  The digital transformation of pharmaceutical industry is a challenging task
due to the high complexity of involved elements and the strict regulatory
compliance. Maintenance activities in the pharmaceutical industry play an
essential role in ensuring product quality and integral functioning of
equipment and premises. This paper first identifies the key challenges of
digitalization in pharmaceutical industry and creates the corresponding problem
space for key involved elements. A literature review is conducted to
investigate the mainstream maintenance strategies, digitalization models, tools
and official guidance from authorities in pharmaceutical industry. Based on the
review result, a semantic-driven digitalization framework is proposed aiming to
improve the digital continuity and cohesion of digital resources and
technologies for maintenance activities in the pharmaceutical industry. A case
study is conducted to verify the feasibility of the proposed framework based on
the water sampling activities in Merck Serono facility in Switzerland. A
tool-chain is presented to enable the functional modules of the framework. Some
of the key functional modules within the framework are implemented and have
demonstrated satisfactory performance. As one of the outcomes, a digital
sampling assistant with web-based services is created to support the automated
workflow of water sampling activities. The implementation result proves the
potential of the proposed framework to solve the identified problems of
maintenance digitalization in the pharmaceutical industry.
