John Lee, Video 6 of 9
This 6th video (out of 9 in total) focuses on Data Integrity.
FDA has expanded its scope concerning Data Integrity. Previously, only direct falsifying of data, but now the scope also includes:
• If IT security is insufficient (biggest issue!)
• If data are not noted at the time, they are generated
• If documentation is deleted or changed without sufficient documentation
• “Selective data recording”
Data Integrity refers to the completeness, consistency and accuracy of data. Complete, consistent, and accurate data should be: Attributable, Legible, Contemporaneously recorded, Original (or a true copy), Accurate ( referred to as ALCOA or ALCOA+).
The video is recorded during the COVID-19 US lock-down by John Lee with mobile recording equipment, and the quality could be better. Focus on the great presentation and content instead.
Relevant guidelines on Data Integrity:
• MHRA GXP Data Integrity Guidance and Definitions (March 2018)
• FDA GFI Data Integrity and Compliance With Drug CGMP (December 2018)
• Genau & More E-book on Data Integrity. Can be downloaded from genauandmore.com
