Utrace Warehouse Manager the implemented Navicon in Ipsen, underwent validation

2019: Validation of the Utrace Warehouse Manager system

On October 1, 2019 it became known that international pharmaceutical company Ipsen completed complex check of work Track&Trace the system of L3 level intended for registration of warehouse transactions on serial numbers of pharmaceuticals. The solution Utrace was implemented in Ipsen system integrator and the developer Navicon. In the course of validation compliance of L3 system Utrace Warehouse Manager to GAMP5 standards was confirmed.

As well as other pharmaceutical companies which work at the territory of the Russian Federation Ipsen need to bring till January 1, 2020 the business processes connected with development and the address of medicines into compliance with the Federal Law of December 28, 2017 No. 425-FZ "About introduction of amendments to the Federal law "About Drug Circulation"". In particular, the company should implement the system of marking of medicines and integrate it from the state IC "Marking". Thanks to it buyers will be able to check legality of the purchased goods, and pharmaceutical business – to make business processes regarding release and the address of pharmaceuticals more transparent.

At the same time marking of medicines – difficult and complex process which happens at several enterprise levels. To automate registration of warehouse transactions on serial numbers of pharmaceuticals, one of levels of marking of a pharmproduktion, the system integrator and Navicon developer set IT solution of L3 UTrace Warehouse manager in Ipsen. It will help to fix, on a centralized basis to store and transfer to the state IC of data on all movements of medicines inside and between warehouses, in full accordance with requirements of Federal Law No. 425 and government decree No. 1556. Besides, for simplification of process of an information access the mobile application compatible to the majority of modern data collection terminals was developed.

The systems of marking belong to discharge of business and critical. Therefore it was important to confirm compliance of the implemented IT solution to the accepted Russian and international standards in the field of data protection and to the quality standards of GAMP5. Therefore L3 UTrace Warehouse manager underwent validation testing from Ipsen which was carried out by specialists of a global command of a pharmproizvoditel. In verification process they carried out the Operation Qualification (OQ), Pre-and Post-installation (IQ) and Security Qualification procedures. According to the results of compliance of the IT system of L3 UTrace Warehouse manager to international quality standards was confirmed.

Validation took place with active participation of the Navicon command in the course of preparation of documentation on GAMP5 standard.

Products of Ipsen is applied in treatment of the difficult diseases affecting quality of life of the patient and also the company has in the portfolio a line of the medicines which are applied in the general therapy, and having distribution in all territory of Russia. It is important for us that the people purchasing our products could check easily compliance of information specified on packaging and were protected from counterfeits and unfair distributors. Development of a system of marking certainly promotes achievement of this of a task, very important for us,

In implementation process of the project we were faced by a task to implement in Ipsen a flexible, adaptive solution for marking of a pharmproduktion which will correspond constantly improved Russian and to international quality standards. Validation of L3 UTrace Warehouse manager confirms that IT solution completely fulfills the requirements and the methodical recommendations of the legislation about marking and control of medicines. So, in the long term we can start development of a system at the L4 level, notes Konstantin Ivanov, the CEO of Utrace company

Validation is an additional project which goes in parallel with the general project on marking. Expenses on it can make a considerable part of the general budget selected for implementation of the systems of serialization. Therefore our task as system integrator, first of all consisted in helping pharmaceutical company to carry out validation with the minimum resource and labor costs. As the Navicon command earlier repeatedly underwent a procedure of validation of the computerized systems for requirements of GxP, process of data collection and certification significantly became simpler and accelerated, adds Evgeny Smirnov, the commercial director of Navicon IT company