White Paper: Managing Data Integrity in FDA-Regulated labs.
March 22, 2023
Download our updated white paper entitled – Managing Data Integrity in FDA-Regulated labs.
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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White Paper: Managing Data Integrity in FDA-Regulated labs.New White Paper LEARN MORE
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