As data integrity issues increasingly find their way into FDA Warning Letters and Form 483s, regulators are demanding companies determine the root cause of these problems by conducting in-depth, objective employee interviews.
This typically appears in FDA Inspectional Observations with the statement below.
“Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.”
In many cases, regulators expect the scope of these investigations to encompass laboratory and production areas in order to fully explain data irregularities and the causes for them, wherever they originated.Continue Reading