Zhejiang PHT Pharma GMP Document Management (DMS) Project

I. Zhejiang PHT Pharma: An Innovator in the Pharmaceutical Industry

Founded in 2010, Zhejiang PHT Pharma Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of PHT International Limited. It mainly engages in the development and production of pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs), with its products primarily exported to markets in the United States and Europe.

Zhejiang Beihede owns its own cGMP-compliant manufacturing facilities. It strictly adheres to FDA standards and produces high-quality pharmaceutical intermediates and APIs through extensive method development. The company has always adhered to the highest quality standards to guide its operations.

Against the backdrop of increasingly fierce market competition and rising requirements for pharmaceutical quality, Zhejiang Beihede recognized that traditional document management models could no longer meet the company’s development needs. It therefore decided to introduce the advanced Hippocrates GMP Document Management System (DMS) and embark on a journey of digital transformation for document management.

II. Urgent Need for Digital Transformation of Document Management

Under the traditional document management model, Zhejiang Beihede faced numerous challenges. Document records relied on manual paper-based record-keeping, which not only made human errors likely but also hindered quick retrieval and analysis of documents. The efficiency of document circulation was low, and there were obstacles to communication and collaboration between departments. Additionally, non-standard document change management led to the risk of employees using outdated documents unintentionally, posing hidden dangers to pharmaceutical quality.

Meanwhile, as a wholly-owned subsidiary of PHT International (U.S.), Zhejiang Beihede undertakes the important responsibility of synchronizing quality data with the headquarters in real time to ensure the efficient operation of the global quality control system. At the same time, the company must be ready to undergo strict audits by overseas customers to meet international standards and customer expectations. Therefore, Chinese-English bilingual support for systems and workflows is a necessary condition for the smooth development of business, and also an important foundation for the company to maintain efficient communication in international cooperation.

To address these issues, Zhejiang Beihede 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 integrates the company’s document management processes, enabling real-time information sharing and collaborative management. Through data collection and analysis, the system can monitor document status in real time, optimize document processes, reduce operating costs, and bring comprehensive changes to the company. The Hippocrates  GMP Document Management System (DMS) has strong multilingual support capabilities, currently adapting to multiple languages including Chinese, English, Japanese, French, and German. This fully meets the needs of multinational enterprises in multicultural scenarios. Furthermore, the system supports flexible customization, allowing for the rapid integration of more language packs based on customers’ personalized needs. This easily addresses language communication challenges in global business and helps enterprises achieve efficient and barrier-free document management and collaboration.

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

(I) Overall Planning Blueprint

Zhejiang Beihede’s DMS project adopted a strategy of “overall planning with phased implementation,” 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 Zhejiang Beihede’s actual needs. During this phase, the company built the infrastructure for the Hippocrates DMS, achieving initial connection between document management equipment and the system, and laying the foundation for subsequent full-scale application.
2. Phase 2: Core Module Implementation and OptimizationIn this phase, the company focused on implementing core modules such as document collection, automated document recording, and document analysis. Through the Hippocrates 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 document management processes, reducing waiting time and resource waste in the document management process.
3. Phase 3: Full Integration and In-depth ApplicationThe Xingdi DMS achieved full integration with other existing information systems of the company (such as ERP and MES), breaking down information silos and enabling seamless data sharing. By in-depth 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 management. In addition, the system also realized full traceability of document management, ensuring transparency and standardization of operations.

(II) Innovation in Core Business Models

The DMS project focused on core modules including document collection, automated document recording, and document analysis, promoting 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 is 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, raw material sources, 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. This helps the company’s management quickly understand the document status, identify potential issues in a timely manner, and take measures. The system supports multi-dimensional data analysis, providing scientific decision support for the company.

(III) Strong Technical Architecture Support

The Hippocrates DMS is based on an advanced digital platform, with 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 user query needs. At the same time, theHippocrates  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 Standards

(I) Internal Transformation of the Enterprise

The introduction of the Xingdi DMS has brought significant internal changes to Zhejiang Beihede:

• Significant Improvement in Operational EfficiencyBy optimizing document management processes and monitoring document status in real time, the Xingdi DMS significantly improved the company’s operational efficiency. The time for document data collection was 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 Hippocrates DMS realized 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 Hippocrates DMS enabled paperless document management in the company, reducing the cost of using and managing paper documents. At the same time, the system improved data accuracy and security, avoiding errors in manual recording.

(II) Industry Demonstration and Social Impact

The successful implementation of Zhejiang Beihede’s DMS project 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 leader in the pharmaceutical industry, Zhejiang Beihede’s successful case demonstrates the great potential of the Hippocrates 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 Xingdi DMS 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 Digital Transformation

The successful implementation of the Hippocrates DMS has laid a solid foundation for Zhejiang Beihede’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 FunctionsBased on the needs of business development, Beihede will continuously optimize the functions of the Hippocrates  DMS. For example, it will further improve the data analysis module to achieve more accurate document prediction and issue early warning; optimize the document management process module to enable quick location and processing of documents.
• Implementation of More Functional Modules such as TMS and QMSAfter the successful launch of the Document Management System (DMS), Beihede will focus on the construction of the OwlTrust Digital Platform and launch a phased function expansion plan. According to the plan, the second phase of the project will focus on deploying the Training Management System (TMS) and Quality Management System (QMS). The introduction of these two core modules aims to build a more complete digital management closed loop, further improve the company’s internal training efficiency and full-process quality control standards, and lay a solid digital management foundation for meeting the headquarters’ data collaboration needs and responding to overseas customer audits.
• Strengthening Data Analysis CapabilitiesThe company will introduce more advanced data analysis technologies and tools to deeply mine document data in the Xingdi DMS. Through data analysis, the company can predict potential issues in advance, optimize document management processes, and further improve operational efficiency.
• Exploring System Integration and CollaborationBeihede will actively explore the integration of the Xingdi DMS with other digital solutions. For example, integrating with the MES system to achieve refined management of the production process; integrating with the ERP system to realize in-depth integration of document data and enterprise resource management.
• Through these continuous efforts, Beihede 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 towards a more brilliant future.

VI. Related Solutions

• Hippocrates GMP Document Management System (DMS)
• Hippocrates GMP Training Management System (TMS)

VII. Related Cases

• Case 1: Beheng Biotechnology GMP Document Management (DMS) Project
• Case 2: Shijiazhuang Yiling Pharmaceutical GMP Training Management (TMS) Project