Shanghai Shenqi Medical GMP Quality Compliance Digitalization (QMS) Project

I. Case Overview

Shanghai Shenqi Medical Technology Co., Ltd. was founded in September 2014 and registered in Shanghai Zhangjiang High-Tech Park. It is a high-tech enterprise specializing in medical devices that integrates R&D, production, and sales. In 2020, Shenqi Medical decided to implement Singdi’s Quality Compliance Management System (Quality Management System, QMS), and completed the construction of a quality system covering documentation, training, and quality management. Through the implementation of this project, the following outcomes were achieved:

• Ensured the authenticity, reliability, and traceability of quality data;
• Established a high-standard quality compliance system;
• Realized high-level sharing and timely transmission of quality documents, relevant records, and reports across all departments of the enterprise;
• Simplified and accelerated the approval and release processes for medical devices;
• Effectively ensured that Shenqi Medical meets GMP regulatory requirements, and guaranteed product safety and quality reliability.

II. Project Background

Shenqi Medical has a team of professionals engaged in the R&D and production of interventional and implantable medical devices, with rich experience in enterprise management, technological innovation, and product R&D. The company is equipped with precision, high-automation processing equipment, testing equipment, and modern laboratories, as well as a 10,000-class clean workshop that meets national standards for the production of Class Ⅲ sterile medical products.

To adapt to the digital transformation needs of domestic and foreign medical device enterprises, ensure data authenticity and traceability, and establish a high-standard quality and compliance management system, Shenqi Medical aimed to enhance its ability to meet GMP regulatory requirements through digital means and comprehensively improve the company’s quality compliance management level.

III. Specific Measures

(I) Overall Planning

Shenqi Medical’s GMP Quality Compliance Digitalization Project (QMS) was divided into four phases and completed under the implementation strategy of "overall planning and phased implementation". The project objectives were achieved in the following steps:

1. Build a basic quality assurance system that meets regulatory requirements;
2. Establish a communication and collaboration mechanism among various departments;
3. Realize the digitalization of employee qualifications and organizational structure;
4. Ultimately achieve quality and compliance management throughout the full life cycle of medical devices, and enhance the enterprise’s ability to meet strict GMP regulatory requirements.

(II) Business Model

Shenqi Medical’s GMP Quality Compliance Digitalization Project (QMS) consisted of four phases, with specific tasks as follows:

• Phase 1: Digital Transformation PlanningDetermined the overall implementation path of the project by researching the digital construction of benchmark enterprises at home and abroad.
• Phase 2: Basic Quality Assurance System ConstructionEstablished a basic quality assurance system through the implementation of document and training management.
• Phase 3: Quality Management System ConstructionCompleted the construction of quality management modules, including deviation management, change management, audit management, and supplier management.
• Phase 4: Business Intelligence ImplementationImplemented business intelligence to provide comprehensive decision-making support for the enterprise.

(III) Technical Architecture

The GMP Quality Compliance Digitalization Solution (QMS) is one of the core solutions based 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 regulations, enhance management capabilities, and accelerate the launch of more safe, effective, and high-quality products.

Key Features of the Aotai Platform:

1. Customizable Digital Management SystemThe applications on the Aotai Platform can be customized into a digital management system according to enterprise needs. Its built-in configuration tools already cover multiple quality management functions, eliminating the need for customization or programming to implement specific processes. Trained personnel can quickly customize forms, decision trees, and dashboards to meet specific business requirements.
2. Efficient Data Access and ProcessingThe platform’s superior design ensures that users can quickly access large volumes of records and data, thereby improving work efficiency:"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.
3. Efficient System Access and IntegrationStandard 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;A standard middleware service layer supporting integration with any third-party system, facilitating data exchange between Aotai and other application systems.

IV. Construction Achievements

(I) Enterprise Achievements

The overall implementation cycle of Shenqi Medical’s GMP Quality Compliance Digitalization Project was 10 months. The finally implemented functions covered major modules such as Organization and Personnel Management, Document and Training Management, Record and Release Management, and Quality Assurance & Control. Among these, the Quality Management module included sub-modules such as Supplier Management, Deviation Management, CAPA (Corrective and Preventive Actions) Management, Change Management, Audit (Self-audit) Management, Validation Management, Complaint Management, Recall Management, and Risk Management.

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

1. Comprehensive Labor Efficiency Improvement

• Real-time, accurate, and reliable data statistics, with an 80% increase in speed;
• Elimination of relevant statistical positions: after the first phase of the project, there was a 20% reduction in staff recruitment compared with the pre-implementation period. The effect will become more significant as the number of users of the project gradually covers all employees.

2. Quality Improvement

• Over 90% informatization traceability of product quality;
• 100% enhancement of data consistency and integrity;
• Online monitoring and real-time early warning, with an average 1-3% improvement in online quality control;
• Over 20% increase in efficiency of PQR (Product Quality Review) analysis.

3. Error Reduction

• Elimination of over 90% of statistical errors;
• Elimination of over 80% of human errors.

4. Efficiency Improvement in Document and Record Management

• Improved document conversion and approval processes, with an approximately 30% increase in approval speed;
• Over 70% digitalization of batch production records, auxiliary records, and on-the-job documents;
• Approximately 80% reduction in document/record printing costs and related consumable expenses;
• Over 50% reduction in time spent on filling out records and documents.

5. Efficiency Improvement in Training

• After shifting training and assessment to online mode, the total time for training organization was reduced by approximately 60%;
• Over 80% increase in efficiency of training effect statistics;
• Approximately 40% improvement in on-the-job training effectiveness.

(II) Social Achievements

Quality is the lifeline of medical device enterprises and the cornerstone of their survival and development. Without a complete quality management system, an enterprise’s products cannot be trusted. The competition among medical device enterprises today is essentially competition in product quality—without quality assurance, enterprises will inevitably lose market share. Many medical device enterprises have exposed more quality problems than ever before during unannounced inspections, which poses a huge challenge to their operations. It has become a mainstream trend for medical device enterprises to prevent and avoid potential quality and safety incidents through a sound quality management system.

The fundamental reason for Shenqi Medical to implement Singdi’s GMP Quality Compliance Digitalization Solution (QMS) is to achieve overall and systematic supervision of the quality management system (both top-down and bottom-up) through strict system-based control of quality processes. The core functions of Singdi’s QMS solution include:

• Automation of quality incident management processes;
• Real-time reporting of quality risk incidents;
• Encrypted protection of core corporate documents;
• Establishment of a standardized corporate training system.
• These functions are essential for achieving high-standard quality management. The implementation of the QMS solution enables Shenqi Medical’s senior management to fully control quality incidents in business activities and minimize any potential issues that may lead to quality and safety accidents. Investment in the QMS system helps Shenqi Medical establish a sound GMP system, comprehensively improve GMP management levels, and ensure that product quality meets regulatory requirements.
• By implementing Hippocrates’s QMS solution, Shenqi Medical has not only improved its quality compliance management capabilities but also achieved good economic benefits. Its case provides a new idea for medical device enterprises on how to comprehensively improve medical device GMP management through digital means.

V. Related Solutions

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

VI. Related Cases

1. Zhejiang Zhenyuan GMP Quality Compliance Digitalization (QMS) Project
2. Kobayashi Pharmaceutical Contract Manufacturing Quality Management Collaboration (OWL MAH) Project
3. Suzhou Fushilai Pharmaceutical GMP Training Management (TMS) Project