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Data Integrity. FDA DRUG GMP

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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

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

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Kvalitet og tillid sat i system

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Risk Assessment, FDA DRUG GMP

John Lee, Video 7 of 9

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