Pre-Release Date: March 23, 2015 | Release Dates: April 10 & April 17, 2015
We are pleased to bring you Vault V11. Read about the new features below. You can find information on enabling new features in V11 Feature Enablement Details.
Show All Details | Hide All Details
Custom Tabs
Custom Tabs is exciting new functionality which allows organizations to configure the primary navigation bar in their vault with objects and documents alongside one another. No longer bound by Vault’s standard navigation, numerous possibilities exist for creating a completely custom look, feel, and functionality in a vault. Show details...Hide details...
Add tabs to the primary navigation bar to:
Display filtered library views featuring important documents
Group related documents or other information underneath individual container tabs
Edit object records outside of the Admin area
Further extending the utility of Custom Tabs is the ability to embed external websites, displayed on the navigation bar as if they were part of vault. Admins can configure web tabs to show a website relevant to their team, provide a customized view of vault data, or display information from related systems. Learn more.
To support custom document type and object tabs, we’ve also updated Vault’s search functionality to make both object records and documents easily searchable. From the main search bar or advanced search, users now choose their search context: a custom document type tab, a custom object tab, or “all documents” without having to first navigate to the tab. The context options in the search bar align with the custom tabs in the vault. For example, the VPharm vault has several objects (Product, Country, Marketing Campaign, etc.), but only one custom tab, which shows products. The search bar selector only shows two options in this vault: All Documents and Products. Learn more about search.
Note that Portal Users do not see custom tabs.
Custom Views
Custom views can eliminate the repetitive work of searching and filtering to find specific documents or object records. A view can save search terms, filters, sorting, and layout options. In tabular layout, the view stores the set of visible columns so users can have many different data layouts among their custom views. Learn more about custom views.
Users can also share custom views with colleagues in the same vault. Show details...Hide details...
Custom View Sharing
Sharing allows organizations to further streamline users’ daily work by providing them with a set of views tailored to their business processes. For example, an administrator creates a custom view to show approved CholeCap materials and shares that view with the entire CholeCap team.
Since sharing can mean that users have a large number of custom views available, this feature includes a new view management window. When users receive a new shared view, they can choose to add it to their own Views panel for quick access (up to 20 total views), or access it through the new window.
By default, only users with the Business Admin, System Admin, or Vault Owner security profile have permission to share views.
Offline Annotations
This new feature helps reviewers to be productive while offline, using familiar PDF review and annotation tools. Users can now export any document’s viewable rendition, along with its annotations, and review offline in their preferred PDF viewer. Reviewers can reply to exported annotations and create new annotations. When finished, they can then import the annotated rendition back into Vault. Show details...Hide details...
Multiple users can even review and annotate offline concurrently: when they import, Vault adds each new annotation to the document as if the users had annotated through the UI. If any mistake happens, Vault helps users to recover easily with the Undo Last Import option. Learn more about offline annotation.
Users must export using the Export Annotations action, not the PDF with Annotations action, in order to annotate offline.
This release also allows exporting and importing of annotations through the API.
Attachments on Documents & Objects
With a comprehensive set of content management tools, Vault provides unparalleled control over document lifecycles, but we understand that not all files require this level of control and processing. In this release, we introduce document and object record attachments. Attachments provide a simple way to upload and associate related files with existing documents or object records without the overhead of Vault’s full document management capabilities. Show details...Hide details...
Unlike “regular” documents, attachments don’t have a document type, document fields, or annotations. They won’t appear in the Library, but can appear in searches, subordinate to their “parent” document or object record. Attachments support simple versioning, but have no lifecycle. Document attachments are automatically bound to all versions of a document.
A single content placeholder with attachments allows users to create organized file collections for general sharing in much the same way as a folder in a traditional file system. Organizations could also use attachments to connect correspondence to a related regulated document.
Learn more about attachments.
Job Scheduler
Vault’s Job Scheduler (now available in all applications and Vault platform) allows organizations to automate tasks and reduce the time users spend on document management. By automating business processes, you also minimize the operational risk inherent in completing the tasks manually. In this release, Vault administrators can access the Operations tab within Admin and define a query to run with a set of actions that occur on the results. These “jobs” run every day at a specific time with no user interaction required. Show details...Hide details...
Job Actions
In this initial release, we support actions to deliver email notifications to users based on document roles and to execute state changes. Using Job Scheduler, organizations can automate processes like the release of Effective documents to consumers or streamline more granular periodic review processes based on the document metadata already captured in their vaults. Learn more about defining jobs.
Monitoring
Admins can also monitor and interact with jobs that are executing in a vault via the Monitoring and Status pages within the Operations tab. Historical run information, status, and configurations for completed job instances are all available to appropriately privileged administrators. Learn about monitoring jobs.
Auditing
Through configuration, organizations can empower jobs to execute mission-critical actions such as expirations and releases of controlled content, even if there are pre-existing workflows which would normally block the action from occurring. All actions that jobs take against your documents have unique markers in the audit trail, making it easy for auditors and document owners to distinguish user-initiated actions from system actions, and to trace business processes throughout a document’s lifecycle.
Custom Dynamically-Populated Groups
Vault V10 saw the introduction of security profiles. One effect of using a custom security profile is that its users are not included in any system-managed groups (All Internal Users, External Users, etc.). Many customers want their own system-managed groups that Vault automatically populates with users who have particular security profiles. For example, the “All Verteo Biopharma” group may contain users that have the “Verteo Business Admin” and “Verteo Document User” security profiles.
This feature adds the ability to automatically include users with specific security profiles in any existing custom group. Once an Admin has set up a group in this way, nobody needs to manage its members. The group will automatically include the users that have the specified security profiles. Learn more. Admins can also configure a security profile-based group through the API.
Improved Object Page Layouts
With new custom tabs that give the same level of visibility to object records and documents, object record page layouts deserved a makeover. These pages now feature a modern, easy-to-navigate design that displays all related records on a single page. Users can quickly browse the object record details or jump between sections using the links on the right side of the page. To facilitate easy access to child-level records, the new table display allows users to search and click into individual records.
Reporting on Binders
Users can now create reports and dashboards that use binders and their relationships with documents. This release introduces new standard report types to support this functionality: Binder with Document, Binder Section with Document, Binder Section with Document and Binder. In these reports, report columns, filters, and grouping can use binder, section or document fields.
For example, a Submissions Manager could create a report that displays all documents in the binder, grouped first by the binder’s top-level sections (CTD Modules 1-5), then by the document status. For each document, users could report on version binding. In a dashboard, users could monitor submission readiness by showing the breakdown of document statuses across each of the submission binder’s modules.
Email Workflow Participants
Sometimes it’s necessary to remind workflow participants when their task due dates are approaching or past due, or to send notifications of workflow changes. In this release, we’ve added an Email Participants action that allows Admins and workflow owners to more easily communicate with participants on active workflows. Learn about managing active workflows.
Opt-In for Veeva Emails
Veeva periodically sends product announcement emails to users (upcoming webinars for releases, etc.) and system availability (service unavailable during maintenance, etc.). Until now, users had to contact Veeva Support to get on these email distribution lists and contact Support again to unsubscribe. In this release, we are allowing any user to sign up (“opt-in”) for the Veeva Vault Product Announcement and Veeva Vault System Availability emails. By default, users with the Vault Owner, System Admin, or Business Admin security profile are enrolled for these email distribution lists, but they may opt out at any time. Non-Admin users can sign up for emails as long as they are able to update their user profile. This user setting is also editable through the API.
CRF & Dataset Import
One of Vault’s strengths is the ease with which users can upload content from other systems. In eTMF and Submissions vaults, users frequently need to extract Case Report Forms (CRFs) and datasets from other systems, and then use those documents as approved content in a submission, or archive them in a TMF. (Note that dataset import is only for Submissions.) This release enhances existing CRF import functionality by leveraging the Clinical Study/Study object to automatically classify, set as Approved, and increments the major version for the content, which can now be CRFs or datasets. In past releases, this feature was only available in eTMF vaults. In this release, we’ve also made the feature available in Submissions vaults. Learn about setting up and using bulk import for Submissions.
In this release, users will also notice the following enhancements for eTMF:
Admins can configure the Document Type that Vault applies to imported CRFs. In past releases, Vault classified all imported CRFs as Final CRF.
Vault will use the existing External ID (external_id__v) field as a unique identifier for CRFs, rather than the CRF External ID field (crf_external_id__v) used in previous releases.
When users upload a new file for a CRF that already exists, Vault increments the document’s major version, for example, 1.0 to 2.0.
Learn more about setting up CRF import for eTMF.
Milestone Object
In this release, we introduce the Milestone object to eTMF vaults. The new object specifies key milestones at the Study, Study Country, and Study Site levels. Those milestones are related to documents so that users can measure and report on TMF completeness per milestone. By assigning milestones (such as site start, country close, database lock, etc.) to documents, organizations can measure the progress of a study based on the status of individual documents in relation to the milestone. Learn more.
2253 for Submissions
With a large number of promotional materials in a US 2253 submission, populating the form with materials’ details is repetitive and time consuming. With this release’s new 2253 form generation action in Submissions vaults, users can auto-populate the form based on the materials included in the submission binder. Users can also source content from a PromoMats vault using CrossLinks functionality. When an Admin enables 2253, Vault automatically creates fields and picklist values in the Submissions vault that align with those used in PromoMats, allowing organizations to maximize reuse and easily ensure proper attribute mapping.
Bulk Actions from Reports
The bulk document action capability released in V9 has saved users many hours of work by streamlining the process of updating fields and sharing settings across many documents. To make this feature even more useful, we have added the ability to initiate bulk actions from report results. Show details...Hide details...
When viewing a document report, users can initiate a bulk action on the report’s results. This provides particular value when updating roles on more than 1,000 documents. For example, after running a report to find all documents where Tracy is not an Approver, users can bulk update to add Tracy to the Approver role on the first 1,000 documents. After refreshing the report, they see the next 1,000 documents and can repeat the process. Users can follow a similar process for editing document fields or starting Read & Understood workflows.
Annotation Proximity Viewer
Vault strives to make the review of annotations as effective as possible. Several key enhancements to the presentation of annotations in sidebar mode make reviewing easier than ever. First, Vault aligns each annotation horizontally with its selected content, rather than aligning with the top of each page. Second, Vault limits the amount of comment text displayed in unselected notes, maximizing the number of notes visible per page. Finally, Vault ensures that both the note and its highlighted content are visible when the user selects either, regardless of the user’s display size, resolution, or level of zoom. Vault now re-positions notes and the document as needed to display both.
With these enhancements, we have also removed footer mode, which displayed annotations below each page of the document. In sidebar mode, there will no longer be a space between each page.
Customizable Standard Groups
In this release, we allow administrators to create custom dynamic user groups which automatically add users with specific security profiles. (See details above.) However, some customers also need to change who is included in the standard provided system managed groups. Show details...Hide details...
Admins with the Vault Owner security profile can now select which security profiles are included in the below groups, allowing organizations to take advantage of custom security profiles without having to migrate existing documents that use the above groups to assign document roles.
All Internal Users
Business Administrators
Document Users
External Users
Read-only Users
System Administrators
Vault Owners
Document Creation in Planned State
Organizations often use the Planned state as an indication that a document is expected, but has not yet been worked on. In the past, only documents created through a binder template originated in Planned state. This feature makes new document creation more consistent: Vault now creates placeholders and documents from template in the Planned state. When users create a new document by uploading a file, these documents still begin in the Starting state for the document’s designated lifecycle. Learn more about planned state.
Streamlined 2253
This enhancement allows users to create a 2253 compliance package binder, populate the binder with corresponding submission materials, and generate the 2253 form as a single action. Previously, users needed to add individual documents to the compliance package. In this release, we’ve streamlined the process. Show details...Hide details...
Using the new Create Compliance Package bulk action, users simply select all promotional materials ready for a submission. Vault then creates the binder and automatically populates it with the selected documents.
In addition to the new bulk action, this release also introduces a new eCTD Compliance Package binder template, based on the FDA’s latest guidance for eCTD Module 1 submission. This template can help users better organize submission materials in the new format.
Improved Component Binder Functionality
This feature improves usability by allowing users to drill into component binder sections from the main binder page. The enhancement, available only in Outline View, allows users to view sections within a component binder, and then to upload or download documents linked to the component binder. In previous releases, users would have to navigate into the component binder (and away from the main binder) to perform these actions.
Enhanced Binder Auto-Filing (eTMF)
In eTMF, it’s important that documents are filed in the appropriate binders and binder sections. Auto-filing facilitates this process by automatically linking documents to their matching master file binder. In this release, we’ve extended the auto-filing logic so that it triggers when users update any field values for a document. Vault also auto-files documents when updating through the API.
Planned Documents Inherit Binder Values for Custom Fields
When documents and their associated binder share a common document field, the field value is generally the same. This feature saves users time and effort when creating a binder from a template and populating fields on planned documents. On all planned documents in the binder, Vault auto-populates values for custom document fields, using the values entered for the binder during binder creation.
Custom Binder Thumbnails & New Standard Thumbnails
We’ve redesigned our thumbnail images for binders, giving them a cleaner look and more prominent size, allowing users to more easily recognize them in the Library. The new binder thumbnails come in two different varieties: orange for standard binders and black for binders configured for CLM or Engage integration. As part of this enhancement, we also now allow users to customize binder thumbnails by showing an image taken from any document within the binder. Learn more.
Standard Date Formats
Inconsistencies in date and time formats in different geographic locations have the potential to introduce errors into your processes. Does 4/2/2014 mean April 2nd or February 4th? The answer depends on the country you’re in. When users can interpret a date differently, it becomes difficult to know what date is represented.
To address this issue, we’ve standardized our date and time formats system-wide. For a given user and region, Vault now uses the same format in every screen and in all exported vault data. We’ve also added new settings which allow organizations to apply settings for users in all geographic locations. Organizations can apply a consistent format to each locale or set one format to use in all locales. Learn more.
Custom Date/Time Fields
In previous releases, all document and object fields of the type Date/Time have been standard, system-managed fields such as Created Date, Last Modified Date, etc. In this release, Vault introduces custom Date/Time fields which are user-configurable. Dates and times can then be easily entered by document and object users. With the addition of Vault’s new standardized date formats, users working with custom Date/Time fields across time zones can be assured there is no ambiguity in the date and time specified, regardless of their geographic location.
Download Source File from Approved Email Viewer
In this release, the Approved Email viewer can allow recipients to download both the PDF rendition and the source document. This new feature benefits Approved Email users who need to provide fuller document access to a person without a Vault login. Commonly, the non-Vault users who need to download source files are HCPs who will be giving talks that require them to use the provided slides for a more effective presentation.
Depending on Admin configuration, users may be able to restrict recipient downloads of both the PDF rendition and source file on a per-document basis. They can set this from the new Approved Email section of Doc Info page’s field panel.
Multichannel Enhancements
For customers using Engage, CLM, or Approved Email integrations, we’ve added new fields and picklist values to the Presentation document type to support the following enhancements to Veeva CRM:
Disable Zoom on CLM Slides
Disable Rotation Lock on CLM Slides
Send Approved Emails from a Medical Inquiry
CLM Survey Overlay
Related Content Display Order
Auto-Generate Email Fragments
MSLs have access to a vast library of documents they can send via Approved Email and creating Email Fragments for each of those documents individually isn’t practical. In this release, we introduce a new Master Email Fragment document type and user action to provide Approved Email users with the ability to quickly create Email Fragments for any available document in Vault. Show details...Hide details...
The new document type acts as the template for automatically generated Email Fragments. This saves customers time and money by allowing them to create just a handful of templates which can be reused over and over again. To create an Email Fragment, users simply select a document they wish to send via Approved Email, select the Create Email Fragment user action, and then select the Master Email Fragment to use. Vault automatically generates the Email Fragment and links it to the selected document.
This feature is also available via API.
Signature Page Sizing
To maintain consistent page dimensions in a PDF document, Vault will define the signature page’s size based on the first page of the viewable rendition. Learn more about managing signature pages.
Report Column Enhancement
This release includes minor changes to report editing and viewing to make reports easier to use:
In the report builder, the leftmost column is now smaller, allowing better visibility for other columns.
Users can now drag column edges to resize columns in both the report viewer and the report builder. In the report viewer, column sizes will default based on the settings applied in the report builder.
Minor Annotation Improvements
This release introduces several modifications to the document viewer and annotation handling, designed to make life easier for users. Show details...Hide details...
Bring Forward Annotations: Limit Undo to Current User’s Annotations
When a user applies the Remove Brought Forward Annotations action, Vault now removes only annotations brought forward by that individual user. Previously, the action removed all annotations brought forward by any user. Vault now offers an additional option to Admins, which allows them to remove annotations brought forward by all users, exactly like the previous default behavior. Learn more.
Visual Indicator for Truncated Notes
Vault now displays a visual indicator when a longer comment on an unselected annotation is partially hidden. Once a user selects the note, the indicator disappears and Vault displays the full comment.
Remember Applied Annotation Filters
Vault now remembers and re-applies annotation Filter menu settings for each user across documents, browsers, and sessions within a single vault. If users modify their filters, the revised settings replace the previously saved settings. The only filter settings not saved are Hide / Show Annotations and Filter Anchors.
Dynamic Resizing on Filter Menu
The annotation Filter menu now dynamically resizes to improve usability on limited-height displays.
Delegated User Support for Annotations
With this enhancement, users can better understand who created or edited an annotation when delegated access is in use. The delegating user’s name now appears in a tooltip when users hover over the signature line of each annotation.
Search Filter Enhancements
In this release, we’ve made two improvements to the filter functionality available in Library and custom tabs:
Clearer Display of Applied Filters: As a user applies filters, Vault now displays both the filter name and the selected values, making the applied filters easier to read. Vault also highlights the filter sections in the sidebar, so users can see the active filters a glance.
Quick Filter Removal: In the sidebar, we’ve added an option on each applied filter to quickly remove that field from the sidebar when it’s no longer needed.
Font Embedding in Viewable Renditions
Regional health authorities often require documents be submitted with full font embedding to ensure the information is displayed consistently across different platforms and devices. This enhancement provides Vault Admins with the ability to define the level of font embedding in PDF renditions generated in Vault. Show details...Hide details...
Admins can set the level of font inclusion within viewable renditions generated by Vault. The settings apply to newly generated renditions. The settings can be applied to existing renditions by re-rendering them from their source files.
Default Settings:
Vault does not embed standard TrueType fonts, i.e., Arial, Times New Roman, etc.
Vault embeds Asian fonts as subsets, i.e., individual characters of a font set will be embedded only when they are being used in a document.
Vault will embed a complete font set only when every character of the font set is used in the document.
Optional Settings:
Always embed complete font sets (including TrueType fonts) for all fonts being used in the document. Asian (double-byte) fonts will remain embedded as subsets.
Always embed font subsets (including TrueType fonts) for each character being used in a document.
Any PDF distributed outside of Vault (submitted to a health agency, for example) may require all font sets embedded to ensure that the recipients can view the text as intended. However, this will increase the rendition file size. Always verify individual health authority requirements for font embedding.
New Overlay Tokens
Overlays with page numbers and page counts can help organizations to uniquely identify each page and make sure that all pages are accounted for. To help users meet this requirement, Vault now provides additional tokens to use in overlays:
${page__v} captures the current page number
${pages_with_sig__v} captures the document’s total page count, including any signature pages
Learn about configuring overlays.
Setting for Admin-Controlled Delegated Access
This new feature provides Admins additional vault-level control over which users can delegate their account access to another user. Admins can now restrict delegate access setup to only Admin users, preventing other users from accessing delegation options through their User Profile page. Since the new setting is configured at the vault level, Admins have the flexibility to configure each vault within a domain to have a different level of restriction on delegate access.
Add Users Directly to Security Profiles
Administrators often want to efficiently add multiple users to a new or existing security profile. This feature adds an Edit Members button to the security profile’s Users tab. By clicking this, Admins can very quickly apply the current security profile to a large number of users. Note that applying a new security profile removes the user’s current security profile. Learn more.
Updates to Message Administration
In this release, we’ve added additional features and improvements to email and message administration in Vault. The Message Admin page has been completely overhauled, providing Admins with a cleaner layout for easier management of messages for both in-application notifications and emails. Admins now have the ability to search and sort message lists. Unnecessary messages can now be deleted.
Rendition Settings: PDF Bookmark Expansion
To accommodate regional health authority requirements regarding the display of PDF bookmarks, Admins can now configure how many bookmark levels should be automatically expanded when someone downloads and views the Vault-generated PDF viewable rendition. This option is available from the Rendition Settings page in Admin. Learn more.
Updates to Single Sign-On (SSO) Settings
Single Sign-On (SSO) allows users to access all authorized applications without having to log in separately to each application. In previous releases, customers wanting to enable SSO in their vault were required to contact Support. In this release, that requirement is no longer in place. Domain Admins with the correct permissions through their security profile can now enable and configure SSO for a domain. Show details...Hide details...
HTTP Redirect SAML Protocol Binding
Vault SSO is further enhanced by adding support for “HTTP Redirect” protocol binding. With this enhancement, Vault now supports the two most widely used bindings for SP-initiated SAML SSO: HTTP Post & HTTP Redirect. Customers whose Identity Provider (IDP) only supports HTTP Redirect binding can now successfully implement SAML SSO with Vault. Learn more.
SAML Request Context for e-Signatures
For customers using Vault SSO with Integrated Windows Authentication (IWA), we’ve added additional functionality to support SAML requests for e-Signatures. Vault can be configured to distinguish SAML requests for normal SSO login versus SAML requests for e-Signatures. With this new functionality, IWA may continue to be used for normal SSO login. During the e-Signature process, your IDP prompts users for a username and password. Learn more.
Updates to Session Duration Settings
Session duration is a domain-level setting. To better reflect this, we’ve restricted modification of this setting to users with the Domain Admin attribute and moved the setting into Settings > Domain Information. When a domain administrator changes the session duration, Vault now records the change in Domain Audit History.
Pagination in Dependent Field Administration
To provide better performance, we’ve updated the Admin > Configuration > Field Dependencies page. Rather than listing all dependencies on a single page, users can now navigate through pages, with each displaying 25 dependencies. This page uses the same pagination controls that appear elsewhere, including the Users and Groups pages.
Export of Dependent Fields
To complement pagination in dependent field administration, we’ve added the ability to export all field dependencies as a Microsoft Excel (XLSX) file. This allows Admins to manipulate and sort through field dependency-related data on their own.
Upcoming Changes to Supported Browsers
As a web application, we need to make use of new capabilities available in modern browsers. Older browsers lack support for features needed to provide users with the highest quality experience. Occasionally, we discontinue support for older browsers. When this occurs, users accessing Vault with the unsupported browser may have trouble using certain features, and eventually the application may stop working entirely.
In coming releases, we will stop supporting the following browsers:
iOS 6 (Mobile Safari) on iPads: We will discontinue support with the V11 release in April 2015.
Internet Explorer 8: We will discontinue support with the V13 release in November 2015.
For additional details, see Supported Browsers & Settings.