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In the context of data integrity, data flows are essential. The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. The key to data integrity compliance is a well-functioning data governance system1
Funded by the European Commission from 2019, the Smart Pharmaceutical Manufacturing Project (SPuMoNI)1 harnesses the potential of state-of-the-art technologies for the pharmaceutical industry. This article discusses the main SPuMoNI accomplishments.
Computational fluid dynamics (CFD) can reduce or eliminate the uncertainty associated with a cleanroom facility as the planned design can be simulated to predict performance to a high degree of accuracy. This article discusses the use of CFD for the purpose of predicting and optimizing the performance of a cleanroom facility in terms of steady-state airborne particulate levels and for...