As new global regulations and mandates are enacted for Drug Supply Chain safety, Axway responds with solutions for our current and prospective clients.
Axway meets the need of our Track & Trace clients by providing compliance solutions.
Axway has met this need to achieve compliance with the Saudi Arabian pharmaceutical requirements. The Saudi Food & Drug Authority (SFDA) initiated Drug Track and Trace System (DTTS) for pharmaceutical products as one of its plans to contribute to the Saudi National Transformation Program.
This program aims to adopt new technology for tracking all human registered drugs manufactured in Saudi Arabia and imported from abroad. The Drug Track and Trace System enhances the Saudi Food and Drug Authority’s role in protecting society and guaranteeing the safety of all drugs by knowing their origin starting from the manufacturing phase until consumption.
The SFDA has implemented a web-based solution for tracking pharmaceutical products to improve the integrity of the supply chain by preventing the counterfeit of drugs and increase drug availability and safety.
Axway initiated the development of an SFDA module to complement the Axway Track & Trace solution. Axway Track & Trace also has a U.S. Drug Supply Chain Safety Act (DSCSA) and EU European Union Falsified Medicines Directive (EU FMD) modules to support serialization in those geographies.
The Axway Track & Trace – Saudi Arabia Compliance Modules provides a dedicated User Interface which is consistent with the U.S. DSCSA and EU FMD Modules.
The module also supports the generation and transmission of DTTS required manufacturer reports:
- Supply report
- Supply Cancel report
- Dispatch report
- Dispatch Cancel report
- Deactivation report
- Deactivation Cancel report
- Import report
- Import Cancel report
- PTS File
The reports Screen lists all the reports that have been generated by the system for SA Compliance and shows report statuses as they are sent to DTTS. The report details allow for the view the details of individual SA Compliance Reports and the SA Compliance Settings Screen provides for the configuration of report triggers based on EPCIS events captured in Axway Track & Trace.
U.S. Pharmaceutical companies need to be compliant with the Drug Supply Chain Security Act (DSCSA) by November 2023. Download our guide to learn how Axway Track & Trace can help meet the DSCSA’s main interoperability requirements.