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Human-Machine Interface Ratted On Apollo Workers Who Fibbed Batch Data

 
• By Bowman Cox

The US FDA applied laboratory data integrity inspection technique to production floor, leading to warning letter, import alert.

Vintage inscription made by old typewriter, warning
Apollo's human-machine interface did not lie.

A warning letter the US Food and Drug Administration posted 7 January provides yet another indication that the agency is taking a powerful method for checking on laboratory data integrity and adapting it for use in the production environment.

Data integrity failures related to production equipment identified during a 12-16 August inspection led the agency on 16 December to issue an import alert, followed on 23 December by the...

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