FDA 21 CFR Part 11 policy template
Review this template's scope and control areas. Then, open it in the Verdictan console to adapt and test the configuration for your environment.
Map controls for electronic records and signatures under FDA 21 CFR Part 11. The template covers validation, change, audit trails, access, retention and signature integrity. Validate the complete records and signature system separately.
Use this template as a starting configuration and control map. It does not provide certification, legal advice or a compliance guarantee. Confirm your obligations, adapt the configuration and test every outcome before deployment.
US
3 source references
6 mapped control areas
Regulated SaaS, Clinical zero-retention, Private cloud
Source frameworks, standards and obligations
Control areas mapped by this template
Deployment options
Adapt the template in three steps
Review the scope
Confirm that the regions, source references, control areas and deployment options fit your use case.
Adapt the configuration
Open the template in the Verdictan console. Set its policies, thresholds, routing and review requirements for your environment.
Test before deployment
Test each policy outcome. Confirm that allowed, redacted, blocked and reviewed requests behave as expected.
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