We are pleased to bring you Vault 19R2. Read about the new features below. You can find information on enabling new features in the 19R2 Release Impact Assessment.
Lifecycles & Workflows
Lifecycle Stages
When moving a document or object record through a lifecycle, it can be hard to understand which steps are completed and which steps still remain. This significant platform feature allows Admins to group document and object lifecycle states into ordered collections of stages. Vault then visually represents a document or object record’s current stage in the Doc Info page and object record detail page, including color coding to represent whether a stage is completed (green), in progress (blue), or upcoming (grey).
Admins can configure up to ten (10) stages per document or object lifecycle. Learn more about Lifecycle Stages.
Multi-Document Workflow: Enhanced Support for Document Fields
Multi-Document Workflows enable users to send multiple documents on a single workflow instance and allows task owners to provide verdicts for each document. With this enhancement, Admins can configure workflows that:
- Update document shared fields in a Content Action step. This enables workflows to set document fields, for example, Effective Date fields.
- Use document fields in conditions in a Content Action step. This enables workflows to perform actions on a document only if the condition is true.
Multi-Document Workflow: Support Specific Lifecycle Configuration
Multi-Document Workflow (MDW) configurations support documents across lifecycles. This means that documents with different lifecycles can use the same workflow. Cross-lifecycle configurations help organizations by allowing them to maintain fewer workflows. Unfortunately, these configurations also limit access to lifecycle-specific elements. For example, a cross-lifecycle workflow could not fill document fields that are not shared by all document types.
Now, Admins can choose to create a MDW workflow that is only available for a specific lifecycle. In these workflows, Admins can use a broader set of document fields to configure workflow update values or to prompt users for field values. Fields from all document types associated with the lifecycle are available. State change actions within these workflows can also use lifecycle states, rather than state types. Learn more about configuring multi-document workflows.
Multi-Document Workflow: Prompt for Fields on Start Step & Task Step
Multi-Document Workflows now support new ways to fill document fields. These workflows can prompt the workflow initiator or task owner for field values. For example, an approval workflow prompts the workflow initiator for a Planned Publication Date. This date would populate on all documents included in the workflow.
This feature works with cross-lifecycle workflows as well as single-lifecycle workflows. (See Multi-Document Workflow: Support Specific Lifecycle Configuration.) With cross-lifecycle workflows, only fields associated with Base Document are available.
Learn more about configuring multi-document workflows.
Multi-Document Workflow: Enhanced Document Timeline View & Audit
This release introduces two enhancements to bring parity between multi* and single-document workflows:
- Document Timeline View displays workflow and task instance details for multi-document workflows. Users can cancel tasks from this view.
- The document audit trail captures all workflow and task events for multi-document workflows. In previous releases, only the object record audit trail captured these events.
Object Lifecycle State Entry Criteria Based on State Type of Related Documents
In this release, users can add entry criteria logic to object record lifecycle states which allows a record’s progression to be directly linked to the statuses of related documents. Configurations will allow records to check if all, any, or at least one of the documents related to a record through a configured relationship are in a specific state type. Additionally, users can add criteria to ensure that at least one document has been related to the record, regardless of the document’s state. This functionality was previously available only in Quality and Quality One but is now available in all applications.
These options allow for configurations such as “Don’t allow a Product lifecycle to be routed for approval until all Product Documents are in the Steady state of their lifecycles,” and “Don’t allow a Batch Approval lifecycle to Complete if any Batch Number documents are in the Rejected state.”
Both document reference field relationships from an object to a document, and object reference field relationships from documents to objects are supported. All lifecycle state types are supported. Learn more about configuring entry criteria for state types of related documents.
Available Tasks Visibility
In past releases, the Home > Available Tasks view only displayed when there were workflows configured that included available tasks. In order to improve performance of the Home page, available tasks will now always be visible in the Home tab.
Document State Type: Deleted
The Deleted state type is not tied to any special behavior in the current release but will be used in future features.
State type definitions allow Admins to map states from specific document lifecycles to a higher level “type”. We’ve introduced a new Deleted state type, which is now available in all vaults. In practice, the Deleted state type will be useful for configurations that use “soft deletion”. In this configuration, a “deleted” document would move into a state where it’s only accessible to Vault Owners. Learn more about document state types.
Vault Objects
Dependent Picklists for Objects
Dependent Picklists for Objects allows Admins to create a dependency between two object picklist fields. Admins can choose to show a subset of values in the dependent picklist based on the value in the controlling picklist. For example, Country values could be controlled by the Language picklist: if a user selects Japanese as the object record’s language, only Japan would appear in the Country picklist. Users must select an option from the controlling picklist before the dependent picklist is editable.
There can be multiple picklists dependent on the same controlling picklist, but Vault only allows one controlling picklist per dependent picklist. Learn more about Dependent Picklists for Objects.
Configurable Tab Filters
When creating custom document and object tabs, Admins can now filter the tab to show a narrower set of documents or records. For example, a document tab could show only documents in the Approved or Effective states to prevent users from taking action on a non- Steady state document. Learn more about configuring custom tabs.
This feature works in combination with existing search and filtering functionality. Within a tab with Admin-defined filters, users can further refine the document or object record list.
Filtering on Related Object Sections
When configuring page layouts, Admins can now filter related object sections using a full set of filter criteria. In past releases, the only filter available was Object Type. With this enhancement, Admins can better configure page layouts to only show relevant related records.
For example, a related record section could show only records in the Active state, filtering out Inactive records. Admins could also create separate related record sections based on the related record lifecycle state. For example, Approved state records would show in a separate section from New and In Approval records.
Vault will convert any existing object type filters to filters under the Filter Related List section. Learn more about Filtering on Related Object Sections.
Secure Object Record Attachments
The Secure Object Record Attachments feature allows Admins to exercise precise control over user access to attachments. It introduces new object actions that Admins can secure through permission sets or Atomic Security settings. These settings control access to attachments for each object record, Application Role, and object lifecycle state. For example, an Admin could prevent users in the Editor role from uploading or deleting attachments once the object record reaches the Approved state.
Admins can control the following actions using object action security:
- Viewing and downloading attachments
- Uploading new attachments or new versions
- Editing attachment descriptions
- Deleting attachments
Vault secures all attachments on a specific record as a whole. Vault cannot secure attachments individually. Learn more about Secure Object Record Attachments.
Create Records in Pop-up Dialog
Admins can configure Vault to allow the creation of object records in a pop-up dialog when creating them from custom tabs and related object sections. This allows for faster record creation and the ability to create related object records while viewing parent record data.
Apart from these options, users will now stay on the related record page after Vault creates the record if those records were created in a new page. This allows users to immediately edit metadata once they create a related record.
Admins can enable the Create records in pop-up dialog option when configuring a custom tab and the Create record in pop-up dialog option when configuring a related object section. When disabled, record creation will function as it does today, with records created in a new page. Both options are disabled by default. Learn more about Creating Records in the Pop-Up Dialog.
Hierarchy Viewer Usability Enhancements
This feature provides several enhancements to the Hierarchy Viewer. The Hierarchy Viewer is available for the XML Element object (used in Form Generation), EDL objects, and Product Report objects.
With these enhancements, users have more room to work in the grid view:
- When users select an object from the All Objects drop-down, Vault filters the grid view to only display columns related to that object.
- Users can collapse the hierarchy view panel to display the grid across the full screen.
Update Record Field & Update Related Record Field Support New Fields
Vault Object Lifecycle and Workflows offer two actions for updating object record fields systematically: Update Record Field and Update Related Record Field. These actions are available within both object workflows and as lifecycle state entry actions. In past releases, Admins could only access fields on the object they were configuring. This release allows Admins to leverage field values on related objects as well. For example, the Scheduled End Date on an audit record could be calculated based on the Closure Due Date on the related Deviation record.
Reporting
Multi-Pass Reporting
Multi-Pass Reporting allows users to build powerful new reports that span further into a data model by joining data from multiple reports.
Admins construct Multi-Pass reports by first creating Admin-only reports called Report Views. These are based on existing report types. Admins then create a Multi-Pass report type by joining Report Views on matching object fields or object reference fields. Vault joins report data by including every row from the Report View on the left side of the relationship and only rows that match the defined object field or object reference field from the Report View on the right side of the relationship. Once the Multi-Pass report type exists in a vault, users may build Multi-Pass reports just like existing reports.
For example, a RIM Admin may define several Report Views that are based on the Registration with Regulatory Objective, Regulatory Objective with Submission, and Content Item with Document report types. The RIM Admin would then create a Multi-Pass report type that joins each Report View on a matching object field or object reference field. Users with appropriate permissions can then build reports using the Multi-Pass report type. Learn more about Multi-Pass Reporting.
Document with Created By User Report Type
This feature provisions the report type Document with Created By User. This new report type allows users to create reports that include both document information and the information of the creating user. Admins can enable this report type from Admin > Configuration > Report Types. Learn more about Report Types.
Report UI Changes
This panel displays:
- Report Type
- Flash report schedule and associated user
- Whether the report includes previous versions
- Whether the report is Multi-Pass
Searching & Filtering
Sticky Filters for Advanced Search
Advanced searches now preserve any previously applied filters so users can easily combine advanced and standard search criteria. This allows users to add or modify advanced search options without needing to reapply filters from their search or saved view.
Now that all filters will remain applied when running an advanced search, any duplicate filters have been removed from the advanced search dialog. For example, the “File Format” filter is no longer displayed in the advanced search dialog because users can now apply that same filter in the standard search prior to opening the advanced search dialog. Learn more about searching in vault.
Working With Documents
Merge Fields for Excel
Merge Fields for Microsoft Excel allows Vault to find tokens within an XLSX source file and replace them with values from Vault document fields. Field merging enables template creation by auto-filling details like Product Name, Document Status, and Version Date.
When Vault replaces tokens with field values, the system saves the updated version as the source file. If a user downloads the source file, they see the Vault field values rather than the tokens. For backup purposes, Vault stores the original uploaded source file without any modifications. Learn more about merge fields for MS Word and MS Excel.
Pop Out Viewer for Document Hovercards
When viewing search results in the library, documents in reports, or object records, you can now click a pop-out icon in the document hovercard to open the document in a new mini-browser window. This can help keep your place when navigating in Vault, and allows you to quickly view a document without being taken away from the current page. When you click another document hovercard pop-out icon, the current mini-browser window refreshes to display the new document. Learn more about document hovercards.
Rendition Profiles: Event Action
This feature introduces an automatic approach to Rendition Profile selection using event actions. Event actions are configurable actions that take place automatically when a user creates a document from a file upload, creates a new draft of an existing document or creates a copy of an existing document.
A new event action, Set Rendition Profile, is available for document lifecycles. With this action, Admins can configure Vault to apply a chosen rendition profile automatically. Admins can also define conditions for the event action. For example Vault could select the EU rendition profile for documents where the Locale field is set to EU. Learn more about Rendition Profiles.
Binder Auto-Filing Limit
Binder auto-filing is flexible functionality for easy reuse of key documents. In order to preserve performance for vaults using binder auto-filing, we’ve introduced a limit: auto-filing rules cannot add more than 15,000 documents to a single binder.
Note that this limit does not apply to Clinical Operations vaults.
Vault File Manager
Auto Open File when Checking Out to Vault File Manager
A new, streamlined document checkout experience is now available using Vault File Manager. When a user checks out a single document, the file will start downloading to Vault File Manager in the background and automatically open upon completion in the designated desktop application. Note that this behavior only applies to single document checkout, and users must already be logged in to the Vault File Manager desktop application. Learn more about Vault File Manager.
Check In from Vault File Manager via Document Actions Menu
In addition to streamlining Vault File Manager checkout, we have also simplified the check in process. If a document is checked out to Vault File Manager, users can now click Check In directly from the document action menu in Vault to automatically begin checking in the document from the Vault File Manager desktop application. Learn more about Vault File Manager.
Undo Checkout from Vault File Manager
If a user has checked out a document to Vault File Manager, but decided not to work on that document, they can right click the file in Vault File Manager and select Undo Checkout. This action simultaneously removes the file from Vault File Manager and performs the Undo Checkout action on that document in Vault. Learn more about Vault File Manager.
Vault File Manager OAuth Enhancements
Customers can now use Microsoft Azure AD to authenticate in Vault File Manager. In addition, this release adds Custom URI support to the ‘PingFederate’ and ‘Other’ Authorization Server Provider options. Learn more about Vault File Manager authentication.
Formulas
Weekday Function & DateValue Enhancement
This feature adds support for the Weekday() function in Vault formulas and allows the DateValue() function to accept an optional time zone parameter.
- Weekday() function: Takes either a Date or DateTime field and returns the day of the week as a number. The number 1 represents Sunday and 7 represents Saturday.
- DateValue() function: By passing a time zone parameter to this function, users are able to decide whether the returned date should be based on the user’s local time zone or a different time zone, instead of always defaulting to Vault Time Zone.
Learn more in the Vault Formula Reference Guide.
Audit Logs
Audit Trail Field-Level Security Enhancement
Currently, if an object has a field that is hidden by field level security, all users that cannot see this field are prevented from seeing the record audit trails for that object. This feature allows users to see the unhidden fields in the audit trail. This feature also filters out hidden fields on related objects. Learn more about audit trails.
This feature has no effect on document audit trails.
Add Event Description to Audit Exports
This feature adds the Event Description field to all exports of the audit trail. The Event Description field provides a human-readable description of the audit event and is currently only available in the UI. Learn more about audit exports.
Administration
Object Field Encryption
Object Field Encryption allows additional encryption of highly secure fields such as Protected Health Information (PHI). Admins can mark a new field as encrypted with a flag on the object field. All Vault data today is stored on encrypted disks. This feature allows an additional layer of encryption by also encrypting field values in our database. Learn more about Object Field Encryption.
Scalable FTP
This release introduces an upgraded Vault FTP infrastructure. We’ve made this infrastructure more robust, scalable, and future-proof by taking greater advantage of AWS. This feature includes the following updates:
- Improvement for the complete migration lifecycle that generally includes moving and testing document creation across development, validation, and production environments
- Improved visibility when the documents are ready for consumption
- Shortens the time it takes for documents to become usable in Vault after uploading files
Learn more about Scalable FTP on the Developer Portal.
Management of Signing Certificates for SAML & Spark
Veeva normally rolls the signing certificates for SAML and Spark every two years. This feature will allow Vault Admins to test the new signing certificate during the rollover period. The rollover period is the time between when the new certificate becomes available and the old certificate expires.
Asynchronous Checksum & Media Type Calculation
With this feature, the process of calculating the checksum will become asynchronous. When the bulk document creation API is called on the files uploaded through the FTP server, Vault will no longer update the Checksum field immediately. Instead, Vault temporarily sets the value to “pending”. While this is the case, querying the checksum through the API or reading it in document or binder exports will show the “pending” value.
Further, the process that determines the media (MIME) type of uploaded files is changing. The final calculation and confirmation of the media type will also become an asynchronous process. Vault will now use a “best effort” approach when users call the bulk document creation API. This means documents uploaded through the bulk document creation API may temporarily show incorrect media types as they finish processing asynchronously.
These changes will create significant performance increases for bulk creation of documents. This feature does not affect duplicate content detection, except for rare cases where a duplicate document is uploaded through the UI and API simultaneously.
Dataset Configuration Migration Enhancements
Previously, Dataset for Configuration Migration only supported a specific list of unique fields for object reference lookup. With this release, we’ve enhanced the feature to allow the specification of any non system managed unique fields to be used as object reference lookup. In addition, users can now include update and delete operations for Dataset Configuration Migration Packages.
Document Workflow Step Details in Vault Compare & Vault Configuration Report
In this release, the Vault Compare and Vault Configuration Report functionality will include step details for document workflow steps.
Vault Compare Enhancements
In this release, we’ve enhanced Vault Compare to support the following settings and configurations for comparison:
- Document & Binder Templates
- Default Rule & Override Rules
- Vault Settings
In addition, we’ve improved the readability of lifecycle state entry criteria, entry action, and user action for both Documents and Object Lifecycles.
Application Owner User
Similar to the System user, Vault applications employ the Application Owner user to run processes for the application. Vault does not include this user in license counts.
Show Family Name in Domain Information
Domain Admins can see details about the current vault’s domain from Admin > Settings > Domain Information, including a list of vaults on the domain and which application family they use. In past releases, PromoMats and MedComms vaults showed the application name, rather than the application family name. These vaults will now show Commercial (for PromoMats) and Medical (for MedComms).
Vault Java SDK
Vault Java SDK: Record Action on Object Lifecycle
Admins can now configure record actions to execute as object lifecycle user actions or event actions. This enables customers to extend their vaults with custom behaviors available to users on all or specific lifecycle states.
Vault Java SDK: Record Workflow Actions
Customers can now extend object workflows with custom behaviors. In this release, Admins can select custom actions created through the Vault Java SDK on the workflow Start step within a Participants control. This enables implementation of custom logic for determining the participants for a workflow, for example, selecting approvers from related documents to participate in an approval task on a change control record. Admins can also select custom actions on the workflow Task step. This enables implementation of custom logic which executes on task events, for example, when tasks are created, accepted, completed, reassigned, or cancelled.
Platform Data Model
See 19R2 Data Model Changes: Platform for details.
Clinical Operations
New TMF Viewer
We’ve overhauled the TMF Viewer to simplify document navigation. Built to replace the existing TMF Viewer, the new viewer has an intuitive hierarchy that can consist of mapped document types, subtypes, and classifications displayed next to an interactive document list. Users can filter documents from the column headers to find relevant documents within a TMF. This viewer also makes prior versions of documents accessible within the document list, reducing the effort needed to locate old documents. Learn more about the TMF Viewer.
Veeva Clinical Network for CRO to Sponsor Transfer
The Veeva Clinical Network is a new feature for Clinical Operations vaults that allows the seamless exchange of documents and records, enhancing the speed and accuracy of sharing data between cooperating vaults.
Vault copies documents and records to a cooperating vault per a defined set of business rules. These business rules define when the data exchange occurs and from which vault data is extracted.
For example, the Veeva Clinical Network can support the transfer of eTMFs from a CRO vault to a sponsor vault. With Veeva Clinical Network enabled and an Agreement active in both cooperating vaults, Vault will transfer all TMF Reference Model 3.0 documents, Study, Study Country, and Study Site records from the CRO vault to the sponsor vault for a study defined on the Agreement record.
Learn more about the Veeva Clinical Network.
Subject Recruitment Planning
This feature allows CTMS customers to plan the number of subjects to screen, enroll, or randomize into a study on a month-to-month basis. It includes the ability to provide a start and end date for each Study, Study Country, and Study Site, and a total number for each Metric. Users can run an action to take this information and create Metrics Over Time records that capture the number of Planned and Actual subjects per month. Information at the Study Country and Study Site levels rolls up to the Study and Study Country levels to allow for a more accurate plan of subject recruitment. Learn more about Subject Recruitment Planning.
Proactive Subject Visit Seeding
In 18R3, we delivered a feature that populated a Monitoring Event record with Subject Visits records based on that subject visit’s SDV Complete Date. With this feature, we are extending this ability to allow the seeding of subject visits that do not have an SDV Complete Date, but do have a Visit Complete Date. This will allow CRAs to know which subject visits they should focus on verifying during their monitoring event. Learn more about Seeding Monitored Subject Data.
Automatically Seed Metrics
This feature allows a customer to configure an entry action that runs when a Study, Study Country, or Study Site record reaches a particular lifecycle state. This action creates the appropriate metric records for that study, country, or site with values of 0 for each field. Learn more about Automatically Seeding Metrics.
Seeding Follow-Up Items on Monitoring Events
This feature allows customers to seed open follow-up items and follow-up items closed since the last Monitoring Event within the current Monitoring Event. Seeding this information instead of querying for it allows customers to pull these lists into confirmation and follow-up letters. Additionally, it allows customers to control which follow-up items end up in those sections by allowing them to add additional items or remove unwanted items. Learn more about Seeding Follow-up Items.
Monitoring Event Object Compliance
In support of the Monitoring Reviewer Comments feature, we are adding the ability for customers to control Monitoring Compliance with a field on the Monitoring Event. This will allow customers to complete the entire process of creation, confirmation, execution, review, approval, and eSignature of their Monitoring Event within the Monitoring Event itself. They can then create a document after eSignature to act as a documented version of the Monitoring Event in their eTMF. Learn more about Monitoring Compliance.
Configurable Metric Usage
This feature allows customers to choose specific metrics, such as Total Randomized, on a study-by-study basis to ignore throughout the system. This would include the creation of the metrics, the creation of matching Monitored Metrics, and the manifestation of those metrics on the CTMS Homepages in the Enrollment Status Graph. Learn more about Configuring Metrics.
Clinical Version-Aware EDLs
This enhancement allows users to define what document version needs to be collected on an Expected Document record, providing clarity on the version missing, as well as an accurate view of milestone completeness. Users can also define when Vault should create a new Expected Document record for the next version needed. Vault will automatically associate the newly created Expected Document records with open Milestones, informing users that a new document version is now available. Learn more about Milestone Administration.
Clinical EDL Template Refactor
This release introduces an alternate configuration to support template-based linking of milestones with expected documents:
- Once enabled, an Admin can select both a template milestone master set and an EDL template for a given study. Vault creates milestones based on the master set and creates expected documents based on the selected EDL template. Those new expected documents are then linked to appropriate milestones.
- Within an EDL template, Admins can assign one or more milestone types to each template expected document.
- Once Vault creates milestones from a template, it then creates expected documents whose templates have the same milestone type value as the newly created milestones. Those new expected documents link automatically to the newly created milestones.
Custom Monitoring Event Milestone Automation
This feature allows customers to create custom types of Monitoring Events and a matching custom Milestone Type. With these two matching items, Vault will automatically create a Milestone for Monitoring Events of that custom type. Learn more about Custom Monitoring Event Types.
Incorporation of Clinical User Tasks into Existing Milestone Features
We have extended several milestone-related features to include clinical user tasks in their capabilities. Clinical user tasks are now considered when using Milestone Gating, Milestone Autocompletion, and the Milestone Hover Card. This includes Milestone Hover Card calculations and the calculation of the overall completeness of a given milestone based on completion of required activities. Learn more about Working with Milestones.
Disable Send as Link for Restricted Documents
In previous versions, enabling Send as Link made the action available for all documents. eTMF customers need to use this action for unrestricted (Blinded) documents without the risk of sharing restricted (Unblinded) content with unintended parties.
This feature introduces a new setting to allow eTMF Admins to restrict their users’ ability to share restricted (Unblinded) documents via the Send As Link action. When enabling the action, Admins select which value from the Content field indicates restricted content. Once configured, any document with that value in the Content field cannot be sent as a link. Learn more about configuring the Send as Link action.
Person & Organization Migration
This feature introduces a series of changes to your Vault Clinical application objects. These changes serve to streamline the process of creating Person, Study Person, and Study Organization object records. Additionally, these updates serve as the foundation for future Vault Clinical Operations functionality and automation. Contact your Veeva CSM or Managed Services teams to learn more about this feature and its enablement.
Vault Payments: Fee Schedule Template
This feature provides the ability to define a fee schedule template at the Study and Study Country levels. Users can use these templates to default the fee schedules at the Site level. Users can then adjust the fee schedules to reflect the site negotiated fees as necessary.
Note: Vault Payments is only available to early adopters and must be enabled by Veeva Support.
Data Model Changes
See 19R2 Data Model Changes: Clinical Operations.
Safety
Safety features are targeted for tentative availability on August 9, 2019.
Adverse Event Report Validity Check
The first step to add a new Vault Safety Case is to enter the source Adverse Event Report. After you create and enter an Adverse Event Report, the system verifies that the report includes the criteria to qualify as a valid individual case safety report (ICSR). An administrator can configure custom criteria for the system to verify.
When an adverse event report contains all of the criteria to qualify as a valid case, you can promote the Adverse Event Report to a Case. Adverse Event Report Overview provides more information.
Adverse Event Report Import
Vault Safety supports importing source files to create an Adverse Event Report. This feature includes populating data from E2B (R2) and (R3) files.
When you import an E2B file, the system extracts the data from the file and maps the information to the matching Vault Safety fields in a new Adverse Event Report. E2B Case Import Data Mapping describes how Vault Safety maps E2B data to a Case.
When you create an Adverse Event Report from a source document, such as a .pdf literature source, the system populates the Organization and Source fields on the Adverse Event Report. Create an Adverse Event Report provides more information.
Duplicate Case Detection
When you start Case promotion, the system automatically compares the source Adverse Event Report against all other Cases and Adverse Event Reports in the system to prevent duplicate adverse event processing.
If the Adverse Event Report is a duplicate of a Case, Vault Safety marks the Adverse Event Report as duplicate and does not create a Case. See Promote an Adverse Event Report to a Case for more information.
Case Processing Workflows
Vault Safety includes a pre-configured Case Processing workflow that automatically assign tasks to guide the Case from Data Entry to Approval and Submission.
See Case Processing Overview for more information about the case processing workflow.
Personal Identifiable Information Field Encryption for Cases
The system encrypts standard Personal Identifiable Information (PII) fields captured in a Vault Safety Case. Once field-level encryption is enabled, only authorized users within vault can access the encrypted information.
Manage Field Encryption provides information on which fields are encrypted and how to encrypt additional fields.
Standardized Medical Dictionaries
Built on modern industry standards, Vault Safety supports industry-standards for medical coding and structured data entry.
MedDRA Coding
Vault Safety supports the Medical Dictionary for Regulatory Activities (MedDRA) to code terms for symptoms, disease, indicators, and adverse events. You can code an event using either the LLT or PT code. See Code MedDRA Terms for more information.
An administrator must upload a MedDRA dictionary to enable coding.
WHODrug Coding
Quickly search, filter, and find standardized medicinal product codes in our IDMP-compliant WHODrug dictionary. The WHODrug dictionary browser makes it easy to find and code products and their corresponding MPIDs during case processing. See Code WHODrug Terms for more information.
Veeva manages the WHODrug dictionary and updates it biannually. However, an administrator must activate the WHODrug dictionary.
Units of Measurement
Vault Safety supports E2B (R3) units of measurement for dose, strength, and time intervals, including support for both the unified code of units of measure (UCUM) and the constrained UCUM.
Controlled Vocabulary
Vault Safety supports the ICH Controlled Vocabularies for Drug Safety and E2B data transmission.
Route of Administration
Vault Safety supports the E2B (R3) data entry standard for route of administration terms. You can enter the route of administration as text or as a code from the E2B (R2) dictionary.
Enhanced Case Narratives
Vault Safety leverages Vault Document Management capabilities to support enhanced narrative document composition, including annotating, versioning, and editing.
Access narratives from the Case and edit narratives on your local machine or directly in your browser with Microsoft Office Online. See Compose a Case Narrative for more information.
Case Assessment Generation
Vault Safety automatically generates a Case Assessment for each suspect product and serious adverse event using data entered on the Case.
This feature ensures the proper mapping of Case Assessments and increases productivity and speed for the reviewer completing the assessments. See Enter a Case Assessment for more information.
Case Locking
Case locking improves access control and data integrity. When a Case is approved, the Case and all of its related data transitions to a locked state, preventing unapproved updates.
When a Case is submitted and closed, it continues to be locked to prevent deviations from submitted reports that would trigger an audit violation.
Locked Case Revision Workflow
Once a Case is locked, authorized users can initiate a Case Revision workflow for a Case to incorporate non-significant follow-up information received from reporting sources.
After the Case Revision workflow, the Case moves back to the Approved state and is locked to prevent changes. See Revise an Approved Case for more information.
Follow-up Cases
Vault Safety supports creating Follow-Up Cases when you must process new case information. When you add a Follow-Up Case, the system creates a new version of the case and carries over all the information and documents from the previous version of the case.
See Add a Follow-Up Case for more information.
User Access Control
Vault Safety protects data by restricting user access to information and records based on their organization and application role. Users must be assigned an application role in their organization to see case-related data and participate in Case Processing workflows.
With this feature, CROs can assign each customer access to Vault Safety, and each customer can only view data belonging to their organization. For more information, see Managing Permissions with User Roles.
Blind Protection
For double-blinded studies, Vault Safety blinds all Cases linked to that study, including imported Cases. If a blinded Case is assessed as serious and unexpected after QC review, the system starts the unblinding workflow and assigns unblinding tasks to authorized users in the Medical Reviewer role.
When you unblind a Case, Vault Safety activates blind protection. Blind protection continues to mask sensitive information that could compromise the integrity of the study from unauthorized users.
Only users with appropriate permissions can see blind-protected information. By default, only users assigned the Medical Reviewer or Head of Safety role can see blind-protected information.
When you add the study to your environment, you can configure Case blinding settings. See Manage Case Blinding for more information on blind protection.
Aggregate Reporting
Vault Safety supports ICH-compliant aggregate reports for product families, including one-click table generation and collaborative document editing for PBRERs and DSURs. This feature includes a workflow for generation, authorship, and a red-line comparison view between table versions.
The system processes relevant Case data within the specified time period to generate aggregate report tables and populate their data. See Aggregate Reports Overview for more information.
Health Authority Reporting and Submissions
Vault Safety includes workflows to support both manual and electronic submissions of Individual Case Safety Report (ICSR) to the FDA.
See Submissions and Distributions Overview for more information.
Individual Case Safety Report Export
Vault Safety supports generating ICSRs in the following standardized formats:
- E2B (R2)
- E2B (R3)
- CIOMS I
- FDA 3500A
The system maps Case data to populate the appropriate fields on the report. During report generation and submission, Vault Safety ensures that files are fully compliant, maintain case versions, and support multiple distribution and submission destinations.
Generated files appear in the Vault Library and are versioned during regeneration. Generate a Regulatory Report provides more information.
FDA AS2 Electronic Submissions Gateway Integration
Schedule Submissions and send individual case safety reports (ICSR) directly to the FDA through the AS2 Electronic Submissions Gateway (ESG). Submit initial, follow-up, amendment, and nullification ICSRs.
Support includes Submissions for biologics and drugs as well as handling of ICSR attachments and acknowledgments. See Submit a Case to the FDA Gateway for more information.
Manual FDA Submissions Tracking
When you cannot submit a case electronically, you can generate submittable case reports and track the manual submission through the Manual Submission workflow. Submit a Case to the FDA Manually provides more information.
FDA Submission Rules
Set up automatic due date and submission rules for all Cases reportable to the FDA. Vault Safety supports rule-based determination of Case due dates and submissions. This feature includes post-market, study, and follow-up reports. The system assigns reporting due dates based on the Case seriousness criteria.
See Complete Case Triage for default submission rule settings. Administrators can configure custom due dates when configuring studies.
Interactive Dashboards and Reports
Drill down through real-time, interactive dashboards to narrow in on the exact source of processing and reporting delays. Take action directly from the reports to address hold-ups and stay on track for submission deadlines. Reports and Dashboards Overview provides more information.
Case Migration Mode
Case Migration Mode is a setting that allows you to migrate external cases to Vault Safety with Vault Loader or Vault API. Contact Veeva Support for assistance with enabling Migration Mode and importing external cases. Migrate External Cases provides more information.
Feature Enablement
The following table describes how to enable each new feature in this release.
| Feature | Enablement |
|---|---|
| Adverse Event Report Validity Check | Auto-on |
| Adverse Event Report Import | Auto-on |
| Duplicate Case Detection | Auto-on |
| Case Processing Workflow | Auto-on |
| Personal Identifiable Information Field Encryption for Cases | Auto-on |
| MedDRA Coding | Configuration |
| WHODrug Coding | Configuration |
| Units of Measurement | Auto-on |
| Controlled Vocabulary | Auto-on |
| E2B Route of Administration | Auto-on |
| Enhanced Case Narratives | Auto-on |
| Case Assessment Generation | Auto-on |
| Case Locking | Auto-on |
| Locked Case Revision Workflow | Auto-on |
| Follow-Up Cases | Auto-on |
| User Access Control | Configuration |
| Blind Protection | Configuration |
| Aggregate Reporting | Configuration |
| Individual Case Safety Report Export | Auto-on |
| FDA AS2 Electronic Submissions Gateway Integration | Configuration |
| Manual FDA Submissions Tracking | Auto-on |
| FDA Submission Rules | Configuration |
| Interactive Dashboards and Reports | Configuration |
| Migrate External Cases | Support |
Site Vault
Study eBinder Enhancements
To better support inspections and quick referencing by study team members, the eBinder now displays only major version documents. This feature also introduces improvements to the icons and column controls used in the eBinder. Learn more about the Study eBinder.
Data Model Changes
See 19R2 Data Model Changes: SiteDocs.
We have set the System ID field on the standard objects Study Product Role, Study Organization Role, and Study Staff Role to read-only. This field is reserved for use by Veeva. Learn more about SiteDocs..
Regulatory
Affiliate Home Tab
The Affiliate Home tab provides users at the local level with a dashboard displaying only the data relevant to their markets and product families. Within this tab, users can view and navigate charts and data, see open tasks, and launch frequently used actions, such as bundling activities or managing registered details, all in one convenient location. Learn more about using the Affiliate Home tab.
XEVMPD Enhancements
This feature delivers enhancements that streamline the XEVMPD data management process. Vault now stores technical validation results on the Product Data Message record to better align with the validated XML. See XEVMPD Validation for details about additional enhancements to the validation process.
In addition, this feature enhances existing XEVMPD functionality to streamline data entry for Administered Products and allow users to generate XEVPRMs for one or more EV Codes at a time. Learn more about creating XEVPRMs.
XEVMPD Validation
This feature delivers the remainder of the XEVMPD business rules in accordance with Article 57 guidelines. This feature also includes additional rules to ensure that users are aware of any required sections that are missing data before Vault generates the XEVPRM XML file.
Additionally, business rule validation now runs when Vault creates the product report tree structure and also when Vault generates the XEVPRM XML, allowing Vault to catch errors at multiple points in the process. Users can also run validation on demand. Running validation independently allows users to update specific Product Report values without needing to modify and re-generate the whole tree structure. Learn more about how Vault validates XEVMPD data.
Inline Validation Results
In past releases, users had to download and open a CSV file to view all validation results for a Content Plan Item record. With Inline Validation Results, users can view all Submission Validation Result records directly from a Content Plan Item. Users can also create reports to view validation results for an entire submission.
Admins must contact Veeva Support to enable this feature in vaults with existing Publishing Validation Result records. In new vaults, or in vaults with no Publishing Validation Result records, this feature is automatically available. Veeva will enable this feature automatically for all vaults in a future release. Learn more about inline validation results for submissions publishing and report level content plans.
Note: Enabling this feature in existing vaults removes the Open Validation Results user action on the Submissions Archive Document object lifecycle.
Simplified Import: Dossier Formats
With this release, Admins can configure dossier formats and parameters within Vault that predefine the application and submission folders for eCTD and non-eCTD dossiers. In addition, Admins can predefine how a non-eCTD is organized for display in the Submissions Archive Viewer, with no prior content staging needing.
This update also allows users to import submissions through a ZIP or TAR.GZ file without defined application or submission folders by setting the Application Folder Name and Submission ID fields on the corresponding Application and Submission records before submission import. In addition, users can upload ZIP or TAR.GZ eCTD submissions with a corresponding working documents folder as a single import.
Learn more about how Vault imports eCTD and non-eCTD submissions.
Submission Import from User FTP
With this release, Submissions Archive users with the FTP: Staging permission can upload dossiers for import from within a Submissions Archive Import folder on the FTP. This feature also updates the Import Submission dialog to hide FTP options when no import locations are available on the FTP root or user FTP folder. Learn more about importing submissions via the FTP.
Report Level Content Plan for Product Family Reports
With this release, customers can use the Report Level Content Plan feature to create other complex reports, such as Pharmacovigilance reports and Investigator Brochures, in addition to Clinical and Nonclinical Study Reports. To create these reports, users can create a report from a Product Family (product__v) object record and publish content using existing Report Level Content Plan functionality.
Show Inactive Records in Content Plan Viewer
With this release, Vault automatically hides Inactive records in the Hierarchy Viewer, making both the tree view and the grid view less cluttered and allowing users to more easily focus on Active records. Inactivating unnecessary records rather than deleting them makes it easier for users to bring back sections that were removed prematurely or in error.
Users can choose to display Inactive records in the Hierarchy Viewer by clicking Show Inactive at the top of the grid. This allows users to toggle between showing and hiding Inactive records. Learn more about using the Hierarchy Viewer.
Content Plan Usability Enhancements
This feature provides several usability enhancements when working with content plans:
- A new Progress Icon formula field on the Content Plan Item object allows users to visually track Content Plan Item progress. In the Hierarchy Viewer, the Content Plan Item icons reflect the formula field outcome. The Progress Icon field includes a formula by default, but Admins can configure custom formulas. For example, Admins could modify the field to track the progress of matched documents. Learn more about configuring the Progress Icon field.
- The Open Matched Document and Open Published Document user actions now open documents in a mini-browser and no longer navigate users away from the current page.
Note: Users must allow pop-ups in order to see the mini-browser.
See Hierarchy Viewer Usability Enhancements for Vault Platform updates that affect the Content Plan Hierarchy Viewer.
Content Plan Item Manual Matching on Create Placeholder & Upload Document Actions
With this release, the Create Placeholder and Upload Document actions on the Content Plan Item record immediately match the document or document placeholder to the Content Plan Item and no longer rely on continuous matching. Vault treats matches from these actions as manual matches. Learn more about document matching on Content Plan Items.
Unreferenced Files in Submissions Publishing
For European eCTD submissions, it is sometimes necessary to include supporting documents, also known as working documents, that are not referenced by the eCTD XMLs. With this feature, organizations can include supporting documents not referenced by XMLs in the published submission output. Learn more about publishing submissions with unreferenced files.
Display Validation Counts in Gateway Confirmation Dialog
Vault now includes counts of open Submission Validation Results related to a submission in the Gateway Submission confirmation dialog. Vault also warns users when their submissions contain outstanding High validation errors.
Open Content Plan Item from Submissions Archive
With this feature, Admins can configure the Open Content Plan Item action to allow users to open a Content Plan Item record directly from a published Submissions Archive document. Users can then view Submission Validation Results for that Content Plan Item.
Prevent State Change When Outstanding Publishing Items Exist
This feature allows Admins to configure a new Publishing Complete entry criteria on the Submission object lifecycle states to prevent state changes while outstanding publishing jobs still exist.
Action Level Security for Additional Regulatory Actions
This feature allows Admins to configure Action Level Security from a permission set or within an object lifecycle for multiple actions in RIM Registrations, RIM Submissions, and RIM Submissions Archive vaults:
- RIM Registrations: Create Related Records, Create Registrations, Chronology Report, Impact Assessment Report
- RIM Submissions: View Content Plan
- RIM Submissions Archive: Import, Export, View
Learn more about configuring Action Level Security.
Show eCTD Metadata Mapping on Submission Import
Admins now have an option on the Admin > Settings > Application Settings page to show or hide the metadata mapping step when users import eCTD submissions. This feature does not impact users’ ability to set or update metadata through the API.
Real-time Correspondence in Viewer
With this release, Vault queues correspondence documents and displays changes in the Submissions Archive Viewer as users import or remove submissions or update correspondence documents. This feature also removes the Submissions Archive Correspondence job from Admin > Operations.
China (CN) 1.0 XSD Support
Submissions Archive users are now able to import submissions using the new China (CN) 1.0 XSD for eCTD submissions. The eCTD specifications are out for review, with feedback requested by 31 March 2019. A pilot phase is expected to begin in May 2019. See more information about the China 1.0 XSD.
XEVMPD Gateway Submission: Supporting Data Model & Configuration
This feature provides the fundamental configuration elements for connection to the EMA Gateway. In addition to the data model updates, Admins will see a new option to configure the Submit XEVPRM user action on the Product Data Message lifecycle, as well as a new area in Admin > Settings with EMA Gateway profile connection details. The Submit XEVPRM action will allow users to submit generated XEVPRM messages to the EMA Gateway in a future release.
Note: Any configuration related to these components will not be active until full gateway connectivity is delivered in a future release.
Data Model Changes
See 19R2 Data Model Changes: Regulatory for Medical Device Data Model, Additional Regulatory Data Model Updates, and data model changes related to 19R2 Regulatory features.
Quality
Risk Management in QMS
This feature allows risk managers to create and manage enterprise and operational risk registers using one or more risk matrices. The risk register contains a list of risk-related events, with an evaluation of their severity and probability of occurrence, along with mitigation activities. The Risk Level allows users to prioritize identified risks to allow mitigation and assessment, and to evaluate residual risk levels once mitigation actions are complete.
Vault Training: Quizzes
This feature allows organizations to use quizzes and assessments as part of a learning plan, an effort to move past simple “read and understood” completion types, and to demonstrate comprehension of competency of a topic. Adding a quiz to the end of an SOP or other training type can help organizations verify a learner’s knowledge of the content.
Vault Training now provides the ability to build and manage quizzes. Quizzes can have various question types: True/false, yes/no, and multiple choice (both single answer and multi-answer). Quiz designers can set a minimum passing score per quiz. During the document revision process, a quiz can be updated before the document is issued for training. This ensures that learners take the proper version of a quiz for a document version. Learn more about configuring Vault Training quizzes.
Quality Teams: Administration & General Availability
This release marks the general availability of the Quality Teams feature set. In previous releases, select Vault QMS customers were able to participate in an Early Adopter program using the Quality Teams feature set to allow users to make individual work assignments to individual Change Controls, Audits, CAPAs, or other Quality Event-related processes. Users choose these individual user assignments directly from the record detail page by selecting from a list of users authorized to perform that role on that record. Quality Teams integrates with Vault’s Sharing Settings & Security platform, allowing for a simple experience for business users without sacrificing critical compliance tools.
Administrators can now create and configure their own Quality Teams and Quality Team Roles to suit the needs of their businesses through Vault’s administration pages.
Quality Teams represents a new, exciting way to think about record access, workflow construction, and, when combined with other features like Matching or Custom Sharing Rules and Auto-Start Object Workflow, process automation. Getting the most out of Quality Teams can require some significant configuration, and we encourage you to reach out to your Veeva contacts to learn more about how your business can leverage Quality Teams in Vault QMS to reduce risk and make role & responsibility management easier for your business. Learn more about configuring Quality Teams.
Quality Teams: Power Delete Team Memberships Record Action
Following the general release of Quality Teams, we are releasing new functionality to help Admins test, configure, and clean up sandboxes and configuration test environments. This feature allows Admins to add a record action which will delete any Quality Team membership assignments on that record. Admins can configure this as a user action on any Team Enabled Record’s lifecycle.
The System user performs the deletions initiated by this action. As such, the deletions ignore Quality Team configuration restrictions on role or team locks and individual user permissions. This user action is intended for use by Admins in non-production environments. Admins cannot “undo” these membership deletions.
Mandatory Participants for Document Change Control
This feature allows selection of mandatory participants for approval or review workflows. For documents associated with a Document Change Control (DCC) record that are secured with specific application roles, Vault can use the membership in these roles to automatically determine the mandatory participants for approval or review workflows for that DCC record.
To support this, workflows assigned to DCC records allow a new type of participant control. When Vault assigns a workflow task through this participant control, the workflow does not progress until participants complete the minimum set of necessary approvals. Vault automatically cancels redundant tasks. Learn more about mandatory participants.
Mandatory Approvers for Document Change Control
With this release, Vault can now dynamically assign mandatory workflow approvers by selecting users assigned to the Document Change Control Approver role on the documents associated with a Document Change Control record. The approval workflow does not progress until the minimum set of mandatory approvers complete their approvals.
Mandatory Reviewers for Document Change Control
Similar to Mandatory Approvers for Document Change Control, in this release Vault can now dynamically assign mandatory workflow reviewers by selecting users assigned to the Document Change Control Reviewer role on the documents associated with a DCC record.
Vault Training: Training Assignment Record Migration Improvements
Previously, Vault Training looked to the Created Date value on migrated Training Assignment records to determine the most recent record. The value for Created Date was the same for most of the migrated records, causing the application to erroneously issue new Training Assignment records. With this release, Vault Training looks to the Assigned Date value on migrated Training Assignment records when determining the most recent record.
Additionally, users can now edit the Assigned Date field on a Training Assignment record if Creation Source is Import. Learn more about importing training assignments.
Vault Training: Cancel Open Training Assignments Entry Action
This feature introduces a new entry action. Admins can use this to cancel open Training Assignments that reference documents in the Superseded lifecycle state.
When an Admin has selected the Keep Open Training Assignments checkbox on the Issue Training Assignment entry action, a Learner may end up with an open Training Assignment that references a superseded document. To prevent a Learner from completing training against a superseded document, Admins can configure the Cancel Open Training Assignments entry action on the Superseded document lifecycle state. When this entry action executes, it cancels open Training Assignments that reference documents in the Superseded state. Learn more about Vault Training automation.
Vault Training: Change Related Training Requirements to Retired Entry Action
When a document is obsolete, organizations may need to find Training Requirement records that reference this document and move those records to Retired state. The Change Related Training Requirement to Retired document lifecycle entry action automatically changes the state of Training Requirement records to the Retired state. This ensures that the Training Requirement record is not used for future Training Assignments. Learn more about Vault Training automation.
Vault Training: Issue Training Assignments Entry Action Enhancement
If a Learner has an open Training Assignment for a document when a new Training Assignment is issued for the same document, the application cancels the open Training Assignment. It then creates a new Training Assignment for the Learner.
The Issue Training Assignment document lifecycle entry action now includes a new checkbox called Keep Open Training Assignments. When Admins use this setting, Vault will not cancel the open Training Assignments and the Learner will have two Training Assignments for the same document, each with a different document version. Learn more about Vault Training automation.
Vault Training: Validation & Learner Enhancement
The following enhancements add validation to prevent misconfiguration between the Person and User records and to automatically add the Learner to the Learner Role for the Assignment Details and TA Response objects.
This enhancement:
- Allows a Vault Training job to continue processing changes even if there is an inactive User associated to a Person. If this occurs, the Vault Training job skips the inactive User record and continues to work on other tasks. When the job ends, its status is then Errors Encountered.
- Prevents a Person record’s user reference from being removed if the Person has Learner Roles
- Prevents a User record from being referenced in multiple Person records
- Adds Learner to the sharing settings for the Assignment Details object
- Adds Learner to the sharing settings for the TA Response object
- Prevents a Person record’s user reference from being updated to another User record if the Person has Training Assignment records
Learn more about Vault Training.
Vault Training: Issue Training Assignments Based on Document State
This feature allows Admins to tag, for each lifecycle, the trainable states for documents referenced by Training Requirements. By default, Vault Training issues Training Assignment tasks regardless of the lifecycle state of a Training Requirement record’s related document. With this enhancement, Vault will use the Steady state and Ready for Training state types to determine whether Training Assignment tasks should be issued. Learn more about Vault Training.
Vault Training: Issue Training Assignments Based on Training Eligibility
By default, Vault Training uses the Status field on the Person object to determine whether a Person should receive Training Assignment tasks. To be flexible in meeting unique business requirements, the Vault Training application can use a different field, Training Eligibility, to determine whether a Person should receive Training Assignment tasks.
This feature is off by default and does not affect existing configurations. The product team will work closely with each customer to transition to using this field. Learn more about Vault Training automation.
Data Model Changes
See 19R2 Data Model Changes: Quality .
QualityOne
QualityOne Training Management
This feature allows organizations to manage training and competency of their employees, including creation of training curricula and training requirements, based on content in Document Control. Admins can create various learner roles and assign them to complete one or more curricula. Organizations can verify competency of assigned training by testing employee understanding with quizzes.
Customers must purchase a new license to use this add-on application within QualityOne. Learn more about QualityOne Training Management.
Checklist Assignment for Audit
This feature allows manual assignment of an audit checklist, based on a checklist design, to a specific user for response without the use of matching fields for QualityOne vaults.
Admins can configure the new Manual Checklist Assignment user action in the appropriate state of the Audit lifecycle. This action creates the selected audit checklist templates for use by auditors. Typically, Admins add this user action in the audit preparation step before auditors conduct their audits. Learn more about Audit Checklists.
Audit Finding Flag for Checklists
This feature allows a user to flag a response to an audit checklist question as an audit finding. Responses that are flagged as an audit finding will automatically generate an Audit Finding record via an entry action. Vault creates the Audit Finding records through a scheduled job in the completed lifecycle state, using the Create Audit Finding Records entry action.
The entry action copies the Finding Type, Observations, and any attachments used for objective evidence in the finding record. In the event the scheduled job fails, users can address the errors and issues previously encountered and manually trigger the job with the user action Create Audit Finding Records. This action attempts to create the audit finding records again. Learn more about Configuring Audit Checklists.
QualityOne Station Manager
QualityOne Station Manager is a mobile application for Android tablets. This application allows workers in manufacturing facilities to view QualityOne documents on shared devices. As more manufacturers replace paper binders on the shop floor with electronic documents accessed via tablets, organizations need a secure way to share these documents on approved devices. QualityOne Station Manager provides a completely mobile, encrypted experience for viewing QualityOne documents, with fast, offline access 24 x 7.
Customers must purchase an additional license to use this new add-on application within QualityOne. Learn more about QualityOne Station Manager.
Risk Matrix Visualization
This feature displays the traditional risk matrix chart as a section in a risk matrix record regardless of whether it is a qualitative or quantitative risk matrix. Admins must add the Risk Matrix to the page layout by configuration. Each cell is based on the risk level defined for each combination of severity and likelihood (also known as occurrence or probability). Learn more about risk matrices.
Data Model Changes
See 19R2 Data Model Changes: QualityOne.
Station Manager
Android Station Manager Enhancements
In this release, we have added several enhancements to the Android Station Manager mobile application:
- The application syncs with Vault every 15 minutes, even when the app is not actively in use, and notifies the user that it is running in the background.
- If a document is removed during a sync with Vault while a user is actively viewing the document, Station Manager notifies the user that the document is no longer available. The user is allowed to continue to use the document to complete any work started with that set of instructions, but will not be able to reopen the document after exiting.
- Version-specific Supporting Document relationships are now supported on the Document Information page.
Commercial & Medical
Set Binder Content Version Binding to Steady State Entry Action
This feature automatically sets binding rules on binder content to bind to the latest Steady state content. This is especially helpful when used with the Enforce Documents are in a Steady State check to ensure that compliance package content is bound to the latest Steady state before going on to an approval cycle.
Compliance Package Generation Improvements: Enforce Documents are in a Steady State Check
This feature prevents non-steady state content from being included when users execute the Generate Compliance Package bulk action. When used in conjunction with the set binder content version binding to Steady State entry action, Vault PromoMats can be utilized to prevent non-steady state content from being added to a compliance package. A final, existing entry criteria, All documents bound to Steady State, can also be utilized to perform a final check on binder content to check that all binder content is bound to a Steady state before the binder enters a Steady state.
Back to Vault from Brand/Medical Portal
Users within a Portal can now easily return to Vault via the Portal Selector dropdown on a Portal Homepage or by clicking the PromoMats or MedComms logo.