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 Kazakhstan Compliance app only has one solution, which is also called Kazakhstan Compliance. MAHs and Importers use the Kazakhstan Compliance solution to meet the reporting requirements for Kazakhtelecom JSC, the traceability operator. Kazakhstan Compliance generates reports for regulated products as they move through the supply chain and submits those reports to the Government systems. The Ministry of Health has established the Order Management Station (OMS) and Information System Center for Electronic Documentation of Labeled Goods (IS CEDM) to enable the traceability of pharmaceuticals.TraceLink automatically submits Aggregation and Utilisation reports to the OMS once they are generated. MAHs must download and submit Transfer of CI to Importer report manually to IS CEDM once it is generated.

• 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.
• Government Credential Administrator – Allows user to manage the government credentials, such as user IDs, passwords, certificates, and certificate passwords.

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 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 Center for more information. If your company does not own OSE, then contact TraceLink Support for more information.

Compliance reports for Kazakhstan can be generated in the following ways:

• Automatically, by enabling event triggers

  Kazakhstan Compliance generates reports when appropriate triggers are enabled and certain events occur in TraceLink (e.g. Product Release). See Generate compliance reports for the events and conditions that generate each type of report.

• Manually, using the Web UI

  MAHs and Importers can manually generate Kazakhstan 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. See Generate compliance reports for information about how to manually generate reports using the Web UI.

Kazakhstan Compliance Owners can view generated compliance reports in the Kazakhstan Compliance Web UI. The Web UI allows Owners to locate specific reports and view their contents, as well as retrieve the report file generated for the OMS.

After generating compliance reports in Kazakhstan Compliance, TraceLink submits reports automatically to the OMS or IS CEDM to ensure compliance with Kazakhstan regulations.

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

• Generated – The report is generated in TraceLink, but is not submitted to the OMS or IS CEDM, as applicable.
• Generation Failed – The report failed to generate in TraceLink.
• Submitted – The report is generated and successfully submitted to the OMS or IS CEDM, as applicable.
• Submission Failed – The report is generated but was not successfully submitted to the OMS or IS CEDM, as applicable.
• Failed – The OMS or IS CEDM, as applicable, received the report successfully but failed to provide a response.
• Accepted – The OMS or IS CEDM, 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 IS CEDM, as applicable, but the OMS or IS CEDM did not accept all of the reports.
• Rejected – The OMS or IS CEDM, 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.