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Audit Trail. FDA DRUG GMP

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An audit trail is the
“Who, What, When, and Why”
of a record.

Check FDA 21 CFR Part 11 (Electronic Records and Electronic Signatures) section (e) + (k), see

FDA GFI Data Integrity and Compliance With Drug cGMP (December 2018):
“Audit trail review is similar to assessing cross-outs on paper.
Personnel responsible for record review under CGMP should review the audit trails that capture changes to data associated with the record as they review the rest of the record.

If the review frequency for the data is not specified in CGMP regulations, you should determine the review frequency for the audit trail using knowledge of your processes and risk assessment tools.”

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 Audit Trail (and Data Integrity) are:
• 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

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