Enable the Safety-RIM Vault Connection

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

About the Feature

Organizations with both a RIM Submissions Vault and a Safety Vault can 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:

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 Object Layouts

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

Create the Organization Registration Holder Object Type Layout

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

  1. Go to Admin > Configuration > Objects > Organization > Layouts.
  2. Select Create. An Add Layout window appears.
  3. In the window, ensure the following fields are completed:
    • Object Type: Registration Holder
    • Page Label: Registration Holder Detail Page Layout
  4. Select Done.
  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 Object Layouts

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

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 Object Layout

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

  1. Go to Configuration > Objects > Product Family > 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 Object Layout

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

  1. Go to Configuration > Objects > Product Family Product > 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 Object Layout

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

  1. Go to Configuration > Objects > Product Variant > 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 Object Layout

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

  1. Go to Configuration > Objects > Product Constituent > 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 Object Layout

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

  1. Go to Configuration > Objects > Product Registration > 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.

24R2 Update: Annex H Support

To include Annex H data in PSMF documents generated from Vault reports, you must also add the following fields to the Product Registration layout in the Registration Details section:

  • Additional Monitoring
  • Application Lead Market
  • Application Number
  • Non-Standard Aggregate Periodicity
  • Procedure Type
  • Procedure Number

Update the Product Family Substance Object Layout

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

  1. Go to Configuration > Objects > Product Family Substance > 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 Object Layout

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

  1. Go to Configuration > Objects > Substance > 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
  4. When the system prompts you, select Continue.
  5. 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.

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