GXP

E-Records Integrity – Data Warehouse And Data Mart Layer

HMA and EMA Regulatory Activity The regulatory agencies are noticing the value of Big Data to medicine development.  As an example, since 2017 the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) Task Force on Big Data are operating to find best practices and opportunities to increase the utility of big data in regulatory activities, from data reliability through study methods to assessment and decision-making (1). Data quality is one of the best practices under review in this task force. Big Data Analytics Configuration In Figure 1 (2), Big Data Analytics are central...

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