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

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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