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:
Ensuring regulatory compliance and data protection
Our Security & Compliance strategy ensures full adherence to regulatory standards such as 21 CFR Part 11, ICH E6 R2, GDPR, and HIPAA. We implement comprehensive security measures, including encryption, secure access controls, regular audits, and independent testing to protect sensitive data.
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.