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Calidad - Cryoport Systems

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class="breadcrumb_last" aria-current="page">Calidad</span></span> </div> </div> <section class="column-content image-content standard list-style-1 center margin-no-top reversed"> <div class="container"> <div class="image-content__image"> <img src="https://www.cryoport.com/wp-content/uploads/2023/11/Quality-Body.jpg" alt="Cryoport Systems" /> </div> <div class="image-content__content"> <h2>Normalización de la cadena de suministro de las ciencias de la vida</h2> <p>Para complementar nuestras soluciones de cadena de suministro líderes en el sector, Cryoport Systems cuenta con un sistema de calidad sólido, probado y fiable para ofrecer a nuestros clientes confianza y seguridad en nuestros procesos. Cryoport Systems colabora estrechamente con ISTA, IATA, ASTM, así como con otros organismos reconocidos y acreditados internacionalmente para diseñar, desarrollar y ejecutar estudios de verificación y validación. Recientemente, nuestra experiencia ha sido parte integrante del desarrollo de la norma ISO 21973:2020, <em>Requisitos generales para el transporte de células para uso terapéutico</em>.</p> </div> </div> </section> <section class="column-content image-content standard list-style-3 top margin-no-top reversed"> <div class="container"> <div class="image-content__image"> <img src="https://www.cryoport.com/wp-content/uploads/2023/11/DSC07993.jpg" alt="Quality Team" /> </div> <div class="image-content__content"> <p><strong>Nuestros sistemas y procesos de calidad incluyen</strong></p> <ul> <li>Chain of Compliance®: trazabilidad de equipos, procesos y logística en apoyo del transporte de materiales críticos en todo el mundo.</li> <li>El Sistema de Gestión Logística Cryoportal® &#8211; validado para demostrar la conformidad con 21 CFR Parte 11 e ISPE GAMP5.</li> <li>El único proceso de limpieza validado del sector para envases a temperatura controlada, Veri-Clean®.</li> <li>Los registros completos de temperatura de los materiales transportados se mantienen como mínimo durante 10 años.</li> <li>Un amplio depósito de datos históricos para facilitar la toma de decisiones basadas en el riesgo.</li> <li>Instaurar normas de Buenas Prácticas de Fabricación (BPF) y de Buenas Prácticas de Distribución (BPD) cuando proceda.</li> <li>Participación en la FACT (Fundación para la Acreditación de la Terapia Celular) y el SCB (Organismo Coordinador de Normas).</li> <li><a href="https://www.cryoport.com/wp-content/uploads/2023/12/Cryoport-Systems-ISO-9001-2015-Certificataion-2023-Issuance.pdf">Certificación ISO 9001:2015</a>.</li> <li>Cumplimiento de la norma ISO 21973.</li> </ul> </div> </div> </section> <section class="contact-cta"> <div class="container"> <div class="contact-cta__content"> <h3>Soluciones innovadoras</h3> <p><a href="https://www.cryoport.com/es/soluciones/">Obtenga más información sobre nuestras soluciones innovadoras</a> y sobre cómo aplicamos nuestros amplios 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