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It is each corporation´s need to wisely use its resources in line with corporate mission, vision, and strategy. The latter considerations and guiding principles set the framework for how the company as a whole or - dependent on size - a department shall set emphasis on maintenance and acquisition of current or future capabilities. These capabilities have to be aligned and shall be implemented over time. Planning and maintenance of a roadmap is key as a compass and communication vehicle and provides the necessary orientation to reach an organization´s goals.
One of the life science industry´s most important areas of scrutiny are patient safety and product quality. These omnipresent principles require operations in a highly regulated environment. Therefore, computerized systems in support of regulated activities and data generated and maintained by these systems have to possess of certain quality characteristics in order to ensure a compliant setup. Moreover, the age of digitalization dictates new trends and tools, may it be cloud-based solutions or the use of artificial intelligence and machine learning components, which require new, creative ways of demonstrating your validation effort.