Our Quality Management System
Quality Management System built on integrity and improvement
Our Quality Management System (QMS) is designed to ensure compliance with the highest industry standards and regulatory requirements. We prioritize continuous improvement, risk management, and data integrity, while fostering a culture of quality throughout all stages of our operations. The following key principles guide our approach to delivering superior quality and regulatory compliance:
Compliance & reporting with regulatory standards.
Continuous improvement & risk-based management
Document control & traceability.
Internal audits & Corrective And Preventive Action.
Staff training & competency development.
Supplier management & performance evaluation.
Data integrity & security.
Customer satisfaction & feedback management.
Change management procedures.
Security & Compliance
Ensuring regulatory compliance and data protection
Our Security & Compliance strategy ensures full adherence to regulatory standards such as 21 CFR Part 11, ICH guidelines, GDPR, and HIPAA. We implement comprehensive security measures, including encryption, secure access controls, regular audits, and independent testing to protect sensitive data.
Ensure 21 CFR Part 11 compliance with audit trails.
Comply with ICH guidelines, GDPR, and HIPAA regulations.
Conduct regular internal audits.
Implement secure access controls.
Enable two-factor authentication.
Perform independent penetration tests.
Use encrypted data centers located in France.
Risk-Based Approach to Compliance and Data Integrity
Ensuring integrity and compliance through tailored risk approaches
Our risk-based approach emphasizes identifying and addressing high-risk areas, particularly data integrity. We develop tailored mitigation strategies for each clinical trial phase, centralize study data, and ensure ongoing regulatory compliance.
Prioritize high-risk areas, such as data integrity.
Develop tailored risk mitigation plans for each clinical trial phase.
Centralize data in study-specific platforms for streamlined access.
Adopt a multi-layered approach (group, study, product levels) to address risks.
Implement and test backups to ensure data integrity.
Prepare clinical trial records for timely authority inspections.
Stay updated on regulatory changes to maintain compliance.