Annex 11 to the good manufacturing practices guide: Computerized Systems: GUI-0050

This annex applies to all forms of computerized systems used as part of Good Manufacturing Practices (GMP) regulated activities. A computerized system is a set of software and hardware components which together fulfil certain functionalities.

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Dernière modification avril 17, 2026, 21:37 (TU)
Créé le avril 17, 2026, 21:37 (TU)
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geographic_scope []
open_canada_collection publication
open_canada_date_published 2021-08-10 00:00:00
open_canada_keywords {"fr": ["rapport de surveillance de la conformité", "bonnes pratiques de fabrication", "produits de santé naturels", "entreprises de produits de santé naturels"], "en": ["Annex 11", "GMP guide", "GUI-0050", "computerized systems", "GMP regulated activities"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Annexe 11 aux lignes directrices sur les bonnes pratiques de fabrication: systèmes informatisés: GUI-0050
update_frequency as_needed