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, workflows, experience tasks, roles, and policies). A solution is associated with an app and can be customized. For more information on solutions and customizing solutions for an app, see the Customize Help Center.

The Russia Health Products Compliance app only has one solution, which is also called Russia Health Products Compliance. MAHs use Russia Health Products Compliance to meet reporting requirements for Federal Law No. 29-FZ of 2000. Russia Health Products Compliance generates reports for regulated products as they are imported and move through the supply chain and allows Owners to submit compliance reports to the Order Management Station (OMS) or Track & Trace Government Information System (TT GIS), as applicable.

• Member - Standard Access – Allows users to view, search, filter, and export reports.
• Member - Expanded Access – Gives users the same permissions as Member - Standard Access in addition to manually generating specific reports and taking action on reports (e.g. regenerating a report).
• Application Administrator – Gives users the same permissions as Member - Expanded Access in addition to setting the workflow subscriptions and performing other administrator operations that relate to the application.

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.

Companies must own Solution Builder to add or edit roles. If your company owns Solution Builder and you also have the Solution Developer role assigned, then contact TraceLink Support for more information.

Compliance reports for Russia BAFS and Medical Products can be generated in the following ways:

• Automatically, by enabling event triggers

  Russia Health Products Compliance generates reports when appropriate triggers are enabled and certain events occur in TraceLink (e.g. Product Status Set is set to Released). See Generate compliance reports for the events and conditions that generate each type of report.

• Manually, using the Web UI

  Owners can manually generate Russia Health Products Compliance reports by using the Web UI. This option is useful if a report:

  • failed to generate automatically and the information must still be submitted to the OMS or TT GIS, as applicable.

  • was rejected by the Government system (OMS or TT GIS, as applicable) and corrections have been made.

  See Generate compliance reports for information about how to manually generate reports using the Web UI.

Russia Health Products Compliance Owners can view generated compliance reports in the Russia Health Products Compliance Web UI. The Web UI allows Owners and Importers to locate specific reports, view their contents, and retrieve the report file generated along with the response from the government system (OMS or TT GIS).

After generating reports in Russia Health Products Compliance, TraceLink submits reports automatically to the OMS or TT GIS, as applicable, to ensure compliance with Russia Health Products Compliance regulations.

Use a report's Status to track its transmission from TraceLink to the OMS:

• Generated – The report is generated in TraceLink but not yet submitted to the OMS or TT GIS, as applicable.
• Generation Failed – The report failed to generate in TraceLink.
• Submitted – The report is generated and successfully submitted to the OMS or TT GIS, as applicable.
• Submission Failed – The report is generated but was not successfully submitted to the OMS or TT GIS, as applicable.
• Failed – The OMS or TT GIS, as applicable, received the report successfully but failed to provide a response.
• Accepted – The OMS or TT GIS, as applicable, received the report successfully and accepted the information.
• Partially Accepted – The event has multiple reports, and all of them are successfully submitted to the OMS or TT GIS, as applicable, but the OMS or TT GIS did not accept all of the reports.
• Rejected – The OMS or TT GIS, as applicable, received the report successfully but rejected the information.

For more information on report status, see Monitor compliance reports.

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.