Zentiva, together with Utrace, has implemented a marking system

2021: Implementing a Cloud-Based System for Comprehensive Labeling Management

On April 2, 2021, Utrace announced the completion of the implementation of a cloud system for integrated drug labeling management L4 Utrace HUB in the Russian division of Zentiva. For April 2021, the system has been tested, put into operation and copes well with the processing of 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 by 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 has chosen the L4 Utrace Hub cloud solution, which helps manufacturers make the labeling process fully manageable. The IT solution was developed by Utrace.

As a result of the implementation of the L4 Utrace Hub, Utrace specialists, together with the Zentiva team and its partners, integrated the IT solution with the ERP system of SAP ECC and the global Track & Trace system of SAP ATTP, as well as with the WMS solution 3PL of the Itella operator and the UKEP 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 FSIS MDLP, and also forms all the necessary reporting on the movement of products. In addition, the L4 Utrace Hub has convenient mechanisms for working with possible deviations: error logs in the integration log and event table with a description of problems; automatic reprocessing of data at a given time interval; Send notifications to the mail.

IT specialists also prepared the necessary documents according to the GAMP5 standard for the L4 Utrace Hub to be validated. The serialization system was launched on time and works automatically for April 2021: Zentiva employees periodically monitor this process and perform a number of planned manual operations.

After starting the system, the HyperCare period began. This is a special support format provided by Utrace in addition to the subscription agreement. Regular meetings with the customer team allow IT professionals to understand whether the system is working correctly, whether all opportunities are being used, whether there are development wishes. HyperCare also analyzes requests related directly to the labeling process: 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, we take into account the import into the Russian Federation, customs clearance, and entry into civilian circulation - before moving to a pharmaceutical warehouse and shipping to customers. As a result, we provide stable data exchange with FGIS MDLP, and Utrace specialists support us and respond to all questions and requests. I would also like to note the prompt response of Utrace support during the period of failures in the work of the FGIS MDLP in September-October 2020., - comments Vladimir Trapkov, Project Manager for Contract Production Zentiva ks.

Zentiva has many contract manufacturers both abroad and in Russia, therefore, 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 worked out two different schemes for data processing and message generation for FSIS MDLP at the first stages of IT solution implementation. 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.