GMP Document Management (DMS) Project of Shanghai Yan'an Pharmaceutical Co., Ltd.

I. Shanghai Yan'an Pharmaceutical Co., Ltd.: A Digital Innovator in the Pharmaceutical Industry

As a leader in China's pharmaceutical industry, Shanghai Yan'an Pharmaceutical Co., Ltd. (hereinafter referred to as "Yan'an Pharmaceutical") focuses on the R&D, production, and sales of innovative pharmaceuticals. Adhering to the core values of "Developing Pharmaceuticals through Technology, Prioritizing Quality, and Delivering Sincere Services", the company is committed to enhancing its core competitiveness through technological innovation and management optimization. With the increasingly fierce market competition and the growing demand for pharmaceutical quality from consumers, Yan'an Pharmaceutical recognizes that traditional document management methods can no longer meet the needs of its development. To achieve the digital upgrading of document management and improve the company's production efficiency and quality management level, Yan'an Pharmaceutical decided to introduce the advanced Hippocrates GMP Document Management System (DMS), initiating its journey of digital transformation in document management.

一、上海延安药业有限公司：医药行业的数字化革新者

II. Urgent Need for Digital Transformation of Document Management

Under the traditional document management model, Yan'an Pharmaceutical faced numerous challenges. Document records relied on manual filling of paper-based records, which not only were prone to human errors but also made it difficult to retrieve and analyze information quickly. The efficiency of document circulation was low, and there were obstacles to communication and collaboration between departments. In addition, the irregular management of document changes might lead to employees using outdated documents by mistake, posing hidden risks to pharmaceutical quality.

To address these issues, Yan'an Pharmaceutical decided to introduce the Hippocrates GMP Document Management System (DMS) to improve the efficiency and transparency of document management through digital means. The DMS integrates the company's document management processes, enabling real-time information sharing and collaborative management. Through data collection and analysis, the DMS can monitor document status in real time, optimize document processes, reduce operational costs, and bring comprehensive changes to the company.

III. DMS Project: Phased Implementation to Steadily Advance Digital Transformation

(I) Overall Planning Blueprint

Yan'an Pharmaceutical adopted the strategy of "overall planning and phased implementation" for its DMS project, gradually outlining a clear path for the digital transformation of the company's document management.

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 Yan'an Pharmaceutical's actual needs. During this phase, the company built the infrastructure of the DMS, realizing the initial connection between document management equipment and the system, and laying the foundation for the subsequent full-scale application.
2. Phase 2: Implementation and Optimization of Core ModulesIn this phase, the company focused on implementing core modules such as document collection, automated document recording, and document analysis. Through the DMS, document data can be collected in real time and recorded automatically; document records are generated and stored automatically; and the document analysis function provides real-time document reports for the company's management. At the same time, the system optimized the document management process, reducing waiting time and resource waste in the document management process.
3. Phase 3: Full Integration and In-depth ApplicationThe DMS was fully integrated with other existing information systems of the company (such as ERP and MES), breaking down information silos and realizing seamless data sharing. By in-depth applying the data analysis function of the DMS, the company can grasp the key indicators in the document management process in real time, providing decision support for the management. In addition, the DMS also realized full-process traceability of document management, ensuring the transparency and standardization of operations.

(II) Innovation in Core Business Models

Centered on core modules including document collection, automated document recording, and document analysis, the DMS project promoted the comprehensive upgrading of the company's document management.

• Document CollectionThe DMS realizes real-time collection of document 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 Document RecordingThe DMS automatically generates document records, which include information such as production batches, sources of raw materials, key parameters in the production process, and test results. The system supports the export and printing of records, facilitating subsequent review and traceability.
• Document AnalysisThe DMS provides powerful data analysis functions, which can generate document reports in real time, helping the company's management quickly understand the document status, identify potential problems in a timely manner, and take countermeasures. The system supports multi-dimensional data analysis, providing scientific decision support for the company.

(III) Strong Technical Architecture Support

Based on an advanced digital platform, the DMS has high customization capabilities and efficient data access capabilities. The system adopts a distributed architecture, optimizing data storage and access efficiency, and can quickly respond to users' query needs. At the same time, the DMS supports integration with third-party systems, realizing data sharing and collaborative work across various business links within the company.

IV. Remarkable Results: Comprehensive Improvement of Document Management Level

(I) Internal Transformation of the Company

The introduction of the DMS has brought significant internal changes to Yan'an Pharmaceutical:

• Significant Improvement in Operational EfficiencyBy optimizing the document management process and monitoring document status in real time, the DMS has significantly improved the company's operational efficiency. The time for document data collection has been reduced by 50%, the time for document record generation by 80%, and the time for document management by 60%.
• Substantial Upgrade in Data Management LevelThe DMS realizes the centralized management and real-time sharing of the company's data, with data consistency and accuracy reaching 100%. All departments of the company can obtain the required data in real time, reducing decision-making errors caused by inconsistent data.
• Full Realization of Paperless OfficeThe application of the DMS has enabled paperless document management in the company, reducing the cost of using and managing paper documents. At the same time, the system improves the accuracy and security of data, avoiding errors in manual recording.

(II) Industry Demonstration and Social Impact

The successful implementation of Yan'an Pharmaceutical's DMS project has not only brought significant benefits to the company itself but also provided valuable experience for the digital transformation of document management in the pharmaceutical industry:

• Industry Demonstration EffectAs a digital innovator in the pharmaceutical industry, Yan'an Pharmaceutical's successful case has demonstrated the great potential of the DMS in improving document management efficiency to peer enterprises, encouraging more enterprises to actively engage in digital transformation.
• Cost Reduction and Efficiency EnhancementThe application of the DMS has reduced the company's labor costs and management costs while improving operational efficiency. The company has invested the saved resources into technological R&D and innovation, further enhancing its core competitiveness.

V. Future Outlook: Continuous Innovation to Lead the Industry's Intelligent Transformation

The successful implementation of the DMS has laid a solid foundation for Yan'an Pharmaceutical's digital transformation. However, the company 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 FunctionsYan'an Pharmaceutical will continuously optimize the functions of the DMS according to the needs of business development. For example, it will further improve the data analysis module to achieve more accurate document prediction and problem early warning; and optimize the document management process module to realize rapid location and processing of documents.
• Strengthening Data Analysis CapabilitiesThe company will introduce more advanced data analysis technologies and tools to conduct in-depth mining of document data in the DMS. Through data analysis, the company can predict potential problems in advance, optimize the document management process, and further improve operational efficiency.
• Exploring System Integration and CollaborationYan'an Pharmaceutical will actively explore the integration of the DMS with other digital solutions. For instance, integrating with the MES to achieve refined management of the production process; and integrating with the ERP to realize in-depth integration of document data and enterprise resource management.
• Through these continuous efforts, Yan'an Pharmaceutical will continue to move forward on the path of digital transformation, moving towards intelligence and high efficiency. This will not only help the company stand out in the fierce market competition but also provide richer and more valuable experience for the digital transformation of document management in the pharmaceutical industry, leading the industry to a more brilliant future.

VI. Related Solutions

• Solution 1: Hippocrates GMP Document Management System (DMS)
• Solution 2: Hippocrates GMP Training Management System (TMS)