Shenqi Medical Implements WMS and Conducts Computerized System Validation (CSV) Simultaneously
Against the backdrop of increasingly fierce competition in the current medical device industry, digital transformation has become a key path for enterprises to enhance their core competitiveness. Shanghai Shenqi Medical Technology Co., Ltd. has proactively adapted to this trend, successfully implemented the InStock Intelligent Warehouse Management System (WMS), and simultaneously launched the Computerized System Validation (CSV) project. Not only do these initiatives mark a solid step taken by Shenqi Medical toward intelligence and informatization in its operation and management, but they also serve as strong evidence of its commitment to strictly upholding the bottom line of quality compliance and continuously improving the quality of its products and services.
I. Shenqi Medical: Strength and Responsibility of an Industry Leader
As an outstanding player in China’s medical device sector, Shenqi Medical has always adhered to the development philosophy of being innovation-driven and quality-first. Its product portfolio covers the fields of cardiovascular intervention, structural heart disease, peripheral vascular intervention, and neurovascular intervention. The company has obtained a series of internationally authoritative certifications, such as the ISO 13485 Medical Device Quality Management System Certification, fully demonstrating its competitiveness in the medical device market. Meanwhile, it has passed strict audits by national regulatory authorities on multiple occasions, laying a solid foundation for the circulation of its products.
II. InStock Intelligent Warehouse Management System (WMS): Ushering in a New Era of Digital Management
(I) Comprehensive Optimization of Warehouse Processes
The InStock Intelligent Warehouse Management System (WMS) has conducted a full-scale review and optimization of Shenqi Medical’s warehouse business processes. From the inspection and acceptance of raw materials upon warehousing, to the storage management of semi-finished and finished products, and then to the accurate outbound delivery of products, every link has achieved seamless connection through informatization and automation. By leveraging advanced barcode recognition technology, automated stereoscopic warehouse equipment, and intelligent inventory allocation algorithms, the system has significantly shortened the time for goods inbound and outbound, reduced errors and losses caused by manual operations, and markedly improved warehouse operation efficiency.
(II) Data-Driven Decision-Making to Enhance Operational Effectiveness
The system functions as a powerful data hub, collecting, organizing, and analyzing various key data in the warehouse operation process in real time. Information such as inventory levels, goods turnover rates, and order fulfillment status is clearly visible, enabling the management team to quickly make scientific and rational decisions based on this accurate and timely data. For instance, through in-depth analysis of inventory data, the company can accurately predict the demand for raw materials, avoid production halts caused by overstocking or stockouts, effectively reduce operating costs, and enhance the overall operational effectiveness of the enterprise.
(III) Full-Process Quality Control to Uphold Quality Standards
Shenqi Medical is well aware that product quality is the lifeline of an enterprise. To this end, the InStock WMS is equipped with a comprehensive quality control module. From the strict inspection records of raw materials upon warehousing, to the quality traceability of semi-finished products during production, and then to the final quality review of finished products before outbound delivery, every quality control point is incorporated into the system management. Through in-depth integration with the company’s existing production management system, real-time sharing and collaborative management of quality information throughout the product’s full lifecycle are realized, ensuring that every product that enters the market meets the highest quality standards.
(IV) Supply Chain Collaborative Management to Ensure Efficient Operation
In terms of supply chain management, the InStock WMS plays a crucial collaborative role. It can monitor the inventory status of suppliers in real time, automatically trigger purchase orders based on Shenqi Medical’s production needs, and optimize the procurement process. At the same time, it closely cooperates with the logistics and distribution links to realize real-time tracking of the cargo transportation status, ensuring that products are delivered to customers in a timely and accurate manner. Through this end-to-end supply chain collaborative management, the overall cost of the supply chain is effectively reduced, and the response speed and flexibility of the supply chain are improved.
III. Hippocrates CSV Validation Services: Solidifying the Compliance Foundation for Digital Transformation
(I) Strict Adherence to International Standards to Ensure Compliant Operation
Hippocrates’s CSV validation services provide comprehensive and professional compliance support for Shenqi Medical’s InStock WMS. During the project implementation, strict adherence is maintained to internationally accepted standards, such as GMP (Good Manufacturing Practice), regulations of the FDA (U.S. Food and Drug Administration), and cGMP (Current Good Manufacturing Practice). Detailed and rigorous plans and processes have been developed for each validation phase, from Design Qualification (DQ), Installation Qualification (IQ), and Operational Qualification (OQ) to Performance Qualification (PQ). Through comprehensive review and testing of all aspects of the system, including hardware, software, network architecture, and data management, the InStock WMS is ensured to fully meet compliance requirements, providing protection for the stable operation of the enterprise.
(II) Safeguarding Data Integrity and Traceability to Strengthen Quality Support
Data integrity and traceability are core elements of quality management in the medical device industry. Hippocrates’s CSV validation services use advanced validation tools and methods to conduct strict validation on links such as data entry, storage, transmission, and backup of the InStock WMS. This ensures that every piece of data generated by the system is true, accurate, complete, and non-tamperable, while also featuring a sound traceability mechanism. In terms of product quality traceability, relevant information—whether it is the source of raw materials, process parameters during production, or the flow and usage of products—can be quickly and accurately queried through the system. This not only provides strong data support for internal quality improvement of the enterprise but also meets the strict requirements of regulatory authorities during product quality audits.
(III) Risk Control and Continuous Improvement to Support Enterprise Development
Based on the concept of risk control, Hippocrates’s CSV validation services have conducted a comprehensive identification and assessment of potential risk points in the InStock WMS during the project. Corresponding risk control measures and emergency plans have been formulated for risks of different levels. After the system is put into use, continuous attention is paid to its operation status, and retrospective validation is conducted regularly. When the system undergoes upgrades, changes, or new business processes are introduced, change control validation is carried out in a timely manner to ensure that the system always operates in a compliant and stable state. Through this mechanism of continuous risk control and optimization, solid support is provided for the long-term development of Shenqi Medical.
IV. Hippocrates’s Dual Drivers of Digitalization and Compliance: Empowering High-Quality Enterprise Development
The organic integration of the InStock Intelligent Warehouse Management System (WMS) and Xingdi’s CSV validation services has enabled Shenqi Medical to build a full-chain digital management system covering from warehouse management to quality compliance. While improving operational efficiency and reducing costs, this system has significantly strengthened the enterprise’s quality control capabilities, ensuring that Shenqi Medical strictly upholds the bottom line of quality compliance while achieving rapid development. This model, driven by the dual engines of digitalization and compliance, has not only improved Shenqi Medical’s internal management level but also won the trust and recognition of customers in the market competition. It has further enhanced the enterprise’s market competitiveness and injected strong impetus into its high-quality and sustainable development.
