Configuring LearnGxP ContentDirect

LearnGxP is Veeva’s accredited regulatory and compliance training content product. With ContentDirect, LearnGxP course subscribers with Veeva Vault Training as their LMS solution can automatically receive content as it is published, eliminating the need for a Training Admin to manually upload and track new and updated course files.

Configuration Overview

LearnGxP courses are E-Learning (SCORM) courses. As such, these instructions assume the E-Learning standard feature checkbox in Admin > Settings > Application Settings is already enabled.

To configure your subscribed Training Vault for ContentDirect:

1. Activate the LearnGxP Training Materials document type.
2. Add the LearnGxP Training Requirement? field to the Training Requirement and Classroom Training Requirement object page layouts. This allows Training Admins to track LearnGxP courses in the training matrix.
3. Review your Vault’s Base Document type to ensure its configuration does not include required fields. See About Required Base Document Fields.
4. Review your Vault’s available document lifecycles and assign or create a lifecycle for the LearnGxP Training Materials document type. Assessing document lifecycles also includes determining which states should include the Preview E-Learning Content action. See Document Lifecycle Recommendations.
5. Review your Vault’s Training Requirement Impact Assessment object lifecycle and update according to your organization’s requirements. See TRIA Recommendations.
6. If your Training Vault includes in-use LearnGxP courses, your organization must decide whether or how to reuse them. See Linking Existing LearnGxP Courses.
7. Contact your LearnGxP representative to activate your subscription, providing your Vault’s Name, ID, and Domain, located in Admin > Settings > General Settings. All configuration steps prior to this must be completed before activation.
8. Recommended: Add LearnGxP-specific fields to the Training Requirement Impact Assessment object page layout. Vault will still set these fields, however this configuration is recommended for maximum Training Admin visibility.
9. Optional: To allow Training Admin visibility into current license usage, for the LearnGxP Users Licensed object:
   • Enable the Display in Business Admin option and/or create a custom tab.
   • Create a report type and/or report views.
   • Grant Training Admin access to the object and report(s).

About Required Base Document Fields

If your Vault’s Base Document (base_document__v) type uses any required fields, you must adjust field configuration such that these fields are not required for the LearnGxP Training Materials document type. Required fields on this document type prevents Vault from automatically creating course files in the Library.

To ensure Vault can automatically create course files:

1. For all impacted fields, deselect the User must always enter a value (required) option.
2. Create Field Dependencies to require impacted fields based on document type. See QualityDocs Base Document Field Updates for an example.

QualityDocs Base Document Field Updates

If your QualityDocs Vault was created on or before the 21R2 release, it likely includes required fields on the Base Document type. If this is the case for your Vault, you will need address them in one of the following ways:

• Convert them with Field Dependencies.
• Convert them to shared fields, then add the fields to all document types except LearnGxP Training Materials.
• Update the field configuration to default to a certain value.

For example, in the 21R3 QualityDocs template, the Owning Facility and Owning Department fields were re-defined as optional by default, with Field Dependencies added based on document type. For the Executed Records document type, the resulting Field Dependency is configured as follows:

Document Lifecycle Recommendations

When selecting a lifecycle for the LearnGxP Training Materials document type, we primarily recommend using an existing lifecycle assigned to other training documents and/or E-Learning files.

Additionally, if this lifecycle requires that a document reaches its Steady state (for example, Approved) as the result of a user task, we recommend configuring the lifecycle such that LearnGxP courses are automatically moved to that state once created. This further enhances the automated delivery of courses to your Vault.

Before configuring, however, consider your organization’s requirements such as:

• Quality checks prior to approving E-Learning courses. This recommendation allows courses to be approved “silently”, aside from the notification and a related Training Requirement Impact Assessment record.
• Different behavior for when a course is new, versus when it is updated. This recommendation does not make this distinction.

To accomplish this:

1. Create a notification indicating a LearnGxP course has been sent and is now approved.
2. Add an entry action in the Steady state to send the notification.
3. Create a Date Based Document Operation job to process a state change based on lifecycle parameters. For example:

TRIA Recommendations

When creating or updating a LearnGxP course, Vault sets various LearnGxP-specific document fields with metadata from ContentDirect. These field values are copied to the resulting Training Requirement Impact Assessment (TRIA) record, and can be used for various lifecycle and workflow configurations.

For example, if you’d like Vault to automatically close the TRIA record for LearnGxP courses based on certain conditions, and only reissue assignments to Learners who have not yet completed the course: Update the impact assessment workflow to set the Re-Issue Training? field to “No” and Cancel Open Training Assignments? to “Yes” only when the LearnGxP Update Type and LearnGxP Update Definition are “Minor” and “Grammar Fix”, respectively.

Linking Existing LearnGxP Courses

If your Training Vault includes in-use LearnGxP courses, your organization must decide whether and how to convert them so that ContentDirect can deliver updated files.

Generally, the options are re-linking or re-creation:

• Re-linking: Convert existing LearnGxP courses as they currently exist within your Library and training matrix, then allow ContentDirect to maintain them once enabled. Your organization may opt for this path if there are a large number of courses.
• Re-creation: Allow ContentDirect to re-create new courses in your Library, then obsolete or retire the existing ones.

Re-Linking LearnGxP Courses

If your organization wishes to re-link existing courses, at minimum, any existing courses must be:

• Reclassified to the LearnGxP Training Material document type. This can be completed individually, or in bulk via Vault API.
• Updated with new Document Link field metadata from the ContentDirect Vault. This may require temporarily adding a Security Override to this field so that it may be edited during migration.
• Added to the existing Training Requirement.

Re-Creating LearnGxP Courses

If your Training Vault includes relatively few LearnGxP courses, you may consider using its existing capabilities to:

• Allow ContentDirect to re-create new courses in your Library once enabled.
• Manually work with Training Requirements, either by updating existing records or replacing retired records with new ones. If you do not want to trigger re-training, we recommend the update option.
• Retire or obsolete the existing LearnGxP course.