Recently, TÜV SÜD China Group (hereinafter referred to as "TÜV SÜD") certified the electronic records and electronic signatures of Haier Biomedical's liquid nitrogen management system in accordance with the requirements of FDA 21 CFR Part 11. Sixteen product solutions, independently developed by Haier Biomedical, were awarded the TÜV SÜD compliance report, including the Smartand Biobank series.
Obtaining FDA 21 CFR Part 11 certification means that the electronic records and signatures of LN₂ management system of Haier Biomedical meet the standards of credibility, integrity, confidentialtity and traceability, thereby ensuring data quality and security. This will accelerate the adoption of liquid nitrogen storage system solutions in markets such as the U.S. and Europe, supporting the international expansion of Haier Biomedical.
Obtaining FDA certification, HB’s liquid nitrogen management system has embarked on a new journey of internationalization
TÜV SÜD, a global leader in third-party testing and certification, consistently focuses on providing professional compliance support across industries, helping enterprises stay attuned to evolving regulations. The standard FDA 21 CFR Part 11 issued by the U.S. Food and Drug Administration (FDA), grants electronic records the same legal effectas written records and signatures, ensuring the validityand reliability of electronic data. This standard is applicable to organizations that use electronic records and signatures in biopharmaceuticals, medical devices, and food industries.
Since its promulgation, the standard has been widely adopted worldwide, not only by American biopharmaceutical companies, hospitals, research institutions, and laboratories, but also by Europe and Asia. For companies that rely on electronic records and signatures, compliance with the requirements of FDA 21 CFR Part 11 requirements is essential for stable international expansion, ensuring compliance with FDA regulations and relevant health and safety standards.
Haier Biomedical’s CryoBio liquid nitrogen management system is essentially an "intelligent brain" for liquid nitrogen containers. It transforms sample resources into data resources, with multiple data being monitored, recorded, and stored in real-time, alerting to any anomalies. It also features independent dual measurement of temperature and liquid levels, as well as hierarchical management of personnel operations. In addition, it also provides visual management of sampels for quick access. Users can switch between manual, gas-phase, and liquid-phase modes with a single click, improving efficiency. Furthermore, the system integrates with IoT and BIMS sample information platform, enabling seamless connection among personnel, equipment, and samples. This provides a scientific, standardized, safe, and efficient ultra-low temperature storage experience.
Haier Biomedical has developed a comprehensive one-stop liquid nitrogen storage solution suitable for all scenes and volume segments, focusing on the diversified requirements of sample cryogenic storage management. The solution covers various scenarios, including medical, laboratory, low-temperature storage, biological series, and biological transportation series, and provides users with a full-process experience including engineering design, sample storage, sample retrieval, sample transportation, and sample management.
By complying with FDA 21 CFR Part 11 standards, Haier Biomedical's CryoBio liquid nitrogen management system has been certified for the validity of our electronic signatures and the integrity of our electronic records. This compliance certification has further enhanced Haier Biomedical's core competitiveness in the field of liquid nitrogen storage solutions, accelerating the brand’s expansion in global markets.
Accelerate international transformation to attract users, and improve the competitiveness of the global markets
Haier Biomedical has always adhered to an international strategy, continuously promoting a "network + localization" dual system. At the same time, we continue to strengthen the development of market systems to face users, enhancing our scenario solutions in interaction, customization, and delivery.
Focusing on creating the best user experience, Haier Biomedical strengthens localization by establishing local teams and systems to quickly respond to user needs. By the end of 2023, Haier Biomedical has owned an overseas distribution network of over 800 partners, collaborated with more than 500 after-sales service providers. Meanwhile, we have established an experience and training center system, centered on the United Arab Emirates, Nigeria and the United Kingdom, and a warehousing and logistics center system located in the Netherlands and the United States. We have deepened our localization in the UK and gradually replicating this model globally, constantly strengthening our overseas market system.
Haier Biomedical is also accelerating the expansion of new products，including laboratory instruments, consumables, and smart pharmacies, enhancing the competitiveness of our scenario solutions. For life science users, our centrifuges have made breakthroughs in Europe and America, our freeze dryers have obtained the first orders in Asia, and our biosafety cabinets have entered the eastern Europe market. Meanwhile, our laboratory consumables have been achieved and replicated in Asia, North America, and Europe. For medical institutions, besides solar vaccine solutions, pharmaceutical refrigerators, blood storage units, and consumables are also developing rapidly. Through continuous interaction with international organizations, Haier Biomedical provides services including laboratory construction, environmental testing and sterilization, creating new growth opportunities.
By the end of 2023, over 400 models of Haier Biomedical have been certificated overseas, and successfully delivered to several major projects in Zimbabwe, the Democratic Republic of Congo, Ethiopia, and Liberia, as well as the China-Africa Union Centers of Disease Control (CDC) project, demonstrating the improvement of delivery performance. Our products and solutions have been e widely adopted in over 150 countries and regions. At the same time, we have maintained long-term cooperation with over 60 international organizations，including the World Health Organization (WHO) and UNICEF.
Obtaining FDA 21 CFR Part 11 certification is a significant milestone for Haier Biomedical as we focus on innovation in our journey of global expansion. It also demonstrates our commitment to meeting user needs through innovation. Looking ahead, Haier Biomedical will continue our user-centric innovation approach, advancing our global strategic deployment across regions, channels, and product categories. By emphasizing local innovation, we aim to explore the international markets by intelligence.
Post time: Jul-15-2024
