New in 22R1.3: Upload Source Files Using Vault File Manager and more

Release Date: June 3, 2022

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

Platform

Vault Objects

Freeze Column for Related Object Sections

Users can now freeze columns in related object sections, meaning they can select one or more columns to remain visible while scrolling horizontally.

Lifecycle & Workflow

Save Task Information

With this release, Vault automatically saves information entered into a task dialog until the subsequent automatic next steps in a workflow are complete. When a user completes a task and a subsequent entry criteria or action fails, they do not need to redo their work in the task dialog. Additionally, workflows on documents prompts for fields now display the current value of the field if populated when the workflow contains a single document.

Include Users Allowed in Role

This feature allows participant controls in workflows on documents to expose users that are allowed in a certain document lifecycle role. This feature supports users and groups allowed for a Dynamic Access Control-enabled role as well as via role defaults and override rules. Admins may enable this feature for a specific participant control by selecting the flag Display users and groups allowed in role.

New Operators for Workflow on Documents

This feature adds new workflow operators for evaluating fields in documents. Admins may now select all, none, or at least one blank field. In addition, this feature adds several user experience enhancements including indicating whether an item in the multi-document viewer has been viewed or not by bolding and unbolding the name of the item.

Enhancement to Document Multi-Value Fields in Expressions

With this release, multi-value picklist and multi-select object fields on documents return all selected values when used in lifecycle and workflow expressions. Prior to this release, Vault returned a single value, even when multiple were selected.

Reporting & Dashboards

Support Document Roles as a Reporting Object

This feature allows users to report on document roles. Users can report on all documents and the users with access to them. Admins can create the Document Role and Document with Document Role report types to enable users to generate reports on document roles. This feature supports all standard, matrix, and multi-pass report types. 

Additional Aggregate Functions in Reports

With this release, Vault supports additional aggregate functions in grouped reports. The List and Distinct List functions return a concatenated list of records in a single cell. The Std Dev and Std Dev Samp functions return the standard deviations for a distribution.

Search

Add Archive Option to Search Settings

Until now, customers needed to request for document archiving to be enabled on their Vaults. The archiving option has been added to the search settings so administrators can enable it themselves if needed. 

Note: This is a one-way enablement so it can’t be turned off. A warning will appear at the time of enablement, alerting the Admin who is doing so.

Add CJK Indexing Option to Search Settings

Customers with a lot of Japanese, Chinese or Korean text in their object records could contact support to optimize searching in these languages. We’ve now added this option to the search settings so administrators can enable or disable it themselves. 

Freeze Column Header & Rows on Object Tabs

When searching records in an object tab, column headers are now frozen so that the names of the columns are always visible, making it easier to navigate the results when scrolling vertically. With this enhancement, the search results have been increased to 50 since the context will never get lost when scrolling deep into the results. Users can now freeze additional columns to make scrolling horizontally easier as well.

This feature was postponed to a future release.

Access Control

Display System-Managed Users in Search & Filters

Starting from this release, Vault exposes System Managed users (such as Application Owner, Java SDK Service Accounts and product family-specific users such as Clinical Transfer) in a consistent way in all user (or users and groups) selection.

When selecting users for data entry purposes (object records, documents, configurations), System Managed users do not appear. For example, this behavior is enforced when selecting users on a user object reference field or when adding users into a role on a document or object records using manual assignments.

When selecting users for search or filtering purposes, System Managed users do appear. For example, this behavior is enforced when selecting users for filtering audit log entries by user, when using filters or conditional filters on Vault Reports, or when selecting users while searching for documents or object records, for example, filtering on the Created by field.  

Delegate Admin CSV Export enhancement

When exporting active Delegations (Admin > Users & Groups > Active Delegations), the limit of a maximum of 1024 active delegations in the export is now lifted: all active delegations are now exported.

Administration

Person: First Name or Last Name is required

With this release, the First Name or Last Name field is required for a Person record when it is not associated with a User. This is enforced when both fields are empty and an Admin attempts to save a Person record.

Outbound Packages: View & Add Dependencies

With this release, you can review and include any blocking component dependencies in an outbound package prior to exporting the VPK so that the outbound package has all the required components for a successful deployment.

Jobs: Audit Logs for External URL Call Jobs

With this release, audit log entries for external URL call jobs now contain the username configured as the Run As user for the job. The login audit entry now includes the Job ID.

Vault File Manager

Upload Source Files Using Vault File Manager

Vault File Manager now supports uploading source files to documents in Vault.  Users have the option to upload via Vault File Manager when they attempt to upload new version, create new draft, or upload to placeholder in Vault.  Additionally, the Vault source file size limit of 4GB is relaxed and users can upload source files up to 100GB in size when using the Vault File Manager.  The file size limit when using the web browser remains at 4GB.  

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 added the following components to the Platform data model to support new features:

Added the Target Vault (target_vault__v) field to the Outbound Package (outbound_package__v) object to support the Outbound Packages: View & Add Dependencies feature.

Vault Connections

PromoMats/RIM: Removed rim_applicant_uir__v Integration Rule

Removed the rim_applicant_uir__v Integration Rule to ensure only one Integration Rule exists for applicants in PromoMats.

Protect Vault Connection Performance and Scalability (All Connections)

The RIM to Clinops Connection will have one Inbound Job and multiple Job Workers for each run (one per active Integration) on the RIM Vault instead of just one Job. The Job Logs will present multiple Job Tasks.

Clinical Operations

Reference Sites

This feature will support the designation, within a study country, of a single Reference Site. Users will be able to tailor expected documents for that site, push that expected document plan out to existing sites, and use the reference site as the basis for expected documents subsequently created at sites within that country.

ePRO in Clinical Operations

With this feature, MyVeeva ePRO customers can now launch ePRO for studies within their Clinical Operations Vault.

MyVeeva ePRO is being released for the first time to early adopters in 22R2. MyVeeva ePRO supports the ability to set up surveys, schedules, notifications, translations, and events for a study’s ePRO in the ePRO Module, work with sites to connect ePRO and set up/manage study participants, and send surveys and notifications to study participants in the MyVeeva for Patients application.

TMF Bot: Auto-Classification Enhancements

Every release we target enhancements to TMF Bot Auto-classification functionality. This feature includes adding Email Ingestion support, streamlining the pipeline to maximize TMF Bot’s potential, and standardizing the report and Excel templates.

TMF Bot: Document QC Step

This feature allows customers to use TMF Bot as part of their document processes, without using the Document Inbox. A TMF Bot QC check can be added as a step to any document workflow to surface possible issues with a document’s classification.

eConsent Documents to SiteVault

With this feature, eConsent customers can now exchange eConsent documents with SiteVault sites directly from Vault Clinical Operations without Site Connect.

CTMS

Standard Content Fields on CTMS Objects

This feature adds a standard Content (blinding__v) field on select CTMS objects.

ClinOps/CDMS: Restricted Data

This feature enhances the ClinOps to CDMS Connection, making restricted data for subject visits and protocol deviations identifiable when transferred from CDMS to CTMS, and CTMS can control access to restricted data through permissions.

Study Startup

Clinical Application Management

This feature adds standard objects to support milestone-specific work and information regarding specific documents, and an action to seed those records based on documents currently linked to the milestone, in order to better manage clinical submissions.

Email Checklists Based on Study Person Records

This feature extends our clinical capability of sending checklists to non-Vault users by introducing a behavior that allows a checklist to be sent to a specific study person. It includes an action to generate new survey links for any subsequent new respondents. Sending a checklist to a non-Vault user via organization is still supported.

Site Connect

Connected Studies for ePRO & eConsent

With this feature, ePRO and eConsent customers will be able to automatically establish Connections to SiteVault and send Study-specific invitations to SiteVault sites.

Site Connect Safety Distribution Update

With this feature, Site Connect’s Safety Distribution functionality has been improved to handle distributing to thousands of Study Sites in a single send action. 

Additionally, study site filters can now be pre-configured on the Safety Distribution Default object, allowing for automated filtering of study sites based on field criteria. With this auto-filtering enhancement comes a behavior change whereby the manual filtering of study sites is no longer available during the sending flow when the ‘Distribute to Sites’ action is taken on a Safety Distribution.

Connected Study Types in Clinical Operations

Site Connect, eConsent, and ePRO customers can now designate a Connected Study appropriately using the Connected Study Type field. This field must be populated in order to:

• Send Connected Study Invitations / Agreements to SiteVault
• Send Safety Distributions
• Launch ePRO

For existing Site Connect customers, the new Connected Study Type field defaults to Document Exchange and Safety Distribution for all new and existing Studies.

Site Connect: Additional Vault Clinical Docs Support

This feature adds support to transfer new document types to SiteVault via Veeva Site Connect.

• Other Submissions
• Source Data Agreement

Clinical Operations 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 Clinical Operations data model to support new features:

Expand this section to view Clinical Operations Data Model Changes.

Commercial

PromoMats & MedComms

Automated Image Rendition Flattening

This feature adds a new option when configuring Automated Image Renditions to request the rendered image be flattened. A flattened image has the same appearance but contains all of the image contents in a single layer.

OCR Pages with Images & Text

With this release, Vault performs OCR on PDF documents that contain both images and text. Prior to this release, Vault only performed OCR on PDFs that contained images.

PromoMats

Optional Linked References for Pre Clearance Packages

With this release, users can select whether to include linked references for Pre Clearance eCTD Compliance Packages. This matches existing functionality for Post Marketing Compliance Packages.

MedComms

Alternative Response Contact for Medical Inquiry Case Response

With this release, Admins can add a new Response Contact field to the Case Response object page layout in MedComms. This allows users to select an alternative recipient of case response emails.  If this field is added and left blank, Vault sends the email to the existing Case Contact on the Case Response object. This feature provides more flexibility when sending case response emails, and allows Admins to configure other _Case Response _types. For example, you may need to send emails internally, within your organization.

Commercial 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 Commercial data model to support new features:

The following changes were made to PromoMats Vaults:

• Added the Pre-Dissemination Review of Television Ads object record to the Promotional Material Document Type object

The following changes were made to MedComms Vaults:

• Added the Response Contact (response_contact_v) field

Vault Training Suite

Study Training

Study Training is a new application in the Vault Training Suite. Study Training simplifies the training of personnel at sponsors, CROs, and sites for greater compliance and inspection-readiness in trials. With Study Training, trial stakeholders can use a single unified system to transform clinical training content into role-based study training. Learn more about setting up Study Training.

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

Quality

Unit of Measure object

A new unit of measure object has been introduced to the Quality Suite. The object label is Unit and name is _quality_unit_of_measure__v_. All Quality applications and customers may utilize this object to further describe a number or quantity with its associated unit of measure using metric or imperial units. Other applications or customer configurations can reference this object to select the appropriate unit of measure as required.

Vault Training

Vault Training: Data Model Updates

The LearnerRole-Person join object was made a complex join to support the new Study Training application. This causes a few differences when viewing a Learner Role assigned to a Person or vice versa. These changes are primarily visual, and do not affect the functionality of Vault Training:

• The first column displayed is the join record ID. Previously, the Name was displayed in the first column.
• The column labels may contain a >.
• Users will need to open the related record in order to perform actions on it.
• Adding the same join record again is possible, but an alert symbol is presented to the user in the selection dialog.
• The label for the Remove action is now Delete from the Actions menu for a join record.
• The Copy Record action appears from the Actions menu for a join record.

QMS

External Notifications: Set Reply To Email Attributes on Complaint and Medtech Emails

The External Notification feature now supports Reply To capability for Complaint and Medtech Complaint external notifications. Users can now utilize the Reply To field to reference a Person record as the reply to email address for emails sent through the External Notification feature.  Email recipients can now directly reply to the email address associated to the Reply To person provided on the email. Learn more about configuring external notifications.

Extend Recurrence Check to Support Standard Object Types on Quality Event

The recurrence check feature has now been expanded to support the additional standard object types on the Quality Event object:

• Change Control
• Proactive Initiatives
• External Findings
• Internal Findings
• Lab Investigations
• Nonconformance

Administrators can now configure recurrence checks for the above object types and users can run recurrence checks to identify potential recurrences. Learn more about configuring recurrence checks.

External Notifications: Distribution Group Filters and Membership Automation

Administrators can now define distribution group filters and leverage these filters to constrain person records to only display persons whose associated field values match that of the record.  In addition, the Create Distribution Group Memberships action can be leveraged to automatically create distribution group memberships based on the filters defined for the distribution group. Learn more about configuring external notifications.

Additional Standard Fields and Objects

Additional standard fields and objects have been added to the QMS data model that standardize commonly utilized fields and relationships between QMS entities. These standard fields and objects can now be leveraged instead of having to define custom fields or objects.  

Quality Team Conditional Role Exclusivity

This feature is being introduced in addition to the existing Quality Teams Role Exclusivity feature to enable users to define specific role membership restrictions for each role within the Quality Team. This enhancement allows greater flexibility so that a user can be selected for more than one role on a team, as necessary, while simultaneously providing exclusivity where it is required. Learn more about creating Quality Team roles.

Vault Product Surveillance

VPS: Data Model Updates

This feature updates the Vault Product Surveillance data model to better support evolving needs and new feature functionality. With this release, we are removing the following fields from the Quality Event object:

• AR Contact Person (ar_contact_person__v)
• AR Contact Person’s Details (ar_contact_details__v)
• Authorized Representative (authorized_representative__v)
• Importer (importer__v)
• Importer Contact Details (importer_contact_details__v)
• Incident - Healthcare Facility (incident_healthcare_facility__v)
• Manufacturer (manufacturer__v)
• Manufacturer - Contact Person (manufacturer_contact_person__v)
• Manufacturer Contact Details (mfg_contact_details__v)
• Manufacturing Site - Contact Info (mfg_site_contact_info__v)
• Product Categorization (product_categorization__v)
• Reporter’s Contact Information (reporter_contact_info__v)
• Reporter - Occupation (reporter_occupation__v)

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:

Expand this section to view Quality Data Model Changes.

Regulatory

RIM PDF Standardization

With this release, Vault will preprocess Submission Publishing documents to produce PDFs compliant with common health authority validation criteria. Customers who enable Renditions Profiles will see a new option to generate a compliant viewable rendition for source PDFs.

RIM Submissions

Application Indication Data Model Harmonization

To harmonize data model inconsistencies across all RIM Vaults, the Indication field name and Indication field inbound relationship name on the Application Indication (application_indication__rim) object have been corrected in Vaults which currently contain the incorrect field name or inbound relationship name as follows:

Attribute	Incorrect Value	Corrected Value (in 22R2)
Indication field name	indication__rim	therapeutic_indication__rim
Indication field outbound relationship name	indication__rimr	therapeutic_indication__rimr

Customers with integrations or customizations that leverage these attributes should work with their Veeva representative to assess impact and plan updates for the 22R2 General Release. This renaming will not break existing Vault configuration referencing these attributes, such as reports and object field criteria VQL.

Content Plan Bulk Actions on Matched Documents

With this release, bulk document actions can be initiated on matched documents in the Content Plan Hierarchy Viewer when the Type = Matched Document filter is applied. Also, filtering in the viewer is available for two additional document fields: Lifecycle State and Ready for Publishing.

Bulk Update Tokens Action

With this release, a new Update Tokens in Fields action is available on the Content Plan object lifecycle. When configured and initiated on a Content Plan record, the action resolves tokens on all descendant Content Plan Items and sends the user a notification and log of the results once complete. Users no longer need to run Update Tokens in Fields one at a time for each node, and can instead run the action at a higher level Content Plan record.

Global Content Plan Object Type Support

With this release, Global Content Plan creation and dispatch will generate Submission relationship records with the appropriate matching object type as the Event relationship records. Previously, Vault used the default object type on the Submission relationship object, regardless of the Event relationship record’s object type.

Content Plan Creation Refactoring and Harmonization

With this release, Content Plan creation, update, and copy processes have been refactored to be more efficient. Instead of copying all records and subsequently updating select field values and deleting irrelevant records, these processes create the relevant records with the new field values inserted at creation. 

Additionally, the Copy Content Plan and Copy Into Content Plan actions have been updated to be compatible with the new data flow introduced by the Submission Wizard in the 22R1 release. For Vaults where the application relationships flag is enabled, these processes will leverage the application relationships as the source data for the Submission relationships that are copied.

Content Plan Viewer Indicator Update

The Content Plan Viewer indicator and pre-validation locking functionality are updated to include all asynchronous state changes.

RIM Registrations

Registrations Wizards Harmonization: Application Relationships

This feature updates the existing Registrations wizards to be compatible with the new data flow introduced with the Submission Wizard. For customers who enable the Submission Wizard, new Application relationships serve as the superset and primary source for Application data, which can then be used by subsequent Regulatory Objectives and Submissions. To ensure proper end-to-end flow, the Create Related Records wizard and Bundling wizards are updated to populate and utilize these new Applications relationships.

Multiple Gateway Support

This feature enables users to create and apply multiple health authority gateway profiles for XEVMPD and publishing submissions.

EUDAMED UDI XML Generation Updates

EU UDI submissions will now be generated using the EUDAMED XML Schema v2.0.2. Also, required elements will now always be included in the XML, making it easier to troubleshoot when they do not have a value.

RIM Publishing & RIM Submissions

Open Validation Results Behavior Updates

With this release, the Open Validation Results field will be updated to show a count of the Validation Results records, rather than a sum of the occurrences. Additionally, informational validation results for bookmark and hyperlink counts will no longer be included in the count.

RIM Publishing

Japanese Validation Criteria Item 7 Support

With this release, Vault Submissions Publishing has been updated to support the Japanese Validation Criteria update to Item 7, allowing for up to 500MB file sizes.

22R2 RIM 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:

Expand this section to view Regulatory Data Model Changes.

Safety

Safety features are targeted for tentative availability on June 9, 2022.

Safety

Auto-Calculations: Warnings for Overridden Values Configuration

Vault Safety now provides a user option to enable or disable auto-calculation for certain fields. While editing a field on the Case, the system informs you when this field change will impact other field values. Upon saving the record, the system will also notify you when a previously manually entered field value will be overridden with a system-calculated value, if auto-calculation is enabled.

Learn More

• Enablement: Enable Auto-Calculation Override
• User Help: Manage Auto-Calculation Override

Partial Date Support for Product-Level Device Fields Support

Vault Safety now supports partial date entry for Combination Products with device constituents for the following dates:

• Implanted Date
• Explanted Date
• Returned Date

The system will support E2B import and export of these partial dates for FDA E2B(R2). All existing field data and security configuration will be automatically copied from the preexisting fields to the new partial date fields.

Learn More

• Enablement: Case Product Device Partial Dates
• Admin Help: Enter Case Data

Partial Date Support for Dose-Level Expiration Support

Vault Safety now supports partial date entry at the Case Product Dosage-level for Expiration Date. This feature is auto-on for customers using the Case Product Dosage section control. All existing field data and security configuration will be automatically copied from the pre-existing expiration_date_v field to the new expiration_date_idate_v field.

Learn More

• Admin Help: Enter Case Data

Copy Patient Information from Existing Case Admin Checkbox

Upon promoting an Inbox Item, Vault Safety now supports the ability to copy patient information from previous Cases. You can select the following case information to be copied from an existing case to a new case: Patient Details (required), Medical History, Drug History, Case Contacts, Test Results, and Suspect/Interacting Products. Additionally, Adverse Events can be copied to Medical History and Concomitant Products can be copied to Drug History.

Learn More

• Admin Help: Configure the Case Promotion Settings Page
• User Help: Copy Patient Information from Existing Case

Improvements to WHODrug Browser and Substance Coding Auto-on

When selecting an External Product from the WHODrug browser, the Substance information is now snapshotted to the Case, which aligns with E2B(R2) Submission requirements. Some improvements have also been made to the WHODrug Browser, such as the order of columns and filters prioritizing the most referenced product details. This makes it easier to select external products.

Learn More

• User Help: Code WHODrug Products

EDQM Dose Forms and Routes of Administration Admin Checkbox

To support mandatory EDQM standard terminology for pharmaceutical dose forms and routes of administration when reporting to EudraVigilance, Vault Safety now supports mapping those fields to the latest EDQM terms when importing and exporting E2B files.

Learn More

• Admin Help: Manage EDQM Mapping for Dose Form and Routes of Administration Terms
• User Help:
  • E2B Case Import Data Mapping: E2B(R3): G.k.4.r Dosage and Relevant Information
  • E2B Generation Data Mapping: E2B(R3): G.k.4.r Dosage and Relevant Information

Receiver Information Export for E2B(R2) and PMDA E2B(R3) Configuration

Vault Safety now supports the generation of the Receiver Block in the E2B(R2) formats. Additionally, this release updates the export logic for PMDA E2B(R3) to include recipient information in the J2.18 block.

Learn More

• Enablement: Receiver Information Export for E2B(R2) & PMDA E2B(R3)
• Admin Help: E2B Generation Data Mapping

Generate and Manage Standalone CIOMS II Line Listing Configuration

Vault Safety now provides the ability to generate the CIOMS II Line Listing as a standalone report, independent of the PSUR aggregated report. All features available in the current PSUR line listing are also available in the standalone CIOMS II. Additionally, both masked and unmasked versions can be generated.

The default version of the report contains all the data required to meet regulations. Optionally, users can choose to include additional fields to the report (for example, Study ID, Patient ID, EUDRA CT number, Seriousness, Assessment Results, and Action Taken).

Learn More

• Enablement: Enable CIOMS II Line Listing
• Admin Help: CIOMS II Line Listing

Case Data Validations and Always Evaluate Criteria Configuration

Vault Safety can now validate case data without an E2B-based submission format. It can also evaluate validation criteria regardless of reportability (for example, submissions to health authorities).

Learn More

• Enablement: Enable Case Data Validations and Always Evaluate Criteria
• Admin Help: Case and Submission Validation

Multi-Format Submissions and Distributions Configuration

Vault Safety now supports the automated generation of multiple document formats within a single transmission record. For example, a CIOMS I and MedWatch 3500A form can be generated within the same Distribution record to transmit to a partner or ethics committee. Additionally, Transmission Profile overrides are now considered when determining which file format validations should be run.

Learn More

• Enablement: Multi-Format Submissions & Distributions
• Admin Help: Create a Submission

SiteVault

Veeva ePRO in SiteVault

This feature introduces Veeva ePRO to SiteVault. When enabled, Veeva ePRO provides SiteVault users the ability to perform the following electronic patient-reported outcomes (ePRO)-related tasks in SiteVault:

• Use ePRO in conjunction with a study
• Establish approved ePRO documents for use on a study
• Assign and distribute ePRO documents to study participants in MyVeeva for Patients
• Monitor and analyze the outcomes reported by participants in MyVeeva for Patients

Connected Study Type on Study

This feature adds the Connected Study Type field to the Study object. This system-managed field indicates which Connected Study components have been enabled by the Sponsor (Document Exchange, Safety Distribution, ePRO, or eConsent).

New Exchangeable Document Types on Connected Studies

This feature adds support to transfer the Ancillary Committee Submission document type to a Sponsor/CRO’s vault on a Connected Study.

Site Viewer System Role

With this feature, the Site Viewer site-level system role is available. This system role provides users limited view-only access to SiteVault.

SiteVault Data Model Changes

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

Added the following components to support the Connected Study Type on Study feature:

• Added the Connected Study Type (connected_study_type__v) picklist to the Study (study__v) object
• Added the Sponsor/CRO Global Study ID (sponsor_global_study_id__v) field to the Study (study__v) object 

QualityOne

QMS

Populating HACCP Plans with Hazard Analysis Details: Entry & User Action

This feature adds the Populate HACCP Plan object action that allows users to populate HACCP Plan details such as a list of ingredients, process steps, and their related hazard analysis records. This object action is available to configure as a user action and an entry action. Customers can maintain the list of Hazards to analyze using the Ingredient Hazard Template and the Process Hazard Template records. Learn more about the Populate HACCP Plan action.

Deep Copying HACCP Plans: Entry & User Action

This feature adds the Deep Copy HACCP Plan object action that allows users to create a copy of HACCP Plan and its related records; HACCP Plan Ingredient, HACCP Plan-Process Step, Ingredient Hazard Analysis, Process Hazard Analysis, and CPP-Hazard Analysis records. This object action is available to configure as a user action and an entry action through HACCP Plan object record actions. Customers can save time and effort by using this action to maintain and reuse content from a HACCP Plan as a template. Learn more about the Deep Copy HACCP Plan action.

Automated Email Intake for Certificate of Analysis (COAs)

This feature adds a capability for External Collaborators, such as suppliers, to submit a Certificate of Analysis (COA) document by email to Vault for a particular COA Inspection record for analysis. External Collaborators are assigned a workflow task to upload a COA file by replying to an Admin-defined email address with the file attached. Vault ingests the incoming document and attaches the document to the correct COA Inspection record by verifying the COA Inspection Record ID string in the subject line of the email reply. Automating email intake for inspection drives efficiency for customers by allowing external collaborators to submit the file to the record without using training resources for external collaborators to learn to use QualityOne Vault: with minimal training required for external collaborators, the submission rate for COAs will increase. Learn more about Learn more about configuring automated email intake for COAs.

Risk Management Framework for HAZOP & FMEA

This feature allows customers to model HAZOP (Hazard and Operability Study) and P-FMEA (Process Failure Mode & Effects Analysis) risk studies within Vault. Customers can perform HAZOP and P-FMEA assessments and create custom Risk Studies from scratch or from an existing Risk Study. Learn more about the new Risk Management framework.

HAZOP Risk Assessments

Customers can perform HAZOP Risk Studies by defining the installation nodes and applying deviations for each node. Risk assessors can assess each node’s risk based on the possible deviations (such as no pressure, no flow, and low temperature). The risk team can define the possible cause, consequence, and risk level for all possible deviations and identify mitigation actions to assign to the appropriate risk team.

Process FMEA Risk Assessments

Customers can perform P-FMEA Risk Studies by defining the process steps and their list of failure modes for each process step for risk assessment. For each mode of failure within each process step, risk assessors can detail the effects of those failures, the causes for those effects, and the controls in place to mitigate such causes. Each element of a possible failure (mode, cause, effect, control) is given a score used in calculating a Risk Priority Number. The risk assessor can identify the actions to mitigate those failures and assess the resulting scores for the mode, cause, effect, and control combination after mitigating action implementation.

COA Inspection Enhancements

This feature provides several capabilities that enhance and prepares the Early Adopter Program (EAP) of the COA Inspection functionality to be available to all customers for a future release. Learn more about COA Inspection enhancements.

Drop-down for Matching Rules

This feature improves the user experience when defining Matching Rules to allow users to select from a drop-down list of fields they can map to.

Lenient Unit Matching Enforcement

This feature modifies our unit matching strategies to reduce the likelihood of false negatives.

Application Security for Inspection Sample Test Result (ISTR) High Volume Object

This feature adds a layer of Application Security to the Inspection Sample Test Result (ISTR) object to anticipate and support the conversion of the ISTR standard Vault object (SVO) to a High Volume object (HVO) delivering in 22R3. To support Application Security, two (2) objects are introduced to allow System Administrators to set up roles for individual Users and User Groups:

• The Object Sharing Rule (OSR) object allows System Administrators to assign an Application Role to a User Group for a secured object (Inspection Sample Test Result object).
• The Record Matching Rule (RMR) object allows System Administrators to assign an Application Role to individual Users for a secured object (Inspection Sample Test Result object).

Learn more about application security for the ISTR secure object.

Linking Complaint, NCR, CAR, CII & Change Control to Material

This feature offers the ability to reference the Material object when creating Complaint, NCR, CAR, CII, and Change Control object records.

FSVP: Including Hazards on the Review & Completed Checklist Page

This feature enhances the functionality of the existing MV Checklist by displaying the list of Hazards on the Checklist Review and Completed page. The name of the Material on the Material Verification record, if available, is displayed at the start of a Checklist Design title as a reference in the Checklist Respondent page.

RegulatoryOne

RegulatoryOne features are targeted for tentative availability on June 14.

Compliance Management

Import Formulation Questionnaires

This feature automates the creation of Compliance Assessment records via Admin-defined mappings by enabling users to import responses to completed formulation questionnaires (checklists). Users can view the generated Compliance Assessments on the right side of the Formulation Composition Viewer for the related Formulation. Learn more about importing formulation questionnaire data.

Registration & Dossier Management

Propagate Fields from Registration Items to Registration & Registration Objective

Users often need to fill out data on a Registration Item that also applies to the corresponding Registration or Registration Objective. This can become duplicative over time when dealing with large volumes of records. With this feature, users can now minimize repetitive data entry by running the Populate Registration Record action on Registration and Registration Objective records, which populates an Admin-defined set of fields based on their related Registration Items. Learn more about populating Registration fields.

Veeva Claims

Veeva Claims features are targeted for tentative availability on June 14.

Veeva Claims

Remove Statement & Associated Records from Project

This feature enables Claims and Project Leads to bulk remove erroneous Statements, Claims, and Local Adaptations from a Project record. When configured, users can run the Remove Statement and Related Records action on a Project record and pick which Claims and Local Adaptations to remove by selecting the associated Project Statement and reviewing related records. Learn more about removing Statements and associated records from a Project.

Bulk Add Substantiation

This feature enables users to add an existing Substantiation record to multiple Claims using a bulk object record action. When configured, users can select Bulk Add Substantiation after selecting the option to perform a bulk action from the All Actions menu. Learn more about bulk adding a Substantiation to multiple Claims.

Bulk Add Claim Comments

This feature enables users to add a Claim Comment to multiple Claims using a bulk object record action. When configured, users can select Bulk Claim Comments after selecting the option to perform a bulk action from the All Actions menu and add the same comment to all selected Claim records. Users can also mention other users by entering the “@” or “+” keys in the Claim Comment. Learn more about bulk adding a comment to multiple Claims.

Bulk Add Project Comments

This feature enables users to add a Project Comment to multiple Projects using a bulk object record action. When configured, users can select Bulk Project Comments after selecting the option to perform a bulk action from the All Actions menu and add the same comment to all selected Project records. Users can also mention other users by entering the “@” or “+” keys in a Project Comment. Learn more about bulk adding a comment to multiple Projects.

Enhanced Configurability for the Claim Project Join Object

In this release, we have added the ability for Admins to enable the Allow hierarchical copy attribute for the Claim (claim__v) field on the Claim Project Join (claim_project_join__v) object.

This feature was released in 22R1.2 without documentation.

Enablement Details

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.

Feature	Enablement	Application
Vault Objects
Freeze Column for Related Object Sections	Auto-on	Platform
Lifecycle & Workflow
Save Task Information	Auto-on	Platform
Include Users Allowed in Role	Configuration	Platform
New Operators for Workflow on Documents	Configuration	Platform
Enhancement to Document Multi-Value Fields in Expressions	Auto-on	Platform
Reporting & Dashboards
Support Document Roles as a Reporting Object	Auto-on	Platform
Additional Aggregate Functions in Reports	Auto-on	Platform
Search
Add Archive Option to Search Settings	Admin Checkbox	Platform
Add CJK Indexing Option to Search Settings	Admin Checkbox	Platform
Freeze Column Header & Rows on Object Tabs
Access Control
Display System-Managed Users in Search & Filters	Auto-on	Platform
Delegate Admin CSV Export enhancement	Auto-on	Platform
Administration
Person: First Name or Last Name is required	Auto-on	Platform
Outbound Packages: View & Add Dependencies	Auto-on	Platform
Jobs: Audit Logs for External URL Call Jobs	Auto-on	Platform
Vault File Manager
Upload Source Files Using Vault File Manager	Auto-on	Platform
Platform Data Model Changes
Platform Data Model Changes	Auto-on	Platform
Vault Connections
PromoMats/RIM: Removed rim_applicant_uir__v Integration Rule	Auto-on	Promomats<>RIM
Protect Vault Connection Performance and Scalability (All Connections)	Auto-on	CTMS<>CDMS, ClinOps<>RIM, Promomats<>RIM
Clinical Operations
Reference Sites	Configuration	Clinical Operations - All
ePRO in Clinical Operations	Support	CTMS, Site Connect, Study Startup, eTMF
TMF Bot: Auto-Classification Enhancements	Auto-on	Clinical Operations - All
TMF Bot: Document QC Step	Configuration	Clinical Operations - All
eConsent Documents to SiteVault	Configuration	Clinical Operations - All
Standard Content Fields on CTMS Objects	Auto-on	CTMS
ClinOps/CDMS: Restricted Data	Admin Checkbox	CTMS<>CDMS
Clinical Application Management	Configuration	Study Startup
Email Checklists Based on Study Person Records	Configuration	Study Startup
Connected Studies for ePRO & eConsent	Configuration	Site Connect
Site Connect Safety Distribution Update	Auto-on	Site Connect
Connected Study Types in Clinical Operations	Auto-on	Site Connect
Site Connect: Additional Vault Clinical Docs Support	Configuration	Site Connect
Clinical Operations Data Model Changes	Auto-on	CTMS, Site Connect, Study Startup, Vault Payments, eTMF
Commercial
Automated Image Rendition Flattening	Admin Checkbox	MedComms, PromoMats
OCR Pages with Images & Text	Auto-on	MedComms, PromoMats
Optional Linked References for Pre Clearance Packages	Auto-on	PromoMats
Alternative Response Contact for Medical Inquiry Case Response	Auto-on	MedComms
Commercial Data Model Changes	Auto-on	MedComms, PromoMats
Vault Training Suite
Study Training	Support	Training
Quality
Unit of Measure object	Auto-on	LIMS, QMS, Quality, Surveillance, Validation Management
Vault Training: Data Model Updates	Auto-on	Training
External Notifications: Set Reply To Email Attributes on Complaint and Medtech Emails	Configuration	QMS
Extend Recurrence Check to Support Standard Object Types on Quality Event	Configuration	QMS
External Notifications: Distribution Group Filter Fields and Membership Automation	Configuration	QMS
Additional Standard Fields and Objects	Auto-on	QMS
Quality Team Conditional Role Exclusivity	Configuration	QMS
VPS: Data Model Updates	Auto-on	QMS, Surveillance
Quality Data Model Changes	Auto-on	LIMS, QMS, QualityDocs, Station Manager, Surveillance, Training
Regulatory
RIM PDF Standardization	Configuration	Platform, RIM Publishing, RIM Submissions
Application Indication Data Model Harmonization	Auto-on	RIM Submissions
Content Plan Bulk Actions on Matched Documents	Auto-on	RIM Submissions
Bulk Update Tokens Action	Configuration	RIM Submissions
Global Content Plan Object Type Support	Auto-on	RIM Submissions
Content Plan Creation Refactoring and Harmonization	Auto-on	RIM Submissions
Registrations Wizards Harmonization: Application Relationships	Admin Checkbox	RIM Registrations
Multiple Gateway Support	Configuration	RIM Registrations
EUDAMED UDI XML Generation Updates	Auto-on	RIM Registrations
Open Validation Results Behavior Updates	Auto-on	RIM Publishing, RIM Submissions
Japanese Validation Criteria Item 7 Support	Auto-on	RIM Publishing
22R2 RIM Data Model Changes	Auto-on	RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive
SiteVault
Veeva ePRO in SiteVault	Auto-on	SiteVault Enterprise, SiteVault Free
Connected Study Type on Study	Configuration	Site Connect, SiteVault Enterprise, SiteVault Free
Site Viewer System Role	Auto-on	SiteVault Enterprise, SiteVault Free
New Exchangeable Document Types on Connected Studies	Configuration	Site Connect, SiteVault Enterprise, SiteVault Free
SiteVault Data Model Changes	Auto-on	SiteVault Enterprise, SiteVault Free
QualityOne
Populating HACCP Plans with Hazard Analysis Details: Entry & User Action	Configuration	QualityOne
Deep Copying HACCP Plans: Entry & User Action	Configuration	QualityOne
Automated Email Intake for Certificate of Analysis (COAs)	Configuration	QualityOne
Risk Management Framework for HAZOP & FMEA	Configuration	QualityOne
HAZOP Risk Assessments	Configuration	QualityOne
Process FMEA Risk Assessments	Configuration	QualityOne
COA Inspection Enhancements	Auto-on	QualityOne
Drop-down for Matching Rules	Auto-on	QualityOne
Lenient Unit Matching Enforcement	Auto-on	QualityOne
Application Security for Inspection Sample Test Result (ISTR) High Volume Object	Configuration	QualityOne
Linking Complaint, NCR, CAR, CII & Change Control to Material	Auto-on	QualityOne
FSVP: Including Hazards on the Review & Completed Checklist Page	Auto-on	QualityOne
RegulatoryOne
Import Formulation Questionnaires	Configuration	RegulatoryOne Compliance Management
Propagate Fields from Registration Items to Registration & Registration Objective	Configuration	RegulatoryOne Registration & Dossier Management
Veeva Claims
Remove Statement & Associated Records from Project	Configuration	Veeva Claims
Bulk Add Substantiation	Configuration	Veeva Claims
Bulk Add Claim Comments	Configuration	Veeva Claims
Bulk Add Project Comments	Configuration	Veeva Claims
Enhanced Configurability for the Claim Project Join Object	Configuration	Veeva Claims