What The FDA Guidance On Data Integrity Means For Your Lab

By Dale Curtis Jr., President, Astrix Technology Group

Regulatory agencies worldwide are increasingly focusing their efforts on data integrity in GxP laboratories. This increased focus has led to a number of guidance documents being published on data integrity in 2016, including:

• The World Health Organization (WHO) published its final version of “Good Data and Records Management Practices” guidance document
• The European Medicines Agency (EMA) issued good manufacturing practice (GMP) guidance to ensure the integrity of data
• The Food and Drug Administration (FDA) issued a “Data Integrity and Compliance With cGMP” guidance document