RBAC
Role-Based Access Control
Access-control model where permissions are assigned to roles, and users are assigned to roles — not permissions assigned directly to users. The minimum bar for any Part 11 / Annex 11 system.
RBAC defines permissions on roles (e.g. Operator, QC Analyst, Reviewer, QA, Site Admin), then assigns users to one or more roles. Adding a new permission updates the role, not every user. RBAC is the minimum access-control model required by 21 CFR Part 11 §11.10(d) (limit system access to authorised individuals) and EU Annex 11 §12 (access controls).
V5 implements role-based access on every regulated table with row-level security; roles are tenant-scoped and platform-admin is gated by a separate allowlist function.
- 21 CFR 11.10(d)
- EU Annex 11 §12
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