Shanghai Saijin Biomedical Implements Traceability Management System

I. Shanghai Saijin Biomedical Co., Ltd.: An Innovation Pioneer in the Biomedical Field

Shanghai Saijin Biomedical Co., Ltd. (hereinafter referred to as "Saijin Biomedical") is a leading domestic biomedical enterprise, focusing on the R&D, production and sales of innovative biopharmaceuticals, recombinant protein drugs and biological products. Relying on its profound accumulation of experience and innovation capabilities in the field of biotechnology, Saijin Biomedical has achieved remarkable results in areas such as tumor treatment and autoimmune diseases, emerging as an outstanding leader in China’s biomedical industry. Guided by the core values of "innovation-driven, quality-first, patient-oriented", the company is committed to enhancing its core competitiveness through technological innovation and management optimization.

However, with the continuous expansion of the enterprise scale and the intensification of market competition, the traditional quality management model has gradually exposed many problems. Quality traceability relied on paper-based records, which were not only prone to errors but also difficult to retrieve and analyze quickly. In the event of quality issues, the traceability process was cumbersome and time-consuming, seriously affecting the company’s market response speed and customer satisfaction. To achieve the digital upgrading of quality control, improve production efficiency and quality management standards, Saijin Biomedical decided to introduce the advanced Xingdi Traceability Management System, initiating its journey towards intelligent transformation of quality control.

II. Urgent Need for Digital Transformation of Quality Traceability

Under the traditional quality management model, Saijin Biomedical faced numerous challenges. Quality records depended on manual paper-based record-keeping, which was not only susceptible to human errors but also made rapid retrieval and analysis difficult. Inconsistencies between quality data and information from production, sales and other departments resulted in difficult quality traceability and low efficiency in problem handling. Furthermore, the inefficiency in statistics and analysis of quality data made it hard to provide timely and accurate decision support for the company’s management.

To address these issues, Saijin Biomedical decided to introduce the Xingdi Traceability System, aiming to improve the efficiency and transparency of quality control through digital means. The Xingdi Traceability System organically integrates the company’s quality control processes, enabling real-time information sharing and collaborative management. Through data collection and analysis, the traceability system can monitor quality status in real time, optimize quality processes, reduce operational costs, and bring comprehensive transformations to the enterprise.

III. Hippocrates Traceability System Project: Phased Implementation to Steadily Advance Intelligent Transformation

A. Overall Planning Blueprint

The Hippocrates Traceability System project of Saijin Biomedical adopted the strategy of "overall planning and phased implementation", gradually outlining a clear path for the intelligent transformation of the enterprise’s quality control.

1. Phase 1: System Planning and Infrastructure ConstructionThe project team conducted in-depth research on the digital construction of advanced enterprises at home and abroad, and formulated a detailed implementation plan based on Saijin Biomedical’s actual needs. During this phase, the enterprise built the infrastructure of the Xingdi Traceability System, realized the initial connection between quality control equipment and the system, and laid the foundation for subsequent full-scale application.
2. Phase 2: Implementation and Optimization of Core ModulesIn this phase, the enterprise focused on implementing core modules such as quality data collection, automated traceability recording, and quality analysis. Through the Xingdi Traceability System, quality data can be collected and recorded automatically in real time; traceability records are generated and stored automatically; and the quality analysis function provides real-time quality reports for the company’s management. Meanwhile, the system optimized quality control processes, reducing waiting time and resource waste in the quality traceability process.
3. Phase 3: Comprehensive Integration and In-depth ApplicationThe Xingdi Traceability System achieved full integration with the enterprise’s existing information systems (such as MES, ERP, and WMS), breaking down information silos and enabling seamless data sharing. By in-depth applying the data analysis function of the traceability system, the enterprise can grasp key indicators in the quality control process in real time, providing decision support for the management. In addition, the traceability system also realized full-process traceability of quality control, ensuring transparency and standardization of operations.

B. Innovation in Core Business Models

Centered on core modules including quality data collection, automated traceability recording, and quality analysis, the Xingdi Traceability System project has promoted the comprehensive upgrading of the enterprise’s quality control.

• Quality Data CollectionThe Xingdi Traceability System enables real-time collection of quality data. Through seamless connection with production equipment and testing equipment, data is automatically transmitted to the system, reducing human errors and improving data accuracy and consistency.
• Automated Traceability RecordingThe Xingdi Traceability System automatically generates traceability records, which include information such as production batches, source of raw materials, key parameters in the production process, and test results. The system supports export and printing of records, facilitating subsequent review and traceability.
• Quality AnalysisThe Xingdi Traceability System provides powerful data analysis functions, which can generate quality reports in real time. This helps the company’s management quickly understand the quality status, identify potential issues in a timely manner, and take responsive measures. The system supports multi-dimensional data analysis, providing scientific decision support for the enterprise.

C. Strong Technical Architecture Support

Based on an advanced digital platform, the Xingdi Traceability System features high customization capabilities and efficient data access capabilities. Adopting a distributed architecture, the system optimizes data storage and access efficiency, and can quickly respond to user query needs. At the same time, the Xingdi Traceability System supports integration with third-party systems, enabling data sharing and collaborative work across various business links within the enterprise.

IV. Remarkable Results: Comprehensive Improvement of Quality Control Standards

A. Internal Transformation of the Enterprise

The introduction of the Xingdi Traceability System has brought significant internal changes to Saijin Biomedical:

• Significant Improvement in Operational EfficiencyBy optimizing quality control processes and monitoring quality status in real time, the Xingdi Traceability System has significantly improved the enterprise’s operational efficiency. The time for quality data collection has been reduced by 50%, the time for generating traceability records by 80%, and the time for handling quality issues by 60%.
• Substantial Upgrade in Data Management StandardsThe Xingdi Traceability System has realized centralized management and real-time sharing of enterprise data, with data consistency and accuracy reaching 100%. All departments of the enterprise can obtain the required data in real time, reducing decision-making errors caused by data inconsistencies.
• Full Realization of Paperless OfficeThe application of the Xingdi Traceability System has achieved paperless quality control in the enterprise, reducing the cost of using and managing paper documents. Meanwhile, the system has improved data accuracy and security, avoiding errors in manual recording.

B. Industry Demonstration and Social Impact

The successful implementation of the Hippocrates Traceability System project by Saijin Biomedical has not only brought significant benefits to the enterprise itself but also provided valuable experience for the digital transformation of quality control in the biomedical industry:

• Industry Demonstration EffectAs an innovation pioneer in the biomedical industry, Saijin Biomedical’s successful case has demonstrated the great potential of the Hippocrates Traceability System in improving quality control efficiency to peer enterprises, encouraging more enterprises to actively engage in digital transformation.
• Cost Reduction and Efficiency ImprovementThe application of the Xingdi Traceability System has reduced the enterprise’s labor costs and management costs while improving operational efficiency. The enterprise has invested the saved resources into technological R&D and innovation, further enhancing its core competitiveness.

V. Future Outlook: Sustained Innovation to Lead the Industry’s Intelligent Transformation

The successful implementation of the Hippocrates Traceability System has laid a solid foundation for Saijin Biomedical’s digital transformation. However, the enterprise is well aware that digital transformation is a continuous process, and there is still broad room for development in the future.

• Continuous Optimization of System FunctionsSaijin Biomedical will continue to optimize the functions of the Xingdi Traceability System according to the needs of business development. For example, it will further improve the data analysis module to achieve more accurate quality prediction and issue early warning; and optimize the traceability process module to realize rapid positioning and handling of quality issues.
• Strengthening Data Analysis CapabilitiesThe enterprise will introduce more advanced data analysis technologies and tools to conduct in-depth mining of quality data in the Xingdi Traceability System. Through data analysis, the enterprise can predict potential issues in advance, optimize quality control processes, and further improve operational efficiency.
• Exploring System Integration and CollaborationSaijin Biomedical will actively explore the integration of the Xingdi Traceability System with other digital solutions. For instance, integrating with the MES system to achieve refined management of the production process; and integrating with the ERP system to realize in-depth integration of quality data and enterprise resource management.
• Through these continuous efforts, Saijin Biomedical will keep moving forward on the path of digital transformation, advancing towards intelligence and high efficiency. This will not only help the enterprise stand out in the fierce market competition but also provide richer and more valuable experience for the digital transformation of quality control in the biomedical industry, leading the industry towards a more brilliant future.

VI. Related Solutions

1. Hippocrates Traceability System Solution
2. MES System Production Management Solution

VII. Related Cases

1. Hippocrates Traceability System Project of Shanghai Qingping Pharmaceutical Co., Ltd.
2. Hippocrates Traceability System Project of Shanghai Tengrui Pharmaceutical Co., Ltd.