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Data Integrity And The Iceberg Concern

 
• By Anju Ghangurde

US FDA official outlines a number of issues around data integrity lapses, including how they trigger concern around all records of a non-compliant firm and that certain factors, including the limited oversight of sponsors over CMOs, could potentially be linked with data integrity problems.

Iceberg
DATA INTEGRITY FINDINGS ARE RARELY ISOLATED AND COULD REPRESENT THE TIP OF THE ICEBERG

Data integrity underpins basic cGMP principles and breaches could therefore cast doubt on all results and records, especially with regulators not knowing how much is “unknown or still hidden.”

Carmelo Rosa, Director, Division of International Drug Quality at the US FDA's Center for Drug Evaluation and Research, noted at...

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