Zhejiang Medicine Company

Zhejiang Medicine Company's new Novus Pharmaceuticals subsidiary needed to transition to a completely paperless environment to meet FDA compliance requirements for its new antibiotic manufacturing facility serving U.S. and European regulated markets.

ZMC implemented FactoryTalk PharmaSuite MES, which integrated production processes from the plant floor to the enterprise, with electronic batch records (EBR) digitizing paper records and automating document management for FDA 21 CFR Part 11 compliance.

ZMC completely eliminated paper-based SOPs, hardcopy records, and equipment/material labels. Labor costs were reduced by 5-10%. Batch product review cycle time was reduced by 46-75%, and management-review cycle time was reduced by 50%.

• Electronic batch records reduce batch review cycle times by 46-75% compared to paper-based pharmaceutical manufacturing documentation
• Paperless MES implementation reduces labor costs 5-10% while simultaneously improving data integrity and regulatory compliance
• Chinese pharmaceutical manufacturers targeting FDA-regulated markets must implement 21 CFR Part 11 compliant EBR systems as a prerequisite for product approval