HIPPOCRATES

GMP Document Management (DMS) Project of Jiangsu Sinomune Pharmaceutical

一、案例概述

I. Case Overview

Jiangsu Sinomune Pharmaceutical Co., Ltd., an enterprise focusing on the R&D, production, and sales of pharmaceuticals and skincare products in the fields of dermatology and nephrology, has always adhered to a clinical value-oriented approach. It upholds the mission of "Focus on Specialty Areas and Do Valuable Things" and the business philosophy of "Zhiyuan Walks Far". Through in-depth cultivation in the dermatology field and innovative R&D in the nephrology field, the company has developed a number of well-known branded products, including Luofu®, Lifu®, Jinnuer®, Zhirun®, etc. As a high-tech enterprise, Jiangsu Sinomune Pharmaceutical not only has a provincial-level technology center and engineering technology research center but also was rated as a Potential Unicorn Enterprise of the 2022 Southern Jiangsu National Independent Innovation Demonstration Zone and a National "Little Giant" Enterprise of Specialization, Refinement, Differentiation, and Innovation. The company also actively advocates sustainable development and has passed a number of international environmental and safety management system certifications.

二、项目背景

II. Project Background

Facing the wave of digital transformation in the domestic and international pharmaceutical industry, Jiangsu Zhiyuan Pharmaceutical Co., Ltd. recognizes that establishing a sound compliance and quality management system is crucial to ensuring the authenticity, reliability, and traceability of data. The company aims to use digital means to ensure that GMP (Good Manufacturing Practice) production processes meet the requirements of regulatory authorities at home and abr

III. Specific Measures

(I) Overall Planning

The GMP Document Management (DMS) Project of Zhiyuan Pharmaceutical is implemented in two phases and completed through the implementation strategy of "overall planning and phased implementation". The project objectives include: building a basic document management system that meets regulatory requirements, establishing a communication and collaboration mechanism among various departments, realizing digital document management, and finally completing the full-lifecycle document system management of pharmaceuticals from R&D to commercialization while ensuring the enterprise’s document system fully complies with regulatory requirements.

(II) Business Model

The GMP Document Management (DMS) Project of Zhiyuan Pharmaceutical consists of two phases: the first phase focuses on document management for the production and quality system; the second phase completes the construction of document management for the R&D system.

(III) Core Functions

The Document Management System (DMS) is mainly designed around GMP requirements. It realizes full-lifecycle management and multi-version control of documents covering all links, including document drafting, approval, distribution, issuance, training, activation, version upgrade, reissue, printing, review, and cancellation.

(IV) Technical Architecture

The GMP Document Management System (DMS) is one of the core products on the Singedi Aotai Digital Platform. Aotai is a digital platform jointly built by Singedi’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 quality-reliable products.

Applications on the Aotai Platform can be customized to meet the enterprise’s needs for a quality system. The built-in configuration tools already cover multiple quality management functions, eliminating the 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 excellent 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 utilization. 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 the workflow, 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 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

(I) Enterprise Achievements

The overall implementation cycle of Zhiyuan Pharmaceutical’s GMP Document Management Project was 4 months. The finally implemented functions include major modules such as organization and personnel management, full-lifecycle management of R&D and production system documents, and collection, organization, and registration submission of R&D documents. The core functions cover: document application, document creation, document revision, document review, document printing, archive management, record document management, and document printing and retrieval management.

Through the implementation of the project, the following objectives have been achieved:

Accelerate information transmission, effectively monitor processes, and ensure the implementation of documents
Seamless connection between online document drafting, approval, activation, and training systems
Clear and intuitive document management within the digital system
Real-time online document viewing on both PC and mobile terminals
Multiple watermark protections, with viewing records, download records, and modification records to protect the enterprise’s core data
The system supports a unified template library
Documents have rigorous and flexible permission management with multi-dimensional/rigorous permission policies
Real-time tracking of the progress of document circulation
Multilingual support with Chinese-English switching
Support for printing authorization and printing control, with clear and complete printing records
One-click document retrieval, with clear visibility of the balance between document issuance and receipt
Support for online document editing and multi-person sharing
Simultaneous management of GMP documents and non-GMP documents within the system
Support for remote and off-site collaborative document signing
Through VDR (Virtual Data Room), the validity period for external viewing can be set, and external parties can view documents via links
Support for real-time generation of document ledgers required by regulatory authorities (e.g., GMP document system directory)

(II) Economic Benefits

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

[Comprehensive Labor Efficiency Improvement]

Real-time, accurate, and reliable data statistics, with a speed increase of 70%
After the implementation of the first phase of the project, compared with before implementation, the number of personnel recruited decreased by approximately 15%. Moreover, as the number of users of the project gradually covers all staff, the effect will become more significant

[Error Reduction]

Elimination of over 80% of statistical errors
Elimination of over 70% of human errors

[Efficiency Improvement in Document and Record Management]

Improved document conversion and approval processes, with an approval speed increase of approximately 35%
Over 90% of batch production records, auxiliary records, post documents, etc., have been digitized
A reduction of approximately 60% in document and record printing costs and related consumable expenses
A reduction of over 50% in the time spent on filling in records and documents

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 Quality Compliance Digitalization (QCMS) Project of Zhejiang Zhenyuan

Case 2: GMP Training Management (TMS) Project of Suzhou Fushilai Pharmaceutical