Canonical Framework Canonical Frameworks
GxP / GMP Annex 11
EU GMP Annex 11 compliance for computerized systems in pharmaceutical manufacturing and clinical research. Covers data integrity (ALCOA+), validation, change management, data backup, and supplier qualification. Aligned to PIC/S GMP Guide and WHO Technical Report Series.
Regions
EU, Global
Regulations
4 covered
Control Domains
7 domains
Deployment
Regulated SaaS, Clinical Zero-Retention, Private Cloud
Regulations & Standards
EU GMP Annex 11 EMA GxP Guidelines PIC/S GMP Guide PE 009-16 WHO TRS 996 Annex 5
Control Domains
Audit Logging
Data Integrity
Access Control
Validation
Change Management
Data Backup
Supplier Qualification
Deployment Options
Regulated SaaS
Clinical Zero-Retention
Private Cloud
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