Regulatory compliance, specifically FDA 21 CFR Part 11 and EU Annex 11, mandates rigorous validation of computer systems. This process ensures that systems consistently deliver accurate and reliable results, meeting predefined specifications and quality standards.

Pharmatek’s risk-based approach to computer system validation (CSV) delivers customized solutions tailored to your specific needs. Our team of validation experts leverages industry best practices and deep domain knowledge to develop and implement robust validation strategies.

Our flexible validation services, coupled with our extensive knowledge of life sciences software and systems, can be seamlessly integrated into your projects. Our experts specialize in validating both commercial off-the-shelf (COTS) and custom-developed applications, adhering to GAMP 5, FDA 21 CFR Part 11, and EU Annex 11 standards.

Pharmatek offers cost-effective, globally accessible solutions that consistently exceed expectations.