EMEA Procedure For Conducting GCP Inspections Requested by the EMEA: Annex III Computer Systems, 11/07

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The EMEA GCP Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections. These inspections are usually requested during the initial review of a Marketing Authorisation Application, but could arise post-authorisation (e.g. inspection of studies conducted or completed as part of the condition of a marketing authorisation, or because of concerns arising about the studies previously submitted).

This document recommends using the PIC/S publication Guidance on Good Practices for Computerised Systems in “GxP” Environments when performing inspections.ﾠ

NOTE: The Scope of this document was corrected in September, 2012