Using the Safety-RIM Connection, organizations with both a Safety Vault and RIM Submissions Vault can exchange data from your RIM Submissions Vault to your Safety Vault, providing a common set of data against which to record Cases. The Safety-RIM connection transfers, creates, and updates the following records in your Safety Vault based on updates made to corresponding records in your RIM Vault:
- Organization (of type Registration Holder)
- Product (for complex products in your RIM Vault, the connection generates Combination Products in your Safety Vault)
- Product Alias
- Product Constituent
- Product Family
- Product Family Product
- Product Family Substance
- Product Dose Form (these track all associated Dose Forms received from RIM)
- Product Registration (of types Marketed Drug Product Registration and Marketed Device Product Registration)
- Product Variant
- Substance
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
Transferring Combination Products
For complex products in your RIM Vault, the connection generates Combination Product types of Products in your Safety Vault and transfers the related registration, variant, constituent, and substance details. Depending on your Admin’s configuration, Vault may generate Combination Products for the following RIM Products:
- All Complex Product types of Products
- All Products associated with the Primary Product Family specified in a Packaging
When your Admin has configured the connection to transfer complex product details for co-packaged product constituents, Vault updates product details in your Safety Vault based on updates to the following records in your RIM Vault:
- Packaging
- Packaging Product Variant
- Product Variant Active Substance
- Registered Packaging
Syncing Product Substances
Vault automatically synchronizes Product Substances in your Safety Vault with data in your RIM Vault for all Products generated by the connection and associated with Product Families generated by the connection. You can also manually trigger substance synchronization in your Safety Vault using the Sync Substances action. When you run this action, Vault updates all applicable Products with the substance details from the corresponding records in your RIM Vault.
Generating the PSMF Annex H Document
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 do this:
- Navigate to Analytics > Reports and open the Annex H report.
- Review the report and identify any missing field data.
- If applicable, populate those fields on the appropriate records.
- If you update any fields, Refresh the report.
- Generate the PSMF document.
Note: The Annex H report automatically excludes any Product Registrations for Countries that do not have a valid ISO country name.