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Zhejiang Beide Pharmaceutical GMP Quality Compliance Digitalization (QMS) Project

I. Case Overview

Zhejiang Beide Pharmaceutical Co., Ltd. is located in the vibrant Shaoxing Paojiang Industrial Park, with a registered capital of RMB 250 million and covering an area of 153 mu (approximately 10.2 hectares). The company produces and sells pharmaceutical active pharmaceutical ingredients (APIs), preparations, and pharmaceutical intermediates. Its production scale reaches an annual output of 500 tons of APIs, 40 million vials of injections, and 1.1 billion units of oral preparations (tablets, sachets, and capsules).

Beide Pharmaceutical strives for high-speed development from a high-quality and high-standard starting point. Taking GMP standards, FDA Certification, and COS Certification as the foundation, it has built workshop facilities, technical processes, and quality control systems that meet international standards. In 2023, Beide Pharmaceutical chose to implement Xingdi’s Quality Compliance Management System (Quality Management System, QMS), and completed the establishment of a quality system covering documentation, 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-level sharing and timely transmission of quality documents, relevant records, reports, and other materials among various departments of the company have been guaranteed; the approval and release processes have been simplified and accelerated; and it has effectively ensured that Beide Pharmaceutical meets GMP regulatory requirements, safeguarding product safety and quality reliability.

II. Project Background

Like other pharmaceutical enterprises, Beide Pharmaceutical has obtained GMP certification. However, obtaining GMP certification only proves that an enterprise’s quality system is consistent with a specific assurance model in the certification standards; it does not guarantee that all drugs produced by the enterprise are safe, effective, and stable. In recent years, some pharmaceutical enterprises that have already obtained GMP certification still experienced serious quality and safety incidents.

Beide Pharmaceutical aims to enhance its ability to meet GMP regulatory requirements and comprehensively improve the company’s quality compliance management level through digital means. The implementation of the QMS system can help senior managers of Zhejiang Beide Pharmaceutical fully control quality incidents in business activities, effectively control "personnel behaviors", reduce human operation errors, ensure that product quality meets requirements, and thereby help enhance the enterprise’s brand and competitiveness.

III. Specific Measures

(I) Overall Planning

Beide Pharmaceutical’s GMP Quality Compliance Digitalization Project (QMS) is divided into four phases and was ultimately completed through the implementation strategy of "overall planning and phased implementation": building a basic quality assurance system that meets regulatory requirements, establishing communication and collaboration mechanisms among various departments, realizing the digitalization of employee qualifications and organizational structure, and finally achieving full-lifecycle quality and compliance while enhancing the enterprise’s ability to meet strict GMP regulatory requirements.

(II) Business Model

Beide Pharmaceutical’s GMP Quality Compliance Digitalization Project (QMS) established a basic quality assurance system through the implementation of document and training management.

Document Management ModuleThe QMS document management module of Beide Pharmaceutical is the core to 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 detailed 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.

Training Management ModuleThe QMS training management module of Beide Pharmaceutical 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 Plans: Based on employees’ roles and responsibilities, the QMS can generate personalized training plans to ensure that each employee receives training relevant to their work.
Continuing Education: The QMS encourages and promotes continuing education by regularly updating training content to ensure that employees’ knowledge is aligned with industry best practices.

Establishment of Quality Assurance SystemThrough the implementation of document and training management, Beide Pharmaceutical’s QMS 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 Beide Pharmaceutical identify problems, take corrective actions, and continuously improve the quality system.
Audit Preparation and Support: The system can help Beide Pharmaceutical 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 develop 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 proper review, approval, and implementation.
Through these measures, Beide Pharmaceutical’s QMS ensures GMP compliance of its production and quality control processes, improves production efficiency, reduces risks, and ultimately safeguards the safety and effectiveness of drugs for patients.

(III) Technical Architecture

The GMP Quality Compliance Digitalization Solution (QMS) is one of the core solutions based on Xingdi’s Aotai Digital Platform. Aotai is a digital platform jointly developed by Xingdi’s industry experts and IT experts, with the management philosophy and market positioning of "quality compliance expert". It helps enterprises improve their quality compliance level, meet industry regulations, enhance management capabilities, and accelerate the launch of more safe, effective, and quality-reliable products.

Applications on the Aotai platform can provide customized digital management systems tailored to enterprise needs. 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. Trained personnel 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 minimizes loading time. Frequently used data is cached to maximize network bandwidth usage. Data is stored in an effective manner, and the distributed architecture is optimized for server expansion. Standard APIs greatly improve system access efficiency, including: automatic email notifications, SMS notifications, and dashboard alerts integrated into workflows, which significantly reduce the risk of missing tasks or approvals. The background task submission and management mode supports users to perform other tasks simultaneously. A standard middleware 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

The overall implementation cycle of Beide Pharmaceutical’s GMP Quality Compliance Digitalization Project was 6 months. Finally, the following functions were realized: main 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 (Corrective and Preventive Actions) management, change management, audit (self-inspection) management, validation 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 speed increased by 80%.
Relevant statistical positions have been eliminated. After the first phase of the project, the number of new hires decreased by approximately 20% compared with that before implementation. Moreover, as the number of users gradually covers all staff, the effect will be more obvious.
【Quality Improvement】

The informatization traceability of product quality reached over 80%.
Data consistency and integrity have been strengthened by 100%.
Online monitoring and real-time early warning have improved online quality control by an average of 1-3%.
The efficiency of Product Quality Review (PQR) analysis has increased by more than 25%.
【Error Reduction】

Eliminated over 95% of statistical errors.
Eliminated over 90% of human errors.
【Efficiency Improvement in Document and Record Management】

Improved document conversion and approval processes, with approval speed increased by approximately 35%.
Over 75% of batch production records, auxiliary records, post documents, etc., have been digitized.
Expenses on document and record printing and related consumables have been reduced by approximately 90%.
Time spent on filling in records and documents has been reduced by more than 70%.
【Efficiency Improvement in Training】

After training and assessment were moved online, the total time for training organization was reduced by approximately 60%.
The time for statistical analysis of training effects has been improved by at least 80%.
The effectiveness of on-the-job training has been improved by approximately 60%.

(II) Social Achievements

Quality is the lifeline of pharmaceutical 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 pharmaceutical enterprises today is essentially competition in product quality; without quality assurance, enterprises will inevitably lose market share. Many pharmaceutical enterprises have exposed more quality problems than ever during unannounced inspections, which poses a huge challenge to their operations. It has become a mainstream trend for pharmaceutical enterprises to prevent and avoid potential quality and safety incidents through a sound quality management system.

The fundamental reason for Beide Pharmaceutical to implement Xingdi’s GMP Quality Compliance Digitalization Solution (QMS) is to strictly control quality processes through the system and realize overall and systematic two-way supervision of the quality management system from top to bottom and bottom to top. The core functions provided by Xingdi’s QMS solution include: automation of quality incident management processes, real-time reporting of quality risk incidents, encrypted protection of core enterprise documents, and establishment of enterprise-standard training systems—all of which are important components of achieving high-standard quality management. The implementation of the QMS solution will help senior managers of Beide Pharmaceutical 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 will help Beide Pharmaceutical establish a sound GMP system, comprehensively improve GMP management level, and ensure that product quality meets regulatory requirements.

By implementing Xingdi’s QMS solution, Beide Pharmaceutical has not only enhanced its quality compliance management capabilities but also achieved good economic benefits. The case of Beide Pharmaceutical’s QMS implementation provides a new idea for pharmaceutical enterprises on how to comprehensively improve GMP management through digital means.

IV. Construction Achievements

(I) Enterprise Achievements

【Comprehensive Labor Efficiency Improvement】

Real-time, accurate, and reliable data statistics, with speed increased by 80%.
Relevant statistical positions have been eliminated. After the first phase of the project, the number of new hires decreased by approximately 20% compared with that before implementation. Moreover, as the number of users gradually covers all staff, the effect will be more obvious.
【Quality Improvement】

The informatization traceability of product quality reached over 80%.
Data consistency and integrity have been strengthened by 100%.
Online monitoring and real-time early warning have improved online quality control by an average of 1-3%.
The efficiency of Product Quality Review (PQR) analysis has increased by more than 25%.
【Error Reduction】

Eliminated over 95% of statistical errors.
Eliminated over 90% of human errors.
【Efficiency Improvement in Document and Record Management】

Improved document conversion and approval processes, with approval speed increased by approximately 35%.
Over 75% of batch production records, auxiliary records, post documents, etc., have been digitized.
Expenses on document and record printing and related consumables have been reduced by approximately 90%.
Time spent on filling in records and documents has been reduced by more than 70%.
【Efficiency Improvement in Training】

After training and assessment were moved online, the total time for training organization was reduced by approximately 60%.
The time for statistical analysis of training effects has been improved by at least 80%.
The effectiveness of on-the-job training has been improved by approximately 60%.

(II) Social Achievements

The fundamental reason for Beide Pharmaceutical to implement Hippocrates’s GMP Quality Compliance Digitalization Solution (QMS) is to strictly control quality processes through the system and realize overall and systematic two-way supervision of the quality management system from top to bottom and bottom to top. The core functions provided by Xingdi’s QMS solution include: automation of quality incident management processes, real-time reporting of quality risk incidents, encrypted protection of core enterprise documents, and establishment of enterprise-standard training systems—all of which are important components of achieving high-standard quality management. The implementation of the QMS solution will help senior managers of Beide Pharmaceutical 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 will help Beide Pharmaceutical establish a sound GMP system, comprehensively improve GMP management level, and ensure that product quality meets regulatory requirements.

By implementing Hippocrates’s QMS solution, Beide Pharmaceutical has not only enhanced its quality compliance management capabilities but also achieved good economic benefits. The case of Beide Pharmaceutical’s QMS implementation provides a new idea for pharmaceutical enterprises on how to comprehensively improve GMP management through digital means.

V. Related Solutions

Solution 1: GMP Quality Compliance Digitalization Solution (QMS)

Solution 2: GMP Training Management Solution (TMS) for Pharmaceutical Enterprises

VI. Related Cases

Case 1: Zhejiang Zhenyuan Pharmaceutical GMP Quality Compliance Digitalization (QMS) Project

Case 2: Kobayashi Pharmaceutical Contract Manufacturing Quality Management Collaboration (OWL MAH) Project

Case 3: Suzhou Fushilai Pharmaceutical GMP Training Management (TMS) Project