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Lessons Learned from Implemented Internal and External Digitisation Processes at the Croatian Agency for Medicinal Products and Medical Devices

The goal of this work is to present and explain the differences between internal and external digitisation process instances in the Croatian Agency for Medicinal Products and Medical Devices. The study is to share lessons learned from Agency's digitisation practice, discuss the applicability of these process instances, and demonstrate ways of evaluating digitisation and accompanying capabilities. The Agency started with digitisation in 2013, and the program ran for four annual cycles. The Agency also established its internal process in 2016. For establishing it, the authors have used business process management methods - interviews, analysis and modelling. For constant process improvement, the authors use capability/maturity modelling methods, focused on the quality component, particular issues and preservation of results.