Customers: National Health Regulatory Authority (NHRA) Pharmaceuticals, Medicine, Healthcare Contractors: Utrace Product: Utrace HubProject date: 2022/07 - 2022/10
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2022: Utrace Hub integration with marking system
Track & Utrace Hub integrated Trace solution with national marking system Bahrain. The universal connector made it possible to build the sequence and logic of the transfer data of pharmaceutical products subject to labeling to the regulatory system N ational Health Regulatory Authority (NHRA) in just 2 months. The company Utrace (Utrace) announced this on November 14, 2022.
The Utrace Hub is an L4 cloud solution for comprehensive labeling management. It helps manufacturers to ensure traceability of the movement of goods at every stage of the supply chain. The Utrace Hub collects product information and automatically sends it to state labeling systems in accordance with the requirements of the regulator. Thus, in Russia, the decision transfers information about more than 40 operations related to the labeling of drugs and medical devices to the FGIS MDLP.
The integration of the Utrace Hub with the state system of the Kingdom of Bahrain will allow international pharmaceutical companies operating or entering the region to accurately and on time transmit information about labeled products to the national operator National Health Regulatory Authority (NHRA). Integration with NHRA allows you to build the business logic of data transfer using the Utrace HUB in accordance with the requirements of a specific regulator.
The correctness of the route when transferring data from the Utrace Hub to the national system of Bahrain is ensured by the so-called country router. It allows you to transfer data to the desired system in the correct format, regardless of whether a particular file contains item numbers of goods in the international GTIN classification, or only SSCC codes of pallets and boxes. The operation of the system was successfully tested: the NHRA system successfully accepted the file from the Utrace Hub and registered the information received.
When configuring the interaction between Utrace Hub and NHRA, Utrace took into account local specifics. In particular, Bahrain uses the global standard GS1 EPCIS 1.2 to exchange data between counterparties. EPCIS-format information messages simultaneously broadcast the full traceability chain of goods to be serialized in NHRA-MVC. The data package includes a message about the use of marking codes, data about the aggregation of primary packages into transport, as well as information about shipment to the Kingdom of Bahrain. Encryption and signing of documents is carried out through the use of the AS2 exchange protocol, which provides synchronous data transfer in real time with immediate delivery messages.
The prerequisite for entering Bahrain was the interest of a large pharmaceutical company, which had a need to expand its presence. Now, with the help of Utrace HUB, the pharmaceutical manufacturer can work in a new market for itself without the need to install a complex and expensive local labeling system. We were able to implement the integration project in the shortest possible time, in just two months, primarily thanks to the UTrace HUB architecture, initially focused on international EPCIS traceability standards, as well as using a proactive approach in communications with the local traceability system operator. Similarly, we are able to help our customers with access to other emerging markets. So, for November 2022, we are actively communicating with the regulator in Indonesia and assessing the potential prospects in the Malaysian market, "said Savin Vasily, director of consulting at Utrace. |