Become part of the team

Data Integrity. FDA DRUG GMP

Share this:

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

If you want to hear more about how Genau & More can help your company, please contact

Genau Shares

Kvalitet og tillid sat i system

For vores medarbejdere og klienter er det selvfølgelig afgørende, at de kan have tillid til os som arbejdsgiver og tæt...

Risk Assessment, FDA DRUG GMP

John Lee, Video 7 of 9


Rigtig god sommer!