Learn how to enable case processing for over-the-counter (OTC) drugs, cosmetics, nutritionals, and non-physical devices.

About the Feature

Safety supports Case processing for the following Product Types:

  • OTC Drugs
  • Cosmetics
  • Nutritionals

You can create new Product records using these Product Types. To support agency-specific reporting requirements, Products can include multiple Product Registrations for different Product Types.

For details on setting up Products with the new Product Types, see Manage Products: Create Products.

Update the Product Detail Page Layout

  1. Navigate to Admin > Configuration > Objects > Product > Layouts.
  2. Select the Product Detail Page Layout.
  3. In the Registrations section, select Edit Default Columns and add the Product and Product Type columns.
  4. Select Save.

Create the Case Product Company Product Detail Page Layout

  1. Navigate to Admin > Configuration > Objects > Case Product > Layouts.
  2. Select Create.
  3. On the Add Layout page, select Company Product from the Object Type picklist, and then select Create.
  4. On the Case Product: Record Name page, configure the sections and fields as shown below. Some fields are control fields, denoted by a Slider (Slider) icon. To rearrange sections and fields, drag and drop.
Section Settings Fields/Columns
Details
  • Type: Detail Form
  • Section Label: Details
  • Section Name: details__c
  • Section Layout: Detail Form - One Column
  • Case
  • Primary
  • Drug Role
  • Product (Reported)
  • app-control Product (Coded)
  • Product
  • Combination Product
  • Product Registration
  • Combination Product Registration
  • Product Code
  • app-control Expiration Date
  • Country Obtained
  • Action Taken
  • app-control Gestation Exposure
  • Additional Information
  • Other Additional Information
  • app-control Cumulative Dose
  • Malfunction
  • Remedial Action
  • Remedial Action Other
Device Information
  • Type: Detail Form
  • Section Label: Device Information
  • Section Name: device_information__c
  • Section Layout: Detail Form - Two Columns
  • Model Number
  • Catalog Number
  • Lot Number
  • Serial Number
  • Unique Identifier
  • Operator of Device
  • Operator of Device (Other)
  • Single Use
  • Reprocessed/Reused
  • Reprocessor
  • app-control Date Implanted
  • app-control Date Explanted
  • app-control Returned Date
  • Device Avaliable
  • Device Evaluated
  • app-control Manufacture Date
  • app-control Device Usage Type
  • app-control Device Age
Case Product Devices Codes
  • Type: Related Object
  • Related Object: Case Product Devices Code
  • Section Label: Case Product Devices Codes
  • Section Name: case_product_device_codes__c
  • Name
  • Device Code Type
  • Device Code
app-controlDosages
  • Type: Dosages
  • Section Label: Dosages
  • Section Name: case_product_dosage_section_control__c
app-controlIndications
  • Type: Indications
  • Section Label: Indications
  • Section Name: case_product_indication_section_control__c
Registration
  • Type: Detail Form
  • Section Label: Registration
  • Section Name: registration__c
  • Section Layout: Detail Form - Two Columns
  • Product Type
  • Registration Number
  • Registration Holder/Applicant
  • Compounding Type
  • MPID
  • MPID Version
  • Product (Coded)
  • Registration Country
  • Combination Type
  • Space
  • PhPID
  • PhPID Version
Case Assessments
  • Type: Related Object
  • Related Object: Case Assessment
  • Section Label: Case Assessments
  • Section Name: case_assessments_codes__c
  • Name
  • Product
  • Event (LLT)
  • Expected
  • Assessment Tag
  • Watchlist Tags
  • Reaction Recurrence?
  • First Dose Latency
  • Last Dose Latency
Case Product Substances
  • Type: Related Object
  • Related Object: Case Product Substance
  • Section Label: Case Product Substances
  • Section Name: case_product_substances__c
  • Name
  • Substance Name
  • Strength (Number)
  • Strength (Unit)
Workflow Timeline Default Settings
System
  • Type: Detail Form
  • Section Label: System
  • Section Name: system__c
  • Section Layout: Detail Form - Two Columns
  • Last Modified By
  • Last Modified Date
  • Lifecycle
  • Name
  • Space
  • Created By
  • Created Date
  • Lifecycle State
  • Status
  • Organization
  1. Navigate to Admin > Configuration > Objects > Case > Layouts.
  2. Select the Case Page Layout.
  3. On the right side of the Products section, select the Edit () icon.
  4. On the Edit Related Object Section page, update the Criteria VQL field to include company product with the following VQL: object_type__vr.api_name__v CONTAINS ('device__v', 'biologic__v', 'drug__v', 'external__v', 'company_product__v')
  5. Select Done.
  6. Select Save.