GMP Training Management (TMS) Project of Shijiazhuang Yiling Pharmaceutical

I. Case Overview

Shijiazhuang Yiling Pharmaceutical Co., Ltd. (Stock Code: 002603) mainly researches and develops patented new drugs, including:

• Tongxinluo Capsules (for treating coronary heart disease and cerebral infarction),
• Shensong Yangxin Capsules (for treating arrhythmia by addressing both rapid and slow symptoms),
• Qili Qiangxin Capsules (for treating chronic heart failure by targeting both the root cause and symptoms),
• Lianhua Qingwen Capsules (for treating colds and combating influenza),
• Bazi Bushen Capsules (for nourishing kidney essence and anti-aging).
• The company has built 5 production and R&D bases in Hebei, Beijing and other regions, and established over 30 Chinese herbal medicine raw material bases nationwide. Its production workshops have successively obtained international certifications from the United States, the European Union, Canada, New Zealand and other countries/regions, and a comprehensive quality control system complying with international standards has been established. Lianhua Qingwen Capsules have been launched in more than 30 countries.
• Yiling Pharmaceutical is a Top 10 Enterprise in China's Traditional Chinese Medicine Industry, a Top 20 Listed Pharmaceutical Enterprise in China, a Top 500 Market Value Listed Company in China, and a Top 100 Chinese Brand Value Enterprise.
• With the continuous expansion of the enterprise scale and increasingly stringent pharmaceutical supervision requirements, the traditional GMP training management model is facing numerous challenges, such as difficulties in training distribution, record archiving, and coordinating the personalized needs of employees. In December 2021, Yiling Pharmaceutical chose to implement Singerdy's Pharmaceutical GMP Training Management Solution (Training Management System, TMS; Kaitai®, AcadTrust®). This solution enables functions including the rapid formulation of annual training plans/training matrices, rapid upload of training courseware and generation of training courses, real-time tracking of learning progress, and quantitative evaluation of training effects. It also realizes unified management of the enterprise's training knowledge base, greatly improving the efficiency and effectiveness of training management.

II. Project Background

Against the backdrop of the continuous expansion of the enterprise scale and increasingly strict pharmaceutical supervision requirements, Shijiazhuang Yiling Pharmaceutical faced multiple challenges under the traditional training management model. These challenges included: formulating accurate job training matrices and employee training plans; resolving difficulties in training distribution and record archiving; and meeting the personalized needs of employees in different positions.

Yiling Pharmaceutical has been seeking effective digital training methods in the market to address the pain points of traditional training management, thereby meeting the strict domestic and international requirements for quality systems, and effectively managing personnel qualifications, product safety, and quality controllability.

III. Specific Measures

(I) Overall Planning

Yiling Pharmaceutical’s original training management system had relatively incomplete functions and lacked professional courses for the pharmaceutical industry. The construction of the new training management system adopted the implementation strategy of "overall planning and phased implementation", and finally achieved the following results: After implementing Singerdy’s TMS, each employee completed an average of 40 courses annually, employee capabilities were significantly improved, the achievements of enterprise training were practically applied, and training administrators also successfully achieved the goal of training management with greater ease.

(II) Business Model

The complex regulatory requirements, diverse job demands, and frequent regulatory updates in the pharmaceutical industry pose significant challenges to personnel qualifications. In previous GMP inspections, typical defects in training-related reports often included:

• No follow-up training and assessment were conducted for personnel who failed the assessment;
• The evaluation and confirmation of employee training effects were insufficiently comprehensive and lacked targeting; individual employees (e.g., new employees, inspectors, and equipment operators) received inadequate training, resulting in a gap between their capabilities and the technical requirements of their positions;
• Inspectors clearly stated in on-site inspection records that "there is no provision for regular evaluation of the actual effect of training";
• The enterprise did not provide targeted orientation training for newly assigned employees, leading to their inability to perform job responsibilities correctly;
• The evaluation and confirmation of employee training effects were not comprehensive, with inadequate training for individual employees;
• Lack of job transfer training (technical personnel and supervisors of the company should receive job transfer training and assessment when changing positions);
• The annual training plan formulated by the enterprise did not include training on the Appendix to Computerized Systems;
• The enterprise failed to conduct training in accordance with the formulated annual training plan.
• By implementing Singerdy’s GMP Training Management Solution (TMS) for pharmaceutical enterprises, Yiling Pharmaceutical has comprehensively improved its quality compliance capabilities in pharmaceutical production in the following aspects, in response to the complex regulatory requirements of the pharmaceutical industry:

1. Training Plan and Matrix Management: The training management system is equipped with efficient training plan and training matrix management functions, which can provide personalized training plans based on employees’ different positions and responsibilities.
2. Standardization of Training Content: The system provides standardized training content to ensure that all employees receive training complying with GMP requirements.
3. Real-Time Evaluation of Training Effects: Through the system, the enterprise can evaluate training effects in real time and timely understand employees’ training progress and mastery, thus ensuring training effectiveness.
4. Compliance of Training Records: The system can record employees’ training history and results, facilitating the enterprise to provide compliant training records to regulatory authorities and meet supervision requirements.
5. Personnel Qualification Management: The system enables the enterprise to better manage employees’ qualifications and certifications, ensuring that all employees have the corresponding qualifications to engage in pharmaceutical production activities.
6. Flexible and Diverse Learning Modes: The system supports multiple learning modes (e.g., online learning, mock exams), enhancing employees’ learning interest and training participation.
7. Report Management: The system can generate detailed training reports, helping the enterprise analyze training data, optimize training plans, and improve training quality.
8. Quality Culture Construction: The system helps the enterprise build a quality-centered culture, and strengthens employees’ quality awareness through continuous training and education.
9. Regulatory Compliance: The system assists the enterprise in ensuring that training content and processes comply with the latest pharmaceutical production regulations and standards, reducing compliance risks.
10. Data Security: The cloud-based training management system features high data security, ensuring the authenticity and integrity of training data and meeting the requirements of GMP training management.
11. The implementation of the training management system not only improves the efficiency and quality of training, but also helps the enterprise establish a sound quality management system, thereby enhancing its quality compliance capabilities in pharmaceutical production.

(III) Technical Architecture

Singerdy’s GMP Training Management Solution is one of the core solutions on Singerdy’s Aotai Digital Platform. Aotai is a digital platform jointly developed by Singerdy’s industry experts and IT experts. With "Quality and Compliance Expert" as its management philosophy and market positioning, it helps enterprises improve quality compliance levels, meet industry supervision requirements, enhance enterprise management capabilities, and accelerate the launch of more safe, effective, and high-quality products.

The applications on the Aotai Platform can be tailored to enterprises’ needs to build a quality system. Its built-in configuration tools already cover multiple quality management functions, eliminating the 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 excellent 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.

The standard APIs significantly improve system access efficiency, including:

• Automatic email notifications, SMS notifications, and dashboard alerts integrated into workflows, greatly reducing the risk of missing tasks or approvals;
• Background task submission and management mode supporting users to perform other tasks simultaneously;
• Provision of a standard middleware service layer supporting integration with any third-party systems, facilitating data exchange between Aotai and other application systems.

IV. Construction Achievements

(I) Enterprise Achievements

The implementation of Singerdy’s training management system by Yiling Pharmaceutical took three months. During this period, each department appointed a training administrator, who formulated monthly/quarterly training plans and assigned courses for employees to study. The completion status was counted quarterly and linked to individual performance. Each department was required to internalize one course based on the learned content every quarter for internal training, which was linked to departmental performance.

The comparison of economic benefits after the project is as follows:

Improvement in Training Efficiency

• After shifting training and assessment online, the total time for training organization has been reduced by approximately 60%;
• The time for statistical analysis of training effects has been shortened by at least 80%;
• The effectiveness of job training has been improved by approximately 40%.

(II) Social Achievements

Article 26 of the GMP (2010 Edition) stipulates that enterprises shall designate a department or a dedicated person responsible for training management, and shall have a training plan or program reviewed and approved by the head of production management or quality management; training records shall be retained.

Article 27 stipulates that all personnel involved in pharmaceutical production and quality shall receive training, and the training content shall be consistent with job requirements. In addition to theoretical and practical training, training on relevant regulations, job responsibilities, and skills shall also be provided, and the actual effect of training shall be evaluated regularly.

In previous GMP inspections, personnel training was a frequent defect item and a common pain point/difficulty for many pharmaceutical enterprises.

Singerdy’s GMP Training Management Solution achieves comprehensive compliance and real-time transparent monitoring through training plans/matrices, training courses, training assessments, and diverse training formats.

Through the implementation of the TMS project, Yiling Pharmaceutical has effectively managed team training, met industry supervision requirements, enhanced employees’ understanding and compliance with GMP, promoted knowledge transfer, ensured the compliance of production management, and ultimately guaranteed the quality and safety of pharmaceuticals.

V. Related Solutions

1. Pharmaceutical Enterprise GMP Training Management Solution (TMS)
2. GMP Quality Compliance Digital Solution

VI. Related Cases

1. GMP Training Management (TMS) Project of Suzhou Fushilai Pharmaceutical
2. GMP Quality Compliance Digital (QCMS) Project of Zhejiang Zhenyuan Pharmaceutical
3. GMP Quality Compliance Digital (QCMS) Project of Shanghai Shenqi Medical