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 Indonesia Compliance app only has one solution, which is also called Indonesia Compliance. Pharmaceutical Manufacturers use Indonesia Compliance to meet reporting requirements for Law No. NOMOR 33 TAHUN 2018 (BPOM Regulation 33-2018). Indonesia Compliance generates reports for regulated products as they move through the supply chain and TraceLink automatically submits those reports to the Indonesian Food and Drug Authority (BPOM), which is Indonesia's national reporting system.

The following Indonesia Compliance roles can be assigned to users:

• 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 – Gives users the same permissions as Member - Standard Access in addition to add, edit, and remove credentials that are used to connect to the BPOM.

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 Developer role assigned, you can add new roles a 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 Solution Builder, then contact TraceLink Support for more information.

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

• Automatically, by enabling event triggers

  Indonesia Compliance generates reports when appropriate triggers are enabled and certain events occur in TraceLink (e.g. when a shipment occurs in Serialized Operations Manager). See Generate compliance reports for the events and conditions that generate each type of report.

• Manually, using the Web UI or API

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

Yes. Indonesia Compliance reports can be generated as needed using the Web UI. See Generate compliance reports for information about how to manually generate reports using the Web UI.

Indonesia Compliance Owners can view generated compliance reports in the Indonesia 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 BPOM.

After generating compliance reports in Indonesia Compliance, TraceLink submit reports automatically to the BPOM to ensure compliance with Indonesia regulations.

Owners need to add the credentials on the Manage Credentials screen in order for TraceLink to automatically submit reports to the BPOM once they are generated.

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

• Generated – The report is generated in TraceLink but not yet submitted to the BPOM.
• Generation Failed – The report failed to generate in TraceLink.
• Submission Failed – The report is generated but was not successfully submitted to the BPOM.
• Accepted – The BPOM received the report successfully and accepted the information.
• Rejected – The BPOM 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.