FDA · EMA · ISO · GxP
Regulatory compliance,
fully traceable.
One auditable system for biotech, pharma, medical device, CRO, and academic teams. Manage regulations, audits, deviations, CAPAs, trials, manufacturing, and submissions — with cryptographic audit trails by default.
Multi-framework
FDA, EMA, ISO 13485/9001, GMP, GLP, GCP coverage.
Audit-grade trail
Append-only logs with before/after snapshots on every change.
Inspection-ready
Continuous readiness scoring and gap remediation workflows.