Qingshan Likang Implements ERP (BIP) While Simultaneously Conducting Computerized System Validation (CSV)
Against the backdrop of increasingly fierce competition in the pharmaceutical industry, Qingshan Likang Pharmaceutical Co., Ltd. (hereinafter referred to as "Qingshan Likang") has opened a new chapter of development with a "digital revolution". Recently, the company announced the full launch of the Yonyou BIP Intelligent Management System and joined hands with Xingdi to initiate the CSV Full-Lifecycle Compliance Validation Project. Driven by the dual engines of technological empowerment and quality, it is committed to building a model of digital transformation in the pharmaceutical manufacturing field.
I. The Way to Break Through: Leaping from Traditional Manufacturing to a Smart Enterprise
As one of the first domestic pharmaceutical enterprises to obtain FDA certification, Qingshan Likang has always regarded innovation as its core competitiveness. In recent years, the company has gradually built a global R&D network. However, with the expansion of its business scale, the traditional management model has gradually exposed problems such as data silos and delayed responses. To address this, Qingshan Likang turned its attention to digital solutions and selected the Yonyou BIP system as the core engine for its strategic transformation.
In terms of supply chain management, the Yonyou ERP (BIP) system optimizes the collaborative operations of raw material procurement, production planning, and logistics distribution to ensure the efficient operation of the supply chain. The system can conduct real-time monitoring of inventory levels and automatically trigger purchase orders, reducing the risk of production halts caused by raw material shortages. At the same time, through close cooperation and information sharing with suppliers, Qingshan Likang can further reduce procurement costs and enhance the stability and flexibility of the supply chain.
II. Compliance Guarantee: Hippocrates’s CSV Validation Builds a Security Line
The in-depth advancement of digital transformation cannot be separated from the guarantee of a compliance system. Qingshan Likang has introduced the unique "Validation+" validation system developed by Xingdi, and carried out in-depth validation of the Yonyou BIP system in line with the FDA 21 CFR Part 11 standard.
Based on a risk-based validation approach, Hippocrates can help Qingshan Likang identify potential risk points and ensure the system remains compliant even after upgrades or changes through continuous validation. This forward-looking risk management model not only improves the company’s operational efficiency but also provides a solid guarantee for the company’s continuous improvement and innovative development.
The CSV services provided by Hippocrates strictly comply with international standards such as GMP, FDA, and cGMP, ensuring that the Yonyou ERP (YonSuite) system fully meets regulatory requirements during operation. Through detailed validation plans and rigorous validation processes, Hippocrates helps Qingshan Likang ensure a high degree of alignment between system functions and business needs, providing strong support for the company’s international development.
III. Related Solutions
- Solution 1: Hippocrates Computerized System Validation (CSV) Consulting Services
IV. Related Cases
- Case 1: Hippocrates CSV Consulting Project for Shandong Taibang Biotechnology
- Case 2: Hippocrates CSV Consulting Project for Hangzhou Xingcheng Biotechnology
