Eudralex V10 Ch IV Annex III: Guidelines for the Conduct of GCP Inspections – Computerised Systems, 5/08
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This EudraLex document for conducting Good Clinical Practice (GCP) inspections refers the reader to the PIC/S document “Guidance on Good Practices for Computerised Systems in Regulated ‘GXP’ Environments”, PI-011-3.
| Issuing Body | European Commission |
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Eudralex V10 Ch IV: Guidelines for the Conduct of GCP Inspections, 5/08
This document provides a framework for conducting Good Clinical Practice (GCP) inspections. Annex III provides additional guidance for computer system inspections.
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PIC/S PI 011-3 PIC/S Guidance: Good Practices for Computerised Systems in Regulated “GXP” Environments, 9/07
PIC/S Guidance for validation, testing, life cycle, change control, electronic signatures, security, back-ups, and inspection of GxP computerized systems.
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