Release Date: October 7, 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 Documents
Create & Relate Object Records from Documents
This release enables users to create object records while working with specific documents and relate the two through a document reference field on the object. Prior to this release, users needed to create or find the document and then navigate away to create a new object record and select the document. This feature introduces a new configurable user action in document lifecycles that can accomplish these steps without leaving the document.
With the new action, users can create an object record directly from a document version and Vault will automatically select the correct document in the document reference field. This feature is available in any application, but is particularly useful for creating document change requests in QualityDocs Multi-Document Change Control or for creating new events related to promotional pieces in PromoMats.
Generate XFA PDF Forms from Vault Objects
In past releases, Vault introduced support for FDA Form 2253 generation in PromoMats and Submissions applications. Now, Vault can generate and populate any XFA PDF form, for example, FDA Form 2301. Using object records in the new XML Element object, Admins can build the underlying structure of a form’s XML and map the field inputs to document fields from within the Admin area. When users trigger the new Generate Form configurable user action, Vault creates a new form document, constructs the XML using the object records, and populates the newly created form with values from the mapped fields.
The existing Generate 2253 action is only available for the Compliance Package document type, and only where the binder’s Country is United States. However, Admins can configure the new Generate Form action to apply to any lifecycle state, and with a variety of conditions. Each action can generate up to five (5) forms, allowing Admins to replicate the current 2253 process by generating both FDA Form 2253 and Supplementary Sheet 1 in a single action. Admins can set up form generation from a binder (where mapped fields can be on the binder or its component documents) or from a single document.
Organizations that wish to use this feature should work with their Vault Services team to complete configuration.
Add to Binder Bulk Action
This release introduces a new bulk document action to efficiently create a binder and add a large number of documents to it. The new Add to Binder action also allows users to add documents to an existing binder. When using this action, Vault always adds documents to top level (“root”) of the binder, rather than to specific sections. If the binder’s root section already includes one of the documents, Vault does not add it again.
Cover Pages for PDF Audit Exports: Enablement Change
This release improves the compliance process by adding an editable cover page and pagination to PDF audit log exports. This feature is now available automatically on all vaults.
My Collection: Enablement Change
The My Collection feature gives users a quicker way to create an ad hoc selection of documents from multiple different filter sets and library views. In the last release, this feature was only available through Veeva Support, but Admins can now enable from Admin > Settings.
Batch Approval: Enablement Change
Batch Approval has been one of Vault’s most requested features. With this feature, users can bulk review and approve documents by relating them to a Batch object record. In the last release, this feature was only available through Veeva Support, but Admins can now enable from Admin > Settings.
Renditions & Annotations
Multi-Document Viewer Enhancements
The multi-document viewer is available on binders and now also available on Multi-Document Change Control object records in QualityDocs. This release enhances Vault’s multi-document viewer to provide more information about the related binder or object record. With this enhancement, open workflow tasks on related object records are visible within the multi-document viewer.
Sort Comments on Videos by Timestamp
This feature allows users to sort document-level comments on video documents by the first valid timestamp in each comment. This enhancement lets users view comments in the same order as the content they discuss. Replies, comments without a valid timestamp, and comments on non-video documents continue to sort by Creation Date.
Create & Import Document Links: Enablement Change
This feature expands link annotations by introducing a fuller set of options. Users can now create Linked Document relationships, including links to anchors in related documents, from the relationship panel. Users can also import Document Links from one document to another in the same vault.
In the last release, this feature was only available by request. In this release, administrators can enable the feature from Admin > Settings.
Vault Objects
Workflow Step to Update Record Fields
This feature extends the ability to automate business processes in Vault with a new type of step in object workflows. Admins can now configure a workflow to update any record field as part of an automated process. For now, we’ve limited this ability to text, number, and date field types. Admins can represent the update value as a formula, which also supports several text and date functions. Support for other field types will be available in future releases.
Available Tasks for Object Workflows
Available Tasks enhances the way that Vault assigns tasks in object workflows. By selecting this option, Admins can configure a workflow that makes a task available to a group of participants, any of whom could claim and complete the task. Once a user has claimed the task, Vault assigns it to that user and it no longer appears as available to others. This pattern for task assignment can streamline business processes by offering work to a group of users who are all qualified to complete the task.
Entry Criteria for Batch Approval Lifecycle
Using the new Batch Approval feature, users sometimes only review a sample of the documents in the batch, approving and rejecting them as necessary. This new entry criteria (only available for the Batch Approval lifecycle) allows Admin users to prevent the Batch record from entering a state unless its related documents meet a particular criteria based on their states.
For example, an Admin configures the Approved state for the Batch Approval lifecycle with an entry criteria that requires that none of its related documents are in the Rejected state type. This criteria prevents the Batch record from changing to Approved state and subsequently prevents its related documents from changing to their Steady state. Alternately, an Admin could configure the Approved state for the Batch Approval lifecycle with an entry criteria that requires all related documents to be in their Steady state.
Create & Relate Documents from Object Records
Create & Relate Documents from Object Records allows users to manage an object record’s related documents while staying in the context of that record. Users can quickly add and remove existing documents from the record, or create a new document and automatically relate it to the record. Prior to this feature, users needed to navigate to each individual document in order to link it with or unlink it from an object record.
Note that this functionality is for documents related through a Object-type document field, not through a document reference field on the object.
Reporting
Workflow with Object Report Types
Workflow with Object report types support reporting on object workflows in a similar manner to the existing Workflow with Document report type. These reports can pinpoint open and late tasks for object workflows, and then group tasks by owner, date, or other attributes.
To use object workflow reports, Admins will need to create a new report types for each workflow-enabled object. Report authors can then use these report types to create new reports. Workflow with Object reports support other recent reporting enhancements such as conditional fields and matrix layouts.
New Options for Workflow with Document Reports
This release enhances the existing Workflow with Document report type by adding support for conditional fields. Conditional fields enable report authors to categorize document workflows and tasks based on conditional expressions that evaluate workflow, task, and document attributes.
Configuration & Administration
Configuration Migration Packages
Configuration Migration Packages allow an Admin to migrate configuration changes between two vaults. Using this feature, customers can now configure and test in a sandbox vault and then migrate their changes to a production vault. On the source vault, Admins select configuration components for an Outbound Package and then export as a Vault Package file (VPK). Admins on the target vault can then import the VPK as an Inbound Package, review, and deploy it.
Support for Auto-Managed Groups in Configurations
Before this release, Admins could not select Auto-Managed groups in various configurations, for example, when configuring document field-level security overrides. In this release, Admins can use a new setting on Auto-Managed groups to make them available for configurations.
As part of this change, vault cloning now includes any Auto-Managed groups that are available for use in configurations. If the related User Role Setup records don’t exist on the new vault, cloning creates empty groups.
New Metrics for Performance Statistics
In this release, we’ve added the following metrics to the Performance Statistics object. These metrics provide insight into system response time and how frequently users view object record lists or object record detail pages:
Avg Time Object List View
Avg Time Object Detail View
Object List View Count
Object Detail View Count
Configuration Mode
This feature allows System Admins or Vault Owners to place their vault into “Configuration Mode.” This mode locks out all non-Admin users, creating a safe environment for performing configuration changes.
QualityDocs
Multi-Document Change Control
V16 introduces a set of enhancements designed for Multi-Document Change Control. In this release, Vault includes the tools needed to accomplish these functions, but organizations must define their own lifecycles and workflows for the routing of Multi-Document Change Controls. The individual components that support this feature are entirely configurable, allowing organization to model many different business processes.
Organizations that wish to use Multi-Document Change Control immediately should contact Veeva Support to discuss enablement and configuration. The next release will introduce enhancements to provide a best practice configuration, and will help customers get started more quickly with this feature.
Better Flows for Change Requests & Change Controls
With this release, organizations can manage change request separately from change controls, which enables collection, organization, and triage of requests. These abilities allow organizations to be proactive about planning and executing changes.
Change Managers can define and capture a plan for simple single document changes or for complex changes affecting multiple documents planned for release or obsolescence. A single Multi-Document Change Control record can govern release of new documents, superseding of existing documents, and obsolescence in a single flow, streamlining some of the most complicated aspects of change management. Organizations can further automate this process via scheduled jobs, mitigating risk and simplifying change execution.
Notifications on Change Requests
As Change Managers route request through their own dedicated lifecycle or the system routes them automatically using a related change control, Vault can send automated notifications to submitters, keeping them in the loop as change happens.
Support for Complex Workflow Configurations
Change control approval flow is fully configurable. Documents may undergo their own lifecycles’ best-practice workflows up to the point where approval would occur. The document change control routes the Change Control record as well as all its governed content. With this, organizations can use a single approval workflow with a single verdict (per approver) to execute large-scale change.
Operations Cascade to Governed Documents
All operations (captured eSignatures, document state changes, and document field updates) executed on or by the Change Control record cascade down to the individual governed documents. This means that documents which undergo change control have complete audit trails linking them to the Change Control records governing them. It also means the documents’ eSignature pages are complete, optionally manifesting signatures captured as part of the Change Control record’s approval. Vault displays this information in the document’s Version History as well as in the audit trail.
Multichannel
Create Presentation Retains Dynamic Content
PowerPoint documents often contain links to other locations within the document and hyperlinks to external sites. The Create Presentation action can now convert PowerPoint source files into HTML content so that the links remain active in CLM.
Create Presentation Supports Incremental Updates
This enhancement improves the Create Presentation action to better handle updates to the related original document. Vault users can now version specific multichannel slides using this action. For example, if only page three (3) of the original document contains updates, Create Presentation will only version the multichannel slide document corresponding to page three.
Feature Enablement Details
Feature
Enablement
Application
Vault Documents
Create & Relate Records from Documents
Configuration
All
Generate XFA PDF Forms from Vault Objects
Configuration
All
Add to Binder Bulk Action
Configuration
All
Cover Pages for PDF Audit Exports: Enablement Change
Auto-On
All
My Collection: Enablement Change
Configuration
All
Batch Approval: Enablement Change
Configuration
All
Renditions & Annotations
Multi-Document Viewer Enhancements
Auto-On
All
Sort Comments on Videos by Timestamp
Auto-On
All
Create & Import Document Links: Enablement Change
Configuration
All
Vault Objects
Workflow Step to Update Record Fields
Configuration
All
Available Tasks for Object Workflows
Configuration
All
Entry Criteria for Batch Approval Lifecycle
Auto-On1
All
Create & Relate Documents from Object Records
Auto-On
All
Reporting
Workflow with Object Report Types
Configuration
All
New Options for Workflow with Document Reports
Auto-On
All
Configuration & Administration
Configuration Migration Packages
Support
All
Support for Auto-Managed Groups in Configurations
Configuration
All
New Metrics for Performance Statistics
Auto-On
All
Configuration Mode
Configuration
All
QualityDocs
Multi-Document Change Control
Support
QualityDocs
Multichannel
Create Presentation Retains Dynamic Content
Auto-On1
Multichannel
Create Presentation Supports Incremental Updates
Configuration
Multichannel
1 In vaults that use Batch Approval
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. In other cases, users need to perform some setup, for example, with new reporting features that require creating of a new report.
Configuration: Admins must use an On/Off switch and/or configure the feature 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