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QualityManagement
QMSandQualityDocuments(SOP,GxP)
CARAforQualityManagementisacon鍖gurationpackagewithfunctionality
requiredformanagingQualitydocumentationaswellasQualityEvents,CAPA,
ChangeRequests,andQualityEvaluations.Thispackagecoversallthestandard
documentcreation,review,approval,signatureandpublishingfunctionality
required,aswellastraining(e.g.ToBeReadandUnderstood),reportingandfull
work鍖ow/lifecycleandChangeRequestManagement,togetherwithControlled
PrintingandQRcodedocumentviewing.Availablewiththispackageisalsothe
CARAPortalwithdedicatedsearchandviewingforconsumers.CARAPortalwithdedicatedsearchandviewingforconsumers.
DIAEDMReferenceModel
Documentandmetadataset-startingfrom
thereferencemodel.
QMSManagement
CreateandmanageQualityEvents,CAPA,
ChangeRequests.
eSignature,ControlledPrinting
CaptureandmanifesteSignaturesaspartofa
workow.Watermarkdocuments,and
managecontrolledprinting.
TrainingManagement
Buildtrainingmatricesandmanage
trainingonSOPsandotherdocuments,or
loggingtrainingonexternalsystems.
Contactusforademoorevaluationinfo@generiscorp.com|www.generiscorp.com
DocumentationFeatures QMSFeatures
Documentnumbering(basedonanycombinationof
properties)
ViewingE鍖ectiveversionsevenwhenmorerecentDraft
versionsexists
DynamicSecuritybasedonanycombinationof
properties
WorkowsforReview,Approval,PeriodicReview,WorkowsforReview,Approval,PeriodicReview,
MakingObsoleteetc
MechanismforSupersedingpreviousE鍖ectiveversions
PeriodicReviewworkowsandnotications
AutomaticallymakedocumentsE鍖ectiveonaparticular
date(e.g.PlannedE鍖ectiveDate)
ViewingdocumentsbyscanningaQRcode(e.g.oniPadViewingdocumentsbyscanningaQRcode(e.g.oniPad
inalab)
ChangeRequestmechanism
Watermarkingdependingonstatusoranyother
attributes-includingdi鍖erentoverlaysforviewing,
printing,exportingandcontrolledprinting
CapturingeSignatureonuseractionsandadding
eSignaturepageseSignaturepages
Controlledprintingincludingprintnumbers,reasonfor
printing,printaddressee
CreateQualityEvents(internalorexternal,forAudit
Findings,Compliants,etc)
UndertakeandcaptureRiskBasedAssessments
UndertakeandcaptureRootCauseAnalysis
CreateandmanageCAPAitemsforaQualityEvent,
includingsharingwithexternalauditeestoallow
themtoupdateCAPAinformationdirectly
Automaticallygenerateevents/CAPAintoasingleAutomaticallygenerateevents/CAPAintoasingle
document,tocreatee.g.AuditReportorCAPAReport
CreateandmanageChangeRequests,andlinkthem
todocumentationtoensuretraceabilityanddepen-
dency(e.g.donotallowclosingaChangeRequest
untiltheassociateddocumentisApproved)
AutomaticallyrelateQualityEvents,CAPA,Change
Requestsandassociatedcontenttoensurewider
traceability
Writerequirements,testscriptsandtextexecution
reports
UndertakeQualityEventE鍖ectivenesscheckingto
ensurethedeviationsolutionwassuccessful
Con鍖gurationPackageandoptions
Pre-con鍖gured
DocumenttypesusedintheDIAReferenceModel
MetadatafromtheDIAReferenceModel
DocumentLifecycle
Securitydenitionbasedontypicalgroupsandlifecycle
WorkowsforReview,Approval,PeriodicReview,
MakingObsolete
ChangeRequestmechanismChangeRequestmechanism
Client-sideControlledPrinting
Templatesdenition
3documentviewsincludingsearch,columns,widgets
anddimensions
Standardreports(user,controlledprints,training,
administrative)
Includedbutneedcon鍖g
1Signaturepagetemplate
1overlaytemplate
1autonaming/numberingscheme
Optionalextras
Additionalsignaturepagetemplates
Additionaloverlaytemplates
Additionalautonamingschemes
AdditionalLifecycles
Additionalworkows
Changingpermissionsmodel
AdditionalviewsandreportsAdditionalviewsandreports
CARAisdesignedtoserveasaseamlessplat-
form forallregulatoryapplicationrequire-
ments.However,werealisethatthereare
otherapplicationsandmanytoolsthatyour
businessrelieson.
Theconceptofacentralsourceoftruthisto
createasingleplacetoaccessallthatcontent
anddataregardlessofwhereitisstoredand
managed.
WhileWhileaparticularbusinessgroupmayusea
particulartoolfortheirnicheprocess,that
contentanddataisavailableinCARAtobe
tracked,managedandre-usedacrossyour
business.
Search&ReportAcrosstheEnterprise
PreventContent,Information,andE鍖ortDuplication
ProvideaCentralAuthority
EnterpriseCentralSourceofTruth
Documentationandtimelines
Documentation
Forallpre-congureditems,andforthoseincludedbut
havingspeciccustomercongs:
UserRequirementsSpecication
FunctionalRequirementsSpecication
SystemDesignSpecication
Systemtestscripts
Traceabilitymatrix
AdditionaloptionalextraswhichareconguredcanbeAdditionaloptionalextraswhichareconguredcanbe
addedtodocumentation.
Timelines
Thetypicaltimelines(dependingoncustomerpro-
cesses)fortheout-of-the-boxdeployment:
Projectplanning1week
Requirements(includeditems)2weeks
Build(includeditems)3weeks
Documentation(includeditems)3weeks
Validation&installation6weeks
Optionalextrasincludearchitecture,installation,
andtrainingandaddtothetime.

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