Implementation of Hippocrates Quality Management System (QMS) by the Biopharmaceutical Subsidiary of Hengrui Pharmaceutical, a Leading Pharmaceutical Enterprise

I. Company Introduction

Hengrui Pharmaceutical Co., Ltd. (Stock Code: 600276.SH), founded in 1970, is an international pharmaceutical and healthcare enterprise focusing on pharmaceutical innovation, R&D, production, and promotion of high-quality drugs. By the first half of 2024, the company had achieved an operating revenue of RMB 13.6 billion, with a year-on-year growth of 21.78%. Hengrui Pharmaceutical offers a wide range of products, focusing on core areas such as anti-tumor drugs, surgical anesthetics, and contrast agents.

Hengrui Pharmaceutical has received numerous honors throughout its development. It has been listed among China’s Top 100 Pharmaceutical Enterprises for many consecutive years and has consistently ranked first in the Ministry of Industry and Information Technology’s China Top 100 Pharmaceutical Industry List since 2006. In the Global Top 50 Pharmaceutical Companies list released by Pharmaceutical Executive magazine, Hengrui has been included for three consecutive years, with its ranking rising to 38th place year by year. These honors fully demonstrate Hengrui’s innovative strength and market position in the pharmaceutical industry.

A cell therapy subsidiary under Hengrui has achieved remarkable results in the field of immune cell therapy for solid tumors. The enterprise focuses on the R&D and product development of immune cell therapy technologies for solid tumors. Its self-developed product "Multi-Antigen Autologous Immune Cell Injection (MASCT-I)" has successfully obtained a clinical trial approval from the National Medical Products Administration (NMPA) of China. The enterprise has eight immune cell therapy production lines, all of which adopt isolators for closed cell preparation in accordance with the high standards of the NMPA, building a domestically advanced cell preparation and production base. In recent years, the enterprise has maintained strong development momentum and has completed nearly RMB 100 million in Series C3 financing.

II. Project Background

Under the traditional quality management model, the enterprise faced a series of tricky issues. Quality data relied on manual paper-based records, which were prone to human errors and made data retrieval and analysis difficult. The efficiency of data transmission and sharing was extremely low, with sluggish information flow between departments—this led to delayed decision-making and undermined the enterprise’s overall operational efficiency. Meanwhile, quality process control lacked precision, making it hard to achieve real-time monitoring and traceability throughout the entire process, thus creating potential risks for product quality.

Faced with these challenges, the enterprise deeply recognized that digital transformation was an inevitable choice to enhance quality management standards, meet regulatory requirements, and strengthen market competitiveness.

To address the above problems, this subsidiary of the Hengrui Group introduced Xingdi’s advanced Quality Management System (QMS) in 2019, fully initiating the digital transformation of training management. Through the implementation of QMS, the enterprise has realized the informatization, intellectualization, and efficiency of quality management, improved quality management efficiency, strengthened data management and collaboration capabilities, and provided strong support for the enterprise’s sustainable development.

III. Hippocrates GMP Quality Management System (QMS)

As an all-in-one solution, Hippocrtaes GMP Quality Management System (QMS) addresses the complex regulatory requirements of the pharmaceutical industry. With a core focus on compliant and efficient handling of processes such as change management, deviation management, CAPA (Corrective and Preventive Actions), OOS/OOT (Out of Specification/Out of Trend), audit management, release management, complaint handling, return management, and non-conforming product handling, it provides enterprises with a comprehensive business solution.

This system helps enterprises achieve full compliance in quality event management and real-time transparent monitoring. While improving the utilization of data, it also accumulates past experience in the form of knowledge for analysis and reuse, enabling data to empower all aspects of business operations. Additionally, it enhances employees’ understanding and compliance with GMP (Good Manufacturing Practice), thereby improving the quality and safety of production processes.

IV. Transformation Results and Value Enhancement from the Implementation of Hippocrtaes GMP QMS by the Subsidiary of Hengrui Group (a Leading Enterprise)

After introducing Xingdi GMP Quality Management System (QMS), the enterprise achieved significant improvements in the following aspects:

1. Comprehensive Product Quality Assurance SystemBy leveraging key modules in the QMS project—including supplier management, deviation management, CAPA management, and change management—the enterprise has built an all-round product quality assurance system.

• Supplier Management: The system conducts real-time monitoring and evaluation of suppliers’ qualifications and supply quality, ensuring the stability and high quality of raw material supply.
• Deviation Management: This module promptly identifies abnormalities in the production process and quickly initiates investigation and handling procedures.
• CAPA Management: It formulates effective corrective and preventive actions for existing quality issues to prevent recurrence.
• Change Management: It ensures that any changes affecting product quality undergo strict evaluation and approval, safeguarding product quality from all dimensions.

1. Improved Data Efficiency and TraceabilityAfter the project implementation, data statistics became real-time and accurate, with efficiency increased by 80%. Tasks that previously required manual collection, collation, and verification of large volumes of data are now automatically completed by the system. The timeliness and accuracy of data provide a reliable basis for enterprise decision-making.The informatized traceability rate of product quality reached over 90%, with significant improvements in data consistency and integrity. This not only enhanced the enterprise’s ability to control product quality but also increased consumers’ trust in its products, laying a solid foundation for brand building and market expansion. In the long run, the real-time capabilities of the QMS will bring more substantial economic benefits to the enterprise.
2. Progress in Electronic RecordsDriven by the QMS project, the electronization of batch production records and auxiliary records achieved remarkable results, with an electronization rate exceeding 70%. Every link in the production process—from raw material input to finished product output—has its relevant data recorded in the electronic system in real time and accurately. This not only makes production process traceability more precise and convenient than ever before but also enables rapid tracing back to the specific link and time point where quality issues occur when problems arise. This facilitates accurate accountability and timely corrective actions, effectively preventing the escalation of issues.

V. About Hippocrates

The name "Hippocrates" is a transliteration of "Hippocrates"—the "Father of Western Medicine" in ancient Greece. Xingdi (Hippocrates) is a leading digital solution provider in China’s life sciences and healthcare sector. It is committed to helping enterprises in the life sciences field (including pharmaceuticals, medical devices, and cosmetics) achieve digital transformation through innovative technologies and products.

Hippocrates’s business covers GMP quality management and digital factory construction, GVP (Good Pharmacovigilance Practice) pharmacovigilance, and GCP (Good Clinical Practice) clinical research. It has served over 200 clients in China, established overseas branches, and formed cooperative relationships with a number of multinational enterprises.

VI. Related Solutions

1. Hippocrates GMP Quality Management System (QMS)
2. Hippocrates GMP Document Management System (DMS)
3. Hippocrates GMP Training Management System (TMS)

VII. Related Cases

1. Shanghai Shenqi Medical GMP Quality Compliance Digitalization (QMS) Project
2. Zhejiang Zhenyuan Pharmaceutical GMP Quality Compliance Digitalization (QMS) Project