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 in the Marketplace Catalog can be saved as Company Solutions 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 Product Information Manager app only has one solution, which is called Product Information Manager. Companies use Product Information Manager to share data across the supply chain, including with indirect trade partners (i.e. entities that the company does not have a direct business relationship with). The Product Information Manager solution is powered by a network application, which means that TraceLink owns the app, and companies link to the app as either a Producer (i.e. a company that owns and shares data with the rest of the supply chain) or a Consumer (i.e. a company that accesses the shared data).

Companies can link to Product Information Manager for different reasons:

• To access shipment notices from indirect trade partners – Product Information Manager allows all members of the supply chain to be in compliance with the US Drug Supply Chain Security Act (DSCSA) even if they do not have a direct business relationship with each other. Pharmaceutical Manufacturers, Repackagers, and Wholesale Distributors can send shipment notices to Product Information Manager so indirect trade partners (e.g. Dispensers) can access these shipment notices without linking to the sender's US Compliance network. Direct trade partners who are not linked to the Owner's US Compliance network (e.g. doctor’s offices) can also access shipment notices.

  For example, a Wholesale Distributor might purchase product from a Pharmaceutical Manufacturer and then sell it to a Dispenser before receiving the physical delivery. The Wholesale Distributor can then ask the Pharmaceutical Manufacturer to send the physical delivery straight to the Dispenser. The Dispenser does not have a direct relationship with the Pharmaceutical Manufacturer, so they are not linked to the Pharmaceutical Manufacturer’s US Compliance network, but the Pharmaceutical Manufacturer can mark the delivery as a drop shipment, provide a portal access code, and send the shipment notice to Product Information Manager. The Dispenser can leverage Product Information Manager and the portal access code provided by the Pharmaceutical Manufacturer to find the shipment notice, which can be provided to an auditor if necessary.

  Or a Pharmaceutical Manufacturer might sell a shipment of vaccines directly to a doctor's office, because the doctor's office will be dispensing those vaccines to their patients in the office rather than sending patients to a pharmacy. However, this doctor's office is not linked to the Pharmaceutical Manufacturer's US Compliance network. When TraceLink attempts to send the shipment notice to the doctor's office, the system cannot find the doctor's office as a linked Partner in the Owner's US Compliance network, so US Compliance sends the shipment notice to Product Information Manager, where the doctor's office can access and download the shipment notices.

To access lot-level transaction histories from indirect trade partners while logged into the Opus Platform, select the Transaction Histories (Classic) side menu item. Users must have the Member - Classic Access role assigned to see this menu item.

• Application Administrator – Allows users to view, filter, and export shipment notices, as well as administer the Product Information Manager app on the Opus Platform by adding users and assigning roles to them.
• Member - Standard Shipment Notices Access – Allows users to view, filter, and export shipment notices.
• Member - Classic Access – Allows users to access the classic Track & Trace Services (TTS) Transaction Histories screens through the Opus Platform.

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, allowing 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 Solution Designer 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 CenterOPUS Solution Environment Help Center for more information. If your company does not own OSE, then contact TraceLink Support for more information.

Once the shipment notices are sent to Product Information Manager, their compliance data is stored in Product Information Manager, which is a network app owned by TraceLink.

Shipment notices can only be generated automatically, by enabling event triggers. See the US Compliance Help Center for the event triggers and conditions that generate deliveries, and see Review shipment notices for the conditions that trigger the shipment notices to be sent to Product Information Manager.

Shipment notices cannot be triggered manually through the Web UI at this time.

No. Shipment notices can only be generated automatically, by enabling event triggers. See the US Compliance Help Center for the event triggers and conditions that generate deliveries, and see Review shipment notices for the conditions that trigger the shipment notices 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.