Release Date: June 3, 2016
We are pleased to bring you the following new features in this week’s release. For details about each feature’s impact and enablement, see below. You can also check out New Features in the API.
Vault Objects
Dynamic Access Control for Objects
In this release, Vault supports Dynamic Access Control (DAC) for object records. This security model works similarly to Dynamic Access Control for documents. It enables Admins to define security rules for controlling access to specific object records. Admins enable this security model on individual objects.
This new model uses the same roles on object records (Viewer, Editor, Owner) as Custom Sharing Rules (formerly called Dynamic Security). In the new model, Admins control user access by creating User Role Setup records and configuring Matching Sharing Rules on an object.
Matching Sharing Rules
When configuring individual matching sharing rules on an object, Admins specify: a role (Viewer, Editor, Owner) and one or more criteria or “context” fields. A criteria field must meet several criteria:
Exist on both the User Role Setup object and the secured object
Have the field type Picklist (not multi-select and using a global picklist) or Object
For example, VeePharm’s Product object has three matching rules: each one uses one of the three roles and the Therapeutic Area picklist field.
User Role Setup
When using DAC, organizations define a specific user’s scope of responsibility by creating User Role Setup records. These records associate a user with an application role and a specific business context. For example, Gladys is a Viewer on products with Endocrinology as the therapeutic area.
Auto Managed Groups
Vault automatically places users into Auto Managed groups, which are governed by matching sharing rules, based on their User Role Setup records. Those groups have specific role assignments on specific object records. When users change User Role Setup records (create a new record, inactivate an existing record, etc.), the system automatically reflects those changes by adding/removing users from Auto Managed groups, so everything stays in-sync.
For example, the Editor: Therapeutic Area rule from above corresponds to a set of groups with the naming convention [CODE] ${therapeutic_area}-${role}-${user role setup}. There’s a User Role Setup record specifying that Gladys is a Viewer for Endocrinology, so Vault places her in the group Endocrinology-Viewer-User Role Setup. When someone creates a new User Role Setup record specifying that Thomas is a Viewer for Endocrinology, Vault places him in the same group.
User Role Setup Object Class
In V14, vaults included a single User Role Setup object to support DAC for documents. In this release, we’re introducing the concept of an “object class” and User Role Setup becomes a class of objects, rather than a single object. Each can define context fields DAC for one or more objects.
An organization might use multiple User Role Setup objects if they use DAC in different contexts. For example, VeePharm’s eTMF vault controls document access using the Study, Study Country, and Study Site fields to indicate a user’s context. In the same vault, VeePharm uses Therapeutic Area to indicate a user’s context and control access to Product records. If VeePharm had a single User Role Setup object, it would need to include all of these fields. By using two objects with the User Role Setup class, each of the objects needs fewer fields and record setup is easier for each object.
Bulk Actions for Objects
This enhancement streamlines object record management by enabling users to edit, delete, or change lifecycle state for up to 1,000 records at a time.
Similar to bulk actions for documents, users access the bulk option from the actions menu (represented by a gear icon) in an object record list page. Bulk actions use a wizard where users can refine record selection, choose an action, and confirm. Users receive notifications in Vault and via email when the process is complete.
Users must have a security profile that grants the Application: Object: Bulk Action permission to access this feature. Their security profile must also grant the necessary object-level permissions (Read, Edit, Delete). On objects that use Matching Sharing Rules or Custom Sharing Rules to secure individual records, users must be in the Editor or Owner role on an object record to edit or delete it.
Automatic Task Reminders for Object Workflows
Building on the Automatic Task Reminders feature for document workflows, this release introduces automatic task reminders for object workflows. Admins can now configure object workflow user tasks with reminders, so users receive notifications that they have open tasks to complete.
Reporting
Cross-Version Reporting
Cross-Version Reporting enables business users to create reports that include all versions of documents. Users can turn this option on for any reports with the document or [object] with document report types by selecting a checkbox during report creation.
Cross-version document reports display:
Rows for each version: A separate row for each major and minor version of each document that meets the report’s filters and that the user can access.
Version field: A sortable and filterable column that concatenates the major and minor version (0.1, 0.2, 1.0, etc.).
State type field: A filterable field that shows the special state (Steady, Superseded, etc.) for each document version.
Steady State Begin and End fields: Filterable fields indicating the first and last date on which a document version was in the Steady state.
The feature is particularly helpful for supporting audits. To generate a list of documents that were in Steady state during a specified window of time, users simply apply date-based filters to the new Steady State Begin and Steady State End fields. The report viewer not only displays details about prior document version but also enables the user to drill into each one for more information.
Conditional Report Fields for Object Reports
Vault first introduced Conditional Fields in V14 for Document Relationship report types. In the last release, we extended them to Document report types. This release makes the feature available for Object reports as well. Report creators can use this feature to apply a label to each report row based on a series of conditions, for example, a conditional field that indicates that a registration commitment has a:
“High” priority if its Therapeutic Area is “Cardiovascular” or “Oncology” and its Country is “China” or “United States”
“Medium” priority if its Therapeutic Area is “Immunology” or “Toxicology” and
“Low” in all other cases
After defining the conditional field, users can group report results accordingly. Conditional fields can also appear in dashboards to visually indicate the distribution of data between categories.
Matrix Layout for Object Reports
Document reports have supported matrix layouts for several releases. In this release, Vault extends matrix layouts to several additional report types: Document Relationship, Object, and Binder. Matrix layout requires that users group records by two parameters: a row grouping and a column grouping. The report displays aggregate values (record count, sum, average, etc.) at the intersection of each row-column combination.
Aggregate values can also appear as a percentage of the total row or column value. For clinical users, this setup makes it easy to quickly assess the share of documents that are complete by country, site, document type, or other relevant parameters. Similarly, commercial customers can leverage this to assess the percent of content that’s reused by a combination of any two attributes (document type, agency, local country, month, etc.).
Search & Navigation
Multi-Document Viewer for Binders
In this release, Vault has a new way to view and interact with multiple documents in a binder, including documents within binder sections. The multi-document viewer provides a seamless and contextual way for users to view the collection of documents in any binder or section. This viewer also allows users to perform bulk actions on all documents in the binder, even if documents are in sections or sub-sections.
Enhancements to Search Modifiers
Search Modifiers allow you to quickly apply a document field filter from within the search bar, rather than searching for a value within all fields. In the last release, this feature required enablement from Veeva Support. In this release, Search Modifiers is automatically available in all vaults.
As part of this update, we’ve also expanded the feature to support additional fields: Document Number, Created By, and Last Modified By.
Filtering on Number Fields
Users can now filter on number fields in the Library, document tabs, and object tabs. Operators for number fields include “in the range” and “equals.”
Updated UI in Library Tabular View
We’ve updated the interface for the tabular view in the Library and other document tabs. In addition to visual changes, users can now also toggle between truncating and wrapping cell contents.
Renditions & Annotations
Restore Placement for Bring Forward Annotations
Bringing annotations forward from a previous version results in page-level annotations, without a text or image selection. As a result, users may spend hours restoring annotation placement in the latest version. In this release, Vault can auto-place text annotations when the matching text is found only once on the same page by number. Vault also allows users to declare when pages have been added or removed in the new version, ensuring more accurate placement of annotations brought forward from past versions.
Fully Annotatable PowerPoint Slides with Speaker Notes
This release introduces the new PowerPoint Rendition Settings action for documents with a PowerPoint source file. Using this option, users can choose whether they want to include Speaker Notes and hidden slides in the Viewable Rendition.
Generate Bookmarks from Table of Contents
Admins can now enable Generate bookmarks based on Table of Contents to ensure that new viewable renditions from MS Word files will include bookmarks based on the links in the Table of Contents. For MS Word source files that don’t include a Table of Contents, Vault dynamically creates bookmarks based on Headings 1 through 9.
This setting only affects renditions generated after enabling the setting. Vault will not regenerate existing viewable renditions to reflect the new setting.
Show/Hide Print Only Watermark
In this release, users will see PDF Rendition Settings in the document actions menu when their source file is a PDF. This action enables users to choose whether the viewable rendition shows or hides “Print Only” watermarks from the source file.
eTMF & Study Startup
Site Activation Progress View
The critical path for site activation requires collecting site documents quickly, finalizing contracts and budgets, and ensuring local approvals are complete. Site Activation Progress is a new view allowing study startup specialists to monitor overall progress across a study country and easily identify what is holding up each site’s greenlight. Status indicator icons and hover cards provide detail at a glance. Startup specialists can also navigate directly to documents to remind the site to submit or take other immediate action, enabling them to get every site to first subject, first visit faster.
TMF Viewer
The TMF Viewer enables customers to actively manage their TMF by enabling them to browse content organized by multiple configured hierarchies. Admins can configure multiple binder templates to represent hierarchical structures, for example, TMF Reference Model 2.0, 3.0, or a completely custom structure.
Using the TMF Viewer, users select a binder template, Study, Study Country and/or Study Site and then browse content organized by the binder template’s hierarchy. Users can easily switch between different hierarchy views. As document types and reference model standards evolve over time, administrators can create new binder templates and make them available through the TMF Viewer.
Bulk Create Binders for a Study
Archiving a TMF in Vault requires creation of a “master file” binder for the study and for each of the study’s countries and sites. In this release, users can trigger bulk creation of master file binders for an entire study or an entire study country, directly from the relevant study or study country page. After binder creation is complete, Vault initiates the auto-filing process the new binder, so that a complete set of master file binders is ready for review and archival.
View Related Expected Document List Items
In V14, Vault allowed a user to navigate to a single Expected Document List Item for a site, edit the item, and then quickly update all related items for all sites in a study or all sites in a study country. In V15, we’ve made it easier for users to change multiple Expected Document List Items when the scope is narrower than “all sites,” for example, only sites in a study that are currently enrolling. The new View Related action on Expected Document List Items navigates users to a filtered list of related items. From there, users filter to narrow the list and use bulk actions to make the required updates.
Form 2253 Generation
Multi-Product 2253 Generation
Vault PromoMats can now auto-generate the Supplementary Sheet required for multi-product 2253 submissions. To support this, we’ve added a new standard Application object, which stores the Application Number and Application Type (previously fields on the binder). Each Application is associated with a Product and Applicant object. Selecting a product when creating a 2253 Compliance Package binder, automatically selects both the Application and Applicant and populates the FDA Form 2253 accordingly.
This release also splits out Responsible Official details from the existing Applicant object, allowing the 2253 administrator to select the appropriate Responsible Official per submission. These details are now stored in a new Contact object.
Note: A feature flag controls the new standard Application and Contact objects, but remapping the FDA Form 2253 requires configuration by Managed Services on existing vaults.
Improved Handling for Form 2253 Generation
For any Form 2253 generated after this release, Vault automatically populates the hidden External ID field. The auto-populated value identifies the form as system-generated so that Vault knows to version the document. If the compliance binder contains a manually uploaded Form 2253, Vault will not version the form, and will instead generate a new form. In past versions, Vault would version the form regardless of whether it was system-generated or manually uploaded.
Note that Vault considers any Form 2253 created before this release to be a manual upload because its External ID field does not contain the system-generated value. When generating Form 2253 documents in this situation, users will notice that their binder contains two Form 2253 documents.
Multichannel
Create Presentation Supports Slide Versioning
Create Presentation better handles content updates. When a user triggers Create Presentation on a document that already has a Multichannel Presentation and Multichannel Slides, that user can now choose to version the existing slides. In past releases, this action always created new slides. Note that the version option only appears if the viewable rendition page counts match between the two versions.
Enhancements for CLM Integration & Approved Email
For customers using Approved Email and CLM integrations, we’ve added new configurations to support enhancements coming to Veeva CRM in V27. These changes are visible starting in this release, but won’t be functional until the Veeva CRM V27 release.
For vaults with Approved Email Integration, we will provision the new Survey object and document field. This configuration, which already exists for CLM, supports survey functionality in Approved Email.
For vaults with CLM Integration, we will provision the new Keywords object and field. This configuration supports classifying CLM in Vault and Veeva CRM.
RIM
Updates to Bulk Activity & Submission Creation
In this release, bulk record creation for RIM Registrations incorporates the following new features:
Any custom required fields now display on the bulk creation wizard for both Activity and Submission objects.
During bulk Submission creation, Vault automatically creates the relationship between the submission and the pharmaceutical (drug) product. This relationship is leveraged in the bulk Registrations creation.
SubmissionsArchive Cancellation Option
In this release, SubmissionsArchive users can cancel import or removal jobs that are in waiting to be processed or in-progress. These options give users the ability to quickly react to errors encountered during the import of submissions or the migration of multi-sequence applications.
New Applications and Submissions Document Fields
With this release, RIM vaults will include two new standard shared document fields: Applications (applications__v) and Submissions (submissions__v). SubmissionsArchive can auto-populate these document fields based on submission imports. These additional fields are valuable for document searches and support more granular Dynamic Access Control rules on documents.
Expand & Collapse in SubmissionsArchive Viewer
This enhancement provides users with an improved experience by minimizing the number of clicks they need to perform in order to reach content in an archive. Previously, users needed to drill down by individual section to reach sections with content. With this enhancement, a single click on the Expand Section action menu item on the binder section opens all sub-sections until a section with content is reached. Similarly, the Collapse action menu item collapses all sections with a single click.
Additional eCTD DTD/Schema Support
SubmissionsArchive users can now import additional DTDs/schemas:
EU 1.0
EU 1.3
Vault Loader
Vault Loader Enhanced Logging
Vault Loader success and failure logs are now combined so you can easily map successes and failures to your original input file. The output log file also returns fields that have been created for each success row by querying the field using VQL. This latter feature will only be available for object types that are VQL-supported and metadata fields that are queryable using VQL.
Document Configuration
Object Attribute Lookup Fields for Documents
In this release, we’ve introduced the new Lookup field type for documents. This field “looks up” an attribute on an object record already associated with a document and brings that value down to the document as a read-only field. Lookup fields can support search, filtering, and reporting. They can also provide additional context for Dynamic Access Control on documents.
Support for Multiple Document Type Groups
Admins can now assign multiple document type groups to Base Document, document types, subtypes, and classifications. This update helps support DAC for documents. With this change, organizations can define and manage both granular and coarse document type security policies, based on specific country and regulatory requirements.
For example, VeePharm assigns a document type group to all classifications associated with the Advertisement subtype and assigns more granular document type groups at each classification level (print, radio, web, television).
Admins can reference these document type groups in User Role Setup records, giving the flexibility to define access based on different groups of document types, subtypes, and classifications. In our example, a Marketing Manager role could access all documents in the “Advertisement” document type group, while a Web Marketer could access only documents assigned to the “Web” document type group.
ISO 8601 Date & Time Format Support
Administrators can now set the ISO 8601 date format (YYYY-MM-DD) as their universal display format throughout Vault. ISO 8601 describes an internationally accepted way to represent dates and times using numbers..
ISO 8601 provides a standardized way of presenting dates and times. It helps cut out the uncertainty and confusion when communicating internationally.
Decreased Limit for Document DAC Rules
As an implementation best practice, and to ensure optimal performance, we recommend using as few matching rules as possible per document lifecycle role.
Starting from this release, the maximum number of matching rules per lifecycle role is now 8 (originally 25). If your vault already uses more than 8 rules per role, your current number becomes the new maximum on your vault.
Authentication
SSO: Configurable RelayState on IdP-Initiated URLs
With this release, Single Sign-On SAML profiles allow greater configurability of IdP-initiated URLs, providing for more flexibility for deep-linking with various Identity Providers. Specifically, Admins can use a new templating syntax to define the required URL query parameters and ensure proper value encodings.
Feature Enablement Details
Feature
Enablement
Application
Vault Objects
Dynamic Access Control for Objects
Configuration
All
Bulk Actions for Objects
Auto-On
All
Automatic Task Reminders for Object Workflows
Configuration
All
Reporting
Cross-Version Reporting
Support
All
Conditional Report Fields for Object Reports
Configuration
All
Matrix Layout for Object Reports
Configuration
All
Search & Navigation
Multi-Document Viewer for Binders
Auto-On
All
Enhancements to Search Modifiers
Auto-On
All
Filtering on Number Fields
Auto-On
All
Updated UI in Library Tabular View
Auto-On
All
Renditions & Annotations
Restore Placement for Bring Forward Annotations
Admin Checkbox
All
Fully Annotatable PowerPoint Slides with Speaker Notes
Auto-On
All
Generate Bookmarks from Table of Contents
Configuration
All
Show/Hide Print Only Watermark
Auto-On
All
eTMF & Study Startup
Site Activation Progress View
Support
Study Startup
TMF Viewer
Support
eTMF
Bulk Create Binders for a Study
Auto-On
eTMF
View Related Expected Document List Items
Auto-On
eTMF
Form 2253 Generation
Multi-Product 2253 Generation
Admin Checkbox1
PromoMats
Improved Handling for Form 2253 Generation
Auto-On
PromoMats, MedComms
Multichannel
Create Presentation Supports Slide Versioning
Auto-On
PromoMats, MedComms
Enhancements for CLM Integration & Approved Email
Configuration
PromoMats, MedComms
RIM
Updates to Bulk Activity & Submission Creation
Auto-On
RIM Registrations
SubmissionsArchive Cancellation Option
Auto-On
RIM SubmissionsArchive
New Applications and Submissions Document Fields
Auto-On
RIM
Expand & Collapse in SubmissionsArchive Viewer
Auto-On
RIM SubmissionsArchive
Additional eCTD DTD/Schema Support
Auto-On
RIM SubmissionsArchive
Vault Loader
Vault Loader Enhanced Logging
Auto-On
All
Document Configuration
Object Attribute Lookup Fields for Documents
Configuration
All
Support for Multiple Document Type Groups
Configuration
All
ISO 8601 Date & Time Format Support
Configuration
All
Decreased Limit for Document DAC Rules
Auto-On
All
Authentication
SSO: Configurable RelayState on IdP-Initiated URLs
Configuration
All
1 Requires additional setup after enablement
See the following explanations of feature enablement options:
Enablement:
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: On/off option controlled by Admins
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