Organizations using both a RIM Submissions Vault and a PromoMats Vault can utilize the Spark messaging framework to create a standard Vault to Vault connection. This connection transfers Application, Submission, and Compliance Package information across Vaults and automates the creation and updating of CrossLink documents.

RIM to PromoMats Vault Connection Components

The following components support the standard RIM to PromoMats Vault Connection.

Connections

The following Connection records are available from Admin > Connections:

  • RIM to PromoMats Connection (promomats_to_rim__v) is available in your PromoMats Vault
  • RIM to PromoMats Connection (rim_to_promomats_connection__v) is available in your RIM Submissions Vault

You will still need to establish the Vault to Vault connection before you can use it.

Integration & Integration Points

The Integration and Integration Point objects enable Vault to manage the message queues and define what documents and data the connection maps from one Vault to another. These records are read-only and used by Vault to manage the connection and track any connection errors.

The RIM to PromoMats Connection record includes the following default Integration records with standard Integration Point records in your Submissions Vault:

Integration Name Integration Point Name(s) Sent From Sent To
PromoMats Compliance Package Integration PromoMats Compliance Package Integration Point PromoMats RIM
PromoMats Compliance Package Integration RIM Submission Outbound Integration Point RIM PromoMats
Submission Management of Compliance Package PromoMats Compliance Package Documents Integration Point PromoMats RIM
PromoMats Contact Integration PromoMats Contact Integration Point PromoMats RIM
RIM Application Integration RIM Application Integration Point RIM PromoMats
RIM Application Integration RIM Applicant Integration Point RIM PromoMats

The RIM to PromoMats Connection record includes the following default Integration records with standard Integration Point records in your PromoMats Vault:

Integration Name Integration Point Name(s) Sent From Sent To
PromoMats Compliance Package Integration PromoMats Compliance Package Outbound Integration Point PromoMats RIM
PromoMats Compliance Package Integration PromoMats Submission Outbound Integration Point PromoMats RIM
PromoMats Compliance Package Integration RIM Submission Inbound Integration Point RIM PromoMats
PromoMats Contact Integration PromoMats Contact Outbound Integration Point PromoMats RIM
RIM Application Integration RIM Application Inbound Integration Point RIM PromoMats

Integration Rules

To support the RIM to PromoMats connection, it may be necessary to transform data from the source Vault’s data model to fit within the target Vault’s data model. You can use Integration Rules to incorporate configurable rules for mapping object and document fields between two Vaults.

Query Object Rules

The connection also supports Query Object Rules for the following RIM integration rules:

  • Promotional Contact (promotional_contact__v)
  • Compliance Package (compliance_package__v)
  • Compliance Package Documents (compliance_package_documents__v)

Queues

This feature includes four (4) standard message processing queues: two (2) in your RIM Vault and two (2) in your PromoMats Vault. You can access and manage these queues from Admin > Connections > Spark Queues.

In your RIM Vault, you have:

  • PromoMats to RIM inbound queue (promomats_to_rim_inbound_queue__v)
  • RIM to PromoMats outbound queue (rim_to_promomats_outbound_queue__v)

In your PromoMats Vault, you have:

  • RIM to PromoMats inbound queue (rim_to_promomats_inbound_queue__v)
  • PromoMats to RIM outbound queue (promomats_to_rim_outbound_queue__v)

User Exception Objects

Vault includes the User Exception Message object and its child object, User Exception Item, to help you track and resolve any errors that occur with a connection. If either end of your integration can’t process an incoming message, Vault creates a User Exception Message record to capture the failure. Vault also creates individual User Exception Item records for each item that failed on the related Integration Point record in the outbound Vault.

You can view and manage these messages from Admin > Connections > User Exception Messages. If you want specific users or groups to receive notifications when Vault creates User Exception Message records, you must create a custom lifecycle for the User Exception Message object and configure a notification entry action.

A User Exception Message means that you need to update your configuration. After you update the configuration, Vault attempts to resolve any errors the next time the connection runs. You can also select the Rerun Integration action to run the connection and resolve errors.

Standard Document Type Groups

The following Document Type Group records are available to support this connection:

  • RIM to PromoMats Connection is available in your PromoMats Vault
  • RIM to PromoMats Connection is available in your RIM Vault

Vault uses these document type groups to determine which document types to send from one Vault to another. When a document belonging to one of these groups enters its Steady state, Vault sends a Spark message to create a CrossLink document in the connected Vault and updates the document fields to reflect changes made to the document in the source Vault. You must also configure a Document Type reference lookup to map the document type in the source Vault to the document type in the target Vault in order for Vault to transfer documents. These groups are inactive by default.

Actual Submitted Date

After successfully submitting a compliance package to the gateway, you’ll need to add an Actual Submitted Date to the package’s Application record in your Submissions Vault. The value is automatically added to the Submission record and the eCTD binder and corresponding documents in PromoMats. Vault moves the eCTD binder to the Submitted steady state once the Actual Submitted Date field is populated.

Configuring Your Vaults for the Connection

You must complete the following steps in your Submissions Vault to enable the standard connection:

  1. Enable CrossLinks in both Vaults. See details about this step below.
  2. Define reference lookups for controlled fields within the integration scope and load these to your Vault. See details about configuring reference lookups below.
  3. Review each field rule. See details about this step below.
  4. Generate missing Global IDs. See details about this step below.
  5. Review the Last Successful Run field.
  6. Review the Applicant and Application records. See details about this step below.

CrossLink documents enable content from one Vault to be used in another Vault within the same domain. In order for the connection to create documents across both your RIM and your PromoMats Vaults, you’ll need to enable CrossLinks in both Vaults. You’ll also need to enable the Exclude source document overlays and Exclude source document signature pages settings.

Configuring Reference Lookups

Reference lookups are a configuration component referenced by integration rules that allow you to map the value of a field on a target object or document indirectly from a value in the source Vault. When you configure the RIM to PromoMats connection, you need to add reference lookups for controlled fields within the integration scope. We recommend creating CSV mapping files and loading these to your Vault to create reference lookups.

For example, in order for Vault to transfer documents from one Vault to the other, you need to create Document Type reference lookups to map the source document types to the target document types. See Creating & Managing SDK Reference Lookups for detailed instructions.

Reviewing Field Rules

You must review the field rules for each integration rule for the RIM to PromoMats connection. To do so, navigate to Admin > Connections > Integration Rules, select an integration rule, and click Field Rules.

Ensure that:

  • A field rule exists for each required field on the target object or document
  • All field defaults for the integration rule are using the RIM UUID value

If the Labeling Category field is required on the Labeling > Labeling-US document type, you’ll need to add the following field rule to the PromoMats Compliance Package Documents (compliance_package_documents__v) Integration Rule:

  • Target Object: Document
  • Target Doc Field: Labeling Category
  • Label: Labeling Category
  • Name: Labeling Category

You can set the field default as desired.

Generating Global IDs

The RIM to PromoMats connection relies on Global IDs to populate the Link field in the target Vault. If a record was last updated before the 19R3 release, the Global ID field may not be populated. If a record is missing the Global ID, contact Veeva Support and request that they generate Global ID values on the Application and Organization objects in your RIM Vault and on the Contact object in your PromoMats Vault.

To avoid duplicate records, you must ensure that the Link field on existing records is populated with the Global ID from the source Vault. Within your RIM Vault, the Contact object is created as part of the integration. Any existing Promotional Labeling and Advertising Contacts must be reviewed and updated as needed.

To update existing records:

  1. In your PromoMats Vault, navigate to the related record for the Contact.
  2. Copy the Global ID value. You may first need to edit the object page layout.
  3. In your RIM Vault, navigate to the Contact.
  4. Click Edit and enter the Global ID into the Link field.
  5. Click Save.
  6. Repeat steps 1 – 5 for all contacts that exist in both Vaults.
  7. In your RIM Vault, navigate to the related record for the Application and Applicant or Organization.
  8. Copy the Global ID value. You may first need to edit the object page layout.
  9. In your PromoMats Vault, navigate to the Contact.
  10. Click Edit and enter the Global ID into the Link field.
  11. Click Save.

Last Successful Run Field

On every inbound Integration record, the Last Successful Run field captures the date and time that the integration last ran with no errors. Vault uses this date to query changes since the integration’s last successful run.

You can use the Last Successful Run field in the following ways:

  • If you don’t want Vault to transfer existing object records or existing Steady state documents as CrossLink documents, set this field to the date and time when you will activate the connection.
  • If you need to rerun every Integration Point within the Integration record, you can clear the Last Successful Run field. The next time an action in either Vault triggers the connection, Vault will re-process all documents or object records within the scope of that integration point.

When activating a RIM to PromoMats Vault Connection, set the Last Successful Run field on each active Integration to the date and time that you want transfers to start. If you do not set a value on the Last Successful Run field, Vault will transfer all relevant records and documents.

Reviewing Applicant and Application Records

When activating a RIM to PromoMats Vault Connection, set the Last Successful Run field on each active Integration to the date and time that you want transfers to start. If you do not set a value on the Last Successful Run field, Vault will transfer all relevant records and documents.

Reviewing Applicant and Application Records

As part of the configuration process, you must update the Applicant and Application records in your PromoMats Vault. When using the RIM to PromoMats Vault Connection to submit your compliance package to the FDA, Vault must use the Applicant and Application records linked by the connection. If your RIM and PromoMats Vaults have matching Applicant or Application records that were created previously, you must copy the Global ID from the record in RIM and add it to the Link field in PromoMats. This ensures that the records match in both Vaults. If there are any Applicant or Application records in your PromoMats Vault without an equivalent in your RIM Vault, you must avoid including these records in compliance packages used with the connection.

Next, you must verify that all preexisting eCTD binders in any non-steady or expired state include Applicant and Application records that are linked to your RIM Vault as described above. If your binder is in the Submission Ready state, update the binders and move them to the Revise and Resubmit state. Then, update the Applicant and Application records and move them to the Submission Ready state.

Configuring RIM for the Connection

You must complete the following steps in your RIM Vault to enable the standard connection:

  1. Verify that the Match Documents to EDL Items job is active.
  2. Optional: Ensure that Content Plans are configured. You only need to configure content plans if you plan to use them as part of your submission process.
  3. Ensure Vault RIM UUIDs exist for controlled vocabularies . See details about this step below.
  4. Navigate to Admin > Configuration > Objects > Submission > Object Types. Add the Related Compliance Package ID field to each object type listed.
  5. Navigate to Admin > Configuration > Objects > Content Plan > Object Types. Add the Match Documents field to each object type.
  6. Edit the Promotional Materials document type and fields. See details about this step below.
  7. Update the Major Version Number field to be editable. See details about this step below.
  8. Update the Content Plan and Content Plan Item object lifecycles. See details about this step below.
  9. Modify the Content Plan Template Constraints. See details about this step below.
  10. Optional: Update the Material ID field. See details about this step below.

Vault RIM UUIDs for Controlled Vocabularies

Veeva provides standard values for many Controlled Vocabularies. To identify these values, Vault assigns a RIM UUID value to each Controlled Vocabulary record provided by Veeva. The RIM to PromoMats Vault Connection requires that Vault RIM UUID values are correctly configured. If you do not have Vault RIM UUID values for Controlled Vocabulary records, please contact Support.

Editing the Promotional Materials Document Type and Fields

Document types must be aligned with the Content Plan Template to ensure documents are only matched once. To align the document types with the Content Plan Template, you must configure document types as follows:

  1. Add the Promotional Material Document Type field to the Regulatory > Promotional Materials document type.
  2. Add the Annotated Label type under the Regulatory > Promotional Materials document type.
  3. Add the Annotated Material type under the Regulatory > Promotional Materials document type.
  4. Add the Annotated Reference type under the Regulatory > Promotional Materials document type.
  5. Add the Clean Material under the Regulatory > Promotional Materials document type.

Editing the Major Version Document Field

The Major Version document field must be editable for the RIM to PromoMats Vault Connection to work. To make the field editable, navigate to Admin > Configuration > Document Fields > Base Document > Major Version Number > Security Overrides. Click Edit, select Application Owner and Editable, then click Save. Making the Major Version Number field editable also updates the Minor Version Number field.

Updating Object Lifecycles

Content Plan Object & Lifecycle

Within the Content Plan object, assign the Lock Matched Documents on Steady State (lock_matched_documents__v) field to the Regional (Module 1) (module_1__rim) object type. Then, complete the below in the Content Plan object lifecycle.

  1. Associate the Baselined state type to the Baselined state.
  2. Associate the Cascade Activation state type to the Activate Section (Intermediate) state.
  3. In the Activate Parent (Intermediate) state, add two entry actions to always change the related object lifecycle state, as well as start the Change CP to Draft workflow:

content plan LC entry actions

Content Plan Item Lifecycle

Within the Content Plan Item lifecycle:

  1. Associate the Baselined state type to the Baselined state.
  2. Associate the Cascade Activation state type to the Set Parent to Draft (Intermediate) state.
  3. In the Set Parent to Draft (Intermediate) state, add two entry actions to always change the related object lifecycle state, as well as start the Change CPI to Draft workflow:

content plan item LC entry actions

Modifying Content Plan Template Constraints

As part of the configuration, you must review any content plan template constraints for Promotional Material submissions. When the connection is used, after documents are matched, all content plan items and sections without a matched document are inactive. Vault does not activate the items.

Updating the Material ID Field

If you’ve configured the Material ID field in your PromoMats Vault and want to use the field across the connection, you’ll need to update the field in your RIM Vault. Contact Veeva Support to update the Material ID field in RIM via MDL.

Configuring PromoMats for the Connection

You must complete the following steps in your PromoMats Vault to enable the standard connection:

  1. Enable eCTD Compliance Package generation. See Configuring the eCTD Compliance Package .
  2. Update the necessary document fields. See details about this step below.
  3. Add the RIM to PromoMats Connection document type group. See details about this step below.
  4. Update the Submission Ready Lifecycle. See details about this step below.
  5. Remove the final submission step in the Submission Ready workflow.

Updating Document Fields

As part of the configuration, you must add document fields to several document types:

  1. Navigate to Admin > Configuration > Document Fields.
  2. Click Health Authority Form.
  3. Add the following fields:
    • Application
    • Primary Submission
    • Actual Submitted Date
    • Submission Notes
  4. Click eCTD Submission Ready Documents.
  5. Add the fields from step 3.
  6. Click eCTD Submission Ready Documents > Submission Ready Copies > Annotated Label.
  7. Add the following fields:
    • Material Type
    • Professional/Consumer
    • Promotional Material Document Type
    • Promotional Material Document Number
  8. Click Annotated Reference and add the fields from step 7.
  9. Click Annotated Material and add the fields from step 7.
  10. Click Clean Material and add the fields from step 7.

You must add additional fields to these document types if you are planning to include any additional document types in the binder.

Adding a Document Type Group

You must add the RIM to PromoMats Connection document type group to the eCTD Submission Ready Documents and Health Authority Form document types. If you plan to include any additional document types in the binder, you must also add the RIM to PromoMats Connection document type group to these types.

Updating the Submission Ready Lifecycle

As part of the configuration process, you must update the Submission Ready Lifecycle:

  1. Navigate to Admin > Configuration > Document Lifecycles.
  2. Select the Submission Ready Lifecycle.
  3. Click the States tab, then click Submission Ready.
  4. Click Entry Actions, then click Edit.
  5. Select Perform with Conditions.
  6. Add the following entry action: If Binder equals Yes, Send Health Authority Ready State spark.
  7. Click Save.

Connection Limitations

See Standard Vault to Vault Connection Limitations for a list of limitations that impact your RIM to PromoMats connection.

You need a System Admin security profile as well as the following permissions to set up the standard RIM to PromoMats connection:

Type Permission Label Controls
Security Profile Admin: Application: Manage Connections Ability to set up the RIM to PromoMats standard connection
Security Profile Object: User Exception Item, User Exception Message: Read Ability to see User Exception Item and User Exception Message records if a connection failure occurs