Built for Regulatory Confidence
Abiozen operates under globally recognized quality and information security frameworks to support audit readiness, data protection, and regulatory alignment across all platform activities.
Ready
Part 11
Framework
Security
Compliance Philosophy
Rather than treating compliance as a feature, Abiozen embeds regulatory alignment into every layer of the platform—from architecture to user workflows.
Core Principles
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Designed for regulated environments
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Audit-ready systems & documentation
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Continuous compliance monitoring
Compliance & Quality Framework
Abiozen operations are built on a foundation of established regulatory principles to ensure data integrity and institutional trust.
cGMP Alignment
Operational Principles
Framework established to support good manufacturing and laboratory practices through phased implementation.
U.S. FDA Alignment
Regulatory-Ready Design
Workflows designed for regulatory submission readiness with active approval pathways in progress.
ISO 9001:2015
Quality Management
Active implementation of QMS standards to ensure consistent service quality and continuous improvement.
ISO 27001
Information Security
Security controls defined and currently rolling out to protect sensitive scientific and clinical data.
Traceability
Chain of Custody
End-to-end material and data traceability controls embedded into the platform’s core architecture.
Data Integrity & Traceability
Fundamental principles that ensure the reliability and trustworthiness of all data generated and managed within the Abiozen ecosystem.
ALCOA+
Attributable, Legible, Contemporaneous, Original, Accurate +
Embedded in all data workflows
Traceability
End-to-end tracking of materials, samples, and documentation.
Unique identifiers throughout workflows
Chain of Custody
Complete documentation of sample handling and transfer.
Digital custody tracking system
Audit Readiness
Systems designed for regulatory inspection and audit.
On-demand documentation retrieval
Secure Document
Management
Controlled access, retention, and retrieval of quality and compliance records with full version control and electronic signature capabilities.
Version Control
Controlled document storage & history
E-Signatures
Integrated signing workflows
Retention Policies
Automated lifecycle management
Access Controls
Strict role-based permissions
Audit Trails & Repository
Secure sharing with full searchable repository tracking
Security & Access
Enterprise-grade architecture designed to protect sensitive scientific data and maintain platform integrity.
Access Control
- Role-based Access (RBAC)
- Multi-factor Auth
- Session Management
Data Protection
- End-to-end Encryption
- TLS 1.3 Transmission
- AES-256 at Rest
Audit Trails
- Real-time Monitoring
- Automated Threat Alerts
- Full Activity Logs
Infrastructure
- Tier 3+ Data Centers
- Biometric Security
- 24/7 Redundancy
Process Compliance
Structured, audit-ready workflows for independent quality control.
| Process Step | Compliance Elements |
|---|---|
| Request Submission | Auth • Access Control • Audit Trail |
| Sample Management | Traceability • Integrity • Documentation |
| Testing & Analysis | Validation • Calibration • SOP Compliance |
| Result Verification | Second Person Review • Quality Review |
| Certificate Generation | Electronic Records • e-Signatures |
Frequently Asked Questions
Quick answers to the most common questions about our compliance features and data integrity measures.
We implement ALCOA+ principles throughout our platform, with automated validation, audit trails, and electronic signature capabilities. All data workflows include built-in checks for completeness, accuracy, and consistency.
Our platform is designed to support compliance with cGMP, FDA requirements, ISO 9001/27001, GDPR, and 21 CFR Part 11. We conduct regular gap assessments and implement controls to maintain alignment with evolving regulations.
All QC results undergo independent review by qualified personnel, with automated consistency checks and audit trail documentation. Digital Certificates of Analysis include electronic signatures and timestamp verification.
We employ multi-layered security including encryption at rest and in transit, role-based access controls, multi-factor authentication, comprehensive monitoring, and regular security assessments by third-party auditors.
Our platform includes dedicated audit portals with controlled access to relevant documentation. All systems maintain complete audit trails, and we provide audit support services to assist clients during regulatory inspections.