Description

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.

Resources

Name	Format	Description	Link
Annex 11 to the good manufacturing practices guide: Computerized Systems: GUI-0050	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/annex-11-guide-computerized-systems-gui-0050.html
Annex 11 to the good manufacturing practices guide: Computerized Systems: GUI-0050	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/conformite-application-loi/bonnes-pratiques-fabrication/documents-orientation/annexe-11-lignes-directrices-systemes-informatises-gui-0050.html

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