Find out more about using the CARA Workspace for Safety including PSURs, SABR, Educational Materials and Aggregate Reports.

1. www.generiscorp.com
PSURs/SABR/EDUCATIONALMATERIALS
/AGGREGATEREPORTS
ManagingSafetyisanongoingtaskofdistributingsafetyinformationonaperiodic
basistoaffiliates,distributorsandotherthirdpartiesresponsibleforsafetyreporting
toNCAs,andtrackingtheregistration/agencyinteractions.CARAfacilitatesthe
entireprocess.
CARAforSafetyDistribution–Exampleworkflow
DISTRIBUTION
Triggerworkowsfordistri-
butionofsafetydataand
documentstoaffiliatesand
distributors–manually,or
automatedviaanAPIcall
fromanexternalsystem.
DOCUMENTATION
Managethecreation,
reviewandapprovalinter-
nallyofPSURs,SABRSig-
nals,EducationalTools,Ag-
gregatereportsandmore.
PORTALACCESS
Distributors,affiliatesand
otherthirdpartiescan
accessCARAviaasimple
portaltoacknowledge,
submitandconrmre-
quiredactionswith
Agencies.
TRACKING
Centralregulatoryaffairs
hasareal-timeview
per-productandper-
countryofthestatusof
safetydocumentreceipt,
submissionandregistra-
tion.
Sendfor
processing
CentralRegulatory
Affiliate/Distributor
Affiliate/Distributor
Acnowledge
Receipt
Receiveandprocess
comments
Receive
Respond
CountryHA
Submission
ConrmHA
processcomplete
DistributepapertoHCPs
DistributeelectronicallytoHCPs

2. Contactusforademoorevaluationinfo@generiscorp.com|www.generiscorp.comContactusforademoorevaluationinfo@generiscorp.com|www.generiscorp.com
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
COMPLEXSAFETYWORKFLOW CARABENEFITS
Therearemultipledocuments(e.g.PSURs,Educational
Tools,SABRSignals,etc)thatarerequiredtobedistrib-
utedtoAffiliatesandDistributorsforregistrationand
processintheirlocalmarkets
Traditionallythosetoolsinvolveexternalsystemsfor
sharingcontentANDsomeseparatesystemforregister-
ingandreportingonsubmissionstatus
ThiscanallbedonethroughCARA,withAffiliates/Dis-
tributorsloggingintoasimpleUItoperformtheirtasks
DenecomplexworkowsinCARAbasedonprocess
ratherthandocuments
DistributedocumentstoAffiliatesDistributorsincluding
SettingServiceLevelAgreementsforeachstepofthe
process
Deningdefaultparticipantspercountry/productcomDeningdefaultparticipantspercountry/productcom-
bination
AllowAffiliatestologintoasimpliedCARAPortaland
see/processjusttheirworkows,includingvisibilityof
theassociateddocuments
Allowforautomatednoticationsoneachstep,includ-
ingoverduenoticationsandescalations
AllactionsaddedtothedashboardsocentralRegulaAllactionsaddedtothedashboardsocentralRegula-
toryhasarealtimeviewofthestatusofeachactivity
countryproduct
Maximisetheuserexperience
simpletolearnanduseandpersonalisedtoeach
individual’srequirements
Accessandmanagecontentfromoneplace
asingledestinationuserinterface,integratedseam-
lesslywithmultiplesystems
Meetcorporateandregulatorystandards
congureCARAtosuityourexactrequirements
Supportsthefulldocumentlifecycle
fromcreationtoaccess,search,review,approvaland
publication
Automatemanualprocesses
withCARAworkows
EasilynavigateandsearchcontentEasilynavigateandsearchcontent
CARAprovidesmultiplewaystoaccesstheinforma-
tionyouneed
Securelyaccesscontentonthego
ourmobileappsgiveyouthefullCARAexperience
Securelyshareinformationwithexternalpartners
securethird-partyaccess,watermarkingandmore