Have you taken time to read the regulations and guidance documents about data integrity, or do you believe the myths, rumors, or third-party opinions?
You may use your company’s QA to interpret the rules for you, but they too can be wrong. However, there is no excuse for incompliance. In Q18 of the FDA Guidance, it says that everyone at every management level involved in any incompliance that is discovered should be subject to personal consequences (i.e. “removed from cGMP positions”).
The unfortunate fact is that lot of organizations are stuck with outdated procedures because they believe well-worn data integrity myths. These myths harden into misconceptions that can lead to incompliant record quality and painful and expensive difficulties with regulators.
The Truth about Data Integrity
In a no-nonsense interview with data integrity expert Bob McDowall, we will work to uncover the truth about data integrity and what instrumentation and software can help you achieve it. Statements heard around the industry that will be addressed include:
In his own colorful style, McDowall will review each statement in turn and classify whether it is a misconception, myth, or maybe even the truth! Afterwards, you should be better able to review your current setup and decide what actions to pursue to ensure all-important data integrity in the workflows you run daily in your lab.