What is Data Integrity ? The definition of Data integrity is that a data need to be complete, consistent, and accurate . The concept applies to CGMP and Good Clinical Practice (ICH E6). Data should be “ALCOA” ( Attributable, Legible , Contemporaneous, Original or true copy, Accurate ) Key Concepts of Data Integrity: Metadata : Read more about FDA’s Dec 2018 Guidance on Data Integrity[…]