Manage Products

View and manage your company Product library from Business Admin > Products.

Sections in This Article

About Product Administration

Configure a Product with product, registration, and substance details for each product family on which your organization monitors and reports.

Product setup is a prerequisite for adding Study Products and Combination Products.

Your company Product library is a key component in many Vault Safety features, which includes the following functionalities:

Functionality Relationship
E2B Import During an E2B import, the system attempts to match products in the E2B file to products configured in the Product library.
ICSR Report Generation When the system generates ICSRs (including E2B, FDA 3500A, and CIOMS I reports) certain fields are mapped from the Product library. These fields are identified in their descriptions below.
Aggregate Reports Products added to an aggregate report Reporting Family are used to filter Cases to include in report tabulations.
Reporting Rules The system looks at local Product Registrations for Case Products to generate Submissions according to reporting rules in your vault.
Watchlists You can set up Watchlists to monitor Cases with certain Products. Case Products must be suspect or interacting to trigger watchlists.
Automatic Expectedness and Listedness Set up Products and Product Datasheets for Vault Safety to automatically determine whether an adverse event is expected or unexpected.

Create Products

Add a Product for each company product for which you will process Cases in Vault Safety.

Snapshotting: When you add a Case Product linked to a record in the company Product library, the system snapshots pre-configured product fields to the Case Product.

Add a Product

  1. Go to Business Admin > Products.
  2. On the Products page, select Create.
  3. In the Create Product window, select the product type, and then select Continue.

    Note When you select a product type registered in the FDA's jurisdiction, the product type determines how the system automatically generates submissions to the FDA. See FDA Report Formats for more information.

  4. Complete the fields on the Create Product page.
  5. Select Save.

Product Fields

Field Description
Organization
(organization__v)

Select the Organization to which the product belongs.

When adding a Case Product, the Case must be associated with this organization to allow users to select this product.

Product Name
(name__v)

Enter the primary name of the product. Vault Safety references the product using the name that you enter in this field.

When a Case Product references this Product record, the system uses this field to generate the Case Product Name.

Abbreviation
(abbreviation__v)

Enter the abbreviated name for the product.

This field is for reference only.

Generic Name
(generic_name__v)

Enter the generic name for the product.

For Device-type products, this field is used in report generation for FDA E2B (R2), FDA VAERS E2B (R3), and FDA MedWatch 3500A report formats.

Vaccine Type
(vaccine_type__v)

If the product is a vaccine, select the vaccine type.

When a Vaccine-type Case Product references this Product record, the system snapshots this field to the Case Product.

International Birthdate
(international_birthdate__v)

Enter the date when a regulatory authority first granted marketing authorization for the product.

If this field is specified, aggregate reports use this date as the start of the reporting period for cumulative reports.

This field is also used in report generation for the FDA MedWatch 3500A format (G.5 Pre-1983).

Expiration Date
(case_product_expiration_control__v)

Enter the expiration date for the product. Partial dates are supported and the minimum precision required is the year.

The system snapshots this field to the Case Product. For Device-type products, this field is used in report generation for FDA E2B (R2) (B.4.k.2.4.FDA.1).

Manufacturer
(manufacturer__v)

Select the organization that manufactures the product, if it is different from the one selected in the Organization field.

For Device-type products, this field is used in report generation for FDA E2B (R2), FDA VAERS E2B (R3), and FDA MedWatch 3500A report formats.

Core Datasheet
(datasheet__v)

Select the Core Datasheet for the product family.

Datasheets are used to automatically detect expectedness for an adverse event and the suspect or interacting Case Products.

API Name
(api_name__v)

Enter a unique identifier that can be used with the Safety Rule "Product" parameter to define a specific Product for a reporting rule.

To learn more, see Reporting Rule Parameter Reference.

Add Product Registration Details

Add Product Registrations for each country the product is registered in.

The system looks at the Product Registration Countries for Case Products to generate Submissions according to reporting rules in your vault. Understand Reporting Rules provides more information.

Snapshotting: When you select the Product Registration on a Case Product, upon saving the record, the system snapshots fields from the Product Registration to the Case Product.

Add a Product Registration

Add product registration details for each country the product is registered in.

  1. Go to the Product record page.
    Find Product records on the Business Admin > Products page.
  2. Under Registrations, select Create.
  3. Complete the Create Product Registration page.
  4. Select Save.

Product Registration Fields

Field Description
Organization
(organization__v)

The system automatically populates this field with a reference link to the Organization on the Product parent record.

The system snapshots this field to the Registration Holder field on a Case Product.

Product
(product__v)
The system automatically populates this field with a reference link to the Product parent record.
Registration Name
(name__v)
(Required) Enter a name for the Product Registration. Vault Safety references the registration using the name that you enter in this field.
Product Type
(product_type__v)
The system automatically populates this field with the product type of the Product parent record.
Combination Type
(combination_type__v)

If the product is a combination product, select the combination type.

The system snapshots this field to the Case Product and is used in report generation for the FDA VAERS E2B (R3) format.

Registration Number
(registration_number__v)

Enter the product authorization or application number for the country where the product is marketed.

For U.S. Registrations, ensure that the value you enter in this field adheres to the FDA E2B format requirements for element B.4.k.4.1 (Authorisation / Application Number).

The system snapshots this field to the Case Product and is used in report generation for E2B, FDA MedWatch 3500A, and PADER formats.

Registration Date
(registration_date__v)

Enter the date when the product was registered.

This field is for reference only.

Registration Type
(registration_type__v)

Select the registration type.

This field is used in report generation for FDA MedWatch 3500A and PADER formats.

Country
(country__v)

Select the country where the product is registered and authorized.

The system snapshots this field to the Registration Country field on a Case Product and is used in report generation for E2B formats.

Route of Administration
(route_of_administration__v)

Select the route of administration TermID code.

This field is for reference only.

Compounding Type
(compounding_type__v)

If the product is a compounded product, select the compounding type.

The system snapshots this field to the Case Product and is used in report generation for E2B formats.

Agency
(agency__v)

Based on the Country selected on the Product Registration, the system automatically populates this field with the Agency assigned jurisdiction over that country.

If configured, reporting rules generate Submissions to this Agency when a Case Product references this Product Registration.

Transmission Profile
(transmission_profile__v)

To specify the Transmission Profile the system should use when automatically generating Submissions for this registration, select the Transmission Profile. We recommend setting this field when you have a Transmission Profile corresponding to this reporting destination and report type.

Local Datasheet
(datasheet__v)

Select the Local Datasheet for this product registration. A Local Datasheet is specific to a country or region, listing expected adverse events that apply to that product registration.

Datasheets are used to automatically detect expectedness for an adverse event and the suspect or interacting Case Products.

MAH
(reporting_organization__v)

This field may also be named Reporting Organization depending on your vault's configuration.

If you have a Marketing Authorization Holder (MAH) that manages your ICSR reporting obligations for this registration, select the Organization. Selecting an Organization in this field creates an MAH Distribution List, and thereby a reporting obligation, for this registration.

Warning Use caution when setting this field. Reporting Obligations are for Distributions only and override agency submission rules. Do not select an Agency such as the FDA or EMA.

Transmission Product Type
(transmission_product_type__v)

Select the product type for this registration.

The system snapshots this field when generating Transmissions for this registration, then uses that value to determine whether Device-type Combination Product Constituents are exported in E2B transmissions.

See Exclude Device Constituents from E2B Exports for more information.

This field does not appear on page layouts by default, but can be added to Transmission page layouts by an administrator.

Strength
(strength_number__v | strength_unit__v)
Enter the strength of the product.
In the first field, enter a numeric value. In the second field, select a unit of measurement from the picklist or enter a custom unit.
Product Code
(product_code__v)

For medical devices only, enter the product code classification.

This field is used in report generation for the FDA MedWatch 3500A format (D.2b).

MPID
(mpid__v)

Enter the Medicinal Product Identifier (MPID) for the product.

Note You can specify only one type of product identifier. Do not specify a MPID if you have entered a PhPID.

The system snapshots this field to the Case Product and is used in report generation for E2B (R3) and CIOMS I formats.

PhPID
(phpid__v)

Enter the Pharmaceutical Product Identifier (PhPID).

Note You can specify only one type of product identifier. Do not specify a PhPID if you have entered a MPID.

The system snapshots this field to the Case Product and is used in report generation for E2B (R3) and CIOMS I formats.

National Drug Code
(ndc__v)

Enter the US National Drug Code (NDC) or unique identifier for the product.

This field is used in report generation for the FDA MedWatch 3500A format.

Product Code
(product_code__v)

Enter the device Product Code.

For Device-type products, this field is used in report generation for FDA E2B (R2), FDA VAERS E2B (R3), and FDA MedWatch 3500A report formats.

Local Product Code
(local_product_code__v)
Enter the region-specific Medicinal Product Identification (MPID) code. This field is used for Localized Cases.

PMDA Fields

Use the PMDA section on a Product Registration to set up information for a Japanese Product Registration. Add a Japan Product Registration provides information on the PMDA fields.

Add Substances

Configure substance information to snapshot information to Cases for E2B R3 section G.k.2.3.r Substance / Specified Substance Identifier and Strength.

PSUR aggregate reports can leverage Substances to filter Cases to include in the report tabulations. Other aggregate reports do not leverage Substances.

You may need to configure your vault to access this feature. See Enable Substances for more information.

Snapshotting: When a Case contains a Case Product linked to a company Product with pre-configured Substances, the system snapshots each Substance to create Case Product Substance records.

Note We recommend that you link a Substance at the Product level instead of adding a Substance to a Study Product. You should only add a Substance at the Study Product level when you need the Strength fields to appear. If a Study Product Substance exists, it will supersede any Product Substances on the Case.

Add a Substance to a Product

  1. On the Product page, expand Substances, and then select Add.
    Your Administrator may need to configure your vault to add the Substance section to the Product page.
  2. There are two options available to add a Substance:
    • Select a Substance(s) from the library.
    • Select Create, then on the Create Substance page, enter the substance details, and then select Save.

    You can also add a Product to a Substance by going to Business Admin > Substances, selecting a Substance, and then expanding Products.

  3. Select OK.

Product Substance Fields

Field Description
Substance Name
(name__v)

(Required) Enter the name of the substance. Vault Safety references the Substance using the name that you enter in this field.

The system snapshots this field to the Case Product Substance and is used in report generation for E2B R2 and E2B R3 formats.

Organization
(organization__v)
(Required) Select the organization or use the binoculars icon to search for the organization associated with the substance.
Substance ID
(substance_id__v)

Enter the unique identifier for the substance.

This field is for reference only.

Term ID
(termid__v)

Enter the substance TermID.

The system snapshots this field to the Case Product Substance and is used in report generation for E2B R3 formats.

Term ID Version
(termid_version__v)

Enter the version date or number for the TermID.

The system snapshots this field to the Case Product Substance and is used in report generation for E2B R3 formats.

Description
(description__v)

Enter a description for the substance.

This field is for reference only.

Create Product and Substance Aliases

During E2B import, the system attempts to match the Case Product with the relevant Product in the Business Admin library.

You can set up Product matching using Product and Substance Aliases. If the system can not find a match for the Case Product using non-Study matching, it will attempt to use aliases you set up in the Business Admin library.

Add a Product Alias

  1. Go to Business Admin > Product Aliases.
  2. Select Create.
  3. Complete the following information:
    • Product: (Required) Select the Product the alias is associated with.
    • Alias: (Required) Enter the alias name.
  4. Select Save.

Result

You have saved the alias in the Product Aliases library. Now, the system can match any Case Product with this alias to the associated Product in the Business Admin library. The Generic and Localized Product Names are automatically added from the Product record as Product aliases.

Note You can also add Substance aliases to the Product Aliases library. You might consider this for cases where users mistakenly enter a Substance Name as the Product.

Add a Substance Alias

  1. Go to Business Admin > Substance Aliases.
  2. Select Create.
  3. Complete the following information:
    • Substance: (Required) Select the Substance the alias is associated with.
    • Alias: (Required) Enter the alias name.
  4. Select Save.

Result

You have saved the alias in the Substance Aliases library. Now, the system can match any Case Product with this Substance alias to the associated Substance in the Business Admin library and, subsequently, to the associated Product in the library.

The Localized Substance Name is added as an alias automatically.

Bulk Import Product and Substance Aliases Using Vault Loader

You can use Vault Loader to load Product and Substance Aliases in bulk from a Company Product in the Vault Library. Note that you must repeat the instructions below to upload two different CSV input files for Product Aliases and Substance Aliases.

The procedure for bulk importing Product and Substance aliases is as follows:

  1. Prepare the CSV Input File
  2. Load Aliases into Your Vault

Prepare the CSV Input File

  • Prepare the Import File for Product Aliases
    1. Use Vault Loader to extract the Product Aliases fields. Keep only the Field Names, which will serve as the column headers for the import file. See Vault’s Preparing CSV Input Files for more information.
    2. Use Vault Loader to extract the following Product (product__v) fields:
      • Product Name (name__v)
      • Organization (organization__v)
      • Generic Name (generic_name__v)
    3. Copy the extracted fields from step 2 into the import file under the respective column. The following table displays the field mapping between the extracted file and the import file columns:
      PRODUCT FIELDS
      FIELD LABEL EXTRACTED FIELD NAME IMPORT FIELD NAME
      Product Name name__v product__v
      Organization organization__v organization__v
      Generic Name generic_name__v alias__v
    4. Use Vault Loader to extract the following Localized Product (localized_product__v) fields.
      • Name (name__v)
      • Product (product__v)
      • Organization (organization__v)
    5. Copy the extracted fields from step 4 into the import file under the respective column. The following table displays the field mapping between the extracted file and the import file columns:
      LOCALIZED PRODUCT FIELDS
      FIELD LABEL EXTRACTED FIELD NAME IMPORT FIELD NAME
      Name name__v alias__v
      Product product__v product__v
      Organization organization__v organization__v
    6. In the import file, perform the following steps:
      1. Capitalize the fields under the Alias (alias__v) column.
      2. Go through the aliases and remove any duplicates.
  • Prepare the Import File for Substance Aliases
    1. Use Vault Loader to extract the Substance Aliases fields. Keep only the Field Names, which will serve as the column headers for the import file. See Vault’s Preparing CSV Input Files for more information.
    2. Use Vault Loader to extract the following Substance (substance__v) fields:
      • Substance Name (name__v)
      • Organization (organization__v)
    3. Copy the extracted fields from step 2 into the import file under the respective column. The following table displays the field mapping between the extracted file and the import file columns:
      SUBSTANCE FIELDS
      FIELD LABEL EXTRACTED FIELD NAME IMPORT FIELD NAME
      Substance Name name__v substance__v
      Organization organization__v organization__v
    4. Use Vault Loader to extract the following Localized Substance (localized_substance__v) fields.
      • Name (name__v)
      • Substance (substance__v)
      • Organization (organization__v)
    5. Copy the extracted fields from step 4 into the import file under the respective column. The following table displays the field mapping between the extracted file and the import file columns:
      LOCALIZED SUBSTANCE FIELDS
      FIELD LABEL EXTRACTED FIELD NAME IMPORT FIELD NAME
      Name name__v alias__v
      Substance substance__v substance__v
      Organization organization__v organization__v
    6. In the import file, perform the following steps:
      1. Capitalize the fields under the Alias (alias__v) column.
      2. Go through the aliases and remove any duplicates.

Load Aliases into Your Vault

Vault Help provides instructions on using Vault Loader to upload object records to your vault. Follow the steps in Loading Object Records with your respective CSV input file.

Note the following when completing the steps:

  • In the Action Type dropdown menu, select “Upsert”.
  • In the Key Field dropdown menu, select “Alias”.

Manage Organizations
Manage Combination Products
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