HIPPOCRATES

Yuezhun Pharmaceutical Technology GMP Training Management (DMS) Project

I. An Innovative Pharmaceutical Enterprise Rising in Qidong

Amid the vigorous development of China's pharmaceutical industry, Yuezhun Pharmaceutical Technology (Qidong) Co., Ltd. (hereinafter referred to as "Yuezhun Pharmaceutical") shines like a rising star, radiating innovation and vitality. Founded in 2015, Yuezhun Pharmaceutical focuses on the R&D, production, and sales of innovative drugs, covering multiple cutting-edge therapeutic areas such as anti-tumor, nervous system, and metabolic diseases. Located in Qidong City, Jiangsu Province, the company has quickly become a key player in China's innovative pharmaceutical sector by virtue of its outstanding R&D capabilities and advanced production technologies.

Yuezhun Pharmaceutical's achievements are remarkable. It holds over 150 drug approval certificates, and its production base has an annual production capacity of 3 billion tablets. The efficient production system ensures the timely and stable supply of drugs to the market. Its product portfolio is diverse, and particularly in the field of anti-tumor drugs, Yuezhun Pharmaceutical has successfully developed a number of internationally competitive drugs through its innovative R&D capabilities, bringing new hope to patients worldwide. In addition, the company actively engages in international cooperation to promote the global market entry of its innovative drugs, demonstrating the strength of Chinese innovative pharmaceutical enterprises.

II. Dilemmas of Traditional Management Models

With the continuous upgrading of regulatory requirements in China's pharmaceutical industry, higher standards have been set for the authenticity and traceability of data throughout the entire drug lifecycle. In the process of Yuezhun Pharmaceutical's rapid development, the shortcomings of traditional management models have gradually emerged, becoming obstacles to the company's further growth.

The inefficiency in document circulation and approval processes is particularly prominent. A document requires repeated transmission among multiple departments from drafting to final approval, resulting in a lengthy approval cycle that seriously hinders work progress. The paper-based document management method also has many drawbacks: it relies on manual filling and signing, which is prone to errors, and the authenticity of signatures is difficult to verify. Moreover, documents often experience delays or losses during circulation, increasing management costs and quality risks.

From a cost perspective, the traditional management model imposes a heavy burden on the enterprise. A large amount of document printing, binding, and archiving consumes substantial office supplies, with paper costs alone reaching hundreds of thousands of yuan annually. Meanwhile, paper documents require valuable storage space, increasing rental costs. Additionally, manual document management necessitates professional personnel, further raising the enterprise's labor costs.

Document change management also faces challenges. The recovery and destruction of outdated documents are difficult to implement, and employees may mistakenly use outdated documents, posing hidden risks to drug quality. During an internal audit, management discovered that some employees were still using outdated production operating procedures. This issue attracted great attention from the enterprise and prompted it to accelerate the pace of digital transformation.

III. The Transformative Journey of Introducing the DMS Project

(I) Overall Planning and Phased Implementation

Faced with the numerous predicaments of the traditional management model, Yuezhun Pharmaceutical actively sought a breakthrough. After in-depth research and evaluation, the company resolutely decided to introduce the GMP Document Management (DMS) Project developed by Shanghai Singdi Health Technology Co., Ltd. This decision, like a timely rain, brought brand-new management concepts and advanced technical means to Yuezhun Pharmaceutical, officially initiating a new chapter of digital transformation.

The DMS Project carefully adopts a scientific strategy of "overall planning and phased implementation" to ensure steady progress. In the first phase, the project team focused entirely on building a basic document management system that meets regulatory requirements—a crucial step that laid a solid foundation for subsequent work. At the same time, an efficient communication and collaboration mechanism among various departments was established to break down inter-departmental barriers and ensure the smooth flow of information within the enterprise. In the second phase, the focus shifted to realizing full digitalization of document management, integrating the entire drug lifecycle from R&D to commercialization into the management scope, which significantly improved the enterprise's internal management efficiency and collaboration capabilities.

(II) Innovative Models Covering All Business Areas

In terms of business models, the DMS Project is innovatively divided into two phases. The first phase mainly focuses on document management for production and quality systems, conducting comprehensive sorting and digital management of various documents in the production process. This initiative significantly enhanced the accuracy, timeliness, and traceability of documents, providing strong support for quality control in drug production. The second phase is committed to completing the construction of document management for the R&D system, digitally integrating experimental data, research reports, patent documents, and other materials in the R&D process. This not only enables efficient sharing and collaborative work but also greatly accelerates the R&D process, allowing the enterprise to advance rapidly in the field of innovative drug R&D.

(III) Technology Empowerment for Efficient Management

As one of the core products of the Hippocrates OwlTrust Digital Platform, the GMP Document Management System (DMS) is jointly developed by industry experts and IT experts. With the core concept of being a "quality compliance expert," the platform provides comprehensive support for enterprises. It boasts strong customization capabilities, with built-in configuration tools covering multiple functional modules of quality management. Enterprises can customize their quality systems according to their own needs without complex programming. Personnel who have received simple training can quickly customize forms, decision trees, and dashboards to meet specific business requirements.

In terms of data access, the platform adopts an "intelligent loading" function that caches frequently used data and optimizes network bandwidth utilization, ensuring users can quickly access large-volume records and data. Its distributed architecture is optimized for server expansion, improving system access efficiency through standard APIs. It integrates functions such as automatic email notifications, SMS notifications, and dashboard alerts to reduce the risk of users missing tasks or approvals. In addition, the platform provides a standard intermediate service layer to facilitate integration with third-party systems and achieve seamless data exchange.

IV. Remarkable Results Brought by the DMS Project

(I) Significant Improvement in Enterprise Benefits

After four months of intensive implementation, the DMS Project has achieved remarkable results at Yuezhun Pharmaceutical, bringing comprehensive improvements to the enterprise.

In terms of comprehensive labor efficiency, data statistics have become real-time, accurate, and reliable, with speed increased by 80%. After the completion of the first phase of the project, relevant statistical positions were eliminated, and the number of new hires was reduced by approximately 20%. As the number of users of the project gradually covers all staff, the effect of labor cost savings becomes increasingly prominent.

In terms of quality improvement, the informatization traceability of product quality has reached over 90%, and data consistency and integrity have been enhanced by 100%. The online monitoring and real-time early warning functions have improved online quality control by an average of 1-3%, and the efficiency of Product Quality Review (PQR) analysis has increased by more than 20%, effectively ensuring the stability and reliability of product quality.

In terms of error reduction, statistical errors have been eliminated by over 90%, and human errors by over 80%. The efficiency of document and record management has been significantly improved, with document conversion and approval processes optimized, and approval speed increased by approximately 30%. More than 70% of batch production records, auxiliary records, and post documents have been digitized, reducing document and record printing costs and related consumable expenses by approximately 80%, and cutting the time spent on filling records and documents by more than 50%.

Training efficiency has also undergone tremendous changes due to the DMS Project. After shifting training and assessment online, the total time for training organization has been reduced by approximately 60%, the time for training effect statistics has been improved by over 80%, and the effectiveness of on-the-job training has been enhanced by approximately 40%, helping the enterprise cultivate more professional and efficient talents.

IV. Remarkable Results Brought by the DMS Project

(I) Significant Improvement in Enterprise Benefits

After four months of intensive implementation, the DMS Project has achieved remarkable results at Yuezhun Pharmaceutical, bringing comprehensive improvements to the enterprise.

(II) Profound Impact Leading Industry Transformation

In the current fiercely competitive pharmaceutical industry environment, digital management has become an inevitable path for enterprise development. By successfully implementing Singdi's GMP quality compliance digital solution, Yuezhun Pharmaceutical has realized two-way overall supervision of its quality management system, providing valuable experience and new ideas for domestic pharmaceutical enterprises.

Its successful experience has set an example for other enterprises in the industry, encouraging more enterprises to courageously embrace the wave of digital transformation. Yuezhun Pharmaceutical's practice has proven that digital technology can effectively improve GMP management levels, ensure drug quality, and enhance enterprise competitiveness. This not only contributes to promoting the high-quality development of China's pharmaceutical industry but also plays an important role in safeguarding public drug safety.

V. Looking to the Future and Sustaining Innovation

Standing in the present and looking to the future, Yuezhun Pharmaceutical has already taken a solid and successful first step in its digital management journey, and this is only the beginning of a brilliant new chapter. In the future, the company will continue to deepen its digital transformation strategy and constantly explore and expand the application boundaries and potential of the GMP Document Management System.

One of the key directions is to realize the intelligent upgrading of document management using cutting-edge technologies. For example, with the powerful data analysis and pattern recognition capabilities of artificial intelligence, the system can automatically identify key information in documents, conduct intelligent classification and accurate push of documents, and provide support for enterprise decision-making through big data analysis. In addition, the risk early warning function will monitor document data in real time to identify potential risks in advance and issue alerts, ensuring the efficiency and safety of enterprise operations.

Yuezhun Pharmaceutical will also actively strengthen exchanges and cooperation with other enterprises in the industry to share valuable experience and innovative achievements gained in the process of digital management. By establishing industry exchange platforms, organizing seminars, and other means, it will promote mutual learning and reference among enterprises, and jointly push the digitalization process of China's pharmaceutical industry to new heights.

Here, we also sincerely call on all pharmaceutical enterprises to actively learn from Yuezhun Pharmaceutical's successful experience and courageously embrace digital transformation. In this era of rapid development, only by keeping pace with the times and actively introducing advanced management concepts and technical means can enterprises remain invincible in the fierce market competition. Let us work together to create a brighter future for China's pharmaceutical industry and contribute more to safeguarding public drug safety and health.

VI. Related Solutions

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

VII. Related Cases

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