FAQs

TraceLink apps are extended through solutions, which pull together assets that define how the app looks and functions when users interact with it (i.e. the app's data model, pages workflows, roles, and policies). Solutions available through the Marketplace Catalog can be saved and configured to meet a company's specific use cases and business needs. For more information on solutions and configuring solutions for an app, see the Opus Solution Environment Help Center.

The US Compliance app only has one solution, which is also called US Compliance. Pharmaceutical Manufacturers, Repackagers, Wholesale Distributors, and Dispensers use US Compliance to meet the interoperable, electronic tracing requirements for serialized products established by the US Drug Supply Chain Security Act (DSCSA). For outbound shipments, US Compliance receives the shipment details from Serialized Operations Manager, parses the NDCs and lot numbers of the products that require traceability, and generates the transaction information and transaction statement documents (often referred to as the T2 documents) for each NDC and lot number combination. US Compliance then sends the shipment details on to the company purchasing the product. For inbound receipts, US Compliance receives the receipt details from the company selling the product, parses the NDCs and lot numbers of the products that require traceability, generates the T2 documents for each NDC and lot number combination, and creates a corresponding receipt in Serialized Operations Manager.

US Compliance on the Opus Platform provides the T2 documents for serialized products, as required by the DSCSA. US Compliance also provides the deliveries that triggered the generation of those T2 documents, so that your company can troubleshoot problems with the delivery and have the original document where the product was recorded.

US Product Track on Track & Trace Services still holds all the historical documents for the lot-level transaction histories, as well as the serialized transaction exchanges created prior to the first release of US Compliance. US Product Track also continues to allow you to manage your shipments, receipts, and inventory for product tracked at the lot level.

After the DSCSA requirements for tracking serialized product are in full effect, the historical documents will be moved to US Compliance in a future release, and US Product Track will be removed from Track & Trace Services.

The US Product Track app on Track & Trace Services still powers most of the processing and logic for US Compliance on the Opus Platform, which is why your company can continue using its US Product Track Links for US Compliance on the Opus Platform.

To access US Product Track while logged into the Opus Platform, select the US Product Track (Classic) side menu item, which displays for all US Compliance networks regardless of the Team or Process selected. Users must have the Member - Classic Access role assigned to see this menu item.

For serialized product, all shipments and receipts must be handled in Serialized Operations Manager. Any changes to your company's inventory (e.g. updating the status of a serial number, marking an item as destroyed) must also be done in Serialized Operations Manager. See the Track & Trace Services Serialized Operations Manager Online Help for more information.

• Application Administrator – Allows users to view, filter, and export both deliveries and T2 documents, as well as administer the US Compliance app on the Opus Platform by adding users and assigning roles to them.
• Member - Expanded Access – Allows users to view, filter, and export both deliveries and T2 documents.
• Member - Standard Deliveries Access – Allows users to view, filter, and export deliveries.
• Member - Standard T2 Documents Access – Allows users to view, filter, and export T2 documents.
• Member - Classic Access – Allows users to access the classic Track & Trace Services (TTS) US Product Track screens through the Opus Platform.
• Member - Standard Recalls Access – Allows users to view, filter, and export deliveries impacted by recalls.

Roles group a set of permissions for specific actions (either in the UI or via API), side menu items, and data within an app. The solution applied to the app or its network determines which roles are available. Administrators assign users to roles when they assign users to an app, its network, or its Links.

Owners assign specific roles to Links, which allow their Partners to assign those roles to the Partner users with access to the Link.

Companies must own Opus Solution Environment (OSE) to add or edit roles. If your company owns OSE and you also have the Company Solution Developer role assigned, you can add new roles to a Company Solution or edit existing roles by navigating to OSE and selecting Roles in the side menu. See the Opus Solution Environment Help Center for more information. If your company does not own OSE, then contact TraceLink Support for more information.

A delivery represents the physical shipment or receipt that carried the serialized product. A delivery can contain multiple products, multiple lots, and even products that do not need to be tracked through the supply chain per the DSCSA. US Compliance provides the deliveries for troubleshooting purposes and to provide the original document where the product was recorded.

A T2 document is the transaction information and transaction statement (T2) information required by the DSCSA for a unique product and lot number combination that must be tracked through the supply chain.

T2 documents can only be generated automatically, by enabling event triggers. See Search deliveries for the event triggers and their conditions that generate deliveries, and see Search T2 documents for the conditions that trigger the T2 documents once the delivery is generated.

Neither deliveries nor T2 documents can be triggered manually through the Web UI at this time.

No. T2 documents can only be generated automatically, by enabling event triggers. See Search deliveries for the event triggers and their conditions that generate deliveries, and see Search T2 documents for the conditions that trigger the T2 documents once the delivery is generated.

On the Search T2 Documents screen, select the Actions icon for a specific document, and then select Export Document. In the Export Document panel, select:

• T2 Document in PDF radio button – To export the T2 document in PDF format.
• T2 Document in CSV radio button – To export the T2 document in CSV format.

When supply chain partners receive product tracing requests via email, they are required to respond with the product history in JSON format defined by the Partnership for DSCSA Governance (PDG). The request that is sent to the supply chain partners via email includes the request type, GTIN-Serial number, NDC-Serial number of the suspected product, or NDC-Lot of the recalled product.

Pharmaceutical Manufacturers, Wholesale Distributors, and Dispensers who own or link to US Compliance can search for and download the Product Tracing - Transaction Information response in JSON format.

On the Search T2 Documents screen, select the Actions icon for a specific document, and then select Export Document. In the Export Document panel, select:

• Product Tracing - Transaction Information radio button – To export the Product Tracing - Transaction Information (TI) response in JSON format.

After the user finds a matching T2 document and exports the Product Tracing - Transaction Information response in JSON format, they must manually enter the value for the following fields and send the response back to the requester.

• tiRequestID – A number to identify the TI Request Message for response and retention purposes. User must enter the Request ID number received as part of the request.
• personOrDepartmentName – The person or Department that can be contacted regarding the response.
• phone – The phone number of the responder.
• email – The email address of the responder.
• emailCallbackAddress – The email address where the TI response is to be sent.
• requestLineNumber – A TI request message may include many individual requests. Each individual request is identified by its requestLineNumber to allow easier reference to the request parameters (e.g. GTIN-Serial Number, NDC-Serial Number).
• productID – Includes GTIN or NDC. NDC will have a value and GTIN will be blank. User must enter the GTIN value if required, and include only GTIN or NDC field in the response based on what was received in the request.
• serialNumberOrLotNumber – Includes Serial Number or Lot Number. User must include only Serial Number or Lot Number field in the response based on what was received in the request.
• responseTypeRequested – The type of information the requester has asked the responder to provide.
• ndc – The FDA National Drug Code. NDC in the response will be of type 5-4-2. User must manually convert it to either 4-4-2, 5-3-2, or 5-4-1 based on what format was received in the request and then update the value against this field with the converted value.
• ownershipFromInformation – Information identifying the Transfer From party recorded in the TI and their connectivity information. User must enter the URI and email address (in their respective fields) of a company that was indicated in a TI record.

• ownershipToInformation – Information identifying the Transfer To party recorded in the TI and their connectivity information. User must enter the URI and email address (in their respective fields) of a company that was indicated in a TI record.

• dropShipToInformation – Information identifying the Ship To party recorded in the TI if this was a drop ship transaction and their connectivity information. User must enter the URI and email address (in their respective fields) of a company that was indicated in a TI record.

Yes. Owners can trigger the T2 documents for a delivery to be sent to Product Information Manager so that indirect trade partners can access them. See Search T2 documents for the conditions that trigger the T2 documents to be sent to Product Information Manager.

Passwords must be a minimum of 8 characters, must not be your email, and must include at least one:

• Numerical digit
• Lowercase letter
• Uppercase letter
• Special character

If your company was enabled on the Opus Platform from Track & Trace Services, the following password settings from Track & Trace Services apply:

• Number of previous passwords that cannot be reused.
• Number of login attempts allowed before the account is locked.
• Number of days until the password expires.

If your company was not originally enabled on Track & Trace Services, the following default settings apply to TraceLink SSO:

• The previous 6 passwords cannot be reused.
• 5 login attempts are allowed before the account is locked.
• Passwords expire in 30 days.