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Procos – EMBRACING DATA INTEGRITY AS COMPANY PHILOSOPHY: PROCOS APPROACH

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Data integrity is the hottest topic in the pharmaceutical business, highlighted by several Health Authorities as necessary for drugs approval, based on the maintenance, assurance of the accuracy and consistency of data over its entire life-cycle. This aspect is well described by the acronym ALCOA (or ALCOA plus) widely used by several health authorities as FDA, MHRA and EMA [for more information please refer to EU GMP references (Part I, Part II and Annex 11)]

With the data integrity it is identified the quality of data itself, but how could be effectively translated in daily working, manufacturing and analysis?

The highest level of data integrity in the QC laboratory would be achievable, ideally, by conveying all the laboratory data into a single integrated system in which instruments, processes and people are ... ...




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