EBMR Software - Electronic Batch ManufacturingRecords
About EBMR Software
eBMRforPharmaisverycriticalforPharmaManufacturingforvariousreasons.Even today,surprisingly,lotofbigpharmaceuticalmanufacturingcompanieshavebeen capturingthebatchmanufacturingdetailsonpaper.ThispaperbasedBMRinvolveslot ofeffortinprintingalltheprocessparametricdatafromdifferentprocessstepsofthe batchmanufacturing.Humanbeingshavetowalkacrossthemanufacturingfloor,collect thesepaperprintouts,compilethemandsometimes,theymayhavetorepeatthis processandmanuallygottoverifythesamebyrespectiveQAindividuals.
Where should one start the eBMR journey?
ThisprocessparametricdatacomesfromwidevarietyofPLCsmonitoringtheprocesses.WhenI say,widevarietyofPLCs,thismeansfromdifferentvendors,differentmodelsthatgotevolveda longperiodof20-30years.Howdowebringallthedatathatiscomingfromthesemachinesinto aneBMR?Whattodowithexistinginvestmentsthatthemanufacturershavemadeforthe automationoftheL1andL2layersofautomation,wherethereislotofHMI/SCADA.Lotofthis machinerycomeswiththeembeddedPLCsandhowdoweensurethatthesemachinesare21 CFRPart11compliant?Now,themanufacturers’havethedilemma,shouldtheymakeeachand everymachine21CFRPart11compliantfirstorshouldtheygoforaneBMRsolution?IseBMR solutiongoingtosolvealltheproblemsinoneshot?Thereisalsoaconcernfromsomeofthe manufacturersthateBMRsolutionisexpensiveanddifficulttoscalebecauseofcostreasonsand validationsinvolved.Whatisthetruthhere?Upgradingofallthemachineryonthefloorfor21CFR Part11complianceisnotanoptionobviously,weallknowthatthenewmachinerycomeswiththe 21CFRPart11compliancebuthowtodealwiththeoldermachinery?Shouldthemanufacturer investintotheHMI/SCADAautomation?Thisissomething,anoptioninthepastbutwiththe availabilityofprovennewIIOTtechnologies,itdoesnotmakesensetoinvestintotheHMI/SCADA nowjustfortheeBMRpurposes.HMI/SCADAhasitsownjustification.
What about the Data retention? Unlike,othereBMRvendors,atAtachiwetaketheresponsibilityofdataretentionthroughoutthe lifeoftheproduct.Duringthiswholelifeoftheproduct(i.e.,tablets,vaccines,etc.)the manufacturerdoesnothavetoworryaboutupgradingtheireBMRplatformandtheassociated reportingtools,datawarehousesdatabases,etc.Thisisabigtaskandobviouslyexpensiveand tediouslifesoftwareandhardwarecyclemanagementtask.AtachiNGIMESprovidestheeBMRfor anybatchthroughoutthedataretentionperiodandbeyondforcontinuousimprovementand manufacturinginsights.
Today,lotofpharmamanufacturers,especiallyIndianPharmamanufacturerscapturelotof informationintheirBMRonpaper.WhentheytrytodigitizethispaperbmrintoeBMRsoftware usingtheinternationaleBMRplatforms,thisfunctionalitiesthattheyarecapturingonpaperisnot availableforonesinglecostorlicense.Whatdoesitmean?WhenyougenerateaBMR,theBMR templateneedstobecreatedatfirstandthatneedstobereviewedandapprovedbyQA department.ThisfunctionalityissoldasaseparatepackagebysomeMESvendors.Aspartofthe preparationoftherawmaterialspriortoproduction,warehouseperformsweighinganddispensing. ThisfunctionalityisofferedasastandalonepackagebylotofMESvendorsandsmallIndian softwarefirms.Whenthepharmamanufacturerstartsdeployingthefunctionalityonebyone,the integrationofthesefunctionalitiesbecomeschallenge.SomeMESplatformshaveintegration issueswiththemachineryontheproductionfloorshencedemandingthesituationofretrofitting thesemachineriesorupgradingthemachinerieswith3rdpartyOPCsoftwareorIIOTgateways. ThisisbecomingachallengeforthePharmamanufacturersindigitizingtheirpaperbasedBMR.
What functionalities do you need as part of eBMR?
