Data Integrity & 21 CFR Part 11 Compliance Requirements

Posted on January 31, 2021May 10, 2021 by admin

21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using: Electronic records (ER), and electronic signatures (ES). Each title of the CFR addresses a different regulated area: 21 CFR relates to Pharmaceuticals and Medical Devices. Part 11 Read more about Data Integrity & 21 CFR Part 11 Compliance Requirements[…]

FDA’s Dec 2018 Guidance on Data Integrity

Posted on November 30, 2020January 31, 2021 by admin

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[…]