities performed before a fee schedule was approved. Your organization’s Admins can configure this user action for the Study, Study Country, and Study Site objects or include it in workflows. Learn more about manually generating Payable Items.

Commercial

Standard Metrics: Make Mandatory

This feature is postponed to a future release.

Auto Claims Linking: Display Claims in Document Fields

With this feature, Vault now displays a list of Claim records in the Document Fields panel of the Doc Info page to indicate which Claims have been used to generate Suggested Links and Approved Links on a document. This new field appears on document versions where Suggested Links or Approved Links exist. Each Claim is also a clickable link to the Claim record. A Claim is removed from the list if all Suggested Links and Approved Links created from that Claim have been rejected, removed, or deleted.

This field helps users to better discover relationships between Claims and documents and enables reporting on documents with references created from specific Claim records.

Vault now displays a link to the related Claim record in the Annotation Info card for Suggested Links and Link Annotations created by accepting a Suggested Link. This provides valuable context to reviewers and helps users when troubleshooting results of the Suggest Links action.

Commercial Data Model Changes

Data model changes related to Standard Metrics: Make Mandatory are postponed to a future release.

Quality

E-Learning Technology Standards Support

Many organizations include e-learning content in their training implementations. This format of training content can be dynamic, engaging, and easier for learners to absorb than other formats.

With this Vault Training release, we have introduced support for the e-learning technology standards AICC and SCORM. Content published in AICC or SCORM can be uploaded into a Vault, just like any other document. Once uploaded into the Vault, training admins can associate the content to a Training Requirement as part of a training matrix.

As the Learner, a user can interact with the course while Vault captures course data to facilitate completion of the associated Training Assignment. If the Learner’s interactions with the e-learning material meets the AICC or SCORM completion criteria, the Learner can then complete the Training Assignment.

With this release, Admins can now configure Quality Event records or CAPA Action Item records to automate the creation and processing of Effectiveness Check records upon entering a configurable lifecycle state.

The Create Effectiveness Check record entry action is available for the Quality Event and CAPA Action Item object lifecycles. Configuration options for the action allow you to define the type of Effectiveness Check record to create (if applicable), and which field on the Effectiveness Check record to populate, linking the new record to the triggering process.

To take full advantage of this feature, you can model configurations to fully automate the business process around completing changes or actions within the QMS.

For example, you can configure the following process based on the Require Effectiveness Check field on the Quality Event or CAPA Action Item:

  • Automatically create the Effectiveness Check record.
  • Set the Effectiveness Check record’s fields based on values from the parent-process record, such as setting Effectiveness Check Due Date and Effectiveness Check Start Date based on Action Completed Date + 120/90 days, respectively.
  • Assign an automated workflow task to describe the effectiveness check details. Use Record Event Actions to prompt responsible parties to describe details of the effectiveness check to take place in the future.
  • Using Vault’s jobs framework to automate the start of the effectiveness check workflow for that change or action at the chosen time in the future.

This feature is recommended to be used with Quality Teams feature to guarantee access for the correct users on the automatically created record. It can also be configured to use security features such as Dynamic Access Control’s Matching or Sharing rules. Learn more about configuring the Create Effectiveness Check entry action.

Auto-Close Completed MDCCs

With this feature, customers can configure a new document lifecycle state entry action in their Vault to automatically transition Multi-Document Change Control (MDCC) records to a closed state when all documents in the MDCC have been released or obsolesced. This automation can lower the amount of manual work involved in monitoring and closing MDCC records. Learn more about configuring Multi-Document Change Control.

Synchronize MDCC & Document States

With this feature, when a Multi-Document Change Control (MDCC) moves through its lifecycle, the state of the documents to be released can be synchronized with the state of the MDCC itself. State-based document controls can then be used to ensure the appropriate permissions and controls are in place.

For example, when an MDCC is routed through an approval workflow, if document states do not change until the approval process is complete, it may result in issues like new drafts being created after the documents have been routed for approval. Configuring your Vault to synchronize document states with the MDCC can alleviate this problem, as state-based document controls can prevent actions, such as creating drafts, which could affect the documents while they are in the approval process. Learn more about configuring Multi-Document Change Control.

Risk Management: Detectability Support for Qualitative & Quantitative Risk Matrices

With this release, users of Vault Quality Risk Management features can now model the likelihood of detecting a risk should it be realized, and use that likelihood to calculate both quantitative and qualitative risk levels for risk events. Admins can now opt-in to add Detectability to Risk Matrices.

The new Detectability object and its associated fields behave similarly to Severity and Occurrence. Included with the new object and matrix support, we’ve introduced new standard fields to the Risk Event object to capture Detectability before and after mitigation actions have been taken. Combined, these new components enable automatic updates to Risk Matrix Setup rows in a Risk Matrix, and interacting with Risk Level on Risk Events.

Customers with existing Quality Risk Management configurations will need to make configuration changes to take advantage of Detectability in risk related activities. Depending on your business needs, you can either update existing risk matrices to include Detectability or include it in newly created risk matrices, add the Detectability fields to Risk Event, and update risk level calculations to include Detectability scores for quantitative risk scoring models. Learn more about QMS Risk Management.

Power Delete Action for the Training Assignment Object

During Vault Training configuration and testing you may need to delete a Training Assignment record and all of its related records, such as Class Schedules, Quizzes, and others. By default, you must delete each record individually.

With this release, we have introduced the Power Delete Training Assignment Records record action, which completely deletes a Training Assignment record and its related records. Learn more about Vault Training configuration.

Quality Data Model Changes

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

Added the following data model changes to support the Risk Management: Detectability Support for Qualitative & Quantitative Risk Matrices feature:

  • The Detectability (detectability__v) object has been added as a child object of Risk Matrix (risk_matrix__v) to Quality Vaults, tied to the QMS Application.
  • The Risk Matrix Setup (risk_matrix_setup__v) object now has the Detectability (detectability__v) field for modeling matrices with a detectability axis.
  • The Risk Event object now has additional fields (detectability_before__v and detectability_after__v) for capturing values necessary to calculate an event’s Risk Levels.

These changes will not immediately affect end-users, and must be configured (fields added to types of the described objects and, if applicable, risk level formulas updated to account for detectability scores on risk events, etc.) before they will modify system behavior.

The following data model changes support the Auto-Close Completed MDCCs feature:

Added a new standard field on the Document Change Control object:

  • Closure System Details (closure_system_details__v)

The following data model changes support the Synchronize MDCC & Document States feature:

Added a new standard document lifecycle state type, available when the Use Document Change Control option is enabled:

  • In Change Control Approval State (in_change_control_approval_state__v)

The following data model changes support the E-Learning Standards Support feature:

Added the following new objects:

  • Training Completion Criteria (training_completion_criteria__v)
  • Training Completion Criteria Detail (training_completion_criteria_detail__v)
  • Training Content Status (training_content_status__v)
  • E-Learning Status Details (e_learning_status_detail__v)

Added the following new object lifecycles:

  • Training Completion Criteria Lifecycle (training_completion_criteria_lifecycle__v)
  • Training Completion Criteria Details Lifecycle (training_completion_criteria_details_lc__v)
  • Training Content Status Lifecycle (training_content_status_lifecycle__v)
  • E-Learning Status Details Lifecycle (e_learning_status_detail_lifecycle__v)

Added the new standard field Training Completion Criteria (training_completion_criteria__v) on the Training Content Set-Document object.

Regulatory

Submission Join Filters

Users now have the option to filter which submissions to display in the Submissions Archive Viewer based on the submission’s related records. For example, users can filter to see only the submissions related to one or more clinical studies based on the Submission Clinical Study records.

Admins can enable this feature on the Application Settings page. Note that enabling this feature will deactivate and remove any metadata that was mapped at the time the submission was imported. Learn more about filtering on submission join records and configuring submission join filters.

Submissions Archive Reimport

Users have a new option to reimport a submission dossier that was previously submitted. Users can select the Reimport action to remove the original dossier and import the updated dossier in a single step. Admins must grant users the correct permissions in order to see this action.

This action is only available through the Vault user interface and does not impact submission imports through the API. Learn more about reimporting submissions.

Copy Content Plan with Constraints

With this release, Admins can choose whether or not Vault respects the target application and submission’s Content Plan Template Constraints when users copy a content plan. When configuring the Copy Content Plan system action, Admins can set the Ignore Content Plan Template Constraints checkbox to allow Vault to create a copy of a content plan without applying Content Plan Template Constraints. Admins can leave this checkbox blank to apply constraints to the new content plan.

When the Ignore Content Plan Template Constraints checkbox is set, Vault creates sections in the new content plan if the target submission contains Submission join records that don’t exist in the source submission. Learn more about configuring the Copy Content Plan system action.

Start Multi-Document Workflow from the Content Plan Hierarchy Viewer

Users can now start a multi-document workflow from the new Content Plan Hierarchy Viewer introduced in 20R1 to send matched documents for review or approval in bulk. In the Content Plan Hierarchy Viewer, users can drill down into a section and apply filters to more specifically target which documents to include in the workflow. Learn more about starting multi-document workflows from the Content Plan Hierarchy Viewer.

The Start Multi-document Workflow action is automatically available on Vaults with the 20R1 Content Plan Hierarchy Viewer enabled. Users can only see the action in Vaults that have at least one active multi-document workflow configured and that have at least one Content Plan Item record or matched document available in the Content Plan Hierarchy Viewer. Contact Veeva Support to enable the Content Plan Hierarchy Viewer in your Vault.

Thailand eCTD DTD 1.0 Publishing & Validation

This feature is postponed to a future release.

GCC eCTD DTD 1.1 Publishing & Validation

With this release, RIM Submissions Publishing Vaults support the GCC v1.5 (DTD 1.1) specification. Users can now create content plans and generate submissions that are compliant with GCC v1.5 specifications. Vault validates these submissions based on the corresponding GCC v1.4 Validation Criteria. Learn more about working with GCC regulatory submissions.

Archived Document Security in RIM Submissions

We made several enhancements to existing features to account for archived documents and binders:

  • When a binder that was created from a content plan is archived, Vault prevents the user from up-versioning the archived binder and sends the user a Vault notification.
  • When a Submission Ready binder that was created as part of report level content plan publishing is archived, Vault prevents the user from up-versioning the archived binder and sends the user a Vault notification.
  • If a Content Plan Item Template references an archived document and a user tries to create a document or Table of Contents from the template for a Content Plan Item record, Vault prevents document creation and sends the user a Vault notification.

Copy Content Plan Update

In past releases, when users copied a content plan, Vault incorrectly applied source Content Plan Template Constraints to the target content plan. With this release, we’ve corrected the behavior. Now, Vault does not apply the source content plan’s Content Plan Template Constraints and when copying a content plan.

Enhancements to Manage Registered Details

This feature includes several enhancements to the user interface and navigation in the Manage Registered Details wizard. Navigating within the wizard is clearer, because users no longer see steps that they cannot take based upon the Regulatory Objective record from which the wizard started. When updating existing details, users now see details grouped by Registration in addition to Country. When adding new details, we’ve increased the size of the Add: Registered Details dialog. Learn more about managing registered details.

QMS to Registrations Spark Connection: Configurable Event Object Types

With this feature, customers can now configure the QMS to Registrations Spark connection to create regulatory Event records of different object types. This change better supports change controls for commercial products versus investigational products and the downstream processes for each change control. Learn more about configuring the QMS to Registrations Spark connection.

Brexit: Remove UK from Centralised Countries for Create Registrations

With this feature, Vault no longer defaults the United Kingdom in the list of EU countries for Centralised Procedures in the Create Registrations wizard. This change aligns with Brexit. If needed, users can still add the UK to the scope manually.

20R2 Regulatory Data Model Changes

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

Added the following components to support the Submission Join Filters feature:

  • Added the Application (application__v) field to the following objects:
    • Submission Active Substance (submission_active_substance__rim)
    • Submission Clinical Study (submission_clinical_study__rim)
    • Submission Country (submission_country__rim)
    • Submission Inactive Ingredient (submission_inactive_ingredient__rim)
    • Submission Indication (submission_indication__rim)
    • Submission Language (submission_language__rim)
    • Submission Nonclinical Study (submission_nonclinical_study__rim)
    • Submission Packaging (submission_packaging__rim)
    • Submission Pharmaceutical Product (submission_pharmaceutical_product__rim)
    • Submission Product Classification (submission_product_classification__v)
    • Submission Regulatory Objective (submission_regulatory_objective__v)

Added the following components to support the GCC v1.5 (DTD 1.1) eCTD feature:

  • Added the Related Application (related_application__v) object

In addition to the changes supporting new features, we added the following components:

  • Added a new field to the Product (drug_product__v) object to indicate the markets where the product is registered. This field can be leveraged for reporting when one market wishes to see data related to all registrations globally after it is approved in a key market, such as the EU.
  • Added a new object, Unverified Registration Data (unverified_registration_data__v), in order to support the Registration Verification workflow feature that will be delivered in a future release. This object is added to all RIM application Vaults but is only unlocked in Registrations Vaults.
  • Added the Regulatory Objective (regulatory_objective__v) field to the following objects to support additional Manage Registered Details enhancements in a future release:
    • Registered Product Classification (registered_product_classification__v)
    • Registered Product Characteristic (registered_product_characteristic__v)
    • Registered Packaging Characteristic (registered_packaging_characteristic__v)

Safety

Safety features are targeted for tentative availability on May 12, 2020.

Manual Case Lock Configuration

Individual users can now lock Cases and their related records, including Case Adverse Events, Products, Medical History, and Assessments, to prevent other users from editing them.

The user who locks the Case can edit the Case normally, but all other users will be prevented from saving changes to the Case. Using role-based atomic security, if necessary, administrators can grant certain users permission to unlock the Case or reassign which user the Case is locked to.

Learn More: Lock and Unlock a Case

Health Canada E2B R2 Export Auto-on

Vault Safety now supports the ability to export ICSRs in the Health Canada compliant E2B(R2) .xml format.

Learn More: E2B Generation Data Mapping

PSUR Cumulative Tabulations and CIOMS II Line Listings Configuration

Vault Safety now supports generating Periodic Safety Update Reports (PSURs) cumulative tabulations along with CIOMS II line listings. Reports can be generated based on drugs, studies, and/or active substances.

Learn More:

MedDRA Browser Hierarchy Tree View Auto-on

The MedDRA Browser now offers a tree view to help users navigate and find MedDRA terms. The MedDRA Browser also has incorporated a number of usability enhancements for resizing and selection.

Learn More: Code MedDRA Terms: Browse for a MedDRA Term

WHODrug Version Selector Configuration

While selecting the active WHODrug dictionary, administrators can now see when the list of releases in their vault is out of sync and fetch the latest WHODrug versions.

Learn More: Manage the WHODrug Dictionary

Optimized Submissions: Local Datasheets & Primary Expectedness Auto-on

This release introduces improvements to the auto-expectedness feature. First, the system now syncs the Case-level expectedness from the primary Case Assessment.

Second, when creating submissions to health authorities, the system evaluates expectedness using pre-configured country-specific product datasheets. This enhancement facilitates more precise reporting, ensuring that submissions for a serious adverse event are generated with the correct due dates, based on their country-specific expectedness.

Learn More:

E2B R2 Product Import Converter and Enhancements Auto-on

During FDA E2B(R2) generation, Vault Safety now exports non-standard frequency measurements (cyclical, as necessary, and total) to the dosage text field (B.4.k.6) and leaves the frequency value and unit blank (B.4.k.5.4 / B.4.k.5.5) to ensure a compliant FDA E2B(R2) file is generated. The system sends a notification when it maps non-standard frequency values this way during an FDA E2B (R2) export.

Learn More: E2B Generation Data Mapping

API Name for Transmission Profiles Auto-on

API Names have been added to the Transmission Profile object. In addition, standard system-generated Transmission Profile records, such as CBER and EVHUMAN, are protected with an __v API Name, preventing their deletion.

Vault Safety System Updates for Case Promotion

The following system updates will be visible to administrators:

  • The Promoting state in the Case lifecycle
  • The Promotion Transmission object record type
  • The External Safety System Transmission Profile and Gateway Profile

RegulatoryOne

Raw Materials

This update provides the objects to support raw materials for RegulatoryOne so that users can include raw material information in submissions. Users can define a list of Raw Materials, their manufacturers, their ingredients, and the formulas that use the raw materials. Users can also associate documents to a Raw Material after an Admin creates the appropriate document type. Learn more about raw materials.

Add Submission Content Plan Token for Raw Materials

This feature adds support for a new Raw Material token that users can reference in a Content Plan Template. The new token generates Content Plan sections for each Submission Raw Material Variant record, improving efficiency for RegulatoryOne users. Learn more about the raw materials token.

Veeva Claims

Reusable Statement Library

This enhancement introduces the ability for companies to create a library of unique statements that users can utilize to create claims. This library enables the reuse of existing unique statements and improves efficiency while creating claim records. Learn more about statements.

Note that Veeva Claims features are targeted for tentative availability on May 12.

Automated Generation of Claims & Local Adaptations from Projects

This enhancement provides an easy and efficient way for users to create claims and their local adaptations in a project. From a project, users can select multiple statements and products, and then initiate a user action to generate claim records. Users can apply scope restrictions on the statements in order to create claims only for specific product classifications (such as brand, sub brand, product). Similarly, users can also create local adaptations of those claims in a project. Learn more about configuring the automated generation of claims and local adaptations from projects.

Note that Veeva Claims features are targeted for tentative availability on May 12.

Enablement Details

Name Enablement Application
Working with Documents    
Archived Document Security Enhancements Auto-on1 Platform
Collaborative Authoring: Alert Box for Documents Being Edited Auto-on2 Platform
XML Rendering Auto-on Platform
Indicate When Annotations Hidden by Filters Auto-on Platform
Move Merge Anchors to Create Anchor Tool Auto-on Platform
Document Migration Mode API Header Auto-on Platform
Vault Objects    
Sharing Settings UI Enhancements for Objects Auto-on Platform
LongText Field Enhancements Auto-on Platform
Audit Captures Source Record ID in Copy Auto-on Platform
Lifecycle & Workflow    
Object & Multi-Document Workflows: Invoke Record Action via a System Action Step Configuration Platform
Auto-Number Envelope Record for Multi-Document Workflow Support Platform
Multi-Document Workflow: Execute Entry Action & Entry Criteria When Canceling Workflows or Removing Documents Auto-on Platform
Search    
Enhanced Document Number & ID Search Auto-on Platform
Minimum Match Logic: Strict Matching Auto-on Platform
Default Search Context Configuration Platform
Constrain Object Reference Search Auto-on Platform
Reporting    
Include Prompts with Filters in Report Builder Auto-on Platform
Auditing    
Individual Audit Filters Auto-on Platform
Display Page X of Y & Datetime in PDF Audit Exports Auto-on Platform
Administration    
Re-establish Vault to Vault Connection Auto-on Platform
VPK Deployment Order Dependency & Validation Auto-on Platform
Vault File Manager    
Configure Auto-Open Safelist for Vault File Manager Auto-on Platform
Platform Data Model Changes    
Platform Data Model Changes Auto-on Platform
Clinical Operations    
Payments: Generate Payable Items User Action Configuration Vault Payments
Commercial    
Standard Metrics: Make Mandatory Auto-on PromoMats
Auto Claims Linking: Display Claims in Document Fields Auto-on PromoMats
Auto Claims Linking: Link to Claim from Link Annotation Info Card Auto-on PromoMats
Commercial Data Model Changes Auto-on MedComms, PromoMats
Quality    
E-Learning Technology Standards Support Support Training
Create Related Records: Effectiveness Checks Configuration QMS
Auto-Close Completed MDCCs Configuration QualityDocs
Synchronize MDCC & Document States Configuration QualityDocs
Risk Management: Detectability Support for Qualitative & Quantitative Risk Matrices Configuration QMS
Power Delete Action for the Training Assignment Object Configuration Training
Quality Data Model Changes Auto-on QMS, QualityDocs, Station Manager, Training
Regulatory    
Submission Join Filters Admin Checkbox RIM Submissions Archive
Submissions Archive Reimport Configuration RIM Submissions Archive
Copy Content Plan with Constraints Configuration RIM Submissions
Start Multi-Document Workflow from the Content Plan Hierarchy Viewer Auto-on3 RIM Submissions
Thailand eCTD DTD 1.0 Publishing & Validation Configuration RIM Publishing
GCC eCTD DTD 1.1 Publishing & Validation Configuration RIM Publishing
Archived Document Security in RIM Submissions Auto-on RIM Submissions
Copy Content Plan Update Auto-on RIM Submissions
Enhancements to Manage Registered Details Auto-on RIM Registrations
QMS to Registrations Spark Connection: Configurable Event Object Types Configuration RIM Registrations
Brexit: Remove UK from Centralised Countries for Create Registrations Auto-on RIM Registrations
20R2 Regulatory Data Model Changes Auto-on RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive
RegulatoryOne    
Raw Materials Configuration RegulatoryOne
Add Submission Content Plan Token for Raw Materials Configuration RegulatoryOne
Veeva Claims    
Reusable Statement Library Configuration Veeva Claims
Automated Generation of Claims & Local Adaptations from Projects Configuration Veeva Claims
  1. In Vaults with Document Archiving enabled
  2. In Vaults with Collaborative Authoring enabled
  3. In Vaults with the Content Plan Hierarchy Viewer enabled and an active multi-document workflow configured

See the following explanations for enablement options:

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