Configuring the Safety-RIM Vault Connection

Configure the Safety-RIM connection to sync product and registration data between Regulatory and Pharmacovigilance systems.

Note Beginning with 24R1 in April 2024 and for all subsequent releases, the new Vault Safety Help site is the official site for all Vault Safety Help content. This site reflects updates until the 23R3 release only. For the latest information, visit the new site.

About the Safety-RIM Vault Connection

With this feature, you can automatically transfer product and registration data from your Regulatory Submissions (RIM) Vault to your Pharmacovigilance (Vault Safety) Vault. For more information, see About the Safety-RIM Vault Connection.

Prerequisites

To use this feature, your Admin 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 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 How to Create Query Object Rules.

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-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.


Define User Actions for Document States