Recently, Kangyuan Pharmaceutical, a benchmark enterprise in intelligent manufacturing of traditional Chinese medicine (TCM), has achieved another milestone in its digital transformation. The brand-new SAP S/4HANA system went live concurrently with its intelligent factory for TCM granular formulations. To fully ensure compliant operation of digital systems and strengthen the data integrity control framework, Kangyuan Pharmaceutical has joined hands with Hippicrates to launch the SAP Computerized System Validation (CSV) project. By advancing digital construction and compliance development in parallel, the company continuously elevates its quality control capabilities for intelligent manufacturing.

As a core initiative under Kangyuan’s intelligent and digital transformation campaign, the newly launched SAP system is deployed on a private cloud, forming an integrated ERP management platform covering group finance, supply chain, production, quality assurance and sales. It fully aligns with TCM GMP specifications and end-to-end batch traceability requirements. Deeply integrated with MES, LIMS, WMS and the company’s self-developed pharmaceutical process knowledge system, the platform closes the full data loop spanning production planning, shop floor execution, quality testing and warehouse outbound logistics. It enables electronic batch record management and real-time full-process quality monitoring, effectively mitigating batch variability in TCM production and significantly improving product quality consistency.

With the full deployment of the SAP system, digital compliance control has become a core driver for operational optimization. The CSV validation project undertaken by Singedi strictly complies with authoritative domestic and international standards, including China’s GMP, EU GMP Annex 11 and FDA 21 CFR Part 11. It delivers full-lifecycle validation covering core compliance modules such as system access control, audit trails, electronic signatures, data backup, change control and operation & maintenance management. The project systematically identifies and remediates operational risks, refines standardized validation frameworks and operation management protocols, and guarantees that all production and quality data are authentic, accurate, complete and traceable.

System investigation, risk assessment and gap analysis have been completed to date, while compliance rectification and validation activities are well underway. The deep integration of SAP system implementation and CSV compliance validation further optimizes Kangyuan Pharmaceutical’s digital control system for its intelligent factory, bolsters the enterprise’s compliance competitiveness, and consolidates its position as an industry benchmark for TCM intelligent manufacturing. It also serves as a key model for the high-quality, digitalized and standardized development of the traditional Chinese medicine sector.