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LABORATORY DATA INTEGRITY: CURRENT EXPECTATIONS FOR OOS RESULT INVESTIGATIONS

April 07, 2020 | (01:00)
USA (United States of America)
SHARESHARESHARE
In multiple recent FDA warning letters, laboratory data integrity was cited as the main reason for concern.  One letter states that the identified data integrity issues “demonstrate a general lack of reliability and accuracy of data generated by the laboratory – a serious CGMP deficiency that raises concerns about the integrity of all data generated by your firm.