Xingcheng Biology Launches Yonyou YonSuite System and Joins Hands with Hippocrates to Initiate Computerized System Validation (CSV)

I. Leading Biotech Enterprise Embarks on a New Digital Chapter

Recently, Hangzhou Xingcheng Biotechnology Co., Ltd. (referred to as "Xingcheng Biology") announced the completion of a strategic upgrade to its core management system – the adoption of the Yonyou YonSuite intelligent ERP platform, and the launch of a Computerized System Validation (CSV) project in collaboration with Xingdi Company. This strategic move not only marks the enterprise’s comprehensive transformation from traditional management to data-driven operations but also lays a solid foundation for compliance, paving the way for its global strategy.

As a biotechnology enterprise integrating R&D, production, and sales, Xingcheng Biology, supported by international certifications such as ISO 9001 and FDA, continuously provides high-standard biological products to global customers. With the expansion of its business scale and the increasing complexity of the market, the enterprise urgently needs to achieve dual breakthroughs in management efficiency and quality control through technological innovation.

II. YonSuite ERP: Building a Full-Link Intelligent Management System

The introduction of the Yonyou YonSuite system has established a digital core for Xingcheng Biology, covering R&D, production, supply chain, and marketing. Its core value is reflected in three key dimensions:

1. Intelligent Decision-Making: Business Empowerment through Data PenetrationThe system connects information silos across multiple dimensions, including R&D data, production dynamics, and inventory status, and generates real-time visual analysis reports. Management can predict market trends based on dynamic data, quickly adjust production capacity layout, and reduce decision-making deviations caused by information lag.
2. Quality Closed-Loop: Precise Control from Raw Materials to Finished ProductsBy integrating LIMS (Laboratory Information Management System), YonSuite enables automated assignment of quality inspection tasks and real-time early warning of abnormal data. For example, if the test value of a batch of raw materials deviates from the standard, the system will automatically freeze the production process and trigger a re-inspection mechanism to ensure "zero outflow" of non-conforming products.
3. Flexible Supply Chain: Agile Response to Global DemandThe system optimizes procurement plans and logistics scheduling based on AI algorithms. When orders surge in a certain region, it can link with suppliers to prepare goods in advance and adjust the priority of production lines simultaneously, shortening the delivery cycle by over 30%.

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

In the biopharmaceutical field, system compliance is directly related to an enterprise’s survival. Through a four-tier validation system, Hippocrates Company has built a safety barrier for Xingcheng Biology:

• Regulatory Compliance ValidationIt strictly aligns with regulations such as FDA 21 CFR Part 11 and EU GMP Annex 11, ensuring that the system’s permission management and audit trail functions are fully compliant, and avoiding the loss of international orders due to the risk of data tampering.
• Full-Lifecycle Stability TestingFrom Installation Qualification (IQ) to Performance Qualification (PQ), it simulates extreme scenarios such as high concurrency and network outages to verify the system’s response stability when more than 2,000 users are online simultaneously, controlling the failure rate below 0.01%.
• Data Traceability MatrixThrough the Validation+ tool, a full-chain data connection from raw material batch numbers to end customers is established. In case of quality complaints, the problematic link can be located within 2 hours, improving traceability efficiency by 85%.
• Dynamic Risk Management ModelBased on real-time operation data, it identifies potential vulnerabilities and generates optimization suggestions. For example, it automatically triggers two-factor authentication for accounts with frequent login failures, reducing the risk of unauthorized access by 90%.

IV. Associated Solutions

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

V. Associated Cases

Case 1: Shandong Taibang Biology Hippocrates CSV Consulting Project

Case 2: Chengdu Qingshan Likang Hippocrates CSV Consulting Project