EMA Classification and Analysis of the GCP Inspection Findings 2000-2012

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In December, 2014, the EMA (European Medicines Agency) published Classification and Analysis of the GCP Inspection Findings of GCP Inspections Conducted at the Request of CHMP for the 398 EMA GCP (Good Clinical Practice) inspections conducted in the years 2000-2012.

Inspection findings were classified into 50 categories. These categories included computer validation, audit trails, access controls, physical security, and back-ups.

• Annex 2 and Annex 3 show the ranking and frequency of computer system findings across all GCP inspections
• Annex 4 and Annex 5 show the ranking and frequency of computer system findings across investigational site inspections.
• Annex 6 and Annex 7 show the ranking and frequency of computer system findings across sponsor inspections.