Zhejiang Medicine Company (ZMC)

Zhejiang Medicine Company (ZMC), a Chinese pharmaceutical manufacturer, needed to improve regulatory compliance and reduce batch review cycle times. Manual batch record review processes were time-consuming and created compliance risks in a heavily regulated pharmaceutical environment.

ZMC implemented PharmaSuite MES (Manufacturing Execution System) from Rockwell Automation to digitize batch records and automate compliance workflows. The pharmaceutical MES replaced manual paper-based processes with electronic batch records and automated review workflows.

ZMC reduced batch review cycle time by 46–75%, dramatically accelerating the release of finished pharmaceutical products to market. The electronic batch record system improved compliance documentation quality and reduced the risk of regulatory findings during audits.

Pharmaceutical batch review cycle time reductions of 46–75% have direct revenue impact by accelerating the time between production completion and product release for sale. PharmaSuite's pharmaceutical-specific MES provides the 21 CFR Part 11 compliant electronic batch records required for both domestic Chinese and international regulatory submissions. Chinese pharmaceutical manufacturers targeting international markets must implement MES systems that produce regulatory-quality batch documentation as a prerequisite for global expansion.