Built for regulated environments
NeuroQuantix meets 21 CFR Part 11 and EU GMP Annex 11 requirements for electronic records and computerized systems, HIPAA data security standards, GxP process quality, and CDISC data format requirements for regulatory submissions. The platform includes complete audit trails, role-based access controls, AES-256 encryption at rest, TLS 1.3 encryption in transit, and IQ/OQ/PQ validation protocol support. Compliance is embedded in the architecture, not added as an afterthought.
21 CFR Part 11
NeuroQuantix is designed to meet all FDA 21 CFR Part 11 requirements for electronic records and electronic signatures in clinical trial settings. The full regulatory text establishes the criteria under which digital records are considered trustworthy, reliable, and equivalent to paper records.
This compliance is not an add-on. Audit trails with timestamps, user identity, reason codes, and before/after values are core system features. Access controls, electronic signature capabilities, and data integrity checksums are embedded in the platform architecture, not optional configurations added for specific deployments.
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 exports data in CDISC ODM format with SDTM-compatible structure, Define.xml metadata support, and controlled terminology alignment. These submission-ready data packages eliminate the data transformation burden that typically delays NDA/BLA submission timelines and introduces transcription errors. Our compliance approach aligns with DiME (Digital Medicine Society) standards for digital clinical measures.
GxP Compatibility
The platform is designed for deployment in GxP-regulated environments with documentation and validation support that IT and quality teams require.
Frequently Asked Questions
Is NeuroQuantix 21 CFR Part 11 compliant?
Yes. NeuroQuantix is designed for 21 CFR Part 11 compliance with complete audit trails (timestamps, user identity, reason codes, before/after values), role-based access controls with unique user accounts and password policies, electronic signature capability with user authentication and meaning designation, and data integrity checksums that detect unauthorized alterations. IQ/OQ/PQ validation protocol templates are available for deployment in sponsor or CRO IT environments.
Does NeuroQuantix support CDISC data standards?
Yes. NeuroQuantix exports data in CDISC ODM format with SDTM-compatible data structure, Define.xml metadata support, and controlled terminology alignment. Data packages are structured for direct inclusion in NDA/BLA regulatory submissions to FDA, EMA, and Health Canada, eliminating the data transformation burden that typically delays submission timelines.
How does NeuroQuantix handle HIPAA compliance and data security?
NeuroQuantix implements AES-256 encryption for all stored data, TLS 1.3 encryption for all data transmission, role-based access control with principle of least privilege, and HIPAA Safe Harbor de-identification. Subject data is keyed by randomization ID with no PII stored alongside clinical data. Automated encrypted backups provide point-in-time recovery with geographic redundancy.
Is NeuroQuantix compatible with GxP-regulated environments?
Yes. NeuroQuantix is designed for deployment in GxP-regulated clinical trial environments with IQ/OQ/PQ validation protocol templates, standard operating procedures for system use, documented change management processes, user training documentation and tracking, and GAMP 5 risk-based validation approach. The platform integrates with existing EDC systems (Medidata Rave, Oracle Clinical, Veeva Vault) and eCOA platforms.
How does NeuroQuantix handle electronic signatures?
Electronic signatures comply with 21 CFR Part 11 requirements. Each signed record includes user authentication, meaning designation, and non-repudiation controls. Signatures are linked to their respective electronic records with date/time stamps.
Can NeuroQuantix data be used in FDA submissions?
Yes. NeuroQuantix produces regulatory-grade data designed for inclusion in submissions to FDA, EMA, and Health Canada. The platform generates submission-ready data packages with CDISC-compliant exports, complete audit trails, and validation documentation.
Need compliance documentation for your team?
Request detailed compliance documentation, validation protocols, or schedule a technical review with your IT and quality teams.