GMP Training Management (TMS) Project of Hengrui Yuanzheng

I. Case Enterprise

Hengrui Yuanzheng (Shanghai) Biotechnology Co., Ltd., a high-tech enterprise jointly established by Jiangsu Hengrui Medicine Group and Yuanzheng Cell, focuses on the cutting-edge technology research and development as well as clinical application promotion of immune cell therapy. With a registered capital of 300 million yuan, the company owns a number of core technologies and patents, and is committed to promoting innovation and development in the biomedical field. As the company's scale continues to expand and regulatory requirements become increasingly stringent, traditional quality management methods can no longer meet its development needs. Therefore, Hengrui Yuanzheng (Shanghai) Biotechnology Co., Ltd. has decided to implement the GMP quality compliance digital project to improve the company's quality management level and ensure the compliance of product development and production processes.

II. Project Background

In the life and health industry, data authenticity and traceability are crucial to ensuring product quality and patient safety. Hengrui Yuanzheng (Shanghai) Biotechnology Co., Ltd. is facing the following challenges:

• Need for electronic signature for administrative management and GxP business contracts: A secure and reliable electronic signature system is required to ensure the legal effect of contracts and data integrity.
• Digital construction of the company-level compliance and internal control system: A comprehensive information-based monitoring platform is needed to realize real-time monitoring and effective management of the quality management system.
• System and training management covering GCP (Good Clinical Practice) and GMP (Good Manufacturing Practice) for new drug development: A complete training management system is required to ensure employees' full understanding and compliance with GCP and GMP standards.
• Electronic document system and electronic archive library meeting domestic and international regulatory requirements: An electronic document management system conforming to international standards is needed to ensure document compliance and traceability.
• Virtual Data Room (VDR) system for document sharing with partners: A secure VDR is required to share confidential data with partners in real time and promote business cooperation.
• Intelligent business auxiliary decision-making system for management: A system capable of providing real-time data analysis and decision support is needed to improve management efficiency and the scientific nature of decision-making.

III. Project Introduction

(I) Overall Planning

The GMP quality compliance digital project of Hengrui Yuanzheng (Shanghai) Biotechnology Co., Ltd. aims to gradually establish and improve the company's quality management system. The core goal of the project is to enhance the company's quality management level and ensure the compliance of product development and production processes through digital means.

(II) Business Model

• Digital training tools: Kaitai® Training Management provides Hengrui Yuanzheng with digital tools required for training and certification in industry regulations, SOPs (Standard Operating Procedures), and internal enterprise processes.
• Training effectiveness evaluation: It helps Hengrui Yuanzheng ensure that employees receive training, assessment, and certification before performing key quality-related tasks, thereby improving employee efficiency, reducing quality problems in work, and maintaining compliance with industry regulations.

(III) Technical Architecture

Singdi's GMP Training Management (TMS) solution is one of the core solutions on the Singdi Aotai digital platform. Aotai is a digital platform jointly developed by Singdi's industry experts and IT experts. With "quality compliance expert" as its management philosophy and market positioning, it helps enterprises improve their quality compliance level, meet industry supervision requirements, enhance enterprise management capabilities, and accelerate the launch of more safe, effective, and high-quality products.

Applications on the Aotai platform can be tailored to enterprises' needs to build quality systems. The built-in configuration tools already include multiple functions of quality management, so there is no need for customization or programming to implement certain special processes. Trained personnel can quickly customize forms, decision trees, and dashboards to meet specific business needs.

The superior design of the Aotai platform ensures that users can quickly access large volumes of records and data, thereby improving work efficiency. The "intelligent loading" of forms minimizes loading time. Frequently used data is cached to maximize network bandwidth utilization. Data is stored in an effective manner, and the distributed architecture is optimized for server expansion.

Access efficiency of the system is greatly improved through standard APIs (Application Programming Interfaces), including: automatic email notifications, SMS notifications, and dashboard alerts integrated into workflows, which greatly reduce the risk of missing tasks or approvals. The background task submission and management mode supports users to perform other tasks simultaneously. A standard intermediate service layer is provided to support integration with any third-party system, facilitating data exchange between Aotai and other application systems.

IV. Project Outcomes

(I) Enterprise Outcomes

With the full support of Singdi, Hengrui Yuanzheng (Shanghai) Biotechnology Co., Ltd. successfully launched the Aotai GMP quality compliance digital platform and achieved remarkable outcomes:

• Comprehensive compliance and internal control system management: Realized comprehensive compliance and internal control system management, ensuring that the company's quality management system meets domestic and international regulatory requirements.
• Digital quality management system: The digital quality management system provides support for pharmaceutical R&D, and realizes the standardization, processization, normalization, and paperless of processes.
• Innovation in work methods: Promoted the innovation of work methods, shifting from human-based management to rule-based management, which significantly reduced human resource input, communication links, communication costs, and various losses caused by document execution errors.
• Controlled system security: Realized controlled system security, solved the problem of data leakage, and enabled knowledge base and template sharing, which is conducive to environmental protection and improving office efficiency.
• Intelligent business decision-making: Significantly reduced the company's management costs, improved management efficiency, and realized intelligent business decision-making.

(II) Social Outcomes

By implementing the GMP quality compliance digital solution, Hengrui Yuanzheng (Shanghai) Biotechnology Co., Ltd. not only improved its own quality management level but also set a benchmark for digital transformation in the industry. The solution helps the company comprehensively enhance the quality compliance capability of pharmaceutical production in the following aspects:

• Training plan and matrix management: Provides efficient training plan and training matrix management functions, and can formulate personalized training plans according to employees' different positions and responsibilities.
• Standardization of training content: Provides standardized training content to ensure that all employees receive training that meets GMP requirements.
• Real-time evaluation of training effectiveness: Through the training management system, the enterprise can evaluate training effectiveness in real time, and timely understand employees' training progress and mastery, thereby ensuring training effectiveness.
• Compliance of training records: Records employees' training history and scores, facilitating enterprises to provide compliant training records to regulatory authorities and meet regulatory requirements.
• Personnel qualification management: Better manages employees' qualifications and certifications, ensuring that all employees have corresponding qualifications to engage in pharmaceutical production activities.
• Diversified and flexible learning modes: Supports multiple learning modes, such as online learning and mock exams, to improve employees' learning interest and training participation.
• Report management: Generates detailed training reports to help enterprises analyze training data, optimize training plans, and improve training quality.
• Quality culture development: Establishes a quality-centered culture, and strengthens employees' quality awareness through continuous training and education.
• Regulatory compliance: Ensures that training content and processes conform to the latest pharmaceutical production regulations and standards, and reduces compliance risks.
• Data security: The cloud-based training management system has high data security, which ensures the authenticity and integrity of training data and meets the requirements of GMP training management.

V. Associated Solutions

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