Boehringer-Ipsen Implements YonSuite and Conducts Simultaneous Computerized System Validation (CSV)

I. When Intelligent Systems Meet Stringent Compliance: A "Dual Revolution" in the Pharmaceutical Industry

Global pharmaceutical regulatory thresholds continue to rise. Recently, pharmaceutical giant Boehringer-Ipsen announced the completion of a strategic-level transformation — deploying Yonyou YonSuite intelligent ERP platform and collaborating with Xingdi to implement Computerized System Validation (CSV). This move not only breaks the shackles of "prioritizing production over data" in traditional pharmaceutical companies, but also redefines the competitive rules of the pharmaceutical industry through the in-depth integration of digitalization and compliance.

As a multinational pharmaceutical company with a century-long history, Boehringer-Ipsen covers markets in more than 80 countries worldwide with its innovative products in the fields of gastrointestinal drugs and neuroscience. Facing challenges such as increased frequency of EMA unannounced inspections and stricter FDA data integrity audits, the company has chosen to drive operations with the "ERP + CSV" dual engine to achieve full-process control from laboratory to pharmacy.

II. YonSuite ERP: Leaping from Data Silos to Intelligent Closed-Loop

The introduction of Yonyou YonSuite system has enabled Boehringer-Ipsen to make a leap from data silos to an intelligent closed-loop. This system not only addresses two core pain points in the pharmaceutical industry, but also brings significant efficiency improvements and quality enhancements to the company.

Seamless Connection Between R&D and Production

In the past, a batch of Boehringer-Ipsen’s gastric motility drugs had excessive fluctuations in active ingredients due to delays in the transmission of process parameters. Today, the YonSuite system connects the R&D database with the production line’s Manufacturing Execution System (MES), enabling automatic distribution of formula parameters and real-time early warning of production deviations. This change has improved process stability.

Efficient Closed-Loop for Quality Traceability

Each drug traceability code is assigned a unique digital identity. Patients can scan the code to view the complete track, from raw material batch number to circulation temperature. When a complaint about packaging defects of a drug batch arises, the system locks the problematic link within 2 minutes, increasing recall efficiency by 90%.

III. Hippocrates CSV Validation: Building a Compliance "Immune System"

Against the backdrop of EMA GMP Annex 11 and the high incidence of FDA 483 warning letters, Hippocrates has built a three-tier protection system for Boehringer-Ipsen:

• Protection Tier 1: Regulatory Penetration ValidationSimulate FDA surprise inspection scenarios to test whether the system’s audit trail function meets the requirements of 21 CFR Part 11, covering more than 80 potential defect items.
• Protection Tier 2: Extreme Stress TestingWhen more than 50 devices are connected concurrently and run continuously for 240 hours, the system’s response delay remains stable within 0.8 seconds, with zero data loss rate.
• Protection Tier 3: Dynamic Risk Prevention and ControlDeploy an AI-driven Validation+ platform to monitor abnormal operations in real time (such as unauthorized account access to chromatographic data) and automatically trigger secondary authentication.

IV. Related Solutions

• Solution 1: HippocratesComputerized System Validation (CSV) Consulting Services

V. Related Cases

1. Hippocrates CSV Consulting Project for Shandong Taibang Biological Products
2. Hippocrates  CSV Consulting Project for Chengdu Qingshan Likang