Canonical Framework Canonical Frameworks
FDA 21 CFR Part 11
FDA 21 CFR Part 11 compliance for electronic records and signatures in pharmaceutical, biotech, and medical-device companies. Covers audit trails, access controls, data integrity (ALCOA+), electronic signature controls, system validation, and change management. Aligned to ICH E6(R2) GCP.
Regions
US
Regulations
3 covered
Control Domains
6 domains
Deployment
Regulated SaaS, Clinical Zero-Retention, Private Cloud
Regulations & Standards
FDA 21 CFR Part 11 FDA Guidance on Electronic Records Scope ICH E6(R2) GCP
Control Domains
Audit Logging
Access Control
Data Integrity
Electronic Signatures
Validation
Change Management
Deployment Options
Regulated SaaS
Clinical Zero-Retention
Private Cloud
Get started in 3 steps
1
Explore the template
Click "Explore in Console" to open this template in the Keeptrusts configuration editor.
2
Customize policies
Adjust detection thresholds, escalation rules, and redaction patterns to match your requirements.
3
Deploy to your gateway
Save your configuration and deploy it to any Keeptrusts gateway — cloud, on-prem, or air-gapped.