HIPPOCRATES

Taibang Biological Implements ERP (BIP) and Conducts Computerized System Validation (CSV) Simultaneously

I. Digital Engine + Compliance Shield: Reshaping the Competitiveness of the Biopharmaceutical Industry

Recently, Taibang Biological Products Co., Ltd. (hereinafter referred to as "Taibang Biological") announced a strategic-level upgrade – the deployment of the Yonyou BIP intelligent ERP platform, and the launch of Computerized System Validation (CSV) in collaboration with Singedi. This combination marks Taibang Biological’s leap from a traditional pharmaceutical enterprise to a "digital native organization," reconstructing production through technology and opening the door to the global market with compliance.

As one of the first domestic biopharmaceutical enterprises to obtain FDA certification, Taibang Biological has long been deeply engaged in fields such as blood products and vaccines, with its products marketed in over 30 countries worldwide. Faced with the complex regulatory environment and challenges in industrial chain collaboration, the enterprise has adopted a dual-track model of "System + Validation" to address the industry’s key issues of quality control and efficiency improvement.

II. Yonyou BIP: Transformation from Data Silos to Intelligent Hub

The implementation of the Yonyou BIP system at Taibang Biological is not a simple tool replacement, but a management revolution. Its value is reflected in three key scenarios:

Scenario 1: "Second-level Linkage" Between R&D, Production and Marketing

Pain Point: In the past, R&D data was disconnected from the production line, leading to a new product launch cycle of up to 6 months.
Outcome: R&D-to-production conversion efficiency increased by 40%, and process deviation rate decreased by 65%.

Scenario 2: Proactive Interception of Quality Risks

Intelligent Quality Inspection: After the system is connected to LIMS, it automatically matches quality inspection standards. For example, in the detection of plasma protein purity, if data fluctuations exceed the threshold, it immediately triggers a production suspension order and notifies the quality team.
End-to-End Traceability: By linking material batch numbers with production work orders, reverse traceability to raw material suppliers can be completed within 2 minutes.

Scenario 3: Construction of a "Resilient Supply Chain Network"

Dynamic Forecasting: Based on historical orders and epidemiological data, AI algorithms predict blood product demand for the next 3 months to guide raw material procurement.

III. Hippocrates CSV Validation: From Compliance Compliance to Risk Immunity

Under the dual pressure of the EU MDR new regulations and FDA Data Integrity Guidelines, Taibang Biological has chosen Hippocrates’s Computerized System Validation (CSV) services to build a three-tier defense system:

Defense Tier 1: Regulatory Penetration Testing

Simulate FDA unannounced audit scenarios to verify whether system functions such as audit trails and electronic signatures comply with 21 CFR Part 11.
Test data tampering prevention capabilities in accordance with EU GMP Annex 11 requirements, achieving a 100% vulnerability repair rate.

Defense Tier 2: Stability Under Extreme Stress Testing

During testing with 5,000 concurrent users and 72 hours of continuous operation, the system response latency was < 1.2 seconds, with an error rate of only 0.005%.
Offline recovery testing showed that the completeness of business data recovery reached 99.99%.

Defense Tier 3: AI-Driven Continuous Compliance

Deploy the Validation+ intelligent monitoring module to conduct real-time scans of high-risk operations such as permission changes and data modifications.
Establish a "validation knowledge database" to automatically push regulatory update notifications, avoiding compliance delays caused by standard iterations.

IV. Strategic Value: Digital Genes Setting a Benchmark for the Industry

Six months after the project implementation, Taibang Biological has achieved breakthroughs in multiple dimensions:

Cost Dimension: Production loss rate decreased from 3.7% to 1.2%, saving over 2 million yuan annually.
Quality Dimension: FDA inspection deficiencies decreased by 82%, and customer complaint response time was improved to 4 hours.
Market Dimension: Relying on a complete electronic data chain, it successfully entered the high-end plasma product market in the EU, with order volume increasing by 230% year-on-year.
"This is not an IT upgrade, but an evolution of survival model," said the CTO of Taibang Biological at an industry summit. "Next, we will explore AI-driven personalized pharmaceutical production, making compliance and innovation truly the two wings of growth."
Through the in-depth integration of Yonyou BIP and Singedi CSV, Taibang Biological has not only built a digital benchmark for biopharmaceuticals, but also proved to the world the quality discourse power of "Intelligent Manufacturing in China." When intelligent systems meet rigorous validation, this enterprise is writing a new paradigm for the Pharmaceutical Industry 4.0 era.

V. Related Solutions

Solution 1: Hippocrates Computerized System Validation (CSV) Consulting Services

VI. Related Cases

Case 1: Hippocrates CSV Consulting Project for Hangzhou Xingcheng Biotechnology
Case 2: Hippocrates CSV Consulting Project for Shanghai Bibo Biotechnology