10 major issues were identified as well as the associated cultural issues: collaboration foundation, product & process data validation, capitalization & reuse, manufacturing process management, data configuration management, organization & business process, partners, regulatory, data management tools, big data.
A mapping of the impacted processes, a synthetic and bio data model as well as a process mapping were produced. These elements made it possible to develop a project roadmap and a business case focused on the digitalization of laboratories.