Built for regulated environments
NeuroQuantix is designed from the ground up for deployment in GxP-regulated clinical trial environments. Every aspect of the platform — from data capture to submission-ready exports — meets the compliance requirements that pharma sponsors, CROs, and regulatory authorities expect.
21 CFR Part 11
FDA 21 CFR Part 11 establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. NeuroQuantix is designed to meet these requirements as deployed in clinical trial settings.
This compliance is not an add-on — it is embedded in the platform architecture. Audit trails, access controls, and electronic signature capabilities are core system features, not optional configurations.
Complete Audit Trail
Every data capture, modification, and access event logged with timestamps, user identity, reason codes, and before/after values.
Access Controls
Role-based access control with unique user accounts, password policies, and session management per organizational requirements.
Electronic Signatures
Signed records with user authentication, meaning designation, and non-repudiation for clinical data submissions.
Data Integrity
Checksums and validation rules ensure that records are not altered without detection. All original data preserved and recoverable.
System Validation
IQ/OQ/PQ validation protocols available. System designed for validation in sponsor or CRO IT environments.
Data Security & HIPAA
Encryption at Rest
All stored data encrypted using AES-256 encryption. Database-level and file-level encryption for complete data protection.
Encryption in Transit
TLS 1.3 for all data transmission. End-to-end encryption between site devices and cloud infrastructure.
Access Control
Role-based access with principle of least privilege. Site staff see only their site data. Sponsor views configurable per protocol.
De-identification
Subject data keyed by randomization ID. No PII stored alongside clinical data. HIPAA Safe Harbor method supported.
Backup & Recovery
Automated encrypted backups with point-in-time recovery. Geographic redundancy for disaster recovery.
Incident Response
Documented breach notification procedures. Monitoring and alerting for unauthorized access attempts.
CDISC & Data Standards
NeuroQuantix data outputs are structured for direct inclusion in regulatory submissions. CDISC-compliant exports eliminate the data transformation burden that typically delays submission timelines.
GxP Compatibility
The platform is designed for deployment in GxP-regulated environments with documentation and validation support that IT and quality teams require.
Need compliance documentation for your team?
Request detailed compliance documentation, validation protocols, or schedule a technical review with your IT and quality teams.