Implementation of Traceability Management System by Xuantai Haimen Pharmaceutical

I. Xuantai Haimen Pharmaceutical Co., Ltd.: A Quality Benchmark in the Pharmaceutical Industry

Xuantai Haimen Pharmaceutical Co., Ltd. (hereinafter referred to as "Xuantai Pharmaceutical"), a well-known domestic pharmaceutical enterprise, focuses on the R&D, production and sales of chemical drugs, biological products and traditional Chinese medicines. Relying on its outstanding product quality and strict quality management system, Xuantai Pharmaceutical has won wide recognition in both domestic and international markets. Guided by the core values of "Quality First, Innovation-Driven, Patient-Centered", 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 case of quality issues, the traceability process was cumbersome and time-consuming, seriously affecting the enterprise’s market response speed and customer satisfaction. To achieve the digital upgrading of quality control, improve production efficiency and quality management level, Xuantai Pharmaceutical decided to introduce the advanced Singdi Traceability Management System, initiating the intelligent transformation journey of quality control.

II. Urgent Need for Digital Transformation of Quality Traceability

Under the traditional quality management model, Xuantai Pharmaceutical faced many challenges. Quality records depended on manual filling of paper documents, which not only easily led to human errors but also made rapid retrieval and analysis difficult. The inconsistency between quality data and information from production, sales and other departments resulted in difficult quality traceability and low efficiency in problem handling. In addition, the efficiency of quality data statistics and analysis was low, making it hard to provide timely and accurate decision support for the enterprise’s management.

To solve these problems, Xuantai Pharmaceutical decided to introduce the Singdi Traceability Management System, aiming to improve the efficiency and transparency of quality control through digital means. The Singdi Traceability Management System organically integrates the enterprise’s quality control processes, enabling real-time information sharing and collaborative management. Through data collection and analysis, the traceability system can monitor the quality status in real time, optimize quality processes, reduce operating costs, and bring all-round changes to the enterprise.

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

(I) Overall Planning Blueprint

The Hippocrates Traceability Management System project of Xuantai Pharmaceutical 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 the actual needs of Xuantai Pharmaceutical. In this phase, the enterprise built the infrastructure of the Singdi Traceability Management System, realized the initial connection between quality control equipment and the system, and laid a foundation for the subsequent comprehensive application.
2. Phase 2: Implementation and Optimization of Core ModulesIn this phase, the enterprise focused on the implementation of core modules such as quality data collection, automated traceability records and quality analysis. With the Hippocrates Traceability Management System, quality data can be collected in real time and recorded automatically; traceability records are generated and stored automatically; and the quality analysis function provides real-time quality reports for the enterprise’s management. At the same time, the system optimized the quality control process, reducing waiting time and resource waste in the quality traceability process.
3. Phase 3: Comprehensive Integration and In-depth ApplicationThe Singdi Traceability Management System was fully integrated with other existing information systems of the enterprise (such as MES, ERP and WMS), breaking down information silos and realizing seamless data sharing. Through in-depth application of the data analysis function of the traceability system, the enterprise can grasp the key indicators in the quality control process in real time, providing decision support for the management. In addition, the traceability system also realized the full-process traceability of quality control, ensuring the transparency and standardization of operations.

(II) Innovation in Core Business Models

Centering on core modules such as quality data collection, automated traceability records and quality analysis, the Hippocrates Traceability Management System promotes the all-round upgrading of the enterprise’s quality control.

• Quality Data CollectionThe Singdi Traceability Management System realizes real-time collection of quality data. Through seamless connection with production equipment and testing equipment, data can be automatically transmitted to the system, reducing human errors and improving the accuracy and consistency of data.
• Automated Traceability RecordsThe HippocratesTraceability Management System supports the automatic generation of traceability records, which include information such as production batches, raw material sources, key parameters in the production process and test results. The system allows the export and printing of records, facilitating subsequent review and traceability.
• Quality AnalysisThe Hippocrates Traceability Management System provides powerful data analysis functions, which can generate real-time quality reports to help the enterprise’s management quickly understand the quality status, timely identify potential problems and take measures. The system supports multi-dimensional data analysis, providing scientific decision support for the enterprise.

(III) Strong Technical Architecture Support

Based on an advanced digital platform, the Hippocrates Traceability Management System has high customization capabilities and efficient data access capabilities. The system adopts a distributed architecture, which optimizes data storage and access efficiency and can quickly respond to users’ query needs. At the same time, the Hippocrates Traceability Management System supports integration with third-party systems, realizing data sharing and collaborative work among various business links within the enterprise.

IV. Remarkable Results: All-round Improvement of Quality Control Level

(I) Internal Transformation of the Enterprise

The introduction of the Singdi Traceability Management System has brought significant internal changes to Xuantai Pharmaceutical:

• Significant Improvement in Operational EfficiencyBy optimizing the quality control process and monitoring the quality status in real time, the Singdi Traceability Management System has significantly improved the enterprise’s operational efficiency. The quality data collection time has been reduced by 50%, the traceability record generation time by 80%, and the quality problem handling time by 60%.
• Greatly Enhanced Data Management LevelThe Singdi Traceability Management System realizes centralized management and real-time sharing of enterprise data, with data consistency and accuracy reaching 100%. Various departments of the enterprise can obtain the required data in real time, reducing decision-making errors caused by data inconsistency.
• Full Realization of Paperless OfficeThe application of the Singdi Traceability Management System has realized paperless quality control in the enterprise, reducing the cost of using and managing paper documents. At the same time, the system improves the accuracy and security of data, avoiding errors caused by manual recording.

(II) Industry Demonstration and Social Impact

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

• Industry Demonstration EffectAs a quality benchmark in the pharmaceutical industry, Xuantai Pharmaceutical’s successful case has demonstrated the great potential of the Hippocrates  Traceability Management System in improving the efficiency of quality control to peer enterprises, encouraging more enterprises to actively engage in digital transformation.
• Cost Reduction and Efficiency ImprovementThe application of the Hippocrates  Traceability Management 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: Continuous Innovation to Lead the Intelligent Transformation of the Industry

The successful implementation of the Singdi Traceability Management System has laid a solid foundation for the digital transformation of Xuantai Pharmaceutical. However, the enterprise is well aware that digital transformation is a continuous process, and there is still broad room for development in the future.

• Continuously Optimize System FunctionsXuantai Pharmaceutical will continuously optimize the functions of the Singdi Traceability Management 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 problem early warning; optimize the traceability process module to realize rapid positioning and handling of quality problems.
• Strengthen Data Analysis CapabilitiesThe enterprise will introduce more advanced data analysis technologies and tools to deeply mine the quality data in the Singdi Traceability Management System. Through data analysis, the enterprise can predict potential problems in advance, optimize the quality control process, and further improve operational efficiency.
• Explore System Integration and CollaborationXuantai Pharmaceutical will actively explore the integration of the Singdi Traceability Management System with other digital solutions. For example, integrating with the MES system to realize refined management of the production process; integrating with the ERP system to achieve in-depth integration of quality data and enterprise resource management.
• Through these continuous efforts, Xuantai Pharmaceutical will continue to move forward on the path of digital transformation, moving 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 pharmaceutical industry, leading the industry towards a more brilliant future.

VI. Related Solutions

• Solution 1: Hippocrates Traceability System Solution
• Solution 2: MES System Production Management Solution

VII. Related Cases

• Case 1: Hippocrates Traceability System Project of Shanghai Qingping Pharmaceutical
• Case 2: Hippocrates Traceability System Project of Shanghai Tengrui Pharmaceutical