ABSTRACT
I.INTRODUCTION Inordertoaddressvariousneeds,manypharmaceuticalandprocess-oriented companiesareinstallingamanufacturingexecutionsystem(MES)toimprove efficiencies,reducecycletimes,andfacilitatethecontrolofmanufacturingprocesses.Sincethesefunctionspotentiallyimpacttheidentity,strength,quality, andpurityoftheproducts,thesefunctionsareregulatedbycurrentgoodmanufacturingpractices(cGMPs)requirementsdefinedintheCodeofFederalRegulations(CFR),title21,chapterI,parts210and211.Thepurposeofthischapter istodiscusstheregulatorycompliancebenefitofanMESratherthanthebusiness ortechnicaldrivers.
