Governance Framework
CHARSTAN operates under a multi-layered governance framework designed for regulatory compliance, data protection, and operational integrity across all markets served.
- Governance board with quarterly review cycles
- Separation of duties matrix enforced across all modules
- Immutable audit trails for all system actions
- Continuous risk assessment and monitoring
Regulatory Alignment
Our platform is architected to align with key global regulatory frameworks.
- ISO 13485 — Quality Management Systems for Medical Devices
- FDA 21 CFR Part 11 — Electronic Records and Signatures
- EU GMP Annex 11 — Computerised Systems
- ISO 27001 — Information Security Management
- LGPD/GDPR — Data Protection
Internal Controls
We maintain rigorous controls across the platform to ensure data integrity and compliance.
- Role-based access control (RBAC) with least-privilege principle
- Document version control with complete audit trail
- Approval workflows with electronic signatures
- Automated data retention and archival
- Backup and disaster recovery procedures
Transparency
We are committed to transparency in our operations, security, and data practices.
- Regular compliance reports available to clients
- Third-party security assessments
- Compliance status published on Trust Center
- Open channel for vulnerability disclosures
Oversight & Accountability
Clear oversight roles ensure accountability at every level.
- Designated Data Protection Officer (DPO)
- Compliance committee with monthly meetings
- Incident escalation process with defined SLAs
- Annual management reviews with full documentation