01 Enterprise Case

Changchun GeneScience Pharmaceutical Co., Ltd. (hereinafter referred to as GeneScience Pharmaceuticals) is a benchmark enterprise in China’s genetic engineering pharmaceutical industry. It focuses on the research, development, production and sales of innovative drugs covering growth hormone, reproductive health and metabolic diseases. Its products are sold nationwide and exported to numerous countries and regions worldwide.

As a leading player in the biopharmaceutical sector, GeneScience Pharmaceuticals strictly complies with GMP specifications. The company has obtained multiple authoritative international certifications including NMPA of China, EMA of the European Union and FDA of the United States, establishing a full-chain quality management system covering R&D, production and supply chain.

With continuous business expansion, the staff size of the group’s supply chain business unit has grown to thousands of employees. The Quality Center of Changchun GeneScience and the Group Quality Center need to oversee unified GMP training compliance management across the company, exposing prominent drawbacks of the traditional training management model. Firstly, customized training content cannot be developed for differentiated business demands of two major business divisions, and generic courses fail to meet distinct requirements of production compliance and R&D specifications. Secondly, the system lacks standardized record management and automatic report generation functions, making it hard to respond to rigorous inspections by domestic and overseas regulatory authorities and achieve quantitative evaluation of training effectiveness.

To tackle these pain points, GeneScience Pharmaceuticals adopted the pharmaceutical GMP Training Management System (TMS) solution developed by Singardi. Custom functional modules were configured to fit operational characteristics of the supply chain division. On-premises deployment was adopted to guarantee data security and system autonomy. The system supports rapid formulation of annual training plans and training matrices, exclusive development and generation of training courseware, real-time learning progress tracking and quantitative training effect assessment. It centrally manages the corporate training knowledge base, greatly boosting training management efficiency and quality, and building a standardized digital training system for thousands of employees.

02 Project Background

Against the backdrop of escalating domestic pharmaceutical industry supervision, regulators impose increasingly stringent requirements on data authenticity, reliability and traceability. Establishing a high-standard quality compliance management system to adapt to large-scale operation, cross-department collaboration and strict compliance criteria has become a core challenge for the quality management teams of GeneScience Pharmaceuticals.

The enterprise was in urgent need of professional training management solutions to resolve key difficulties including adaptive courses for diverse business units, large-scale user access and compliant record maintenance. Meanwhile, independent control over core training data must be ensured to satisfy strict domestic and overseas regulatory requirements, as well as effective administration of personnel qualification, product safety and quality stability.

03 Project Introduction

(1) Overall Planning

After evaluating training solutions from multiple suppliers, GeneScience Pharmaceuticals finally selected Hippocrates’s professional TMS system to enhance employees’ professional competence and build a regulatory-compliant training framework.

A special working group jointly formed by GeneScience Pharmaceuticals and Hippocrates conducted comprehensive surveys on the two business divisions to clarify core job training demands. The project was implemented in three phases:

• Phase 1 (1.5 months): Complete on-premises server deployment, system setup and basic configuration, alongside establishment of corporate organizational and post hierarchies.
• Phase 2 (2 months): Develop and upload customized courses, build training matrices, and optimize system response speed adapting to local deployment.
• Phase 3 (1 month): Conduct system operation training and trial run, adjust functions based on practical feedback, and launch the full-process formal operation.

(2) Business Model

Common non-conformities identified in GMP training inspections include untracked re-training for unqualified staff, inadequate training effect evaluation, deficient post-transfer training and incomplete annual plans failing regulatory rules. Leveraging Hippocrates’s GMP training management system, GeneScience Pharmaceuticals improved overall pharmaceutical quality compliance capabilities tailored to complex regulatory rules and dual-business operation features.

Supply Chain Division: Focus on Production Compliance and Operational Standards

• Accurate matching of post training matrices: Preset targeted course packages for different positions via matrix management tools.
• Integrated online-offline training and assessment: Employees finish online courses and submit practical operation videos or on-site assessment records. Department supervisors verify qualifications via the system to eliminate superficial assessment.
• Timely updated compliance courses: The system synchronizes the latest domestic and international pharmaceutical laws and regulations, and pushes updated courses to corresponding positions to keep training content aligned with regulatory updates.

(3) Technical Architecture

The TMS system is built on Hippocrates OwlTrust Digital Platform, jointly developed by industrial quality compliance experts and IT specialists. Positioned as a professional quality compliance management platform, it helps enterprises meet regulatory standards and elevate overall management proficiency.

Hierarchical Architecture

1. Basic Service Layer: Ensure stability and security of on-premises deployment

• On-premises server cluster: High-performance physical servers support concurrent access of 2,000 users. Master-slave server synchronization prevents data loss caused by hardware failures.
• Hybrid storage structure: MySQL, Redis and local storage arrays store classified data. Redis caches frequent access information, while local storage saves videos and documents to ensure smooth loading.
• Comprehensive security protection: Firewall, intrusion detection system and data encryption are equipped. Hierarchical access control and SSL encrypted data transmission fully satisfy GMP data security norms.

1. Application Service Layer: Adapt to diversified business scenarios

• Visual configuration tools: Custom forms, reports and workflows can be created without coding to meet personalized demands of production and R&D departments.
• Intelligent notification and early warning: Automatic alerts are sent via system messages and internal emails for overdue training and failed assessments. Custom warning thresholds help managers identify potential risks promptly.
• Regulatory compliance assurance: The system complies with Computerized System Validation criteria, with complete operation logs and data backup & restoration functions, facilitating convenient data retrieval during official inspections.

Platform Advantages

• Low-code customization: Abundant built-in quality management functions allow quick configuration of exclusive business processes without extra programming.
• High-efficiency data processing: Optimized data loading and distributed architecture deliver stable performance amid massive data operation and server expansion.
• Full risk control: Integrated multi-channel reminders and dashboard alarms avoid delayed task handling, supporting concurrent daily business operations.

04 Project Outcomes

The whole project took 4.5 months for full implementation. Thousands of employees completed online training and obtained valid job qualifications covering supply chain and central research institute divisions. The training system covers new recruitment induction, on-the-job training and professional skill learning, forming a closed-loop management workflow including annual planning, matrix formulation, training execution, qualification certification and data analysis.

Digitalized and paperless standardized procedures are realized, and an exclusive enterprise training knowledge repository is established. The system lays a solid foundation for long-term corporate development and professional talent cultivation.