GMP Document Management (DMS) Project of Bailuda Pharmaceutical

I. Shanghai Bailuda Pharmaceutical Co., Ltd.: A Digital Pioneer in the Pharmaceutical Industry

Shanghai Bailuda Pharmaceutical Co., Ltd. (hereinafter referred to as "Bailuda Pharmaceutical"), a pioneering enterprise in China's pharmaceutical industry, focuses on the R&D, production, and sales of innovative drugs. Adhering to the core values of "Innovation-Driven, Quality-First, and Sincere Service", the company is committed to enhancing its core competitiveness through technological innovation and management optimization. With the intensification of market competition and the growing demand for pharmaceutical quality from consumers, Bailuda Pharmaceutical recognized that traditional document management methods could no longer meet the needs of its development. To achieve the digital upgrade of document management and improve the company's production efficiency and quality management level, Bailuda Pharmaceutical decided to introduce the advanced Hippocrates GMP Document Management System (DMS), thus kicking off the journey of digital transformation in document management.

II Urgent Need for Digital Transformation in Document Management

Under the traditional document management model, Bailuda 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 rapid retrieval and analysis difficult. The efficiency of document circulation was low, and there were obstacles to communication and collaboration between departments. In addition, the management of document changes was non-standardized, leading to the risk of employees mistakenly using outdated documents and thus posing hidden threats to pharmaceutical quality.

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

III DMS Project: Phased Implementation to Steadily Advance Digital Transformation

(1) Overall Planning Blueprint

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

• 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 Bailuda Pharmaceutical's actual needs. During this phase, the company built the infrastructure of the Singdi DMS, realized the initial connection between document management equipment and the system, and laid the foundation for subsequent full-scale application.
• Phase 2: Implementation and Optimization of Core ModulesIn this phase, the company focused on the implementation of core modules such as document collection, automated document recording, and document analysis. Through the Hippocrates DMS, document data can be collected and recorded in real time and 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.
• Phase 3: Comprehensive Integration and In-depth ApplicationThe Hippocrates DMS was fully integrated with the company's existing information systems (such as Enterprise Resource Planning (ERP) and Manufacturing Execution System (MES)), breaking down information silos and realizing seamless data sharing. By deeply applying the data analysis function of the Hippocrates DMS, the company can grasp key indicators in the document management process in real time, providing decision support for the management. In addition, the Hippocrates DMS also realized full-process traceability of document management, ensuring the transparency and standardization of operations.

(2) Innovation in Core Business Models

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

• Document CollectionThe Hippocrates DMS enables 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 data accuracy and consistency.
• Automated Document RecordingThe Hippocrates 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 Hippocrates DMS provides powerful data analysis functions, which can generate document reports in real time, helping the company's management quickly understand the status of documents, identify potential problems in a timely manner, and take countermeasures. The system supports multi-dimensional data analysis, providing scientific decision support for the company.

(3) Strong Technical Architecture Support

The Hippocrates DMS is built on an advanced digital platform, with 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 Singdi DMS supports integration with third-party systems, enabling data sharing and collaborative work across various business links within the company.

IV. Remarkable Results: Comprehensive Improvement of Document Management Level

(1) Internal Transformation of the Enterprise

The introduction of the Hippocrates DMS has brought significant internal changes to Bailuda Pharmaceutical:

• Significant Improvement in Operational EfficiencyBy optimizing the document management process and monitoring document status in real time, the Singdi 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 has been cut by 80%, and the time for document management has been shortened by 60%.
• Greatly Enhanced Data Management LevelThe Singdi DMS has realized 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 data inconsistency.
• Full Realization of Paperless OfficeThe application of the Hippocrates  DMS has realized paperless document management in the company, reducing the cost of using and managing paper documents. At the same time, the system has improved data accuracy and security, avoiding errors caused by manual recording.

(2) Industry Demonstration and Social Impact

The successful implementation of Bailuda 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 pioneer in the pharmaceutical industry, Bailuda Pharmaceutical's successful case has demonstrated the great potential of the Singdi DMS in improving document management efficiency to peer enterprises, encouraging more enterprises to actively engage in digital transformation.
• Cost Reduction and Efficiency ImprovementThe application of the Hippocrates 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 Hippocrtaes DMS has laid a solid foundation for Bailuda 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 FunctionsBailuda Pharmaceutical will continuously optimize the functions of the Hippocrtaes 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 positioning and processing of documents.
• Strengthening Data Analysis CapabilitiesThe company will introduce more advanced data analysis technologies and tools to deeply mine the document data in the Hippocrtaes 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 CollaborationBailuda Pharmaceutical will actively explore the integration of the Hippocrtaes DMS with other digital solutions. For example, integrating with the MES to realize refined management of the production process; and integrating with the ERP to achieve in-depth integration of document data and enterprise resource management.
• Through these continuous efforts, Bailuda Pharmaceutical will continue to move forward on the path of digital transformation, advancing toward 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 toward a more brilliant future.

VI. Related Solutions

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

VII. Related Case

• Case 1: GMP Document Management (DMS) Project of Hefei Xiaolin
• Case 2: GMP Training Management (TMS) Project of Suzhou Fushilai Pharmaceutical