PDA Letter Article

Get Your Data Integrity Basics Down for Success

by Silvia Martins, Five Validation

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In recent years, regulatory investigators have observed an increase in violations involving data integrity (1). Inconsistencies related to data integrity pose risks to product safety, effectiveness and quality. At the same time, pharmaceutical manufacturing is growing ever more digitized, raising the criticality of data integrity even further. In light of these technological changes, it pays for companies to invest in a data integrity strategy.