How NewTn System Helps You to Be Compliant
Comprehensive solution for regulatory compliance and security in clinical trial data management
FDA
ICH
K-FDA
ISO
Clinical Trials Data Security
NewTn System Security Policy Overview
We strictly comply with international standards and regulatory requirements to ensure the integrity and security of clinical trial data. All data is stored encrypted, and access permissions are managed according to the principle of least privilege.
Our comprehensive security policy is based on FDA CFR 21 Part 11, ICH guidelines, and GAMP 5 principles.
Core Security Features
End-to-End Encryption
AES-256 encryption applied to all data transmission and storage
Access Control Management
Role-based access control (RBAC) and multi-factor authentication
Complete Audit Trail
Track and archive all system activities and data changes
Data Protection Principles
Customer Data Non-Access Policy
Ensures that our staff do not directly access customer data
Data Integrity Verification
Prevent data tampering through checksums and digital signatures
Regular Security Audits
Continuous security enhancement through internal and external audits
Compliance Standards & Guidelines
CFR 21 Part 11
Developed to meet FDA electronic records and electronic signatures regulation requirements, ensuring reliability and integrity of clinical trial data.
FDA Computerized Systems Guidance
Developed to meet FDA guidance requirements for computerized systems used in clinical investigations, ensuring system reliability.
GAMP 5
Developed to meet GAMP 5 principle requirements for validation and lifecycle management of computerized systems, ensuring system quality.
Certification Status
ISO 9001:2015
Quality Management System Certification
ISO 27001:2013
Information Security Management System Certification in Progress
Validation as a Service
We provide comprehensive validation services that comply with all regulatory requirements including CFR 21 Part 11, FDA Guidance, and GAMP 5. Through Agile & SCRUM methodologies, we ensure rapid response to industry trends and regulatory changes while maintaining quality-driven system development and continuous improvement.
Validation Documentation
User Requirements Specifications (URS)
IQ/OQ/PQ/DQ Testing Documentation
Validation Summary Reports
User Manuals & Release Notes
Training Certificates & Maintenance Plans
Change Control Documentation
Additional Security Measures
Data Backup & Recovery
- Daily automated backup system operation
- Geographically distributed backup centers
Monitoring & Response
- 24/7 system monitoring
- Real-time security threat detection and response
- Regular penetration testing and vulnerability assessment
Trusted Partner for Regulatory Compliance and Data Security
Dodlab provides the highest level of compliance and security through continuous improvement and innovation.
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C-1221 161-8, Magokjungang-ro, Gangseo-gu, Seoul, Republic of Korea