The CARA workspace allows you to manage QMS and Quality Documents such as SOPs and GxP.

1. www.generiscorp.com
QualityManagement
QMSandQualityDocuments(SOP,GxP)
CARAforQualityManagementisaconfigurationpackagewithfunctionality
requiredformanagingQualitydocumentationaswellasQualityEvents,CAPA,
ChangeRequests,andQualityEvaluations.Thispackagecoversallthestandard
documentcreation,review,approval,signatureandpublishingfunctionality
required,aswellastraining(e.g.ToBeReadandUnderstood),reportingandfull
workflow/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.

2. Contactusforademoorevaluationinfo@generiscorp.com|www.generiscorp.com
DocumentationFeatures QMSFeatures
Documentnumbering(basedonanycombinationof
properties)
ViewingEffectiveversionsevenwhenmorerecentDraft
versionsexists
DynamicSecuritybasedonanycombinationof
properties
WorkowsforReview,Approval,PeriodicReview,WorkowsforReview,Approval,PeriodicReview,
MakingObsoleteetc
MechanismforSupersedingpreviousEffectiveversions
PeriodicReviewworkowsandnotications
AutomaticallymakedocumentsEffectiveonaparticular
date(e.g.PlannedEffectiveDate)
ViewingdocumentsbyscanningaQRcode(e.g.oniPadViewingdocumentsbyscanningaQRcode(e.g.oniPad
inalab)
ChangeRequestmechanism
Watermarkingdependingonstatusoranyother
attributes-includingdifferentoverlaysforviewing,
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
UndertakeQualityEventEffectivenesscheckingto
ensurethedeviationsolutionwassuccessful
ConfigurationPackageandoptions
Pre-configured
DocumenttypesusedintheDIAReferenceModel
MetadatafromtheDIAReferenceModel
DocumentLifecycle
Securitydenitionbasedontypicalgroupsandlifecycle
WorkowsforReview,Approval,PeriodicReview,
MakingObsolete
ChangeRequestmechanismChangeRequestmechanism
Client-sideControlledPrinting
Templatesdenition
3documentviewsincludingsearch,columns,widgets
anddimensions
Standardreports(user,controlledprints,training,
administrative)
Includedbutneedconfig
1Signaturepagetemplate
1overlaytemplate
1autonaming/numberingscheme
Optionalextras
Additionalsignaturepagetemplates
Additionaloverlaytemplates
Additionalautonamingschemes
AdditionalLifecycles
Additionalworkows
Changingpermissionsmodel
AdditionalviewsandreportsAdditionalviewsandreports

3. CARAisdesignedtoserveasaseamlessplat-
form forallregulatoryapplicationrequire-
ments.However,werealisethatthereare
otherapplicationsandmanytoolsthatyour
businessrelieson.
Theconceptofacentralsourceoftruthisto
createasingleplacetoaccessallthatcontent
anddataregardlessofwhereitisstoredand
managed.
WhileWhileaparticularbusinessgroupmayusea
particulartoolfortheirnicheprocess,that
contentanddataisavailableinCARAtobe
tracked,managedandre-usedacrossyour
business.
Search&ReportAcrosstheEnterprise
PreventContent,Information,andEffortDuplication
ProvideaCentralAuthority
EnterpriseCentralSourceofTruth
Documentationandtimelines
Documentation
Forallpre-congureditems,andforthoseincludedbut
havingspeciccustomercongs:
UserRequirementsSpecication
FunctionalRequirementsSpecication
SystemDesignSpecication
Systemtestscripts
Traceabilitymatrix
AdditionaloptionalextraswhichareconguredcanbeAdditionaloptionalextraswhichareconguredcanbe
addedtodocumentation.
Timelines
Thetypicaltimelines(dependingoncustomerpro-
cesses)fortheout-of-the-boxdeployment:
Projectplanning–1week
Requirements(includeditems)–2weeks
Build(includeditems)–3weeks
Documentation(includeditems)–3weeks
Validation&installation–6weeks
Optionalextrasincludearchitecture,installation,
andtrainingandaddtothetime.