| Drug is a special type of product,the quality of drug is closely related to patient’s treatment effect.When disease is inevitable,using good quality drugs is highly expected by doctors and patients.The quality of drug is determined by several factors.Among all the factors,the quality of the production process is particularly prominent.With the same formula and similar raw materials,good production technology can significantly improve the quality of drug,and thus enhance the treatment effect,reduce the pain of patients,and ultimately benefit the society.CQ Group is a pioneer in domestic pharmaceutical industry,its overall capability has ranked in the top five among domestic pharmaceutical companies.The company successfully implemented SAP ECC based ERP system in 2010.In the next few years,ERP has contributed a lot in increasing the effectiveness and efficiency of the company’s business operations.But like the vast majority of domestic pharmaceutical companies,the production processes in CQ Group are still based on paper batch production record and packaging record.This results in low production efficiency,relative high human error rate and other quality problems.As the company’s business continues to grow,the traditional paper-based production style has to be changed,implementing MES system is highly necessary.By the end of 2013,after serious consideration,the company decided to implement an MES system in its first workshop by using a solution developed by HN Group.In the enterprise information system organizational structure,ERP system is located at the top,playing a role overseeing the general operations of a company;MES system stands in the middle,receiving information and orders from ERP system and send them down to workshop automation equipments.A successful integration of MES system and ERP system will bring significant benefits to enterprise.Since the big difference of the background and target customers between ERP system and MES system,commercial ERP systems are generally designed for a wide range of industries,but commercial MES systems are generally developed based on the needs from specific industries.This brings many difficulties when integrating ERP system and MES system.This thesis starts its discussion based on the business process of CQ Group and picks up the business model and demand as its starting point.Firstly,the background of CQ Group,related theories such as ERP,MES,GMP and GAMP5,and the research purpose,significance,method and path are introduced.Secondly,all the processes related to production are discussed in details.Based on the processes,a blue print describing the optimized processes after MES will have been implemented is generated.Thirdly,the interface between MES and ERP,with detailed data transfer specifications becomes the focus.Fourthly,various project management methodologies,the work breakdown structure,and the key factors related to project success are discussed.After that,a comparison of the detailed production data collecting before and after MES goes to live proves that MES has made a lot of contribution to CQ Group by improving drug quality and reducing production time.Finally,the thesis reviews the entire project by analyzing gains and losses in nearly one year.The thesis,as a summary of the first phase of the MES project,can be a good reference for CQ Group when implementing MES throughout the entire group. |
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