Configure the Safety-RIM 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 RIM Vault to your Safety Vault.
Prerequisites
To use this connection, you must:
Safety-RIM Connection Components
The components below support the standard Safety-RIM 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 Vault.
In your Safety Vault, you can update the Connections object layout to include the following fields in the Connection Stats section:
- RIM: Product Families Created
- RIM: Registrations Created
Integration & Integration Points
The Integration and Integration Point objects enable Safety to manage the message queues and define what data the connection maps from RIM to Safety. These records are read-only and are used by Safety to manage the connection and track any connection errors. The Safety to RIM connection record in each Vault includes the default RIM-Safety: Product Integration record with the following standard Integration Point records:
- Safety Vaults
- RIM-Safety: Organization
- RIM-Safety: Product
- RIM-Safety: Product Alias
- RIM-Safety: Product Constituent
- RIM-Safety: Product Dose Form
- 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
- RIM-Safety: Substance Alias
- RIM Vaults
- RIM-Safety: Co-Packaged Product Constituents
- RIM-Safety: Organization
- RIM-Safety: Product
- RIM-Safety: Product Alias
- RIM-Safety: Product Constituent
- RIM-Safety: Product Family
- RIM-Safety: Product Family Active Substance
- RIM-Safety: Product Family Product
- RIM-Safety: Product Manufactured Dose Form
- RIM-Safety: Product Registration
- RIM-Safety: Product Substance
- RIM-Safety: Substance Alias
- RIM-Safety: Product Variant
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. The Safety-RIM connection includes the following Integration Rules, which transfer, create, and update the following records in your Safety Vault based on updates made to corresponding records in your RIM Vault:
| Integration Rule | Source RIM Object | Target Safety Object |
|---|---|---|
| 1.0 Organization | Organization (organization__rim) |
Organization (organization__v) of type Registration Holder (registration_holder__v) |
| 2.0 Substance | Active Substance (drug_substance__v) |
Substance (substance__v) |
| 2.1 Substance Alias | Active Substance Alias (active_substance_translation__v) |
Substance Alias (substance_alias__v) |
| 3.0 Product Family | Product Family (product__v) |
Product Family (product_family__v) |
| 3.1 Product Family Substance | Product Family Active Substance (product_active_substance__rim) |
Product Family Substance (product_family_substance__v) |
| 4.0 Product | Product (drug_product__v) |
Product (product__v) |
| 4.1 Product - FDA Product Code Update | Product Nomenclature Code (product_classification__v) |
Product (product__v) |
| 4.2 Combo Product (Packaging) | Packaging (packaging__rim) |
Product (product__v) |
| 4.3 Product Family Product | Product Family Product (product_pharmaceutical_product__rim) |
Product Family Product (product_family_product__v) |
| 4.4 Product Dose Form | Product Manufactured Dosage Form (product_manufactured_dosage_form__v) |
Manufactured Dosage Form (manufactured_dosage_form__v) |
| 5.0 Product Variant | Product Variant (product_detail__v) |
Product Variant (product_variant__v) |
| 5.1 Product Variant Substance | Product Variant Active Substance (product_detail_active_substance__rim) |
Product Variant Substance (product_variant_substance__v) |
| 6.0 Product Constituent | Product Component (product_component__rim) |
Product Constituent (product_constituent__v) |
| 6.1 Product Constituent (Packaging) | Product Packaging Variant (packaging_product_detail__rim) |
Product Constituent (product_constituent__v) |
| 7.0 Product Registration | Registration (registration__rim) |
Product Registration (product_registration__v) |
| 7.1 Registration (Packaging) | Registered Packaging (registration_packaging__rim) |
Product Registration (product_registration__v) |
| 7.2 Product Reg - Med Product Update | Medicinal Product Registration (medicinal_product_registration__v) |
Product Registration (product_registration__v) |
| 8.0 Product Alias | Registered Regulatory Text (registered_regulatory_text__v) |
Product Alias (product_alias__v) |
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 Safety if they do not meet certain criteria.
To ensure the connection does not transfer planned Registrations from RIM to Safety, we recommend the following query object rule for the 7.0 Product Registration (rs_product_registration__v) rule:
- Query Object:
registration__rim - Label: Registrations
- Name:
registrations__c - Filter Clause:
state__v = 'planned_state1__c
These elements can be Vault specific, especially API names such as planned_state1__c. Verify the naming convention in your RIM Vault when creating rules.
Queues
This feature includes two standard message processing queues. You can access and manage these queues from Admin > Connections > Spark Queues.
- In your Safety Vault: RIM to Safety Product Inbound Queue (
rim_safety_product_inbound_queue__v) - In your RIM Vault: RIM to Safety Product Outbound Queue (
rim_safety_product_outbound_queue__v)
User Exception Objects
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 Safety side of the integration can’t process an incoming message, Safety creates a User Exception Message to capture the failure.
You can view and manage these messages from Admin > Connections > User Exception Messages.
Safety also creates individual User Exception Items for each item that failed on the related Integration Point 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, 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 to run the connection and resolve errors. When the connection job runs, Safety processes all active User Exception Messages. Any new errors result in new active User Exception Messages. Once the connections on both the Safety and RIM side run, Vault inactivates any User Exception Messages.
Configuring Your Vaults
To configure your Vaults to transfer data with the Safety-RIM Connection:
RIM Vault:
- Add the Safety Product Type field to the Product object layout. Vault uses this value when determining which type of Product record the connection generates in the Safety Vault.
- Add the Safety Registered As field to the Registered As object layout.
- Optional: Configure co-packaged product constituents.
Safety Vault:
- To transfer multiple Trade Names for each Product Registration, update the Product Registration object layout to include a related object section for the Registration Trade Name object.
- Update the applicable permission sets so that the appropriate users can view the Product Variant Substance, Registered Trade Name, and Substance Alias objects as well as License Category (PMDA) types of Controlled Vocabularies.
- Optional: Configure PSMF Annex H support.
Both Vaults:
- After updating all object layouts, populate fields on all applicable records in both Vaults.
- To sync unit values between your RIM and Safety Vaults transferred by the Product Variant Substance integration rule, ensure both Vaults have matching units of measurement for all applicable fields.
- Ensure any custom values you’ve added to the Safety Registered As field in your RIM Vault and Registered As field in your Safety Vault are duplicated in both Vaults.
Configuring Co-Packaged Product Constituents
For complex products in your RIM Vault, including products with shared packaging, the connection generates Combination Product types of Products in your Safety Vault for the following Products in your RIM Vault:
- All Complex Product types of Products
- All co-packaged Products associated with the Primary Product Family specified in a Packaging record
To configure your RIM Vault to transfer co-packaged product constituent details:
- Add the Primary Product Family field to the Packaging object layouts for the Device Packaging, Drug Packaging, and Multiform Packaging object types.
- Add the Product Component field to the Packaging Product Variant object layout.
- Add the Primary Product Component field to the Product Component object layout.
- Add the Primary Product Constituent field to the Complex Product and Co-Package Product object layouts.
- Add the Primary Co-Packaged Product field to the Packaging Product Variant object layout.
- Populate the field of the applicable records.
- Activate the RIM-Safety: Co-Packaged Product Constituents point.
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:
- 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
- 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.
- Optional: Go to Analytics > Reports and open the Annex H report to review the fields included in the report.
- Configure your Safety Vault to automatically generate 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.