Contract Manufacturing Quality Management Collaboration (OWL MAH) Project of Zhejiang Furuixi

I. Zhejiang Furuixi Pharmaceutical Co., Ltd.: A Digital Transformer in the Pharmaceutical Industry

Zhejiang Furuixi Pharmaceutical Co., Ltd. (hereinafter referred to as "Furuixi Pharmaceutical"), as an innovative enterprise in China's domestic pharmaceutical industry, focuses on the R&D, production and sales of high-quality pharmaceuticals. Adhering to the core values of "quality-oriented, innovation-driven, and service-first", 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, Furuixi Pharmaceutical recognizes that traditional contract manufacturing management methods can no longer meet the needs of the enterprise's development. To achieve the digital upgrading of contract manufacturing management and improve the enterprise's production efficiency and quality management level, Furuixi Pharmaceutical has decided to introduce the advanced Xingdi Contract Manufacturing Quality Management Collaboration (OWL MAH) System, thus embarking on the journey of digital transformation in contract manufacturing management.

II. Urgent Need for Digital Transformation in Contract Manufacturing Management

Under the traditional contract manufacturing management model, Furuixi Pharmaceutical faces a series of challenges. Contract manufacturing records rely on manual filling of paper-based documents, which not only tends to cause human errors but also makes it difficult to retrieve and analyze information quickly. The efficiency of the contract manufacturing process is low, and there are obstacles to communication and collaboration between departments. In addition, the management of changes in contract manufacturing is non-standardized, leading to the risk that employees may use outdated documents by mistake, which poses hidden dangers to pharmaceutical quality.

To address these issues, Furuixi Pharmaceutical has decided to introduce the Xingdi Contract Manufacturing Quality Management Collaboration (OWL MAH) System, aiming to improve the efficiency and transparency of contract manufacturing management through digital means. The OWL MAH System organically integrates the enterprise's contract manufacturing processes, enabling real-time information sharing and collaborative management. Through data collection and analysis, the system can monitor the status of contract manufacturing in real time, optimize the contract manufacturing process, reduce operating costs, and bring comprehensive changes to the enterprise.

III. OWL MAH Project: Phased Implementation to Steadily Advance Digital Transformation

(I) Overall Planning Blueprint

The OWL MAH Project of Furuixi Pharmaceutical adopts the strategy of "overall planning and phased implementation", gradually outlining a clear path for the digital transformation of the enterprise's contract manufacturing 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 in combination with Furuixi Pharmaceutical's actual needs. During this phase, the enterprise built the infrastructure of the OWL MAH System, realized the initial connection between contract manufacturing equipment and the system, and laid the foundation for the subsequent full-scale application.
2. Phase 2: Implementation and Optimization of Core ModulesIn this phase, the enterprise focused on the implementation of core modules such as contract manufacturing data collection, automated contract manufacturing records, and contract manufacturing analysis. Through the OWL MAH System, contract manufacturing data can be collected in real time and recorded automatically; contract manufacturing records are generated and stored automatically; and the contract manufacturing analysis function provides real-time contract manufacturing reports for the enterprise's management. At the same time, the system optimized the contract manufacturing process, reducing waiting time and resource waste in the contract manufacturing process.
3. Phase 3: Full Integration and In-depth ApplicationThe OWL MAH System was fully integrated with other existing information systems of the enterprise (such as ERP and MES), breaking down information silos and realizing seamless data sharing. By in-depth applying the data analysis function of the OWL MAH System, the enterprise can grasp the key indicators in the contract manufacturing process in real time, providing decision support for the management. In addition, the OWL MAH System also realized the full-process traceability of contract manufacturing, ensuring the transparency and standardization of operations.

(II) Innovation in Core Business Models

Centered on core modules including contract manufacturing data collection, automated contract manufacturing records, and contract manufacturing analysis, the OWL MAH Project promotes the comprehensive upgrading of the enterprise's contract manufacturing.

• Contract Manufacturing Data CollectionThe OWL MAH System enables real-time collection of contract manufacturing data. Through seamless connection with production equipment and testing equipment, data is automatically transmitted to the system, reducing human errors and improving the accuracy and consistency of data.
• Automated Contract Manufacturing RecordsThe OWL MAH System automatically generates contract manufacturing 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.
• Contract Manufacturing AnalysisThe OWL MAH System provides powerful data analysis functions, which can generate real-time contract manufacturing reports. This helps the enterprise's management quickly understand the status of contract manufacturing, identify potential problems in a timely manner, and take corresponding 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 OWL MAH System features high customization capabilities and efficient data access capabilities. Adopting a distributed architecture, the system optimizes data storage and access efficiency, and can quickly respond to users' query needs. At the same time, the OWL MAH System supports integration with third-party systems, realizing data sharing and collaborative work across various business links within the enterprise.

IV. Remarkable Results: Comprehensive Improvement in Contract Manufacturing Management Level

(I) Internal Transformation of the Enterprise

The introduction of the OWL MAH System has brought significant internal changes to Furuixi Pharmaceutical:

• Significant Improvement in Operational EfficiencyBy optimizing the contract manufacturing process and monitoring the status of contract manufacturing in real time, the OWL MAH System has significantly improved the enterprise's operational efficiency. The time for contract manufacturing data collection has been reduced by 50%, the time for contract manufacturing record generation by 80%, and the time for contract manufacturing management by 60%.
• Substantial Enhancement in Data Management LevelThe OWL MAH System has realized the 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 OWL MAH System has realized paperless management in the enterprise's contract manufacturing, reducing the cost of paper document use and management. At the same time, the system has improved the accuracy and security of data, avoiding errors caused by manual recording.

(II) Industry Demonstration and Social Impact

The successful implementation of Furuixi Pharmaceutical's OWL MAH Project has not only brought significant benefits to the enterprise itself but also provided valuable experience for the digital transformation of contract manufacturing management in the pharmaceutical industry:

• Industry Demonstration EffectAs a digital transformer in the pharmaceutical industry, Furuixi Pharmaceutical's successful case has demonstrated to peer enterprises the great potential of the OWL MAH System in improving the efficiency of contract manufacturing management, encouraging more enterprises to actively engage in digital transformation.
• Cost Reduction and Efficiency ImprovementThe application of the OWL MAH 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: Sustained Innovation to Lead the Industry's Intelligent Transformation

The successful implementation of the OWL MAH System has laid a solid foundation for Furuixi Pharmaceutical's digital transformation. However, the enterprise 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 FunctionsFuruixi Pharmaceutical will continuously optimize the functions of the OWL MAH System according to the needs of business development. For example, it will further improve the data analysis module to achieve more accurate contract manufacturing prediction and problem early warning; optimize the contract manufacturing process module to realize rapid positioning and handling of contract manufacturing issues.
• Strengthening Data Analysis CapabilitiesThe enterprise will introduce more advanced data analysis technologies and tools to deeply mine the contract manufacturing data in the OWL MAH System. Through data analysis, the enterprise can predict potential problems in advance, optimize the contract manufacturing process, and further improve operational efficiency.
• Exploring System Integration and CollaborationFuruixi Pharmaceutical will actively explore the integration of the OWL MAH 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 contract manufacturing data and enterprise resource management.
• Through these continuous efforts, Furuixi 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 contract manufacturing management in the pharmaceutical industry, leading the industry towards a more brilliant future.

VI. Related Solutions

• Solution 1: Pharmaceutical Contract Manufacturing Quality Management Collaboration Solution (OWL MAH)
• Solution 2: GMP Quality Compliance Digital Solution (QMS)

VII. Related Cases

• Case 1: Contract Manufacturing Quality Management Collaboration (OWL MAH) Project of Kobayashi Pharmaceutical
• Case 2: Contract Manufacturing Quality Management Collaboration (OWL MAH) Project of Zhejiang Gaozhi Pharmaceutical
• Case 3: GMP Quality Compliance Digital (QMS) Project of Zhejiang Zhenyuan Pharmaceutical