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FDA, Industry Call For Human Factors Approaches To Assuring Data Integrity

Human factors could be the key to data integrity. Agency and industry officials envision ways to stem the flow of data integrity warning letters and ensure data integrity by design with robust electronic production control systems and strong top-down cultural reforms.

With data integrity issues increasingly dominating FDA's drug GMP warning letters, agency and industry representatives are urging pharmaceutical manufacturers to attack the problem with cultural and electronic "human factors" preventive measures.

"One of the themes I think that we see is the issue of human factors continuing with respect to data integrity," said Thomas Cosgrove, acting director of the Office of...

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