Enable the Safety-RIM Vault Connection

Learn how to configure your Safety Vault to enable the Safety-RIM connection.

Last Updated

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 Feature

In 23R3, organizations with both a RIM Submissions Vault and a Safety Vault can now use a standard Vault to Vault connection. The Safety-RIM Connection automatically transfers the creation, updates, and deletion of Product and Product Registration records from RIM to Vault Safety.

Before starting the enablement instructions on this page, ensure you have established a Vault to Vault connection.

Once you have completed the enablement instructions on this page, see the following resources:

Note If your Vault was provisioned in 23R3 or later, some of this configuration may already exist. Customers with Vaults before 23R3 must complete all the configuration steps listed on this page.

Activate the Safety-RIM Product Integration

The Safety-RIM Product Integration is inactive by default. Follow the steps below to activate this Product Integration:

  1. Go to Admin > Connections > Safety to RIM.
  2. Expand the Integrations section.
  3. Select RIM-Safety: Product Integration.
  4. Edit the Status field to Active.
  5. Save the page.

Add Values to the Therapeutic Area Picklist

Follow the steps below to add new picklist values to the Therapeutic Area picklist:

  1. Go to Business Admin > Picklists > Therapeutic Area.
  2. Select Edit.
  3. In the picklist values section, enter the following values and then select the Plus (Plus Button) icon or the Enter key to add it:
    • Cardiology/Vascular Diseases
    • Dental/Maxillofacial Surgery
    • Dermatology/Plastic Surgery
    • Endocrinology
    • Gastroenterology
    • Hematology
    • Immunology/Infectious Diseases
    • Musculoskeletal
    • Nephrology/Urology
    • Neurology
    • Obstetrics/Gynecology
    • Oncology
    • Ophthalmology
    • Otolaryngology
    • Pediatrics/Neonatology
    • Pharmacology/Toxicology
    • Psychiatry/Psychology
    • Pulmonary/Respiratory Diseases
    • Rheumatology
    • Trauma/Emergency Medicine
    After selecting the Plus icon or the Enter key, Vault Safety sets the Picklist Value Name and the Picklist Status Value automatically.
  4. Save the page.

Create and Update Page Layouts

Follow the sections below to create new and update existing page layouts.

Create the Organization Registration Holder Object Type Page Layout

Follow the steps below to create a new Organization page layout for the Registration Holder object type:

  1. Go to Admin > Configuration > Objects > Organization > Page Layouts.
  2. Select Create.
    An Add Page Layout window appears.
  3. In the window, ensure the following fields are completed:
    • Object Type: Registration Holder
    • Page Layout Label: Registration Holder Detail Page Layout
  4. Select Create.
  5. Modify the Details section to display the following fields:
    • Name
    • Official Name
    • Organization UID Code
    • Localization
    • Email Address
    • Telephone Country Code
    • Telephone Number
    • DUNS Number
  6. Select Add Section > Detail Form.
    An Add Detail Section window appears.
  7. Complete the following fields:
    • Section Label: Address
    • Section Name: address__c
  8. Select Done.
  9. (Optional) Move the Address section after the Details section.
  10. In the Address section, add the following fields:
    • Street Number
    • Street
    • City
    • Postal Code
    • State/Province
    • Country
    • PO Box
  11. Select Add Section > Related Object.
    An Add Related Object Section window appears.
  12. Complete the following fields:
    • Related Object: Product Registration
    • Section Label: Product Registrations
    • Section Name: product_registrations__c
  13. (Optional) Move the Product Registrations section after the Address section.
  14. In the Product Registration section, ensure the default columns display:
    • Registration Name
    • Product
    • Product Family
    • Product Variant
    • Trade Name
    • Country
    • Agency
    • Registration Number
    • MPID
  15. Select Add Section > Detail Form.
    An Add Detail Section window appears.
  16. Complete the following fields:
    • Section Label: System Information
    • Section Name: system_information__c
    • Section Layout: Detail Form - Two Columns
  17. In the System Information section, add the following fields:
    • Organization Type
    • Status
    • Created By
    • Created Date
    • Last Modified By
    • Last Modified Date
    • RIM Status
    • Deleted in RIM?
    • Link
  18. Save the page.

Update the Product Page Layouts

Go to Configuration > Objects > Product > Page Layouts and add the following fields and related object sections to the respective page layouts listed in the table below:

PAGE LAYOUT DETAILS SECTION FIELDS SYSTEM INFORMATION FIELDS ADD SECTION > RELATED OBJECT EDIT RELATED OBJECT COLUMNS
Biologic Page Layout
  • Comparator Product
  • Dosage Form
  • Product Family
 N/A
  • Related Object: Product Family Product
  • Section Label: Product Families
  • Section Name: product_family_products__c
(Optional): Move this section after the Details section.
  • Name
  • Product Family > Name
  • Product Family > Generic Name
  • Product Family > Product Family Abbreviation
  • Product Family > Therapeutic Area
Combination Product Detail Page Layout
  • Comparator Product
  • Dosage Form
  • Device Name
  • Basic UDI-DI
  • FDA Product Code
  • International Birthdate
  • Product Family
  • RIM Status
  • Deleted in RIM?
  • Link
  • RIM Product Type
Device Detail Page Layout
  • Device Name
  • Basic UDI-DI
  • FDA Product Code
  • Product Family
 N/A
Drug Page Layout
  • Comparator Product
  • Dosage Form
  • RIM Status
  • Deleted in RIM?
  • Link
  • RIM Product Type
Product Detail Page Layout (of Company Product object type)
  • Comparator Product
  • Dosage Form
  • Device Name
  • Basic UDI-DI
  • FDA Product Code
  • Product Family
  • RIM Status
  • Deleted in RIM?
  • Link
  • RIM Product Type
Vaccine Detail Page Layout
  • Comparator Product
  • Dosage Form
 N/A

Update the Product Family Page Layout

Follow the steps below to add fields and related object sections to the Product Family page layout:

  1. Go to Configuration > Objects > Product Family > Page Layouts > Product Family Detail Page Layout.
  2. In the Details section, add the following fields:
    • Product Family Abbreviation
    • Generic Name
  3. Select Add Section > Related Object.
    An Add Related Object Section window appears.
  4. Complete the following fields:
    • Related Object: Product Family Product
    • Section Label: Products
    • Section Name: product_family_products__c
  5. Select Done.
  6. (Optional) Move the Products section after the Details section.
  7. In the Products section, ensure the default columns display:
    • Name
    • Product > Product Name
    • Product > Product Type
    • Product > Organization
    • Product > International Birthdate
    • Product > Abbreviation
  8. Select Add Section > Related Object.
    An Add Related Object Section window appears.
  9. Complete the following fields:
    • Related Object: Product Family Substance
    • Section Label: Substances
    • Section Name: product_family_substances__c
  10. Select Done.
  11. (Optional) Move the Substances section after the Products section.
  12. In the Substances section, ensure the default columns display:
    • Name
    • Substance > Substance Name
    • Substance > Description
    • Substance > Substance ID
  13. In the System Information section, add the following fields:
    • RIM Status
    • Deleted in RIM?
    • Link
  14. Save the page.

Update the Product Family Product Page Layout

Follow the steps below to add fields to the Product Family Product page layout:

  1. Go to Configuration > Objects > Product Family Product > Page Layouts > product_family_product_detail_page_layou__c.
  2. Select Add Section > Detail Form.
    An Add Detail Section window appears.
  3. Complete the following fields:
    • Section Label: System Information
    • Section Name: system_information__c
    • Section Layout: Detail Form - Two Columns
  4. Select Done.
  5. In the System Information section, add the following fields:
    • RIM Status
    • Deleted in RIM?
    • Link
    You may need to remove these fields from another section first before adding them to this section.
  6. Save the page.

Update the Product Variant Page Layout

Follow the steps below to add fields to the Product Variant page layout:

  1. Go to Configuration > Objects > Product Variant > Page Layouts > product_variant_detail_page_layout__c.
  2. Select Add Section > Detail Form.
    An Add Detail Section window appears.
  3. Complete the following fields:
    • Section Label: System Information
    • Section Name: system_information__c
    • Section Layout: Detail Form - Two Columns
  4. Select Done.
  5. In the System Information section, add the following fields:
    • RIM Status
    • Deleted in RIM?
    • Link
    • RIM Product Type
      • You may need to remove these fields from another section first before adding them to this section.
  6. Save the page.

Update the Product Constituent Page Layout

Follow the steps below to add fields and a new section to the Product Constituent page layout:

  1. Go to Configuration > Objects > Product Constituent > Page Layouts > Product Constituent Detail Page Layout.
  2. In the Details section, add the Product Variant field.
  3. Select Add Section > Detail Form.
    An Add Detail Section window appears.
  4. Complete the following fields:
    • Section Label: System Information
    • Section Name: system_information__c
    • Section Layout: Detail Form - Two Columns
  5. Select Done.
  6. In the System Information section, add the following fields:
    • RIM Status
    • Deleted in RIM?
    • Link
  7. Save the page.

Update the Product Registration Page Layout

Follow the steps below to add fields to the Product Registration page layout:

  1. Go to Configuration > Objects > Product Registration > Page Layouts > Product Registration Detail Page Layout.
  2. In the Details section, add the following fields:
    • Product Family
    • Product Variant
    • Product Alias
    • Trade Name
  3. In the Registration Details section, add the following fields:
    • Registration Status Date
    • Marketing Status
    • Marketing Start Date
    • Marketing End Date
    • Registration End Date
    • Expiration Date
  4. In the System Information section, add the following fields:
    • RIM Status
    • Deleted in RIM?
    • Link
    • RIM Registration Type
  5. Save the page.

Update the Product Family Substance Page Layout

Follow the steps below to add fields to the Product Family Substance page layout:

  1. Go to Configuration > Objects > Product Family Substance > Page Layouts > product_family_substance_detail_page_lay__c.
  2. Select Add Section > Detail Form.
    An Add Detail Section window appears.
  3. Complete the following fields:
    • Section Label: System Information
    • Section Name: system_information__c
    • Section Layout: Detail Form - Two Columns
  4. Select Done.
  5. In the System Information section, add the following fields:
    • RIM Status
    • Deleted in RIM?
    • Link
  6. Save the page.

Update the Substance Page Layout

Follow the steps below to add fields and related object sections to the Substance page layout:

  1. Go to Configuration > Objects > Substance > Page Layouts > Substance Detail Page Layout.
  2. In the Details section, add the following fields:
    • Substance Name Long Text
    • Primary Product Family
    • EV Code
    • SPOR Substance Code
    • SPOR Term
    • US Substance Code
    • EUDAMED INN
    • CAS Number
    • EC Number
  3. Select Add Section > Related Object.
    An Add Related Object Section window appears.
  4. Complete the following fields:
    • Related Object: Product Family Substance
    • Section Label: Product Families
    • Section Name: product_family_substances__c
  5. Select Done.
  6. (Optional) Move the Product Families section after the Details section.
  7. In the Product Families section, ensure the following default columns display:
    • Name
    • Product Family > Name
    • Product Family > Generic Name
    • Product Family > Product Family Abbreviation
    • Product Family > Therapeutic Area
  8. In the System Information section, add the following fields:
    • RIM Status
    • Deleted in RIM?
    • Link
  9. Save the page.

Clear Custom and Matching Sharing Rules

Follow the steps below to clear Matching and Custom Sharing Rules for the following objects:

  • Product Family Product
  • Product Family Substance
  • Product Variant
  1. Go to Configuration > Objects > [object] > Details.
  2. Select Edit.
  3. In the Options section, clear the following checkboxes:
    • Enable Custom Sharing Rules
    • Enable Matching Sharing Rules
    When the system prompts you, select Continue.
  4. Save the page.

Update Permission Sets

Use the table below to update the respective permission sets with permissions. Go to Admin > Users & Groups > Permission Sets > [Permission Set] > Objects.

Note The permission sets displayed in the table are for both Safety Management and SafetyDocs. Depending on your Vault's configuration and when it was provisioned, some permission sets may not be available.

PERMISSION SET OBJECT PERMISSIONS
Administration Actions Product Variant
  • Read
  • Create
  • Edit
  • Delete
Product Family Product
Product Family Substance
Aggregate Report Writer Product Variant
  • Read
Product Family Product
Product Family Substance
Case Distribution Actions Product Variant
  • Read
Product Family Product
Product Family Substance
Case Entry Actions Product Variant
  • Read
Product Family Product
Product Family Substance
Case Intake Actions Product Variant
  • Read
Product Family Product
Product Family Substance
Case Review Actions Product Variant
  • Read
Product Family Product
Product Family Substance
Case Translation Actions Organization > Registration Holder
  • Read
Product Alias
Product Family
Product Variant
Product Family Product
Product Family Substance
Literature Actions Product Variant
  • Read
Product Family Product
Product Family Substance
PSMF Contributor Actions Organization > Registration Holder
  • Read
Product Variant
Product Family Product
Product Family Substance
PSMF Coordination Actions Organization > Registration Holder
  • Read
Product Variant
Product Family Product
Product Family Substance
PVA Actions Organization > Registration Holder
  • Read
  • Create
  • Edit
Product Variant
  • Read
Product Family Product
Product Family Substance
Safety Operations Actions Organization > Registration Holder
  • Read
Product Variant
Product Family Product
Product Family Substance
Signal Management Product Variant
  • Read
Product Family Product
Product Family Substance
Submission Actions Product Variant
  • Read
Product Family Product
Product Family Substance