In the era of Big Data, where digitalization and industrie 4.0 significantly increase the production of data, there are more and more companies who want to control the way they produce, collect, distribute, share and analyze their critical data. First and foremost is the pharmaceutical industry which needs data control due to the severe constraints issued by regulatory bodies such as the FDA, EMA, MHRA, and ANSM, etc.
As data is considered « fuel » for a company with a 4.0 vision of industry, it adds value. The problem of data integrity is therefore becoming a sensitive subject involving, at the highest level, the organization of companies. This leads to an extensive readjustment of the Quality Systems and so puts data at the heart of the debate.