01 Case Overview

Nantong Lianya Pharmaceutical Co., Ltd. is an international pharmaceutical enterprise focusing on the R&D, production and sales of high-end complex preparations. Its products are mainly exported to overseas markets. Forty-seven products have obtained FDA approval and nearly 40 have been launched commercially, among which four are FDA reference listed drugs. The company has repeatedly passed FDA on-site inspections, with multiple sustained and controlled-release drugs holding leading market shares in the US.

It has obtained authoritative certifications including China NMPA and US FDA cGMP compliance, ranking among the domestic benchmark enterprises that realize dual approval in China and the US and large-scale overseas expansion of high-end preparations. With rapid business expansion and increasingly stringent domestic and overseas regulatory requirements, the traditional training management mode can no longer meet strict criteria concerning training compliance, data integrity and personnel qualification control set by FDA and NMPA.

To establish an internationally compliant GMP training system, Lianya Pharmaceutical launched a digital GMP training management project and adopted Singerd GMP Training Management System (TMS). Built on the OwlTrust digital platform, the system enables full-process digital management covering training planning, training matrix, course administration, online learning, assessment evaluation, personnel qualification and compliance reporting. Completed within 4 months, the project finished system deployment, business blueprint design and configuration testing, greatly boosting training management efficiency and compliance capacity, and underpinning the enterprise’s high-quality development and global operation.

02 Project Background

As a high-end preparation supplier serving the global market, Lianya Pharmaceutical is subject to dual supervision of China GMP and US cGMP, confronting prominent pain points in training management:

1. Manual compilation of training plans fails to cover all posts and regulatory provisions, easily resulting in omitted and insufficient training.
2. Delayed tracking of training progress disables automatic alerts for unfinished learning, assessments and refresher training.
3. Scattered training records hinder traceability and rapid generation of compliance reports for FDA audits.
4. Disconnection between personnel qualifications and job authorization gives rise to compliance risks such as expired credentials and unqualified employment.
5. The original system cannot support international compliance demands including Chinese-English bilingual display, audit trail and electronic records.
6. Isolated data hinders interconnection with HR, OA, ERP and other systems, dragging down overall management efficiency.
7. To tackle the above challenges, Lianya Pharmaceutical introduced Singerd TMS to build a standardized, digital and traceable GMP training management system, ensuring compliant personnel behavior, operational procedures and documentation for smooth passage of domestic and overseas regulatory inspections.

03 Implementation Measures

The project was carried out in five standardized phases within a 4-month implementation cycle:

1. Project Initiation & Demand Research: Establish project teams, investigate operational status, confirm implementation scope and unify development objectives.
2. Business Blueprint Design & Scheme Confirmation: Sort out job positions, design training matrices, optimize business workflows and finalize implementation plans.
3. Demand Negotiation & Customized Development: Verify personalized requirements, streamline procedures and develop tailored functional modules.
4. System Configuration, Integration & Optimization: Complete server deployment, functional setup, user testing and system iteration.
5. Acceptance & Pre-launch Preparation: Conduct full-function acceptance, organize user training, compile operation manuals and collate complete project documents.
6. Compliant with pharmaceutical digital construction specifications, the project strictly controls demand verification, functional testing, procedure validation and data security, making the system conform to GMP codes, data integrity standards and internal quality management requirements of NMPA and FDA.

Business Model & Functional Application

1. Training Matrix & Plan ManagementBuild standardized training matrices by position, department and job type, automatically generate annual and monthly training schedules, and classify compulsory and optional courses to match training content with job requirements.
2. Course & Question Bank ManagementUpload and categorize documents, audio and video course materials, create exclusive enterprise question banks, and support random paper generation, anti-cheating settings and automatic scoring to integrate learning and assessment.
3. Online Learning & Task ReminderEmployees access courses via PC and mobile terminals. The system pushes pending tasks, learning notifications and overdue warnings to achieve transparent and trackable learning progress.
4. Assessment & Effect EvaluationCombine online examinations with offline practical assessment records. Unqualified staff will be arranged for supplementary training and re-examination. Regular evaluation guarantees valid training outcomes in line with regulatory standards.
5. Personnel Qualification ManagementCentralize management of employee certificates and employment authorization with automatic expiry reminders, forming a closed-loop mechanism covering training qualification verification, credential activation and job approval.
6. Compliance Reporting & Audit TrailGenerate multi-dimensional training reports with complete operational logs and audit trails. Chinese-English bilingual switching fully satisfies audit requirements of FDA and NMPA.
7. System Integration & Access ControlConnect with HR, OA and ERP systems via standard APIs to synchronize organizational and personnel data. Role-based hierarchical authorization ensures separated power and secure data management.

Technical Architecture

Developed based on Singerd OwlTrust digital platform, the microservice-based system features outstanding stability, security and scalability:

• Terminal Layer: Compatible with independent PC and mobile applications
• Application Layer: Modular configuration of training, course, examination, qualification and report functions
• Infrastructure Layer: Supported by MySQL, Redis, OSS and Elasticsearch for high-efficiency operation
• Integration Layer: Standard API interfaces for enterprise existing system docking
• Security Layer: Oauth2 authentication, SSL encryption and log audit for international compliance
• The platform supports configurable customization to adapt to business workflows without additional coding.

Project Management

A standardized management mechanism is adopted, featuring dedicated project teams, weekly regular meetings, problem solving protocols, document specifications and quality control procedures to guarantee on-time and high-quality project delivery.

04 Achievements

Enterprise Benefits

• Enhanced Compliance CapacityFully comply with NMPA and FDA regulations on training records, data integrity and computerized systems; eliminate training-related non-conformities and pass internal and external audits successfully.
• Improved Management EfficiencyTraining organization time cut by around 70%; report statistics efficiency raised by over 70%; manual sorting, filing and tracking workload reduced by more than 60%.
• Optimized Training Quality & Staff CompetenceJob training effectiveness improved by approximately 40%; staff learning completion rate nearly reaches 100%; qualification review cycle for new recruits shortened remarkably.
• Reduced Operational Costs70% decrease in paper printing and filing expenditure; lower communication and repeated training costs; minimized compliance risks and potential production losses.
• Strengthened Global Operation SupportSeamless bilingual switching adapts to overseas business and FDA inspections; electronic records, timestamps and audit trails meet international standards and facilitate sustained overseas expansion of pharmaceutical preparations.

Social Benefits

The replicable digital compliance solution for GMP training serves enterprises engaged in high-end preparation export. It promotes digital, paperless and intelligent upgrading of pharmaceutical training management, safeguards drug safety and efficacy with high-standard quality systems and benefits patients worldwide.

05 Solution Portfolio

1. GMP Training Management Solution (TMS) for Pharmaceutical Enterprises
2. GMP Quality Compliance Digital Solution (QMS)

06 Related Cases

1. GMP Training Management (TMS) Project of Changchun GeneScience Pharmaceutical
2. GMP Training Management (TMS) Project of Suzhou Fule Pharmaceutical
3. GMP Quality Compliance Digital (QMS) Project of Zhejiang Zhenyuan Pharmaceutical