Quality
Robust support departments and reliable IT infrastructure, the foundations of our expertise.
Quality assurance is essential for drug developers and health authorities. At PhinC, we have implemented all the necessary measures to ensure fully secure data for our clients. We care about information security and physical protection, which is configured, monitored, and optimized in close collaboration with our quality assurance department.
A Quality Management System designed to support every aspect of the company and to anticipate and adapt to any changes.
- Pharmacometrics activities according to SOPs & Mos
- Compliance with regulatory requirements
- Regular internal audits and strict document management
- Effective process monitoring:
- Regulatory compliance
- Continuous improvement
- Risk management
Our IT infrastructure is highly reliable and ensures top security standards.
- Server’s management under ISO 27001
- Regular Backup and Double Data Center
- Compliance with 21 CFR Part 11 & GAMP Guidelines
- Validation of Modeling Computerized Systems
- Disaster Recovery Plan (DRP)
- Access Management
Risk management and compliance with contractual & data protection requirements are an integral part of our organization.
- A Quality Management System designed to support every aspect of the company and to anticipate and adapt to any changes.
- A Data Privacy Officer available for each aspect of data privacy management (GDPR).
- Legal affairs ensuring the reliability of our contractual engagements.