HIPPOCRATES

GMP Training Management (TMS) Project of Suzhou Fushilai Pharmaceutical

I. Case Overview

Fushilai Pharmaceutical Co., Ltd. is located in Changshu, a beautiful water town in the Jiangnan region. Its predecessor was Changshu Fushilai Pharmaceutical & Chemical Co., Ltd. Starting with an initial area of only over 6,667 square meters (10 mu), the company has gradually expanded to more than 66,667 square meters (100 mu). In recent years, with rapid development, Fushilai has emerged as a dark horse and grown into one of China’s large-scale professional manufacturers specializing in three major series of active pharmaceutical ingredients (APIs) and pharmaceutical intermediates: lipoic acid series, carnosine series, and phosphatidylcholine.

Fushilai implements a comprehensive quality management system, organizes production in accordance with GMP requirements, and has obtained GMP certification for pharmaceutical APIs and passed on-site inspections by the U.S. FDA. Its products are mainly exported to overseas markets in Europe, America, Southeast Asia, etc., and the company has established long-term supply and marketing cooperation relationships with foreign merchants.

With the continuous expansion of the enterprise scale and the increasingly strict requirements of pharmaceutical supervision, the traditional GMP training management model faces many challenges. These include: how to formulate an effective annual corporate training plan, how to ensure training courses meet the needs of different positions, how to address the lack of effective record management in the original training system, and how to quickly, efficiently and accurately meet the training system inspection requirements of domestic and foreign regulatory authorities.

In October 2022, Fushilai Pharmaceutical chose to implement Singdi’s GMP Training Management Solution for the pharmaceutical industry (Training Management System, TMS; Kaitai®, AcadTrust®). This implementation enabled functions such as the rapid formulation of annual training plans/training matrices, quick upload of training courseware and generation of training courses, real-time tracking of learning progress, and quantitative evaluation of training effects. It also realized the unified management of the enterprise’s training knowledge base, greatly improving the efficiency and effectiveness of training management.

II. Project Background

With the upgrading of supervision in China’s pharmaceutical industry, regulatory authorities have imposed higher requirements on data authenticity, reliability, and traceability. Meanwhile, establishing a high-standard quality compliance management system to support the enterprise’s needs for better, faster, and higher-quality development has become one of the major challenges faced by Suzhou Fushilai Pharmaceutical in its development process.

Fushilai Pharmaceutical has long sought to implement an effective training management system to address the pain points of the traditional training management model. This would help the company meet the stringent regulatory requirements on quality systems from home and abroad, as well as achieve effective management of personnel qualifications, product safety, and quality controllability.

III. Specific Measures

(I) Overall Planning

Previously, Fushilai Pharmaceutical used an OA system for document training management. However, the OA system had limitations: it could not pass industry CSV verification and could not generate records and reports that meet the requirements of foreign regulatory authorities. After comparing training solutions from multiple suppliers, Fushilai finally selected Singdi’s professional TMS solution. This choice significantly improved employees’ professional capabilities and helped the company establish a training system that meets regulatory requirements.

(II) Business Model

Pharmaceutical enterprises with overseas export business often face more stringent regulatory requirements. Typical deficiencies related to training in GMP inspection reports include:

No follow-up training and assessment were conducted for personnel who failed the assessment.
The evaluation and confirmation of personnel training effects were insufficiently comprehensive, with inadequate training for some personnel (e.g., new employees, inspectors, and equipment operators).
The training effects of on-the-job personnel were poor, showing 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 appointed personnel, resulting in these personnel being unable to perform their job duties correctly.
Lack of transfer training: technical personnel and supervisors of the company were not provided with transfer training and assessment when changing positions.
The annual training plan formulated by the enterprise did not include training on the Annex to Computerized Systems.
The enterprise failed to conduct training in accordance with the formulated annual training plan.
By implementing Singdi’s GMP Training Management Solution (TMS) for pharmaceutical enterprises, Fushilai Pharmaceutical addressed the complex regulatory requirements of the pharmaceutical industry and comprehensively improved the quality compliance capabilities of its pharmaceutical production through the following aspects:

Standardization of training content: The training management system provides standardized training content, ensuring all employees receive training that meets GMP requirements.
Real-time evaluation of training effects: Through the training management system, the enterprise can evaluate training effects in real time, gain timely insights into employees’ training progress and mastery of knowledge, and thus ensure training effectiveness.
Compliance of training records: The system records employees’ training history and scores, making it easy for the enterprise to provide compliant training records to regulatory authorities and meet regulatory requirements.
Training matrix management: The system is equipped with an efficient training matrix management function, which can provide personalized training plans based on employees’ different positions and responsibilities.
Personnel qualification management: The system enables the enterprise to better manage employees’ qualifications and certifications, ensuring all employees have the necessary qualifications to engage in pharmaceutical production activities.
Diversified learning modes: The system supports multiple learning modes (e.g., online learning, mock exams), enhancing employees’ learning interest and participation in training.
Report management: The system can generate detailed training reports, helping the enterprise analyze training data, optimize training plans, and improve training quality.
Quality culture building: The system facilitates the enterprise in establishing a quality-centered culture, strengthening employees’ quality awareness through continuous training and education.
Regulatory compliance: The system helps the enterprise ensure that training content and processes comply with the latest pharmaceutical production regulations and standards, reducing compliance risks.
Data security: The cloud-based training management system features high data security, safeguarding the authenticity and integrity of training data and meeting GMP training management requirements.
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 the quality compliance capabilities of pharmaceutical production.

(III) Technical Architecture

Singdi’s GMP Training Management (TMS) Solution is one of the core solutions on 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.

The applications on the Aotai Platform can be customized to meet the enterprise’s needs for quality systems. The 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 superior design of the Aotai Platform ensures 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 system access efficiency is greatly improved through standard APIs, including:

Automatic email notifications, SMS notifications, and dashboard alerts integrated into workflows, significantly reducing the risk of missing tasks or approvals.
Background task submission and management mode support 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. Construction Achievements

(I) Enterprise Achievements

Fushilai Pharmaceutical spent two months implementing Singdi’s training management software. The project achieved the following results:

Over 500 in-service employees participated in online training, ensuring the on-the-job qualifications of personnel in relevant positions.
The training system covers employee orientation training, on-the-job training, professional knowledge training, and customized courses.
The system supports the establishment of the enterprise’s annual training plans, training matrices, training implementation, personnel management, training assessment, certificate acquisition, and data statistics, forming a comprehensive training system for Fushilai.
It realizes the standardization, normalization, and paperless workflow of processes, establishes a professional corporate training knowledge base, and is of great significance to the long-term development of the enterprise and the building of its talent team.
The economic benefits of implementing the training system are as follows:
Improvement in Training Efficiency

200 sets of self-developed courseware and test papers are created monthly.
Over 20 internal trainers are developed.
The average number of online learning sessions per employee per quarter exceeds 80.
The total time for training organization is reduced by approximately 70%.
The time for training effect statistics is improved by at least 70%.
The effect of on-the-job training is improved by approximately 40%.

(II) Social Achievements

Through training matrices, branded courses, and diversified training formats, Singdi’s GMP Training Management Solution for the pharmaceutical industry achieves comprehensive compliance and real-time transparent monitoring.

By implementing the TMS project, Fushilai Pharmaceutical has realized effective management of team training, met industry regulatory requirements, strengthened employees’ understanding and compliance with GMP, ensured the compliance of production management, and thus guaranteed the quality and safety of pharmaceuticals.

V. Related Solutions

Solution 1: GMP Training Management Solution (TMS) for Pharmaceutical Enterprises
Solution 2: GMP Quality Compliance Digital Solution (QCMS)

VI. Related Cases

Case 1: GMP Quality Compliance Digital (QCMS) Project of Zhejiang Zhenyuan Pharmaceutical
Case 2: GMP Quality Compliance Digital (QCMS) Project of Shanghai Shenqi Medical