At Vazyme, we believe that "Quality is all in the details." This principle is deeply ingrained in our corporate culture and represents a shared commitment among all employees.
We recognize that product quality directly affects customer trust, satisfaction, and public health and safety.
In a rapidly changing market, we consistently prioritize quality in our pursuit of excellence. Our team engages in continuous self-assessment and improvement, adopting advanced technologies and management practices to ensure that every product meets the highest standards. We oversee every stage of production and prioritize quality control at every step, from raw material procurement and manufacturing processes, to final inspection and delivery.
Quality from Intelligent Manufacturing
Vazyme has increased investments in intelligent manufacturing technologies. By automating production lines and standardizing processes, we have enhanced product quality, reduced lead times, and improved efficiency. By implementing information management systems such as the Cyber-Physical System (CPS), the Supplier Relationship Management System (SRM), the Warehouse Management System (WMS), and the Manufacturing Execution System (MES), we have realized end-to-end digital management, covering everything from raw material storage to finished product warehousing. These technologies provide full traceability of production data for better data collection and analysis, enable real-time production monitoring, and allow for quick issue identification and resolution, significantly boosting production efficiency and quality control.
Our innovative production management enables us to rapidly respond to customer demands and greatly enhances our supply capabilities while ensuring consistent, high product quality, which helps our customers gain an advantage in the competitive market.
Quality from Strong Supply Chain
Vazyme boasts manufacturing facilities that meet Good Manufacturing Practices (GMP) standards. Our GMP-level utilities, premises, production equipment, and test instruments lay a solid foundation for scientific and pharmaceutical research, development, and production. The facilities feature a well-designed layout that separates personnel and material flows and keeps product lines isolated from each other, thereby ensuring efficiency and high-quality production.
Vazyme has been strictly adhering to GMP guidelines from the inception of its quality system development. Our GMP-based management system was launched in 2023 and upgraded in 2024. The system covers various key aspects, including quality assurance, quality control, facility and equipment management, production management, material management, organizational structure and personnel qualifications, verification process, production process control and record management, and quality standard formulation and testing. To ensure that every employee possesses in-depth knowledge and skills in quality management, we also organize regular training on the GMP management system.
Thanks to years of sound growth, Vazyme has built large-scale manufacturing facilities and production lines that cater to diverse business needs. Specifically, the life science manufacturing facility spans over 36,000 m2, the in vitro diagnostic (IVD) production line boasts a 5,000 m2 cleanroom, and the bio-medicine production line occupies an area of 10,000 m2. Our large, standardized supply chain has improved production efficiency and enhanced product consistency and reliability. A network of global warehouses and cold chain logistics infrastructure has also been developed to ensure that products.
Quality from Highest Standards
Quality is of utmost importance to Vazyme. We have obtained a number of ISO certifications, including IS0 9001 Quality Management Systems, IS0 13485 Quality Management Systems for Medical Devices, IS0 14001 Environmental Management Systems, and IS0 45001 Occupational Health and Safety Management Systems, and have established a comprehensive quality management system.
In the first half of 2024, the Life Science Division underwent 15 customer on-site audits and hosted visits and exchanges from 61 peer companies. We have gained great recognition from customers in various segments, such as pathogen testing, tumor testing, and sequencing services.
In terms of IVD business, we have been strictly implementing international regulations and standards such as In Vitro Diagnostic Regulation (IVDR), Quality System requirements of US FDA (QSR 820), and ISO 13485, and have successfully obtained certifications including EU CE, Medical Device Single Audit Program (MDSAP), and ISO 13485:2016. These certificates demonstrate our industry-leading competence in terms of product quality, supply stability, and experience in clinical application.
Quality from All of Us
Vazyme is committed to fostering a culture that "Quality is a shared goal for everyone". We have formed a professional team for quality management throughout the entire product life cycle. Our aim is to ensure that competent professionals adhering to high quality standards are always available to oversee quality management and risk control throughout the process, from conception and development to production, sales, and after-sales services.
To further strengthen quality awareness among our employees, we have incorporated into our daily operation a diverse array of quality improvement initiatives, including encouraging constructive suggestions from employees, promoting the use of the Eight Disciplines (8D) reports to solve problems, and organizing regular Quality Control Circle (QCC) activities. Through these collective efforts, we are exploring a new path towards enhanced quality and efficiency, harnessing the power of small yet impactful improvements to drive a giant leap in quality.
Quality is our unwavering pursuit. Vazyme remains steadfast in its vision of "For Science For Health." Focusing on the discovery, diagnosis, prevention, and treatment of diseases, we are, and will always be, bringing better technologies, products, and services to the biotechnology industry, serving the public with real technological innovation and contributing to human health.
Media Contact
Company Name: Vazyme-
Email: Send Email
Phone: +1(415)9729973
Country: China
Website: https://www.vazymeglobal.com/
