HIPPOCRATES

Akesbio GMP Quality Compliance Digitalization (QMS) Project

I. Case Overview

Shanghai Akesbio Biomedical Technology Co., Ltd. was founded on April 29, 2014, with its registered address at No. 25, Lane 388, Shengrong Road, Pudong New Area, Shanghai. In 2023, Akesbio chose to implement Xingdi's GMP Quality Compliance Management System (Quality Management System, QMS) (referred to as "QMS" for short), and completed the establishment of a quality system covering documentation, training, and quality management. Through the project implementation, the authenticity, reliability, and traceability of business data have been ensured; a sound 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; and the work of drug approval and release has been simplified and accelerated. This has effectively improved Akesbio's GMP management level and ensured that the company's GMP production meets domestic and international regulatory requirements.

II. Project Background

Akesbio focuses on R&D and commercialization of innovative drugs in specific disease areas. To adapt to the development trend of digitalization in domestic and international pharmaceutical enterprises, ensure the authenticity, reliability, and traceability of data, establish a sound compliance and quality management system, the company aims to ensure that GMP production meets domestic and overseas regulatory requirements through digital means, thereby improving the overall GMP management level of the enterprise.

III. Specific Measures

(I) Overall Planning

Akesbio's GMP Quality Compliance Digitalization Project (QMS) 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 completing the whole lifecycle quality management of pharmaceuticals while ensuring that the company's quality system fully meets domestic and overseas regulatory requirements.

(II) Business Model

Akesbio's GMP Quality Compliance Digitalization Project (QMS) includes four phases: The first phase is digital transformation planning, during which the overall implementation path of the project was determined by investigating the digital construction of domestic and international benchmarking enterprises; the second phase established a basic quality assurance system through the implementation of document and training management; the third phase completed the construction of quality management covering deviation, change, audit, and supplier management; the fourth phase implemented business intelligence to provide comprehensive decision-making basis for the enterprise.

(III) Technical Architecture

The GMP Quality Compliance Digitalization Solution (QMS) is one of the core solutions 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 customize quality systems according to enterprise needs. The built-in configuration tools already include multiple functions of quality management, 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

Akesbio's GMP Quality Compliance Digitalization Project has finally realized functions including: 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, incident (OOX) 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 has reached over 90%.
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 PQR (Product Quality Review) analysis has increased by more than 20%.
【Error Reduction】

Eliminated over 90% of statistical errors.
Eliminated over 80% of human errors.
【Efficiency Improvement in Document and Record Management】

Improved document conversion and approval processes, with approval speed increased by approximately 30%.
Over 70% of batch production records, auxiliary records, post documents, etc., have been digitized.
Expenses on printing documents and records and related consumables have been reduced by approximately 80%.
Time spent on filling in records and documents has been reduced by more than 50%.
【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 40%.

(II) Social Achievements

Quality is the lifeline of pharmaceutical enterprises and the cornerstone of their survival and development. Currently, more and more pharmaceutical enterprises are implementing digital quality compliance management systems to prevent and avoid quality and safety incidents, and digital management has become the mainstream trend in the development of pharmaceutical enterprises.

The fundamental reason for Akesbio to implement Xingdi's GMP Quality Compliance Digitalization Solution (QMS) is to strictly control quality processes through the system and realize two-way overall supervision of the quality management system from top to bottom and from 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 Akesbio's managers 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 Akesbio establish a sound GMP system, ensure that business execution complies with GMP standards, reduce human operation errors, and comprehensively improve the drug quality management level.

By implementing Hippocrates's QMS solution, Akesbio has effectively established a sound quality management system, ensured the compliance of drug production, and achieved high economic benefits. Akesbio's case of implementing QMS provides a new idea for pharmaceutical enterprises on how to improve GMP management level through digital technology.

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: Shanghai Shenqi Medical GMP Quality Compliance Digitalization (QMS) Project

Case 2: Zhejiang Zhenyuan Pharmaceutical GMP Quality Compliance Digitalization (QMS) Project

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