Configuring the Safety-RIM Vault Connection

Configure the Safety-RIM Vault Connection to sync product and registration data between Regulatory and Pharmacovigilance systems. With this feature, you can automatically transfer product and registration data from your Regulatory Submissions (RIM) Vault to your Pharmacovigilance (Vault Safety) Vault.

Prerequisites

To use this feature, you must:

Safety-RIM Connection Components

The components below support the standard Safety-RIM Vault Connection.

Connections

The following connection records are available in Admin > Connections:

  • Safety to RIM connection (safety_to_rim__v) is available in your Safety Vault.
  • Safety RIM connection (safety_rim_connection__v) is available in your RIM Submissions Vault.

Integration & Integration Points

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

The Safety to RIM connection record includes the default RIM-Safety: Product Integration record with the following standard Integration Point records in your Safety Vault:

  • RIM-Safety: Organization
  • RIM-Safety: Product
  • RIM-Safety: Product Alias
  • RIM-Safety: Product Constituent
  • RIM-Safety: Product Family
  • RIM-Safety: Product Family Product
  • RIM-Safety: Product Family Substance
  • RIM-Safety: Product Registration
  • RIM-Safety: Product Variant
  • RIM-Safety: Substance

Integration Rules

To support the Safety-RIM connection, it may be necessary to transform data from the source RIM Vault’s data model to fit within the target Safety 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

With Query Object Rules, you can use Criteria VQL to determine which records get created, updated, and deleted in your Safety Vault. For example, you can configure a rule in your Safety Vault to prevent Organization records from being sent to Vault Safety if they do not meet certain criteria.

For more information, see Creating & Managing Integration Rules for Vault Connections.

To ensure only Approved Registrations are transferred from RIM to Vault Safety, we recommend the following Query Object Rule for the 9.0 Product Registration (rs_product_registration__v) rule:

  • Query Object: registration__rim
  • Label: Registrations
  • Name: registrations__c
  • Filter Clause: state__v = 'approved_state1__c

If you would like Registrations in all lifecycle states (for example, Inactive, Withdrawn, or Expired) to transfer, you can ignore this Query Object Rule.

Queues

This feature includes two (2) standard message processing queues. You can access and manage these queues from Admin > Connections > Spark Queues. In your Safety Vault, you have:

  • RIM to Safety Product Inbound Queue (rim_safety_product_inbound_queue__v)

In your RIM Vault, you have:

  • RIM to Safety Product Outbound Queue (rim_safety_product_outbound_queue__v)

User Exception Objects

Vault Safety includes the User Exception Message object and its child object, User Exception Item, to help you track and resolve any errors that occur with your Safety to RIM connection. If the Vault Safety side of the integration can’t process an incoming message, Vault Safety creates a User Exception Message record to capture the failure.

You can view and manage these messages from Admin > Connections > User Exception Messages.

Vault Safety also creates individual User Exception Item records for each item that failed on the related Integration Point record in your Safety Vault. The User Exception Item’s Error Message field contains the reason for the error.

A User Exception Message means you need to update your configuration. After you update the configuration, Vault Safety attempts to resolve any errors the next time the connection runs. You can also select the Reprocess Request action on the User Exception Message record to run the connection and resolve errors.

When the connection job runs, Vault Safety processes all User Exception Messages in the Active state. Any new errors result in new User Exception Messages in the Active state. Once the connections on both the Safety and RIM side run, previously Active User Exception Messages are inactivated.

Configuring PSMF Annex H Support

You can use the standard Annex H report to generate the PSMF Annex H document in your SafetyDocs Vault using product registration data received from your RIM Vault. To include Annex H data in PSMF documents generated from Vault reports , follow the steps below to configure your Safety Vault:

  1. Add the following fields to the Product Registration object layout:
    • Additional Monitoring
    • Application Lead Market
    • Application Number
    • Non-Standard Aggregate Periodicity
    • Procedure Type
    • Procedure Number
  2. Ensure all Country records referenced in Product Registrations follow the standard ISO naming convention. The standard Annex H report excludes any European Union (EU) Countries that do not follow the naming convention.
  3. Optional: Go to Analytics > Reports and open the Annex H report to review the fields included in the report.
  4. Configure your Safety Vault to automatically generate PSMF documents from Vault reports. For more information, see Enable Automatic Generation of PSMF Documents from Vault Reports .

You can copy the Annex H report to create a new report based on the standard report and then customize the columns and filters on the new report.