Vývoj aplikace pro podporu procesu validace softwaru

Abstract

The thesis focuses on the design and development of an application supporting the software tool validation process in an organization involved in the production of medical devices and the development of medical software. Validation of such tools is essential in this highly regulated environment to ensure compliance with the quality management system (QMS) according to ISO 13485 and ISO 9001 standards. The application also takes into account the requirements of ISO 13485 regarding the control of documents and records and complies with FDA 21 CFR Part 11 regulations governing electronic records and electronic signatures. The aim was to develop a functional application that digitalizes the software validation process while meeting both legal and regulatory requirements as well as the specific needs and internal processes of the organization. The resulting solution also demonstrates that even complex processes in a regulated environment can be effectively digitalized and automated using low-code technologies. For development, Microsoft Power Platform tools were used – specifically Power Apps and Power Automate, which enable rapid design of business applications in a low-code environment – along with SharePoint for storing records and documentation. The work first summarizes the theoretical background, including the regulatory requirements of ISO 13485 and FDA 21 CFR Part 11, the potential of the Microsoft ecosystem for ensuring compliance with these standards, the technologies used, and agile development methodologies suitable for working with Power Platform. Subsequently, the thesis focuses on analysing the current validation process within the organization and defining requirements for the new solution. The final part describes the actual development of the application, from architectural design through data storage in SharePoint to implementation in Power Apps and process automation in Power Automate. The result is a functional application that improves the efficiency, clarity, and transparency of the software tools validation process in the organization. The work confirms that low-code platforms are an effective tool for the digitalization and management of complex processes even in the highly regulated environment of the medical device industry. The outcomes of the thesis can serve as a basis for further development of the application, potential migration to a more robust platform, and inspiration for digitalizing other supporting processes within the organization.