Security & Regulatory Compliance
Public alignment with clinical trial software qualifications, data protection mandates, and audit traceability controls.
FDA 21 CFR Part 11 Electronic Signatures
G-Flow's Consensus Scrum Gate is fully aligned with 21 CFR Part 11 electronic signature rules. The compiled trial database files are locked cryptographically, generating audit logs and tracking signature details for the Data Manager, Study Designer, Biostatistician, and Sponsor Reviewer before release.
Data Privacy: HIPAA & GDPR Compliance
Because G-Flow operates 100% locally on-premises (using containers running inside your local secure networks), the system transmits no clinical trial protocol text or study design data to external clouds. This guarantees data sovereignty, preventing patient record or study design leaks and ensuring compliance with HIPAA and GDPR regulations.
GxP Validation Methodology
We provide automated GxP container testing scripts and installation qualification/operational qualification (IQ/OQ) validation documentation with every cohort release. Deployed local instances run in sandboxed Docker container boundaries, ensuring immutable setups and reproducible compiler executions.
Audit Logs and GitOps Change Control
All database schema changes and consensus canvas adjustments write back to a local Git repository, creating a versioned, cryptographically versioned trail of every database configuration edit.