Pharmaceutical Firm Darnitsa Transforms the Process of the Product Cycle and Quality Management

Pharmaceutical Firm Darnitsa in cooperation with the Spanish company Stratesys implements the project of digital transformation of the pharmaceutical product life-cycle management and quality management processes. The introduction of the electronic document management system is meant ensure for the company both the efficient operation of development processes, an increase of the staff production performance, and a reduction of risks relating to quality characteristics of these processes. As a result, the company plans to reduce the time of the market release of new medicines and to ensure the integrity and reliability of processes covering the life cycle of a medicinal product.

According to the data available to the company, in 2018 at least 6 million patients received treatment thanks to medicinal products of “Darnytsia”. Provision of efficient and rational solutions for improvement of the quality of life and increasing the longevity is the mission of the company which faces new challenges every year. How to speed up the development of effective, safe and affordable medicines and to expand access to them? Finding an answer to these questions is made possible by digital technology tools for data management and integration. The implementation of a seamless and integrated document management system for management of documents and processes that accompany the life cycle of medicinal products is the opportunity to handle a huge array of information and data generated, to work on the development and research of medicinal products on another quality level, to comply with all regulatory requirements. By taking this step towards modern information flow management and communication, “Darnytsia” will break through in meeting the patients' needs.

Andrii Obrizan, General Director of the Pharmaceutical Firm Darnitsa:

“We have made a long way before deciding on the choice of partners and the configuration itself. This is a challenge for us. We understand that in this area we might not be the pioneers, but the number of processes to be integrated is rather ambitious. Now we are looked at not only by the key personnel of the company, whose expectations it is extremely important to justify, the whole market watches us. In 15 months, we will become a benchmark in the field of management of drug master file documents and the quality system to which not only Ukraine will look up.”

The project of electronic document management is implemented by a joint team of specialists from Darnitsa, Stratesys, and industry and technology experts of SAP and OpenText. Its total duration is 15 months and it includes two stages: designing of the processes of development, clinical research, interaction with the registrar and the formation of a platform for so-called GMP relevant documents, as well as processes related to quality management of both production processes and the entire life-cycle of medicinal products.

The project is a part of the transformational processes in the company aimed, in particular, at improving the processes of development and production of pharmaceutical products by optimizing the processes of life-cycle management of medicinal products.

To achieve these ambitious goals, Darnitsa chose SAP Extended ECM by Opentext as the primary management solution for enterprise information. This information system is characterized by a high degree of adaptability and uncompromising integrity and security of data.

Luis Fernandez-Sanguino Peña, the Managing Partner of Stratesys, emphasizes “the significant investment in the development of specific industry solutions of the company that is undergoing transformations under the influence of regulatory changes and globalization challenges”.

According to Andrii Romanenko, IT Director of Darnitsa, this project is a key element of the company’s development plan, as it ensures not only reliability in storage, access to and integrity of information, but also allows to create ready-made content for regulatory reporting according to the requirements of national regulators of other countries including the EU and the USA. The cooperation between Darnitsa and Stratesys is an example of the international competence and capabilities of the Spanish system integrators, which at Stratesys are reflected in more than 1,000 projects implemented in more than 60 countries of the world.

So far the first phase of the project implementation has been completed, an analysis of the current processes and functionalities of the system has been performed, the scope of its adaptation and the way of integration of the future GxP Suite document management platform and SAP systems of Darnitsa have been determined. As a result, its implementation will enable the company to scale up solutions to cover related business processes, starting with specific pharmaceutical processes and ending with complete paperless document circulation in quality functions or back office processes (procurement, human resources management, etc.)