The first indications of data integrity issues in the pharmaceutical industry began in the 1980’s, with the revelation
that several generic drug manufacturers had submitted fraudulent data to the FDA on their Abbreviated New Drug
Applications (ANDAs). Some of these generic drug manufacturers even went so far as to repackage name brand
drugs as samples of their own products before submitting them for bioequivalency tests. Since then Data Integrity has taken on a life of its own and is now a critical facet of Laboratory Compliance. This paper will explore this in great detail.
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