Computer System Validation (CSV)

MOEXT stands out as a leader in Computer System Validation (CSV), offering unmatched expertise to ensure that systems meet compliance and integrity standards within the pharmaceutical and life sciences sectors. Our team specializes in validating highly complex systems while adhering to critical regulatory frameworks such as GxP, FDA 21 CFR Part 11, and EU Annex 11. We employ a comprehensive approach to meticulously document, test, and confirm the accuracy, reliability, and consistent performance of these computer systems. By leveraging our specialized knowledge and precision, MOEXT ensures that our clients’ systems align with global regulatory standards, safeguarding their operations and data.

At the core of MOEXT's CSV methodology lies strict adherence to ALCOA+ principles, emphasizing that all data is Attributable, Legible, Contemporaneous, Original, and Accurate, while also focusing on Completeness, Consistency, Endurance, and Availability. These principles are vital in ensuring data integrity and reliability throughout the validation process. Our rigorous approach guarantees that every validated system operates with trustworthiness and full compliance, enabling seamless regulatory adherence. Beyond compliance, this meticulous validation enhances operational efficiency, minimizes risks, and empowers organizations to maintain robust, secure, and high-performing systems in an increasingly regulated and competitive industry.