More and more frequently, organizations in the medical and life science sectors decide to digitize their internal processes due to the growing importance of modern technologies and the need to adapt to rapidly changing industry regulations. Among them are GxP or CSV (Computerized System Validation) restrictions on the development, production, distribution or promotion of medical products. One of the largest, leading dermatology companies operating in many countries around the world also needed to undergo a transformation and adapt their IT systems to the existing requirements. Thanks to the involvement of Sii Poland’s interdisciplinary expert team in the project, the implementation works were completed in only 5 months.
Need for global production and training management
Before the start of the project, the client worked based on business solutions whose efficiency was much lower than expected. The organization needed support in the area of validation and qualification during the performance of CSV process activities within a framework of two multi-stage projects – Zinc MAPS Migration (a web-based application designed to accommodate materials requiring multiple-stakeholder approval) and Training Management System. The main objective was to replace the current Zinc MAPS system and to create a global system and standard used for the production of packaging, labels, blisters or leaflets, taking into account all processes in specific regions, as well as one universal training system.
Achieving ambitious goals
As a long-term partner of pharmaceutical companies, aware of their needs, Sii Poland offered the client a model of cooperation that allowed achieving the desired results in less than half a year. During this time, a fully validated system for medical and marketing departments as well as a universal standard for the production and distribution of local and global promotional materials, medical content and packaging graphics were provided. In addition, Sii experts implemented a registration and packaging approval system meeting the requirements of the FDA (Food and Drug Administration). Another challenge, which ended with success, was the migration of all production materials from Zinc MAPS to the new system, as well as the transfer of a set of training materials to the created, validated training platform.
— The client was looking for support in a specialist healthcare area, and thanks to the experience of experts from the Testing Competency Center, Sii was ready to start the project in a very short time. Our expertise in the field of validation, medical processes and workflows had a decisive impact on the outcome of the project — explains Marcin Laksander, Testing Competency Center Director at Sii Poland.
Results above all else
As planned, the implementation of dedicated solutions improved the operational efficiency of the client, at the same time allowing them to create a modern workplace based on digitization. Flexible systems and universal standards, adapted to the needs of the healthcare industry leader, made it
possible to optimize both the production process of packaging or blisters as well as global management and marketing processes. The project was a success thanks to the dedication of the expert team and the support of highly qualified technology consultants.
— Digitization of a company is one of the most important processes taking place as part of a broadly defined transformation or adaptation to changes, especially in a validated environment. Our competencies, experience in CSV and Paperless Approach, as well as knowledge of the processes and guidelines of regulatory bodies are crucial and much desired by organizations in the healthcare and pharmaceutical industry. We are proud that through our implementations we help clients increase their competitiveness and gain an advantage – Wojciech Drescher, Head of Healthcare Industry at Sii Poland, concludes.
If you are also interested in digitizing your production or training processes and want to find out which solution will work for your organization, contact our expert. To learn more about Sii Poland’s offer for the healthcare sector, visit our website.