Zentiva together with Utrace implemented a marking system

2021: Implementation of Cloud System for Integrated Label Management

On April 2, 2021, Utrace announced the completion of the implementation of a cloud system for the integrated management of labeling of drugs L4 Utrace HUB in the Russian division of Zentiva. As of April 2021, the system has been tested, launched and is doing well in processing information from a large number of contract manufacturers - both Russian and foreign.

Like other pharmaceutical companies that operate in Russia, Zentiva needed to introduce a serialization system before July 1, 2020, which would allow it to comply with the requirements of Russian legislation and transmit messages to the FGIS MDLP about the movement of its products in the country. The pharmaceutical company chose the L4 Utrace Hub cloud solution, which helps manufacturers make the labeling process fully manageable. IT solution developed by Utrace.

As a result of the implementation of L4 Utrace Hub, Utrace, together with the Zentiva team and its partners, integrated the IT solution with the SAP ECC ERP system and the global Track & Trace SAP ATTP system, as well as with Itella's 3PL WMS solution and UCEP document signing service. As a result, Zentiva employees received a serialization system that completely closes the tasks of receiving, processing and subsequent transmission of messages to the FGIS MDLP, and also forms all the necessary reports on product movement. In addition, L4 Utrace Hub has convenient mechanisms for working with possible deviations: error logs in the integration log and the event table with a description of the problems; possibility of automatic processing of data after a specified time interval; sending notifications to mail.

IT specialists also prepared the necessary documents according to the GAMP5 standard so that the L4 Utrace Hub passes validation. The serialization system was launched on time and is operating automatically in April 2021: Zentiva employees periodically monitor this process and perform a number of planned manual operations.

After the start of the system, the period of HyperCare began. This is a special support format provided by Utrace in addition to the subscription agreement. Regular meetings with the customer team allow IT specialists to understand whether the system is working correctly, whether all opportunities are used, whether there are development wishes. Also within the framework of the HyperCare, queries related directly to the marking process are analyzed: for example, Zentiva and Utrace specialists have found several options for optimizing work with Itella in terms of sending a hierarchy and processing incoming aggregations.

The labeling system processes all operations: from production and packaging - and if we are talking about foreign, then we take into account import into the Russian Federation, and customs clearance, and commissioning into civil circulation - to transfer to a pharmaceutical warehouse and shipment to customers. As a result, we ensure a stable exchange of data with the FGIS MDLP, and Utrace specialists provide us with support and respond to all questions and appeals. Separately, I would like to note the rapid response of Utrace support during the period of failures in the FGIS MDLP in September-October 2020., - comments Vladimir Trapkov, Project Manager for contract production Zentiva k.s.

Zentiva has many contract manufacturers both abroad and in Russia, so when implementing the project it was important for us to ensure stable interaction of the serialization system with each of them. To do this, our specialists have worked out two different data processing and message generation schemes for FGIS MDLP during the first stages of the implementation of the IT solution. In addition, we have laid down the possibility of scaling in the system, taking into account forecasts of growth in turnover by the number of SGTIN, "adds Konstantin Ivanov, CEO of Utrace.