GMP Document Management (DMS) Project of Suzhou Vigonvita Life Sciences

I. Suzhou Vigonvita Life SciencesCo., Ltd.: A Digital Explorer in the Biopharmaceutical Industry

As an innovative enterprise in China’s biopharmaceutical industry, Suzhou Wangshan Wangshui Biopharmaceutical Co., Ltd. (hereinafter referred to as "Wangshan Wangshui") focuses on the R&D, production, and sales of biological products. Upholding the core values of "revitalizing pharmaceuticals through technology, prioritizing quality, and delivering 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 demands of consumers for pharmaceutical quality, Wangshan Wangshui has recognized that traditional document management methods can 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 standards, Wangshan Wangshui has decided to introduce the advanced Xingdi GMP Document Management System (DMS), thus embarking on the journey of digital transformation in document management.

II. Urgent Need for Digital Transformation of Document Management

Under the traditional document management model, Wangshan Wangshui faced a series of challenges. Document records relied on manual completion of paper-based forms, which not only made human errors prone but also hindered quick retrieval and analysis. The efficiency of document circulation was low, creating obstacles to communication and collaboration between departments. Furthermore, non-standard document change management meant employees might mistakenly use outdated documents, posing risks to pharmaceutical quality.

To address these issues, Wangshan Wangshui decided to introduce the Hippocratecrates GMP Document Management System (DMS), aiming 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 workflows, reduce operational costs, and drive comprehensive transformation for the enterprise.

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

(I) Overall Planning Blueprint

Wangshan Wangshui’s DMS project adopted a strategy of "overall planning and phased implementation", gradually mapping out a clear path for the digital transformation of the company’s document management.

1. Phase 1: System Planning and Infrastructure SetupThe 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 Wangshan Wangshui’s actual needs. During this phase, the company built the infrastructure for the DMS, achieved initial connection between document management 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 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. Meanwhile, the system optimized document management workflows, reducing waiting time and resource waste in the document management process.
3. Phase 3: Comprehensive 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 enabling seamless data sharing. By leveraging the in-depth application of the DMS’s data analysis function, the company can grasp key indicators in the document management process in real time, providing decision support for management. In addition, the DMS also realized full-process traceability of document management, ensuring 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 drove the comprehensive upgrading of the company’s document management.

• Document CollectionThe DMS enables real-time collection of document 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 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 testing results. The system supports export and printing of records, facilitating subsequent review and traceability.
• Document AnalysisThe DMS provides powerful data analysis functions, capable of generating real-time document reports. This helps the company’s management quickly understand the document status, identify potential issues in a timely manner, and take countermeasures. 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 DMS features high customization capabilities and efficient data access capabilities. Adopting a distributed architecture, the system optimizes data storage and access efficiency, enabling rapid response to user 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 enterprise.

IV. Remarkable Results: Comprehensive Improvement of Document Management Standards

(I) Internal Transformation of the Enterprise

The introduction of the DMS has brought significant internal changes to Wangshan Wangshui:

• Significant Improvement in Operational EfficiencyBy optimizing document management workflows 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 Enhancement in Data Management StandardsThe DMS has realized centralized management and real-time sharing of enterprise 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 DMS has enabled paperless document management in the enterprise, reducing the cost of using and managing paper documents. Meanwhile, the system has improved data accuracy and security, avoiding errors caused by manual recording.

(II) Industry Demonstration and Social Impact

The successful implementation of Wangshan Wangshui’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 biopharmaceutical industry:

• Industry Demonstration EffectAs a digital explorer in the biopharmaceutical industry, Wangshan Wangshui’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 ImprovementThe 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: Sustained Innovation to Lead the Industry’s Intelligent Transformation

The successful implementation of the DMS has laid a solid foundation for Wangshan Wangshui’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 FunctionsWangshan Wangshui 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 issue early warning; optimize the document management workflow module to enable rapid positioning 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, it can predict potential issues in advance, optimize document management workflows, and further improve operational efficiency.
• Exploring System Integration and CollaborationWangshan Wangshui 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; integrating with the ERP to realize in-depth integration of document data and enterprise resource management.
• Through these continuous efforts, Wangshan Wangshui 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 biopharmaceutical industry, leading the industry toward a more brilliant future.

VI. Related Solutions

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

VII. Related Cases

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