HIPPOCRATES

GMP Document Management System (DMS) Project of Beiheng Biology

I. Case Enterprise

Nanjing Bioheng Biotech Co., Ltd., an innovative biotech enterprise with solid R&D capabilities and industrialization strength in the field of cellular immunotherapy, has always been committed to the development of universal chimeric antigen receptor T-cell (UCAR-T) products and has shown strong development momentum in the CAR-T sector. Located in Jiangsu Province, one of the key pillars of domestic pharmaceutical innovation, the company was co-founded by doctors from renowned domestic and foreign universities and an operation team with rich commercial experience. It has secured RMB 520 million in Series B financing from institutions such as Hillhouse Ventures and Decheng Capital, and has built an R&D and industrialization team of over 150 people. In recent years, relying on its mature R&D advantages, Beiheng Biology has successfully developed universal CAR-T cellular immunotherapy products and carried out early-phase clinical trials in collaboration with a number of domestic Grade A tertiary hospitals.

II. Project Background

Facing the increasingly stringent regulatory requirements in China’s life and health industry, Beiheng Biology recognized that establishing a compliance and quality management system that meets the company’s future development needs is crucial to ensuring the authenticity and traceability of data related to product development, as well as future plasmid virus production, cell expansion and quality control. The company aimed to leverage digital means to meet its development needs of becoming a market leader in the CAR-T field, ensure data authenticity and traceability, and enhance its GMP management level.

III. Project Introduction

(I) Overall Planning

The GMP Document Management (DMS) Project of Bioheng Biotech was implemented in two phases and completed under the strategy of "overall planning and phased implementation". The objectives included: building a basic document management system that meets regulatory requirements, establishing a communication and collaboration mechanism among various departments, realizing digital document management, and ultimately completing the full-lifecycle document system management of pharmaceuticals from R&D to commercialization while ensuring the company’s document system is fully compliant with regulatory requirements.

(II) Business Model

The GMP Document Management (DMS) Project of Bioheng Biotech consists of two phases:

Phase I: Document management for the production and quality system;
Phase II: Completion of document management system construction for the R&D system.

(III) Technical Architecture

The GMP Document Management System (DMS) is one of the core products on Hippocrates OwlTrust Digital Platform. Aotai is a digital platform jointly developed by Hippocrates’s industry experts and IT experts. With the management concept 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 high-quality products.

Applications on the OwlTrust Platform can provide tailor-made quality systems based on enterprise needs. The 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.

The excellent design of the Aotai Platform 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;
Standard APIs significantly improve system access efficiency, including: automatic email notifications, SMS notifications and dashboard alerts integrated into workflows, 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.

(III) Technical Architecture

The GMP Document Management System (DMS) is one of the core products on Singedi Aotai Digital Platform. Aotai is a digital platform jointly developed by Singedi’s industry experts and IT experts. With the management concept 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 high-quality products.

Applications on the Aotai Platform can provide tailor-made quality systems based on enterprise needs. The 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.

The excellent design of the Aotai Platform 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;
Standard APIs significantly improve system access efficiency, including: automatic email notifications, SMS notifications and dashboard alerts integrated into workflows, 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. Project Outcomes

(I) Enterprise Outcomes

The overall implementation cycle of Beiheng Biology’s GMP Quality Compliance Digital Project was 3.5 months. The finally realized functions cover major modules including organization and personnel management, document and training management, record and release management, and quality assurance and control. Among them, quality management further includes modules such as supplier management, deviation management, out-of-specification (OOX) event management, corrective and preventive actions (CAPA) 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:

1. Comprehensive Labor Efficiency Improvement

Data statistics are real-time, accurate and reliable, with an 80% increase in speed;
Relevant statistical positions have been eliminated. After the implementation of Phase I, the number of new hires has decreased by approximately 20% compared with the pre-implementation period, and the effect will become more significant as the number of system users gradually covers all staff.

2. Quality Improvement

The informatized traceability rate of product quality reaches over 90%;
Data consistency and integrity reach 100%;
Online monitoring is strengthened with real-time early warnings, and online quality control is improved by an average of 1-3%;
The efficiency of Product Quality Review (PQR) analysis is increased by over 20%.

3. Error Reduction

Over 90% of statistical errors are eliminated;
Over 80% of human errors are eliminated.

4. Labor Efficiency Improvement in Document and Record Management

Document conversion and approval processes are optimized, with an approximately 30% increase in approval speed;
Over 70% of batch production records, auxiliary records, post documents and other materials have adopted electronic formats;
Expenses on printing and related consumables have been reduced by approximately 80%;
Time spent on filling in records and documents has been reduced by over 50%.

5. Labor Efficiency Improvement in Training

After training and assessment are moved online, the total time for training organization is reduced by approximately 60%;
The time for training effect statistics is shortened by at least 80%;
The effectiveness of on-the-job training is improved by approximately 40%.

(II) Social Outcomes

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 Beiheng Biology to implement Singedi’s GMP Quality Compliance Digital Solution 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 bottom to top. The core functions of Singedi’s Quality Management System (QMS) Solution include: automation of quality event management processes, real-time reporting of quality risk events, encrypted protection of core enterprise documents, and establishment of an enterprise-standard training system — all of which are essential for achieving high-standard quality management.

The implementation of the QMS Solution enables Beiheng Biology’s management to have a clear grasp of quality events in business operations, minimizing any potential issues that may lead to quality and safety accidents. Investment in the QMS system helps Beiheng Biology establish a sound GMP system, ensure that business operations comply with GMP standards, reduce human operation errors, and comprehensively improve the quality management level of pharmaceuticals.

By implementing Singedi’s QMS Solution, Beiheng Biology has effectively established a sound quality management system, ensured the compliance of pharmaceutical production, and achieved significant economic benefits. The case of Beiheng Biology’s QMS implementation provides a new idea for pharmaceutical enterprises on how to improve GMP management level through digital technology.

V. Related Solutions

Solution 1: Hippocrates GMP Document Management System (DMS)
Solution 2: Hippocrates GMP Training Management System (TMS)

VI. Related Cases

Case 1: GMP Document Management (DMS) Project of Jiangsu Zhiyuan
Case 2: GMP Training Management (TMS) Project of Suzhou Fushilai Pharmaceutical