Electronic Batch Record System Project of Shanghai Jieshi Medical

I. Case Enterprise

Shanghai Jieshi Medical Technology Co., Ltd. (hereinafter referred to as "Jieshi Medical") was founded in December 2012. Located in Zhangjiang Modern Medical Device Park within the East Area of Shanghai Zhangjiang High-Tech Park, it is a company focusing on the production of Class III medical devices, mainly engaging in the production and R&D of ophthalmic implant products. Adhering to the quality policy of "Quality First, Customer Foremost, Reputation-Oriented, Continuous Improvement", the company is committed to promoting the sound development of China's health sector.

To comply with the new version of GMP standards, strengthen the monitoring of production data integrity, ensure data authenticity and traceability, and make full use of electronic batch records to accumulate raw data for lean production, Jieshi Medical has launched the Electronic Batch Record System Project. This project aims to improve the enterprise's production management capabilities through digital means, meet domestic and international regulatory requirements, and lay a foundation for the company's digital transformation.

II. Project Background

With the rapid development of the medical device industry and increasingly stringent regulatory requirements, Jieshi Medical recognized that the traditional paper-based batch record management method could no longer meet the enterprise's development needs. To achieve digital and intelligent management of the production process and ensure data integrity and traceability, the company decided to introduce Hippocrates’s Electronic Batch Record System (EBRS). This system will help the enterprise realize automated management of batch records, reduce human intervention, and improve production efficiency and data quality.

III. Project Introduction

A. Overall Planning

The Electronic Batch Record System Project of Jieshi Medical is implemented in two phases:

1. Phase 1: Build a basic Electronic Batch Record System and realize the application of modules such as workshop management, process control, operation management, quality inspection, and product release.
2. Phase 2: Complete system optimization and expansion, realize integration with the SCADA system, and enhance the automation and intelligence level of the production process.

B. Business Model

1. Construction of Electronic Batch Record System

• System Functions: The Electronic Batch Record System covers multiple modules including workshop management, process control, operation management, quality testing, and product release, realizing comprehensive digital management of the production process.
• Data Collection: Through integration with production equipment, the system automatically collects key data in the production process to ensure data authenticity and integrity.
• Process Optimization: The system optimizes the production process, reduces the use of paper records, improves work efficiency, and lowers human errors.

2. SCADA System Integration

• Real-Time Monitoring: Through integration with the SCADA (Supervisory Control and Data Acquisition) System, real-time monitoring and data collection of production equipment are realized, improving the transparency and controllability of production.
• Data Analysis: The system analyzes the collected data and generates detailed production reports to help the enterprise optimize the production process and improve product quality.

C. Technical Architecture

The Electronic Batch Record System is one of the core products on Hippocrates OwlTrust Digital Platform. Developed jointly by Xingdi’s industry experts and IT experts, the Aotai Platform takes "Quality Compliance Expert" as its management concept and market positioning, helping enterprises improve quality compliance levels and meet industry regulatory requirements.

• Customized Applications: According to Jieshi Medical’s specific needs, the system provides highly customized functions to meet the enterprise’s special business requirements.
• Efficient Data Access: The system adopts a distributed architecture, optimizes data storage and access efficiency, and ensures that users can quickly access a large number of records and data.
• System Integration: It provides a standard middleware service layer to support integration with third-party systems (such as ERP, MES, and WMS), realizing seamless data exchange.

IV. Project Outcomes

A. Enterprise Outcomes

The overall implementation cycle of Jieshi Medical’s Electronic Batch Record System Project was 3 months. The finally realized functions include:

• Workshop Management: Achieved centralized control and management of workshop production equipment, improving production efficiency.
• Process Control: Optimized the production process, reduced human intervention, and improved product quality.
• Quality Testing: Realized automation of quality testing, reducing testing time and errors.
• Product Release: Simplified the product release process and improved release efficiency.
• The comparison of economic benefits after the project is as follows:

1. Comprehensive Labor Efficiency Improvement

• Production data statistics are real-time, accurate, and reliable, with speed increased by 80%.
• Relevant statistical positions have been eliminated; after the completion of Phase 1 of the project, the number of new employee recruits decreased by 20% compared with the pre-implementation period.

2. Quality Improvement

• The informatization traceability rate of product quality reached over 90%.
• Data consistency and integrity reached 100%.
• Strengthened online monitoring and real-time early warning; online quality control improved by 1-3% on average.
• The efficiency of product quality review and analysis increased by over 20%.

3. Error Reduction

• Eliminated over 90% of statistical errors.
• Eliminated over 80% of human errors.

4. Efficiency Improvement in Document and Record Management

• Improved document conversion and approval processes; approval speed increased by about 30%.
• Over 70% of batch production records, auxiliary records, and post documents are now in electronic form.
• Costs for record printing and related consumables decreased by about 80%.
• Time spent on filling in records and documents was reduced by over 50%.

B. Social Outcomes

Quality is the lifeline of medical device enterprises and the cornerstone of their survival and development. By implementing the Electronic Batch Record System, Jieshi Medical has not only improved its own production management level but also set a benchmark for digital transformation in the industry. Through strict control of the production process, the system realizes two-way supervision of the quality management system, helping the enterprise avoid quality and safety incidents to the greatest extent and ensuring that business operations comply with GMP standards.

V. Relevant Solutions

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

VI. Relevant Cases

1. Electronic Batch Record Project of Shanghai Saijin Biomedical
2. Electronic Batch Record Project of Shanghai Hongqiao Traditional Chinese Medicine Decoction Piece Factory