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19 November 2019

Darnitsa Introduced Electronic Document Management System

19 November 2019

In November the Pharmaceutical Firm “Darnitsa” commenced the operation of the first phase of the electronic document management system. This is the first such project in the pharmaceutical market of Ukraine, the implementation of which covers the entire life cycle of a medicinal product.

The system functions on the basis of solutions by OpenText - the Canadian company, which is the world leader in the development of software for enterprise process and information management and the world-renowned leader in the field of SAP AG enterprise management information systems. A holistic and integrated document management system for management of documents and processes accompanying the lifecycle of medicinal products in accordance with international quality requirements is a standard for many countries of the world.

“The strategy of “Darnitsa” envisages the building of an international pharmaceutical brand. To this end, we carry out the digital transformation of the company and introduce the state-of-the-art tools that meet pharmaceutical standards of the EU and USA,” Andrii Obrizan, General Director of the Pharmaceutical Firm “Darnitsa”, says. With the implementation of the project of electronic document management, “Darnitsa” made a determining step towards modern management of information flows and communications. This provides additional opportunities for development and faster achievement of business objectives. As a result of the project, we have gained significant benefits – from improving the productivity of the staff involved in product development, research and registration to effective project management and ensuring the integrity of change management processes. We are ready to form the dossier in electronic form and we expect that such practice will be implemented in Ukraine at the state level, - the General Director of “Darnitsa” sums up.

The key users of the electronic document management system of “Darnitsa” are the units of pharmaceutical development, Ukrainian and foreign registration, pharmaceutical supervision, clinical research and monitoring, as well as the department of manufacture and quality management. In total, after the final implementation, the number of authorized users will be about 400 and they will be able to join the work on documents simultaneously, therewith saving all generated versions and comments. The processes at different stages occur in parallel; documents are approved and applied faster and in a maximally transparent way. As a result, it accelerates the whole process of dossier formation, makes it possible to avoid the mistakes that result from the simultaneous involvement of a large number of experts. All parties involved have access to the current version of the document.

In the process of implementation the system got its proper name – EasyDoc. At “Darnitsa”, EasyDoc ensures the improvement and continuity of multiple business processes in one place, makes it possible to process the vast amount of information and data, perform the work of development and research of medicinal products at a higher quality level, minimize operational risks and follow all regulatory requirements. The electronic document management system in place also allows “Darnitsa” to grant access to registration dossiers to foreign partners, where necessary.

The implementation of the project of electronic document management at “Darnitsa” commenced in February 2019, its total duration is 15 months. The partners of “Darnitsa” are the Canadian company OPENTEXT, multinational company STRATESYS and SAP, German developer of automated management systems.

About the companies

The Pharmaceutical Firm “Darnitsa” was founded in 1930. It is the leader in Ukraine in terms of the manufacturing scale of medicines by volume. The company’s portfolio includes about 280 different finished pharmaceutical products. In 2017 the company’s net income from sale of products amounted to UAH 2,530 bln, which is 19% more than in 2016. The net profit in 2017 was UAH 342,111 bln. The beneficiaries of the Pharmaceutical Firm “Darnitsa” is the Zahorii family.

OPENTEXT is the Canadian company that develops software for management of enterprise information: business processes, client data, information exchange, software for research and analytics.

STRATESYS is the multinational company majoring in digital services, is the leader in strategic and technological consulting.

SAP is the German developer of automated systems for management of such internal enterprise processes as accounting, trade, production, finance, personnel management, warehouse management, etc.

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