GMP Quality Compliance Digitalization (QMS) Project of Hemei Biology (Cosmetics)

I. Case Overview

Hemei Biotechnology (Zhejiang) Co., Ltd. is a national high-tech enterprise established in 2018, focusing on the technological R&D and application of bioactive peptide raw materials. The company is committed to providing overall solutions from raw materials to products and from R&D to end terminals, with in-depth research particularly in the anti-aging field. Relying on its technological innovation and R&D capabilities in the bioactive peptide field, Hemei Biotechnology (Zhejiang) Co., Ltd. has become a leading enterprise in the industry and is dedicated to developing into an internationally leading high-tech enterprise. In 2021, Hemei Biotechnology chose to implement a Quality Management System (QMS), completing the construction of a quality system covering documents, training, and quality management. Through the project implementation, the authenticity, reliability, and traceability of quality data have been ensured; a high-standard quality compliance system has been established; the high-degree sharing and timely transmission of quality documents, relevant records, reports, etc. among various departments of the enterprise have been realized; the approval and release process of medical devices has been simplified and accelerated; and it has effectively ensured that Hemei Biotechnology meets GMP regulatory requirements, thus guaranteeing product safety and quality reliability.

II. Project Background

With the advancement of digital transformation, more and more enterprises have begun to adopt digital QMS to optimize quality management processes. Digital QMS can not only improve the integrity and accuracy of data but also reduce human errors through automation and enhance overall operational efficiency. For example, by deploying a computer system-validated eGMP system, enterprises can achieve paperless office work, reduce compliance risks caused by paper records, and improve quality control levels through data analysis and real-time monitoring.

In addition, digital QMS also supports cross-departmental collaboration and resource optimization, enabling enterprises to better respond to complex regulatory requirements and market changes. For instance, by integrating functions such as supplier management, deviation handling, and CAPA (Corrective and Preventive Actions) management, the QMS system helps enterprises effectively manage various risks in the supply chain and production process.

The GMP Quality Compliance Digitalization (QMS) Project of Hemei Biotechnology aims to enhance the enterprise's quality management capabilities by introducing advanced digital QMS solutions, ensure that products comply with strict domestic and international regulatory requirements, and at the same time improve production efficiency and market competitiveness.

III. Specific Measures

(1) Overall Planning

The GMP Quality Compliance Digitalization (QMS) Project of Hemei Biotechnology aims to establish a basic quality assurance system that meets regulatory requirements, build a communication and collaboration mechanism among various departments, realize the digitalization of employee qualifications and organizational structure, and ultimately achieve the full-life-cycle quality and compliance management of medical devices while enhancing the enterprise's ability to meet strict GMP regulatory requirements.

(2) Business Model

The GMP Quality Compliance Digitalization (QMS) Project of Hemei Biotechnology has established a basic quality assurance system through the implementation of document and training management.

1. Document Management Module

The QMS Document Management Module of Hemei Biotechnology is the core for ensuring GMP compliance. This module includes the following key components:

• Document Creation and Approval: All GMP-related documents, including Standard Operating Procedures (SOPs), work instructions, and quality manuals, are created, approved, and released in the system to ensure the accuracy and up-to-dateness of documents.
• Version Control: The system automatically tracks document versions to ensure that all employees can access the latest versions of documents and avoid using outdated guidance documents.
• Access Control: Through refined permission management, only authorized personnel can access, edit, or delete documents, thereby protecting the security and integrity of documents.
• Document Distribution and Archiving: The QMS supports the electronic distribution and archiving of documents, simplifying the document management process and improving retrieval efficiency.

2. Training Management Module

The QMS Training Management Module of Hemei Biotechnology is designed to enhance employees' quality awareness and operational skills, ensuring that each employee meets GMP requirements:

• Online Training Platform: An online training platform is provided where employees can take GMP-related training courses, including video tutorials, online tests, and interactive seminars.
• Training Record and Tracking: The system records each employee's training history and scores, ensuring that all training requirements are met and enabling easy evaluation of training effectiveness.
• Personalized Training Programs: Based on employees' roles and responsibilities, the QMS can generate personalized training programs to ensure that each employee receives training relevant to their work.
• Continuous Education: The QMS encourages and promotes continuous education by regularly updating training content to ensure that employees' knowledge keeps pace with industry best practices.

3. Establishment of Quality Assurance System

Through the implementation of document and training management, the QMS of Hemei Biotechnology has established a basic quality assurance system, which not only includes documented standards and procedures but also covers the following aspects:

• Quality Monitoring and Improvement: The QMS provides tools for monitoring and analyzing quality data, helping Hemei Biotechnology identify problems, take corrective actions, and continuously improve the quality system.
• Audit Preparation and Support: The system can help Hemei Biotechnology prepare for and respond to internal and external audits by providing necessary documents and records, simplifying the audit process.
• Risk Management: The QMS includes risk assessment tools to help identify potential risk points and formulate corresponding preventive and mitigation measures.
• Change Control: Any changes to production processes or the quality system are managed in the QMS to ensure that changes undergo appropriate review, approval, and implementation.
• Through these measures, the QMS of Hemei Biotechnology has ensured the GMP compliance of its production and quality control processes, improved production efficiency, reduced risks, and ultimately guaranteed the safety and effectiveness of products for patients.

(3) Technical Architecture

The GMP Quality Compliance Digitalization Solution (QMS) is one of the core solutions on the Singdi Aotai digital platform. Aotai is a digital platform jointly built by Singdi's industry experts and IT experts. With "quality compliance expert" as its management concept 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 specific needs of enterprises for quality systems. The built-in configuration tools already include multiple quality management functions, so there is no need for customization or programming to implement certain special processes. Personnel who have received training can quickly customize forms, decision trees, and dashboards to meet specific business needs.

The superior 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 can minimize 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 the workflow, which greatly reduce the risk of missing tasks or approvals. The background task submission and management mode supports 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

(1) Enterprise Achievements

The overall implementation cycle of the GMP Quality Compliance Digitalization Project of Hemei Biotechnology was 8 months. The finally realized functions include major functional modules such as organization and personnel management, document and training management, record and release management, and quality assurance and control. Among them, quality management includes modules such as supplier management, deviation management, CAPA management, change management, audit (self-inspection) management, verification management, complaint management, recall management, and risk management. The comparison of economic benefits after the project is as follows:

Comprehensive Labor Efficiency Improvement

• Real-time, accurate, and reliable data statistics, with a 90% increase in speed.
• Relevant statistical positions have been eliminated. After the first phase of the project implementation, compared with before implementation, the number of new employee recruits has decreased by approximately 20%. Moreover, as the number of users of the project gradually covers all staff, the effect will become more obvious.

Quality Improvement

• The informatization traceability of product quality has reached over 90%.
• The consistency and integrity of data have been enhanced by 100%.
• Real-time monitoring and early warning have been realized, and the average level of online quality control has increased by 1-3%.
• The efficiency of PQR (Product Quality Review) analysis has increased by over 30%.

Error Reduction

• Statistical errors have been eliminated by over 95%.
• Human errors have been eliminated by over 90%.

Labor Efficiency Improvement in Document and Record Management

• The document conversion and approval process has been optimized, with the approval speed increased by approximately 40%.
• Over 85% of batch production records, auxiliary records, post documents, etc., have been digitized.
• The expenditure on document and record printing and related consumables has decreased by approximately 90%.
• The time spent on filling in records and documents has been reduced by over 80%.

Labor Efficiency Improvement in Training

• After training and assessment were shifted online, the total time for training organization has been reduced by approximately 60%.
• The time for training effect statistics has been shortened by at least 80%.
• The effectiveness of on-the-job training has been improved by approximately 70%.

(2) Social Achievements

Quality is the lifeline of medical device enterprises and the cornerstone of their survival and development. Without a complete quality management system, their products cannot be trusted. The competition among medical device enterprises today is the competition of product quality; without quality assurance, enterprises will inevitably lose their market share. Many medical device enterprises have exposed more quality problems than ever before during unannounced inspections, which has brought huge challenges 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 Hemei Biotechnology to implement the Singdi GMP Quality Compliance Digitalization Solution (QMS) is to achieve overall and systematic supervision of the quality management system in both top-down and bottom-up directions through strict system-based control of quality processes. The core functions provided by Singdi's QMS solution include automation of quality incident management processes, real-time reporting of quality risk incidents, encrypted protection of enterprise core documents, and establishment of an enterprise-standard training system—all of which are important components of achieving high-standard quality management. The implementation of the QMS solution will enable senior managers of Hemei Biotechnology to fully control quality incidents in business activities and minimize any problem points that may trigger quality and safety accidents. Through investment in the QMS system, Hemei Biotechnology can establish a sound GMP system, comprehensively improve GMP management levels, and ensure that product quality meets regulatory requirements.

By implementing Singdi's QMS solution, Hemei Biotechnology has not only improved its quality compliance management capabilities but also achieved good economic effects. The case of Hemei Biotechnology's QMS implementation provides a new idea for a large number of medical device enterprises on how to comprehensively improve medical device GMP management through digital means.

V. Related Solutions

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

VI. Related Cases

• Case 1: GMP Quality Compliance Digitalization (QMS) Project of Shanghai Shenqi Medical
• Case 2: GMP Quality Compliance Digitalization (QMS) Project of Jiangsu Zhiyuan
• Case 3: GMP Training Management (TMS) Project of Suzhou Fushilai Pharmaceutical