GUIDELINES FOR VALIDATING ELECTRONIC CHART …Jun 01, 2018 · The primary focus of 21 CFR Part 11 is on data reliability and integrity of electronic records and signatures. The aim

IFTPSGuidelinesValidatingElectronicChartRecorders

IssueDate:June1,2018 1

Institute For Thermal Processing Specialists

GUIDELINES FOR VALIDATING ELECTRONIC CHART RECORDERS

Various methods may be employed to validate electronic chart and the following recommendations are to be considered voluntary guidelines. While this does not preclude the application of other methods and equipment, these guidelines have been developed by consensus of the Institute For Thermal Processing Specialists and should be given serious consideration for adoption as methodology by individuals validating electronic chart recorders.

1.0SCOPE

In 1997, the US Food and Drug Administration (FDA) introduced 21 CFR Part 11 regulation to providecriteria underwhich the FDAwill consider electronic records and signatures to be equivalent to paperrecords and handwritten signatures. This mandatory regulation provides requirements to ensure theaccuracyandintegrityofelectronicrecords,specificonlytorecordsrequiredbytheFDA.ThescopeoftheregulationcoversbothelectronicrecordsthatwillbesubmittedtotheFDAandelectronicrecordsthatarebeingkepttomeetFDAregulatoryrequirements.RecordsgeneratedbyacompanythatarenotrequiredunderFDAregulationsdonotneedtocomplywithPart11.

FDAdefines Part 11Records and Electronic Signatures as “Records that are required to bemaintainedunderpredicaterulerequirements;thataremaintainedinelectronicformatinplaceofpaperformatandthatarereliedontoperformregulatedactivities”and“Electronicsignaturesthatareintendedtobetheequivalentofhandwrittensignatures,initials,andothergeneralsigningsrequiredbypredicaterules.”

ThisdocumentwillfocusonelectronicchartrecordersusedinthefoodprocessingandpackagingindustrytocreateandmaintainrecordsrequiredbytheFDA(e.g.,21CFRParts113and114),andhencefallunder21CFRPart11.

FormanufacturersutilizingfoodsafetyplansmandatedundertheFoodSafetyModernizationAct(FSMA)and fornon-USmanufacturers, adopting this validation guidance is voluntary. This guidance, however,maybeconsideredasbestpracticeforanyfoodmanufacturingoperationsthatintendtoutilizeelectronicrecordingsystemsandwould like toensure thatelectronic recordsare secureandcannotbeamendedwithoutaudittrailnotation.



2.0OBJECTIVE

Thepurposeof thisdocument is toprovideguidanceon the validationof electronic chart recorders tomeetFDAregulationonElectronicRecordsandSignatures,21CFRPart11.Thisguidancedocumentwillnot ensure compliance, but rather intends to outline a validation approach for the food processingindustrytouseandadapttomeet21CFRPart11requirements.

3.0BACKGROUND

3.1 Historically, food processing facilities have used paper chart recorders to record and trend criticalprocessing and packaging data. Over the years, limited advancement has occurred with paper chartrecordingtechnology,andthetransitiontomoreadvancedandreliableelectronicsystemshasbeenslowdespiteitsmanyadvantages.Paperchartrecordersrequiremovingmechanicalpartsandthepurchaseofpensandpaperonanongoingbasis.Maintenanceforthesesystemscanbecostlyandrepetitive.Paperjamsand/orskipsanddryinkassociatedwithpaper-typerecorderscanleadtodataloss,overwriting,andnon-conformancewithfoodsafetyregulationsand/orcorporatestandards.Electronicchartrecorders,onthe other hand, prevent paper chart recorder associated deviations, and do not have the associatedupkeepcostsandphysicalspacerequirementsrelatedtopaperstorage.

3.2 Reliability isanothermajoradvantageofelectronicchartrecordingsystemsovertraditionalpaperchartrecorders. Electronic recordsstoredatmultipledata locationsprevent lossofcritical records,allowforquick retrieval, remote access, and have improved data security and integrity. Process data is morelegible in electronic chart recorders since there is the capability to zoom inondata for review. Unlikepaper chart data, electronic data can easily be compiled into summary reports, and alarm logs whichautomatically provide a snapshot of events that occurred during production. Despite the significantadvantages, the vast majority of food processing facilities continue to use traditional paper chartrecorders as their singular and primary recording device. While the change may appear daunting inregards to proper validation and management of electronic data/records, the benefits of making theswitch toelectronicchart recording faroutweighthe issues involvedwithcontinueduseofpaperchartrecordingsystems.

4.0OVERVIEWOF21CFRPART11&FDAPREDICATERULEREQUIREMENTS

The primary focus of 21 CFR Part 11 is on data reliability and integrity of electronic records andsignatures. The aim is to minimize the risk of data loss and manipulation while ensuring electronicsystemsmeettherequirementssetforthbytheFDA.Table1summarizesthemainrequirementscoveredunder21CFRPart11.Itisnecessarytounderstandtheserequirementspriortoselectingandvalidatinganelectronicrecordingandstoragesystemthatisclaimedbythevendortobe21CFRPart11compliant.



Table1:21CFRPart11Requirements

Part11Requirement MainPoints

DataSecurityand

DataAccess

• Electronicrecordsmustbeprotectedtoenableaccurateandeasyretrievalthroughouttheirretentionperiod.

• Systemaccessmustbelimitedtotheauthorizedindividuals.• Systemmustbecapableofperformingoperationalsystemchecks,

authoritychecks,anddevicechecks.• Systemmusthaveappropriatecontrolsover:

o Distributionofandaccesstodocumentationforsystemoperationandmaintenance.

o Revisionandchangecontrolprocedurestomaintainanaudittrail.

AuditTrailand

RecordTraceability

• Systemmustusesecure,computer-generated,timestampedaudittrailstoindependentlyrecordthedateandtimeofoperatoractions/entries.

• Audittrailsarenecessarywhenusersareexpectedtocreate,modify,ordeleteregulatedrecordsduringnormaloperation.• Personswhodevelop,maintain,oruseelectronicsystemsmustbe

properlytrainedtoperformassignedtasks.• Adherencetowrittenpoliciesholdsindividualsaccountableforactions

performedundertheirelectronicsignatures.

CopiesofRecordsand

RecordRetention

• Systemmustbeabletogeneratecopiesofrecordsinbothhumanreadableandelectronicformatsuitableforinspection,review,andcopyingbytheFDA.

ElectronicSignatures• Eachelectronicsignaturemustbeuniquetoeachindividual.• Beforeassigninganelectronicsignature,theidentityofanindividual

mustbeverified.• Personsusingelectronicsignaturesmustcertifythattheirelectronic

signatureisalegallybindingequivalenttotheirhandwrittensignature.• Identificationcodesandpasswordsusedforelectronicsignaturesmust

beperiodicallycheckedand/orrevisedtoensureauthenticity.

Validation• “Systemsusedtocreate,modify,andmaintainelectronicrecordsmust

bevalidatedtoensureaccuracy,reliability,consistentintendedperformanceandtheabilitytodiscerninvalidoralteredrecords”(21CFR11.10(a)).



Inadditionto21CFRPart11requirements,foodcompaniesthatintendtomanufacturelowacidoracidifiedfoodproductsfortheUSmarketmustensurethatFDApredicaterulerequirementsaremet. Table2summarizestheFDApredicaterulerequirementsforLowAcidCannedFood(LACF,21CFRPart113)andbestpracticesforAcidifiedFoods(AF,21CFRPart114)astheyrelatetocriticalfactorsrecording.

Table2:21CFRPart113Requirementsand21CFR114BestPractices

21CFRPart113 MainPoints

TemperatureIndicatingDevice

(TID)

• TheTIDshallbethereference(official)instrumentforindicatingtheprocessingtemperature.

• TheTIDisastandalonedevice.

TemperatureRecordingDevice

(TRD)

• ThereshallbeanaccurateTRDforeachproductsterilizer.• Thetemperaturechartshallbeadjustedtoagreeasnearlyaspossiblewith,but

tobeinnoeventhigherthan,aknownaccurateTID.• Thechartshallhavegraduationsthatdonotexceed2°Fwithintherangeof

10°Foftheprocessingtemperature.*• Eachtemperaturechartshallhaveaworkingscaleofnotmorethan55°Fper

inchwithintherangeof20°Fofthedesiredproductsterilizationtemperature.*

• Thegraduationshallnotexceed2poundspersquareinchontheworkingscaleofnotmorethan20poundspersquareinchperinch(situationswhereproducttoproductregeneratorisused).*

• Alock,oranoticefrommanagementshallbepostedatorneartherecordingdevicethatprovidesawarningthatonlyauthorizedpersonsarepermittedtomakeadjustments.

CriticalFactorRecording

• Criticalfactorsspecifiedinthescheduledprocessshallbemeasuredandrecordedontheprocessingrecordatintervalsofsufficientfrequencytoensurethatthefactorsarewithinthelimitsspecifiedinthescheduledprocess.Suchmeasurementsandrecordingsshouldbedoneatintervalsnottoexceed15minutes.

• Observationsandmeasurementsofoperatingconditionsshallbemadeandrecordedatintervalsofsufficientfrequencytoensurethatcommercialsterilityofthefoodproductisbeingachieved;forexampleinasepticsystemssuchmeasurementsshallincludethesterilizationmediaflowrates,temperatures,thecontainerandclosurerates(ifapplicable)throughthesterilizingsystem,andthesterilizationconditionsifabatchsystemisusedforcontainersterilization.Themeasurementsandrecordingsshouldbemadeatintervalsnottoexceed1hour.

• Clocktimesonrecording-temperaturechartsshouldcorrespondtothetimeofdayonthewrittenprocessingrecordstoprovidecorrelationoftheserecords.

RecordKeepingand

RecordReviewRequirements

• Recordingchartsshallbeidentifiedbydate,system#etc.sotheycanbecorrelatedwiththewrittenrecordoflotsprocessed.

• Copiesofallprocessingandpackagingrecordsshallberetainedattheprocessingplantforaperiodofnotlessthan1yearfromthedateofmanufacture,andattheprocessingplantorotherreasonablyaccessible



Table2:21CFRPart113Requirementsand21CFR114BestPractices

21CFRPart113 MainPoints

locationforatleastanadditional2years.• Aqualifiedrepresentativeofplantmanagementshallreviewallprocessingand

packagingrecordswithin1workingdayaftertheactualdeliveryoftheprocessforcompletenessandensurethattheproductreceivedthescheduledprocess.Therecords,includingthecharts,shallbesignedorinitialedanddatedbythereviewer.

*Ifforanyreason,electronicrecordsareprintedasofficialthermalprocessingrecordsforregulatoryreview,thenthegraduationscalerequirementsmustbemet.

This validation guidancedocument is developed to assist theenduser inmeetingUnited States FDA regulatoryrequirements. It is the responsibility of the end user to ensure compliance with other local regulations andcorporatestandards,whereapplicable.

5.0APPLICATIONOFELECTRONICCHARTRECORDERSINFOODMANUFACTURINGANDPROCESSINGFACILITIES

Thereareseveraloptionsforusingelectronicchartrecordersonfoodprocessingandpackagingmachinesinplaceofpaperchartrecorders.Theoptionselecteddependsonfacilityneeds,companycommitment,andoverallreadinesstoinvestinanintegratedelectronicrecorderanddatastoragesystemthatis21CFRPart11compliant.

5.1 Option 1: Electronic chart recorders may be used as a backup recorder to paper chartrecorders. An electronic backup (i.e., secondary recorder) can assist in alleviating issues withpapercharts thatautomaticallyresult inprocessdeviations (i.e.,paper jams/skips,dry ink,penadjustment, paper replacement). This option is a good choice for facilities that intend to gainexperience with electronic chart recorders, or, that are considering to implement/exploreelectronicrecordsinthefuture.Insituationswherethesecondaryelectronicdataisprintedandusedinplaceofthepaperchart,therecordermustbesetupsuchthatitmeetsallpredicateruleand relevant sections of 21 CFR Part 11 requirements. This printed recordmust be reviewedwithinoneworkingdaytomeetpredicaterulerequirements.Iftheprimarychartrecorderfails,andthesecondaryelectronicchart recorder isusedtomakedecisionsaboutthedispositionoftheproduct,itbecomestheprimaryrecorder,whichmustsatisfyalltheregulatoryrequirementspreviouslymentioned.Adisadvantagewiththisoptionisthattwo(2)separatedevicesmustbemaintainedandconfiguredtoreceive inputsignals fromthesameor identical fielddevices. Insuchsituations,theplantshouldclearlydefinetheprimarychartrecorderthatwillbeutilizedforregulatoryreviewofthermalprocessingrecords.

5.2 Option2:Electronicchartrecordersmayalsobeinstalledinplaceofpaperchartrecorderswiththe ability to print, review, and sign-off on the printed records in compliancewith applicableregulations (including relevant sections of 21 CFR Part 11) and/or corporate standards. Dailyprintouts can be used as the legal production records provided that the predicate rules aresatisfied. Thisoptionappears tobeapreferred choice for facilitieswhohaveexperiencewithelectronicrecordsbecauseitallowsfortheoptionofgoingfullyelectronicinthefuture.Someoftheissuesassociatedwithpaperchartrecordsareavoidedwiththisoption.However,inabsence



of a system that is validated to be 21 CFR Part 11 compliant, the validity and life span ofelectronicrecordscanbequestionableoncepaperrecordsareprintedforregulatoryreview.

5.3 Option3:Thethirdoptionisafullyintegratedelectronicchartrecordinganddatastoragesystemthatis21CFRPart11compliant.Thisoptioncompletelyeliminatestheneedofpaperrecordsforrecordkeeping.Athorough21CFRPart11validationofthechartrecordersetupandassociatedintegrated systems and network (if applicable) should be completed following proceduresoutlinedinthisguidancedocument.

6.0ELECTRONICCHARTRECORDINGSYSTEMVALIDATIONAPPROACH

Prior to use in production, the entire system should be validated to ensure that it meets Part 11requirements. The electronic chart recorder itself is just one part of the system that needs to bevalidated.Thedataserver,datamanagementsystem,dataaccess&security,andsignaldistributionfromsensor to recorder will also be included in the electronic chart recording system validation. Systemvalidationstartspriortothepurchaseandinstallationofthesystemandcoverstheseriesofactivitiesthatmust takeplaceover thevalidation lifecycleof thesystem. This includesdevelopingavalidationplan,establishingaUserRequirementSpecification(URS),generatingdocumentedevidenceofthevalidation,and continued verification to ensure that the system remains in its validated state. A detailed systemvalidationstrategycanguardagainstunnecessaryissuesatalaterstage.

Validationismentionedbrieflyin21CFRPart11.However,itdoesnotspecifyordescribeindetailhowvalidation should be carried out. The following sections outline a validation approach for Part 11compliantelectronicchartrecordingsystemstobeusedinfoodmanufacturingandprocessingfacilities.

7.0VALIDATIONPLAN

First,aplanforcarryingoutthevalidationshouldbecreated.Thevalidationplanshouldbedevelopedbyperson(s) knowledgeable of 21 CFR Part 11 requirements and preferably with project managementexperience. Senior Management should sign-off on the plan and have awareness of the activities,timelineandobjectiveofthevalidationasearlyaspossibleintheproject.AcceptanceandsupportfromSeniorManagementatanearlystageiscritical.

Thevalidationplanshouldclearlydefinethefollowing:

1)ValidationStudyScope

2)Cross-functionalTeamRolesandResponsibilities

3)RiskAssessment

4)ValidationActivities&Timeline

7.1 ValidationStudyScope

The scope of the validation should clearly outlinewhat is and is not part of the project. This includesoutliningwhichfoodprocessingequipmentwillbeaffected,whichelectronicchartrecordingsystemwillbepurchasedorpaperchartrecorderwillbereplacedbytheelectronicchartrecordingsystem,andwhichcritical parametersmust be electronically trended. Signal distribution is fundamental to determining avalidationapproachinelectronicsystemsandshouldalsobedefinedinthescope.Thesignal(s)goingtothe electronic chart recorder may be coming from a Programmable Logic Controller (PLC) system ordirectly from the transmitter of the field device (e.g., Resistance Temperature Detectors (RTD),manometers,flowmetersetc.). Adirectconnectionfromthesensortothechartrecorder(asshowninFigure 1, Option A) is the simplest option since the raw signal from the RTD transmitter is connected



directly to the input card of the chart recorder. This option precludes the use of hardware that mayinterferewiththereliabilityofthesignaland/ortheuseofunsecuredthirdpartyhardwareandsoftwarethatinterprettherawsignal.IfacontrolmodulesuchasaPLCsystemisnecessary,itshouldbeplacedinthesamecurrentloopasthatofthechartrecorder.Theuseofaseparatetransmitter,analoginputcard,PLC,andanalogoutputcardasan interfacebetweentheRTDandchartrecorder(Figure1,OptionB) ispossible,but itcreatesadditionalcomplexity,requiringthatthePLCsystembesecuredandvalidatedinaddition to thevalidationwork for thechart recorder. For thepurposeof thisvalidationguidance, thefocuswillbeonsignaldistributiondirectlyfromafielddevice(e.g.,anRTD/sensor)tothechartrecordingsystem(Figure1,OptionsAorC).ForFigure1,OptionC,adualprobewithtwoindependenttransmittersisusedtotransferasignalfromthefielddevicestotheanaloginputcardsofthePLCandrecorder.

Regardless of the option selected, the network and server configured to the chart recorder for datastorage, retention and retrieval must also be within the scope of the Part 11 validation. Piping andInstrumentation Diagram (P&ID) should be included for any of options selected. Also, proper changecontrolwillneedtobeimplementedwhenusinganyofthe3options.

Figure1:SignalDistribution(Note:areawithindottedlinerepresentsPart11validationscope)

7.2 Roles&ResponsibilitiesoftheCross-FunctionalTeam

The roles and responsibilities of the cross-functional team members should also be detailed in thevalidationplan.ThevalidationteamshouldincluderepresentationfromProcessAuthority,FoodSafety,Engineering, Quality, Maintenance, IT and the Equipment Supplier. See Table 3 below for examplevalidation team roles and their responsibilities. The teammembers and responsibilitiesmay vary fromfacility to facility, however each of the following duties should be accounted for within the team. Aconsultant or consulting group may be responsible for some of the roles and responsibilities of thevalidationteam.



Table3:CrossFunctionalTeamRoles&Responsibilities

DepartmentRepresentative Roles&Responsibilities

ProcessAuthority/FoodSafetyManager

• Outlinesvalidationrequirements/expectationsfromCorporateStandardand/orRegulatoryperspective(i.e.,21CFRParts11,113,114,117etc.;Statementof21CFRPart11CompliancefromtheSupplier).

• Reviewsandapprovesvalidationplanandactivities.• Ensuresproperdocumentationofqualificationandvalidationresults.• Providesguidanceandapprovalonselectionofe-chartrecorder.• Providesguidanceoninformationthatmustberecordedone-chart

recorder(e.g.,criticalprocessparameters,operatorinitialsandcomments,product&equipmentID,alarms,datacollectionandtransferrateetc.).

EngineeringManager• ActingValidationProjectManager–developsvalidationplan,activities,etc.• Servesaskeyengineeringresource.• Managesprojectcostandtimeline.• ProvidesInstallationQualification(IQ),OperationalQualification(OQ)and

PerformanceQualification(PQ)documentationtemplatestothecross-functionalteam.

• Responsibleforcompilingvalidationdocumentsand/orcreatingthevalidationreportincollaborationwithothercross-functionalteammembers.

QualityManager• Providesoversightonimplementationtomeetlocal/predicaterule

requirements(e.g.,21CFRPart113,etc.).• Verifye-chartrecordersetup(e.g.,criticalparameterrecording,operator

initials,product&equipmentID,datatransferfrequency,e-dataarchiving,extraction,security,e-signaturecomplianceetc.).

• Verifyaudittrailsandstorageofaudittrailrecordswithactive/archivedrecords.

• Responsibleforrecordreview,definingaccessrightandlevels,identifyingauthorizedusers,andestablishingrecordkeepingandrecordretentionrequirements.

• Challengealarmsanddocumentaccuracyofcriticalsensors,ife-chartrecorderissetuptogeneratealarms.

• ResponsibleforcreatingapplicableSOPsfore-chartrecordingsystemoperation,recordkeepingandrecordreview,electronicsignatures,changecontrol,etc.

• Providesapplicabletrainingforoperatorsandrecordreviewers.• ResponsiblefordrivingtheChangeControlprocess.• Handlesuserpasswordviolationsandramification.



Table3:CrossFunctionalTeamRoles&Responsibilities

DepartmentRepresentative Roles&Responsibilities

MaintenanceManager• Providestechnicalsupportnecessaryduringinstallation,operationand

performancequalification.• Setupdatatransferfrequencyine-chartrecorderinternal&external

memoryandtotheserver,setupe-chartrecorderdisplayconfiguration,setupalarms,ifapplicable.

• Challengeanddocumente-chartrecorderforelectromagneticinterference(i.e.,cellphone,WalkieTalkie,highvoltagemotors,etc.).

• Responsiblefortrainingoperatorsonspecificrequirementsandfeaturesofelectronicchartrecorder.

ITManager• ProvidesITsupportforsoftwareandhardwareinstallation,

communication,storage,archivingandretentionofelectronicdata.• Assistsinsettingupdataaccess,dataretrieval,dataarchiving,securityand

integrityrequirementsasitrelatestoserversystemandsoftware.• Configuresnetworkserver(companyvs.localserver)—filenameformat,

servername,networkpath,directoryname,IPaddress,etc.• Setupsoftwareremoteaccessforauthorizedusers.• Setupprinterasabackup.• Handlesuserpasswordrequirementsandmanagement.

EquipmentSupplier• Technicalsupporttoaddressquestionsonrecorderfunctions,datasecurity

andintegrity,systeminstallationanduse.• ProvidestatementofcompliancetoPart11requirements.• ProvidesFunctionalSpecificationandOperator’sManual.• ProvidestroubleshootingsupportduringIQandOQactivities,asneeded.• Communicatesanychangestofirmware,hardwareandsoftware(version

updates,etc.)totheenduser.

7.3RiskAssessment

Aspartofthevalidationplan,ariskassessmentshouldbeconducted.Theriskassessment,createdwithinputfromthevalidationteam,shouldtakeintoaccountanyandallfactorsthatmayaffectdatareliability,accuracy and security in an electronic recording system. This assessment will aid in selection of theappropriate electronic chart recording system (i.e., Part 11 compliant-able hardware and software,recordermakeandmodel,etc.)andcreateanawarenessaroundtheriskareasthatshouldbeevaluatedpriortobeginningqualificationactivities.

Examplerisksinclude(butarenotlimitedto)thefollowing:

• SelectingPart11compliantrecorder(hardware&software).• Opensystemvs.closedsystemserver.• Databackup(recorderinternal/externalmemory,serverbackup).• Servercapacityandrecordretentionduration.• Datasignalflow(refertoFigure1).



• Impactoffuturefirmware,hardwareorsoftwareversionupdates.• Network/connectionfailureandimpactofapoweroutage.• Plantnetwork/separateservertobeused.• Environmentalconditions(humidity,temperature).• Time/clock synchronization to real time and other system clocks; also taking into account daylight

savingstime.• Potentialelectromagneticandheavyequipment(i.e.,motorandpump)interference.• Compliancewithapplicablepredicaterulerequirements(e.g.,21CFRPart113,114).

Basedontheriskassessment,amorerobustUserRequirementSpecification(URS)shouldbeestablished.

7.4ValidationActivities&Timeline

Asummaryofvalidationactivitiesshouldalsobewrittenintothevalidationplan.Thisincludes:

• UserRequirementsSpecification• FunctionalSpecification• DesignSpecification• InstallationQualification• OperationalQualification• PerformanceQualification• DevelopmentofValidationReport• Changecontrolprogramforcontinuedverification

SeeFigure2belowforavalidationlifecyclediagram.Theseitemswillbediscussedingreaterdetailinthefollowingsections.

Figure2:ValidationLifeCycleDiagram.



An approximate timeline for the activities should also be devised as part of the validationplan. The Validation Lead/Project Manager should be in charge of managing the validationtimelineandcommunicatinganychangestothecross-functionalteam.

8.0USERREQUIREMENTSPECIFICATION(URS)

Taking into account the risks determined from the Risk Assessment, a User Requirement Specification(URS) document should be generated. This is themost important document involved in the validationprocessas it setsout todefine systemrequirements fromtheenduser’spointofview in selecting theappropriate electronic chart recorder. TheURS should clearly describe required items (i.e., user needsandregulatorymusts)andwantsfortheelectronicrecordingsystem.ThisincludesCriticalControlPoints(CCP) and Critical Factors (CF) that must be continuously recorded as well as operationalrequirements.Allcross-functionalteammembersshouldbeinvolvedintheURSapprovalprocess.

BelowinTable4isanexamplelistofsome“musts”and“wants”foraPart11compliantelectronicchartrecording,datatransferandstoragesystem.

Table4:UserRequirementsSpecification

Musts• Complywith21CFRPart11requirements(hardwareandsoftware).• Abletomeetpredicaterulerequirements(e.g.,21CFRPart113chartgraduationscale

requirements).• Goodchartresolutionforchartsnotunderpredicaterulerequirements.• Monitors,recordsandtrendsspecifiedCCPs/CFsforeachmodeofoperation.• Provideanaudittrailforchangesindataunlessdataencrypted.• Provideanaudittrailforcommentsthatareeitheraddedoredited.• Enablesecureelectronicsignaturewithpasswordcontrol.• Measure,storeandrecordinformationthatmustbedisplayedontherecorder(e.g.,Date,

Productcode,Equipmentnumber,Operatorinitials,signatureandcomments,etc.).• Serversetup(openvs.closedsystem).• Meetsmaximumnumberofprocessparametersthatneedstobetrended.• Specificdatameasurementandrecordingfrequencytotherecorderandtotheserver(e.g.,

everysecond/minute).• Chartrecordermemorycardstoragespace.• Timesynchronizationcapability(betweensystems,daylightsavingsetc.).• Intranet/internetconnectivity.• Remoteaccessandconfigurationcapability.• Othersbasedonriskassessment,asnecessary.

Wants• Trendsnon-criticalprocessparameters.• Abilitytodisplaytrendsindifferentchartformats(i.e.,stripvs.circular).• Printersetupatrecorder.• Alarmsetupincaseofoutofspecrecordingorprocessdeviation.

UsingtheinformationgatheredintheURS,anelectronicchartrecordingsystemshouldbeselectedandpurchasedwiththeappropriateapprovals. It isagoodpracticeto involvetheelectronicchartrecordersupplier early in the validation process to obtain the appropriate technical support and expertise (seeTable3forRolesandResponsibilities).



Upon purchase of the electronic chart recording system, the supplier should also provide a writtenstatementofPart11complianceorcertification.Thestatementofcompliancewillserveasproofthattheelectronicrecordingsystemiscapableofmeetingalltheprovisionsof21CFRPart11(e.g.,thesystemisabletobevalidated)priortomovingforwardwiththevalidation.

9.0FUNCTIONALSPECIFICATION(FS)

Afteranelectronicchartrecordingsystemisselected,aFunctionalSpecification(FS)shouldbeprovidedby the system supplier. The FS describes major components and functions of the electronic chartrecording system. It should contain descriptions of the SystemDisplay,OperationalOverview, SystemSet-upOptions,ProcessInstrumentation,ListofHardware&Software,UserInterface,SystemNetworking,DataSecurity&Storage,DataMonitoring,andDataRecordingandReporting.Thisdocumentshouldalsocontain themethods for verifying that the requirementsof theURShavebeenmet. All the functionalrequirements (“Musts” and “Wants”) fromTable 3 should be addressedby the FS and satisfied by thechosenelectronicchartrecordingsystem.

10.0DESIGNSPECIFICATION(DS)

A Design Specification should be provided by the electronic recording system supplier as well. Thistechnicaldocumentdescribeshow the system is configuredandprogrammed toperform the functionsidentified in the Functional Specification. The DS will assist in verifying the correct installation of theelectronicchartrecorder.

11.0ELECTRONICRECORDINGSYSTEMQUALIFICATION

Oncethevalidationplanisinplace,electronicrecordingsystemqualificationmaybegin.Thequalificationactivities ensure that the system meets the requirements set forth by the end user. InstallationQualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) are the 3qualificationphasesthatmustbecompleted. Theseactivitiesshouldbeplannedfor inadvanceastheyrequire test protocols and templates to be generated and used during the qualification process. Theprotocolsandtemplatesserveasdocumentedevidencethatthevalidationhasbeencompletedandthesystemisinstalledandoperatingasexpected.

12.0INSTALLATIONQUALIFICATION(IQ)

Thefirstqualificationphase,InstallationQualification,confirmsthedesignspecificationsoftheelectronicrecording system. This verifies that the system hardware and software have been built, installed andconnected properly. P&ID diagrams, component lists and system manuals should be collected andverifiedduringthisphase.

TheIQprotocolanddocumentationtemplatesshouldbedevelopedbytheenduserwithinputfromtherecordingsystemsupplier.Theprotocolshoulddescribetheverificationandqualificationteststhataretobeperformeduponinstallationoftherecordingsystem.IneachsectionoftheIQprotocol,responsiblepartiesshouldsign-offanddatethetaskscompleted.Ataminimum,theInstallationQualificationshouldcoverthefollowing:

12.1 System Installation – The chart recorder installation, both hardware and software, must beverified as per supplier and corporate requirements. For the entire system, this includes



electrical and mechanical drawing verification, as well as checking the critical equipmentinstallationagainstsuppliermanualsandotherspecifications. Intheprotocol, thesecheck-offswillensureeachcomponentofthesystemisinstalledasrequired.RefertoTable5belowforanexample.

Table5:SystemInstallation

SystemInstallationCriteria Drawing/SpecificationReference InstallationVerified?SignatureandDate

PipingandInstrumentationDiagram

P&IDdated1/1/2016;Title:P&IDAsepticLine;DrawingNumber:

123456

Yes

HardwareTechnicalManual SupplierNameManual Yes

SoftwareTechnicalManual SupplierNameManual Yes

12.2 Hardware and Software Connections – Hardware and software connections related to themonitoringand recording of critical factors must also be checked and documented for proper installation. Forhardware, this includes wiring for signal transmission, signal distribution verification, signal channelconfiguration, panel and instrument connections, server connections (independent server or shared),memory card presence and storage limit, and confirmation that the environment is suitable for thesystem (e.g.,power supply, relativehumidity, roomtemperature). The localplantnetwork thatwillbeutilizedfordataarchivingshouldbesetupandnetworkconfiguration,IPaddress,servername,networkpath, directory name, data transfer frequency,maximumdata storage capacity, file formats for futuredataretrievalshouldbeconfirmedaswell.

On the software side, server connections, system security deliverables, procedures for assigningusernames and passwords, and other critical software capabilities for the record reviewer must beverified. How the system is setup during Installation Qualification dictates the testing that will becompletedduringOperationalQualification.SeeTable6forexampleHardwareandSoftwareConnectionteststobeincludedintheIQprotocol.

Table6:HardwareandSoftwareConnections

DeviceSpecification Tag# Description/Location Manufacturer/Serial#

Wiring/SignalsVerified?

SignatureandDate

TemperatureSensorWiring&

Configuration

TE-1 ProductTemperatureRTD–HoldTubeInlet

ABCCo.#11111 Yes



Table6:HardwareandSoftwareConnections


Wiring/SignalsVerified?

SignatureandDate

ServerConnection NA Sharedorstandalone?connectiontohardware

andsoftware

BBDCo.#11112 Yes

E-RecorderSetUp(MechanicalInstallation)

TAG-123 InstallationasperVendorManual,sensorsignalandchannelconfiguration,displayconfiguration

BCDCo.

#11113

Yes

MemoryCard NA Location,StorageSize DCDCo.

#11114

Yes

UninterruptablePowerSupply(UPS)

TAG-456 Serverand/ore-recorderback-up?

ABCDCo.

#11115

Yes

12.3 Input/Output(I/O)Checks–Afterhardwareandsoftwareconnectionsaresetupandverified,I/Ochecks(alsoknownasfunctionalchecks)shouldbecompleted.I/Ocheckstestallcriticalfielddevicesforproperoperation. These functional checks also verify that electrical output signals to all critical devices arefunctioningproperly.SuchchecksshouldbedocumentedasseeninTable7.

Table7:FunctionalityChecks


FunctionalityVerified?

SignatureandDate

TemperatureSensor

TE-1 ProductTemperatureRTD–HoldTubeInlet

ABCCo.

#11115

Yes

PressureTransmitter

PT-3 SystemPressurePTD–HoldTubeOutlet

ABCCo.

#11116

Yes



Table7:FunctionalityChecks


FunctionalityVerified?

SignatureandDate

E-Recorder TAG-123 CriticalFactorDataRecording

BCDCo.

#11117

Yes

12.4 CalibrationVerification–Allcriticalsensorsandtransmittersthataretoberecordedmustbeverifiedforcalibration after the electronic chart recorder is installed and periodically thereafter.Also, signals fromthe same sensor should display the same value on the HMI/Display device as on the recorder. Theseresultsmustbedocumented.Forexample,thefollowingcriticalsensorsshouldbeverifiedforcalibrationonanaseptic system:Hold tubeexit temperature,product flow rate,pressuredifferential, finalheatertemperature,timers,CIPparameters,etc.SeeTable8belowforexampledocumentation.

Table8:CalibrationVerification

DeviceSpecification Tag# Description/Location Manufacturer/

Serial#CalibrationVerified?

SignatureandDate

TemperatureSensor TE-1 ProductTemperature–HoldTubeInlet

ABCCo.

#11115

Yes

TemperatureIndicatingDevice

TI-2 ProductTemperatureRTD–HoldTubeOutlet

ABCCo.

#11118

Yes

PressureTransmitter PT-3 SystemPressurePTD–HoldTubeOutlet

ABCCo.

#11119

Yes

12.5 Deviation Handling A Deviation handling section should be created for the Installation Qualificationprotocol ifadeviationorabnormality isexperiencedduring IQ. Properdocumentationwillensure thatthedeviationishandledcorrectlyandfollowedup.ThevalidationteamshouldevaluateifthedeviationintheIQprotocolissignificantenoughtoconsiderrevalidatingallitemsrelatedtothefailure.SeeTable9belowforexample.



Table9:DeviationHandlingDuringInstallationQualification

DeviationDescription RecommendedCorrectiveActions ResultsVerification SignatureandDate

13.0OPERATIONALQUALIFICATION(OQ)

After InstallationQualificationhasbeencompleted, theOperationalQualificationphasecanbegin. ThepurposeoftheOQistoconfirmthattheelectronicchartrecordingsystemoperatesas intendedduringnormal and abnormal operating conditions. This is accomplished through completion of functionalitychallenge tests which will verify the operation of each item listed in the Functional Specification. Inaddition, several Standard Operating Procedures (SOPs) must be created and implemented prior toclosureofOperationalQualification.

13.1 StandardOperatingProcedures(SOPs)–TheOQprotocoldevelopedwillverifyimplementationofseveralcriticalStandardOperatingProceduresfortheelectronicchartrecordingsystem.TheSOPs should include a System Operation SOP and a Logical Security SOP detailing therequirements and handling of user IDs and passwords. The Logical Security SOP should becompletedpriortoperformingtheOQfunctionalitytestsastheoperationoftheprocedurewillbetestedduringthechallengetests.

Table10:RequiredStandardOperatingProcedures

StandardOperatingProcedure(SOP) Verification/Comments SignatureandDate

ElectronicChartRecorderUserProcedure SOP#dated01/01/01

LogicalSecurityProcedure(UserIDandPasswordHandlingProgram)

Document#dated01/01/01

E-Recordkeeping&RecordReviewProcedure Document#dated01/01/01

13.2 Functionality Challenge Tests –OQ Functionality Challenge Tests should clearly demonstratethat the electronic chart recording system will function as expected, and that data can be collected,stored,retrievedandsecuredasper21CFRPart11,local/predicateruleandcorporaterequirements.In



order to ensure that all local/predicate rule requirements have beenmet, functionality tests must beperformed during eachmode of operation of the processing equipment as applicable (i.e., Cleaning inPlace, Equipment Pre-sterilization, and Production modes for an aseptic system). As with IQ, testingresultsmustbedocumentedwithapplicablesign-offs.BelowisalistoffunctionalitytestcasesthatmustbeconductedduringOQphase.

FunctionalityChallengeTestCases:

DataCollection• Set up and verify organization of processing charts on e-recorder display screen for each mode of

operation and on data management software (including chart format, chart display of date & time,graduation/scale,etc.).

• Verifyproperdateandtimearerecordedbyrecordingsystem;verifyDaylight SavingsTimeadjustmentcontrolisenabled.

• Verifythatthedatacapturedbythee-recorderisstoredintheinternalmemoryoftherecorderpriortobeingtransferredtothememorycardandserver.

• Ifmemorycardisused,determinethecapacityandamountofdataitwillholdbeforeitistransferredtoasecondarystoragesystem(i.e.,server),orbeginstooverwrite.

• Setupand verifydata transfer frome-recorder to thedatamanagement softwareand to thenetworkserver(testonbothadministratorandusercomputer).

• Setupandverifyprocessingdatacollectionandtransferratefore-recorderinternalmemoryandmemorycard.

• Verifydataforeachcriticalsensorisproperlyrecordedandnottransposedfromanothersensor.• Verifydatatransfertotheserveratthedesignatedrate(whethertransferredviaFTPordonebyarchiving

softwareinstalledontheserver).• Verifyserverdatascheduledbackup(i.e.onceevery12or24hours).• Set up and verify accuracy of product, equipment and processing information on electronic records to

ensuretraceability.• Setupalarmsandchallengealarmtoinitiateforoutofspecreadings,ifapplicable.• Verifyalarmsarefunctioningtoalertreachingacriticallimit(i.e.,minimumormaximum).

DataSecurity• VerifythatElectromagneticInterference(EMI)frommobilephones,walkietalkiesandothersources(e.g.,

electronicdrills)doesnotaffectreadingand/orrecordingofcriticalinstrumentdata.• Verify that the system is setupsuch that itwill automatically logout inactiveusersafteradefined time

period(e.g.,automaticlogoutafter10minutes).• Verifythatsystemwillnotlosedataforspecifiedtimeafterpoweroutage.• Verifysystemreactionforpowerlossorcommunicationfailure(e.g.,willtherebeanalarm?);verifyhow

thearchivingfunctionwillresumeundersuchsituations(i.e.,manuallyorautomatic?).• IfUPSinplace,howlongisthebackuppowersupplyavailableforandverifythatUPScoversbothserver

andrecorder.• Verifythatdataisstoredlocallywithoutinterruption,whenthecommunicationtotheserverisdisrupted.• Verify that thedata is transferred to theserverwithoutmissing recordswhen thecommunicationwith

theserverisrestored.

DataAccessTest e-recorder/server/software accessibility by unauthorized and authorized users at the plant,corporateandsupplieraccess(ifapplicable).

AuditTrailandRecordTraceability• Verifycommentsmadebytheoperatorand/reviewerhaveanaudittrail(i.e.,who,whenandwhat).• Verifythatelectronicsignatures/initialshaveadateandtimestamp.



• Verifythateventlog(i.e.,who,when&what)canbeproperlydisplayedontheelectronicchartrecorder.

CopiesofRecords&RecordRetention• Setupandverifycreationofprocessrecords/chartsondatamanagementsoftware.• Verifythatdatacanbeextractedbyuserswithauthorizedcredentialsonly(e.g.,recordreviewer).• Verifythatthedatatransferredtodatamanagementsoftwarecanberetrievedandsigned;chartscanbe

createdandprintedasrequired.• Verifyprocessrecordsarchivingandrecordretentiondurationasperregulatoryandcorporatestandards

(e.g.,checkarchiveddataeverymonth).• Setupandtestprinterfunctionscorrectlyandiscapableofprintingrecordswithcorrectscalegraduation

and/orresolution.Ifthedataareprintedinagraphicalformatfortherecordreviewer,theprintedcopymustmeetthecorrespondingpredicateregulations.

• Verifythatrecordretentiontimeframemeetsregulatoryandcorporaterequirements.• Verifythatprintedrecordsfrome-chartrecordersmeettherequirementsofapplicableregulations(i.e.,

predicaterulesrequirements).

ElectronicSignatures• Verifytherequirements/procedureslistedintheLogicalSecuritySOP,including:

• Verify that record reviewer can successfully apply electronic signature with timestamp toelectronicrecordusingsecuredsoftwareprogram.

• Verifythat“reviewed”electronicrecordsare“saved”tothedatastoragedeviceandpreferablysegregatedfrom“un-reviewed”records.

• VerifythatpasswordsexpireeveryXmonths,afterwhichtimeuserwillbeaskedtoresettheirpassword.

• VerifythatafterXunsuccessfuluserIDandpasswordloginattempts,logincredentialsarelockedandusermustbereinstatedbyasystemadministrator.

AdditionalfunctionalitytestsmayberequiredbasedontheRiskAssessment.Thelistaboveshouldbereviewedtoensure all functions are covered. Table 11 below shows an example format for documenting the FunctionalityChallenge Tests. This will be the proof and verification that each of the functionality tests was completed andsatisfactoryresultswereachieved.

Table11:OQFunctionalityChallengeTests

Test AnticipatedResultActualResult

SignatureandDate

Verifyhowsystemwillreacttopoweroutage/communicationfailure

Systemreactsappropriatelyforspecifiedtimefollowingsimulatedpower

outage/communicationfailure

VerifyElectromagneticInterference(EMI)one-recordingsystem

EMIfrommobilephone,2-waywalkie,andothersourcesdoesnotaffectrecordingof

criticalinstrumentdata



Table11:OQFunctionalityChallengeTests

Test AnticipatedResultActualResult

SignatureandDate

Verifyproperdateandtimearerecordedbye-recordingsystem

Correctdateandtimearerecordedbyrecordingsystem;DaylightSavingstimeenabled

Verifythatuserscanproperlyapplyelectronicsignaturewithtimestamp

afterreview

Userscanproperlyapplyelectronicsignatureandtimestamptorecordsafterreview

VerifySOPsareappropriatelyimplemented

Allnecessaryrequirementsasoutlinedintheprocedureareimplementedasdefined

Verifydatacollectionandtransferrate

Datacollectionandtransferrate(e.g.,3datapointspersecond)isenabled

13.3 Deviation Handling – A complete and comprehensive Operational Qualification, including allSOPs and tests, is requiredprior tomoving forwardwith the validation. ADeviationHandlingsection shouldbe created for thisdocument in caseadeviationor abnormality is experiencedduring OQ. The validation team should evaluate if the deviation in OQ protocol is significantenoughtoconsiderrevalidatingallitemsrelatedtothefailure.SeeTable12forexample.

Table12:DeviationHandlingDuringOperationalQualification


14.0PERFORMANCEQUALIFICATION(PQ)

ThePerformanceQualificationverifiesthatthechartrecordingsystemperformsasintendedthroughoutall anticipated operating ranges. In practice, this is to ensure that the system in its normal operating



environmentproducesacceptablerecordsthatmeetpredicaterulesand21CFRPart11requirementsandthatsufficientdocumentaryevidenceexiststodemonstratethattheserequirementsweremet.

PriortoperformingPQ,trainingshouldbecompletedtoencompassallSOPsgeneratedfromOperationalQualification.Plantpersonnel(e.g.,Operators,SupervisorsandRecordReviewers)whowilluseelectronicsignaturesmustcertifypriortousethattheirelectronicsignaturesareintendedtobethelegallybindingequivalent of their handwritten signature. Training must be documented and must cover proceduresspecifictooperator,recordreviewerandmaintenanceduties.

Following training, verification tests should be completed as defined in the PQ test protocol. PQ testresultsmustbedocumentedwithapplicablesignoffsandshouldbeperformedduringnormaloperatingconditions.

ThesuccesscriteriaforPQshouldincludeatminimum,butnotlimitedto,thefollowing:

14.1 All requirements (e.g., user needs and regulatorymusts) as outlined in the URS aremet anddemonstrated through three independent, successful, normal production runs. This includesmeeting21CFRPart11andapplicablepredicaterulerequirements(e.g.,21CFRPart113).

14.2 All tests as outlined in PQ test protocol produce anticipated results and are appropriatelydocumented.Seetable13belowforexample.

• For systems under 21 CFR Part 113, monitor the display of the unit over several cycles andcomparereadingswithcalibratedRTDand/orreferenceTID.

• Compare records from the electronic chart recorder with readings from either calibrated orreferenceinstrumentstoverifytheiraccuracy.Thedisplayofthecurrentdata,thedisplayofthehistoricaldata,andtheprintedrecordsshouldbeverifiedforaccuracy.

• The response time in the changes of values throughout the processmust bewithin the limitsspecifiedintheusermanualorDesignSpecificationsfortheunit.

• IntentionallygeneratefailurestoverifytheproficiencyoftheoperatorsinidentifyingthefailureandfollowingSOP.Forexample,generatelowtemperaturedeviation,and/ordeviationsinothercritical variablesmonitored by the electronic chart recorder, challenge communication failure,ensureclarityofthedatadisplay,checkthattheinformationonthechartdisplayis legibleanddoes not create confusion for the end user, challenge the proficiency of theoperators/supervisorsinenteringdata,reviewingandsigningrecords.

• Challengerecordretrievalfromstoragedevice,drive,and/orserverbyresponsibleparties(e.g.,personnelfromIT,QA,PA).

• Verifytheaccuracyandaccessibilityofhistorical(backup)records:Historicalrecordsareverifiedagainstprocesslogs,comments,audittrailsetc.

• Verifythatthestaffknowshowtoassociateatime/temperaturehistorywiththecorrespondingprocess cycleunder review:Whenchartsarepulledand recordsare reviewed, the transferredfileshaveatimebaracrossthebottomthatisthecorrecttime,whichallowscross-referencingaparticularprocesstimeandcyclefromtheoperatorlogs.Therefore,thereviewercancheckthathe/sheisreviewingthecorrectrecord.

• Verifythatwhenrecordsarereviewed,thedataarestoredinsuchamannerthattheyareclearlyaccessibleviatheuserinterface.Thispreventstheaccidentalmisreadingofdataandeliminatesthe possible confusion. Data are pulled from the Chart by group and stored in the samestructure.

• Verify that the electronic chart records are reviewedwithin oneworking day by the staff foraccuracyandcompletenessofnotes.



• Verify thatwhentherevieweraddscommentstotherecord, thedetailedaudit trail (i.e.,who,when,what)areappendedtotherecord.Verifythattheaudittrailinformationcanbedisplayedwiththerecord.

• Verify charts can be printed out to meet predicate rule requirements (e.g., chart scalegraduations).

• Some companies and consulting groups conduct most of the challenge testing of the systemundernormalandabnormaloperatingconditionsduringtheOQphaseofqualification.

Table13:PerformanceQualificationTests

RUN1 RUN2 RUN3

Test AnticipatedResult

ActualResult

SignandDate

ActualResult

SignandDate

ActualResult

SignandDate

OperatorLogOn InputofcorrectUserIDandPasswordwillallowaccesstotherecorder.

Operator/SupervisorDataEntryandRecord

Review

Userscanmakecomments,adde-signaturetothechartandfollow

applicableSOP’s.

E-RecorderDisplaySetUp

E-recordergraduationscalecannotbeamendedbyunauthorizeduser,DisplayclarityisacceptableandE-recorderissetupsuchthatitiseasytousebythe

enduser.

CriticalFactorTrendsPrintingCapability

Printedchartworkingscaledoesnotexceed55F°perinchandgraduationnotexceeding2F°tomeetpredicate

rulerequirements.

QualityManager/recordreviewerlogon

toreviewdata

QualityManager/recordreviewercanlogonandreviewdatausingsoftware.

QualityManager/RecordReviewer

signature

QualityManager/RecordReviewercaninputsignature,addcommentswith

date&timestampwithinrequiredtimeframe.




RUN1 RUN2 RUN3


ActualResult

SignandDate

ActualResult

SignandDate

ActualResult

SignandDate

DataBackuptoServer Dataisappropriatelybacking-uptothedesignatedserveranddataisstoredat

apre-definedfrequency.

DataStorageandRetrieval

DatacanbestoredandretrievedfromE-recorderinternalmemory,externalmemorycardandserverbyresponsibleparties(e.g.,IT,QA,ProcessAuthority

etc.)

AuditTrail Audittrail(i.e.,who,when&what)isappendedtotherecord.Audittrailinformationisdisplayedwiththe

record.

CriticalFactorDataRecords

Processingdataforallcriticalfactorsarerecordedandtrendedasper

corporateandapplicableregulatoryrequirements.

E-RecorderCriticalFactorReadings

ProcesscriticalfactorreadingsonE-Recordermatcheswithcalibrated

sensorand/orTID.Appendoperatorlogsheets,PLCprintouts,e-chart

images/trendsetc.

UserProficiencytoIdentifyFailures

OperatorandRecordReviewersidentifiedfailures/deviationsand

CommunicationfailureviaE-recordermonitoringorduringrecordreview.




RUN1 RUN2 RUN3


ActualResult

SignandDate

ActualResult

SignandDate

ActualResult

SignandDate

E-RecordIdentification Records/trendsaccuratelycorrespondtoprocesscycleunderreview.The

recordIDisbasedonbatchcodeand/ordaycodewhichallowscross-referencingparticularprocesstimeandcyclefromtheoperatorlogstoensurecorrect

recordisreviewed.

RemoteDataAccessviauserinterface

Softwareisconfiguredsuchthatdataispulledfromthechartbygroupnameandstoredinthesamemannertopreventmisreadingandtoeliminate

confusion.

14.3 AnydeviationsfromPQtestsaredocumented.Thecrossfunctionalteamshouldreviewthe impactthatthedeviationmayhaveonvalidationandevaluate ifchangesmustbemadetotheURS,FS,DS,IQ,OQ,andPQ.Correctiveactionsareverifiedandapprovedbytheresponsibleparty.

Table14:DeviationHandlingDuringPerformanceQualification


15.0VALIDATIONREPORT

Thequalificationactivitiesshouldconcludewiththecreationofafinalvalidationreport.Thisfinalreportwillactasdocumentedevidencethatthevalidationwascompletedwithsuccessfulresults.Thevalidationreportmaybeasummaryofallthedocumentationgeneratedfromthevalidationplan,URS,FS,DS,IQ,



OQ,andPQ. Thevalidationrecordsshould includeapplicableteamsign-offs foreachactivityaswellasdocumentedsign-offontheoveralloutcomeofthevalidation.

Thevalidationdocumentsandfinalvalidationreportmustbeconsideredaspermanentrecordsandkeptonfileattheplantand/oratthecorporatelevel.Ifanyregulatoryquestionshouldarise,thesevalidationrecordsshouldbemadereadilyavailabletoanauditororFDAinvestigator.

16.0CONTINUEDVERIFICATION,ONGOINGTRAINING,ANDCHANGECONTROL

The documentation of the validation for the electronic chart recorder is a live document. Continuedverificationisanintegralpartofanywellqualifiedandvalidatedsystem.Thefunctioningandoperationof the electronic chart recording system should be verified and documented on a periodic basisthroughoutitslifetimetoensureintegrityandreliability.Thehardwareshouldalsocomplywithsuitablestandardsforprotectioninafactoryenvironment(e.g.,electricalshielding,dustandwateretc.).

Trainingandawareness sessionsaround the functioningofelectronic chart recording systemshouldbeconductedtoeducatetheendusers,andtoensurecontinuedcompliancewith21CFRPart11andrelatedSOPs. Depending on access level, different types of training sessions may be required for the endusers. Such training sessions shouldbedocumented for all users and conductedona regularbasis fornewandexperiencedpersonnel.Thevalidationdocumentsareausefulsourceoftraininginformationfornewtraineesorstaffturn-over.

Oncequalified,anelectronicchartrecordingsystemmustbemaintainedinitsvalidatedstatethroughthesite’s effective change control program. Changes to hardware, software and/or procedures might benecessary toupgrade the system, to replaceobsoletecomponents,and/or toenhance its functionality.Theimpactofthesechangesmustbereviewed,approvedanddocumentedbythevalidationteam.Anychangestothesystemmayhaveanimpactthatmayrequirereviewingand/oreditingpartortheentirevalidationdocumentationsuchasURS,FS,DS,IQ,OQ,andPQ.



17.0REFERENCES

1. Aleem,H.,Zhao,Y.,Lord,S.,McCarthy,T.andSharratt,P.2003.Pharmaceuticalprocessvalidation:anoverview.JournalofProcessMechanicalEngineering.217:141-51.

2. CampdenBRI.Guidelinesforapplicationofpaperlesschartrecordersinthermalprocessing.CampdenBRI,ChippingCampden,Gloucestershire,GL556LD,UK.https://www.campdenbri.co.uk/white-papers/recorders.php.

3. CodeofFederalRegulations,Title21,Part113–ThermallyProcessedLow-AcidFoodsPackagedinHermeticallySealedContainers.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=113,accessedJanuary2016.

4. CodeofFederalRegulations,Title21,Part11–ElectronicRecords;ElectronicSignatures.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11,accessedJanuary2016.

5. Daniel,P.2014.UsingtheISPE’sGAMPMethodologytoValidateEnvironmentalMonitoringSystemSoftware.Vaisala.http://www.vaisala.com/Vaisala%20Documents/White%20Papers/CEN-LSC-G-Using-GAMP-Methods-to-Validate-CMS-Software-B211370EN-A.pdf.

6. DeSpautz,J.,Kovacs,K.S.,andWerling,G.2008March11.GAMPStandardsforValidationofAutomatedSystems.PharmaceuticalProcessing.http://www.pharmpro.com/article/2008/03/gamp-standards-validation-automated-systems.

7. Gough,M.2002March1.FacilityMonitoringSystemsValidation:APracticalApproach.ControlledEnvironments.http://www.cemag.us/articles/2002/05/facility-monitoring-systems-validation-practical-approach.

8. NationalFoodProcessorsAssociation.2002.NFPABulletin43-L,2nded.ValidationGuidelinesforAutomatedControlofFoodProcessingSystemsUsedfortheProcessingandPackagingofPreservedFoods.Washington,DC.

9. U.S.FoodandDrugAdministration.2011.Guidanceforindustryprocessvalidation:generalprinciplesandpractices.http://www.fda.gov/downloads/Drugs/Guidances/UCM070336.pdf.

10. U.S.FoodandDrugAdministration.2003.Guidanceforindustrypart11,electronicrecords;electronicsignatures—scopeandapplication.http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125125.pdf.

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ACKNOWLEDGMENTS

Thisguidancedocumentwaswrittenandeditedbyanadhoccommitteewhosemembersincluded:GeorgeAwuah,Amanda Beitler, Jenab Bhatia, Jacques Bichier, Don Guan, Aakash Khurana, Glenn Long, Tony Moh, StephanieNguyen,FerhanOzadali,MarcioScucugliaandAbdullatifTay.



The Institute forThermalProcessingSpecialists is anon-profitorganisationestablishedexclusively forthepurposeoffosteringeducationandtrainingforthosepersonsinterestedinprocedures,techniquesandregulatoryrequirementsforthermalprocessingofalltypesoffoodorothermaterials,andforthecommunicationofinformationamongitsmembersandotherorganisations.

Part of themandate of IFTPS Technical Committees is to develop protocols to be used as guides forcarrying out the work of thermal processing specialists. This protocol was prepared by an ad hoccommitteeofInstituteandreviewedextensivelybymembersoftheInstitute.

Thisdocumentmaybephotocopiedinitsentiretyforusebyinterestedparties.©IFTPS2018

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