FDA 21 CFR Part 11 ERES Checklists? Do this instead!
21CFRPart11Checklists.We'vecomealongway....orhavewe?Theyearis 1997.BillClintonisinhissecondterm,Windows95isrevolutionary,a laptoponlyweighs6-8poundsand21CFRPart11,theUSFoodandDrug
Administration's(FDA)regulationonelectronicrecordsandelectronic signatureswentintoeffect(enforcementtobeginin2001). Twodecades ago,mostsoftwareusedinthelife-sciencesindustrywasnotcompliantand manytomostqualityprocessesweremanagedviapaperrecords.I rememberpaper-basedSOPmanagement,partdrawings,batchrecords andCAPAforms. Inanefforttomakesureacomputerapplication compliedwith21CFRPart11requirements,mostorganizationsmapped theregulation,line-by-line,toachecklist,executedtoidentifyanygapsand createremediationplans.
It's2020;softwarevendorsacrossregulatedindustriesdon'tjust understandcomplianceofe-recordsande-signatures,it'sbecomestandard androutine.Neithernovelnornew,it'ssimplyanexpectationinthe aeronautical,financial,medical,life-sciencesandnumerousotherbusiness sectorsthatsoftwarevendorsarecapableofmeetingbasicERES requirements.So,whyarewestillexecutingthose 21 CFR Part 11 checklists?I'vereachedouttoanumberofmycontactstobetter understandthiscuriosartifactfromthe90's.Followmedowntherabbit holeandletallowmetoproposeanotheroption.
ThePart11Checklist,typicallyexecutedbeforeoraftertesting,determines whatERESrequirementsareapplicableand/orwhetherthecomputer systemunderevaluation/testingsatisfiesthem.That'sallgooduntilyou realizethatwedon'tdopredicaterulechecklists.IfI'mvalidatinga compliantmanagementsystem,Idon'tmapapplicableportionsof21CFR Part210/211or21CFRPart820,doI?Why?It'sfullyunderstoodthat we'redefiningrequirementsforthatsystem(userand/orfunctional)that considerbusinessneedsandregulatoryexpectations.We"bake"regulatory complianceintothoserequirements.Well,whydon'twedothesamething forERES?
Ratherthancreatingaseparate 21 CFR Part 11 Checklist,buildallofthe ERESrequirementsintoyourRequirementsSpecificationtemplate.Include appropriatesubsections:OpenSystems,ClosedSystemsAuditTrails; NonbiometricSignatures,BiometricSignaturesandProcedural.Populate thetemplatewilleverypossibleERESrequirement.You'llstillneedto performanERESApplicabilityAssessment,buttheoutputofthatsimply determinesifthatsystemmustadhereto21CFRPart11,andwhatifyes, whichsubsections(groupsofrequirements)areapplicable.Those applicablesectionsthenmaptothesubsectionsIjustdefinedinyour RequirementsSpecificationtemplate.TheValidationLeadkeepstheones thatareapplicableanddeletestheonesthatarenow.
It'sasimpleconceptanditeliminatesacurious20yearoldartefact.The importantpitfallstoconsiderare:
1. EnsuringyourApplicabilityAssessmentquestionsalignto requirementssub-sections
2. Sub-sectionsareclearlywritten,testable/verifiablerequirements
Whatdoyouthink?Areyoureadytoeliminateonemorevalidation documentonyourjourneytoefficient,streamlined,value-addedcomputer validationpractices.Ifyou'dliketodiscussthistopicfurther,callusforan appointment!Asalways,we'reheretohelp.