FAQs

General

Saudi Arabia Compliance is a TraceLink application that allows Owners to search and view compliance reports generated in TraceLink and submitted to the following Saudi Arabia regulatory systems:

  • The Drug Track and Trace System (DTTS), which collects regulatory reports.
  • The Package Transfer Service (PTS), which manages change of ownership by distributing serialization information to the appropriate trade partners.

Pharmaceutical Manufacturers, Importers, and Wholesale Distributors use the Saudi Arabia Compliance application to comply with Saudi Food & Drug Authority (SFDA) regulations. The Saudi Arabia Compliance application generates reports for regulated products as they move through the supply chain, displays those reports in the Web UI, and distributes the reports to the DTTS and PTS, which are the Saudi Arabia regulatory systems.

TraceLink supports the following browsers:

  • Google Chrome: The most recent stable version.
  • Mozilla Firefox: The most recent stable version.

Reports

Compliance reports for Saudi Arabia can be generated two ways:

  • Automatically, by enabling workflows in Company Administration:

    When the appropriate workflows are enabled, the Saudi Arabia Compliance application generates reports when certain events occur in TraceLink (e.g. when a product release occurs in Serialized Operations Manager). See the Company Administration Online Help for more information.

  • Manually, by generating the report in Serialized Operations Manager:

    Saudi Arabia Compliance Owners can identify the serialized items to create the report for in Serialized Operations Manager. Use this option if a report failed to generate automatically, and the information must still be submitted to the DTTS or PTS. See the Serialized Operations Manager Online Help for more information.

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

  • Submitted – The report is sent to the DTTS.
  • Successful – The DTTS received the report successfully and accepted the information.
  • Failed – There was a problem submitting the report to the DTTS.

To enable TraceLink to download and process serialization data from the PTS, the Saudi Arabia Compliance Owner must work with TraceLink Services to onboard any trade partners that upload data to the PTS onto the TraceLink Network. As part of the onboarding process, trade partners must specify whether they plan to upload serialization data to the PTS in EPCIS v1.2 or CSV format. The Owner must then link the onboarded company to the Saudi Arabia Compliance app as a Partner.

The Saudi Arabia Compliance Owner is responsible for managing all Links from the app, including contacting TraceLink Services about configuration changes for their Partners, if needed.

TraceLink automatically checks the PTS once per hour for serialization data associated with any of the GLNs specified on the DTTS Credentials tab in Company Administration for the Saudi Arabia Compliance app and downloads the data, if available. After downloading the serialization data, the Saudi Arabia Compliance app generates a PTS Download report as a record of the download.

If the PTS Download Received event workflow is enabled in Company Administration, TraceLink also processes the serialization data from the PTS to register and aggregate the serial numbers, creating an inbound delivery in the Pending Receipt state in Serialized Operations Manager. The delivery can then be received and reported to the DTTS in an Accept or Import report.