All industries have had to evolve in some form over the past decade – and the pharmaceutical and bioscience industries are no different. The continued global recession coupled with an influx in expiring patents, and long research and development cycles have caused many pharmaceutical and medical companies to focus on increasing efficiencies and driving cost savings in order to ensure prosperity.
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Christopher Anderson SPHR CBS VP HR HR Compliance
1. HR Compliance inpharmaceuticals
All industrieshave hadtoevolve insome formoverthe pastdecade – and the pharmaceutical and
bioscience industriesare nodifferent.The continuedglobalrecessioncoupledwithaninfluxin
expiringpatents,and longresearchanddevelopmentcycleshave causedmanypharmaceuticaland
medical companiestofocusonincreasingefficienciesanddrivingcostsavingsinorderto ensure
prosperity.
However,whilereducingcostsmaybe a toppriority,bioscience,pharmaceutical andmedical device
companiescannotdoit byweakeningtheirfocusoncompliance.Compliance isakeyissue forthe
pharmaceutical industryandnon-compliance canresultinbillionsof dollarsinfines,auditsand
recalls.Despite the dangersof non-compliance,recentresearchfromCuttingEdge Information
foundthat compliance teambudgetsdroppedbyanaverage of 24 percentin2012 for medical
device companiesandremainedflatforpharmaceuticalorganizations.Withfewerresources
devotedtocompliance,companiesintheseindustriesmustleverage all toolsavailabletoensure
theyare adheringtoregulations.
One way thatmany pharmaceutical andbioscience organizationscanfocusoncompliance while
savingmoneyandresourcesisbyleveraginghumanresourcestechnologiesandoutsourcing.Many
pharmaceutical companiesalreadyemployHRtechnologiesandoutsourcingtostreamline
administrativetasksandcut costsin payroll,talentmanagement,benefitsadministrationandother
HR functions.HRtechnologiesandoutsourcingcanalsohelpcompaniesfocusoncompliance related
to humanresourcesmanagement,compensationandfinancialreporting.Byunderstandingwhatto
lookforin the rightHR processproviderpartner,pharmaceutical,bioscience andmediadevice
companiescanbuildstronginfrastructuresformanagingHRthat alsoprovide immensegainsin
compliance.
AchievingPayroll andCompliance Harmony
Human resourcesshouldbe topof mindwhencompaniesthinkaboutcompliance ashumancapital
expensescanaccount for40 to 60 percentof a company’sexpenditure –resultinginHR
departmentsmanagingalarge percentage of anorganization’sfinances.WithHRtransactionsso
inextricablylinkedtoacompany’sfinancials,the operationsandcostsof HR can have a huge impact
on compliance.
The focus oncompliance isespeciallyimportantinpayroll asatall timescompaniesmustfocuson
bothlocal compliance andglobal implicationsif theywishtosucceedinthe global marketplace and
provide theiremployeeswithqualityservices.Organizationsmustensure theyare compensating
theiremployeesaccordingtolocal law,while beingmindfulof the impactthiscan have ontheir
global workforce.Global trendscanaffectlocal lawsandvice versa,reinforcingthe importance of
havinga commandof bothtypesof regulations.
HR technologiescanplayapivotal role inhelpingpharmaceutical companiesmanage local and
global compensationregulations.Byleveragingoutsourcedpayroll solutions,pharmaceutical
companiescangainvisibilityintothe compensationlandscape of theirentire workforce.Thisis
particularlyvaluableforcompanieswithamulti-countryemployeebase,asorganizationscanthen
compare salariesandcompensationacrossthe entire workforce toensure consistency,fairnessand
adherence withthe company’spaymentstandards.
2. In additiontograntingvisibility,outsourcedpayrollsolutionsandHRtechnologiescanalsohelp
organizationsstayabreastof legislativechangesthatimpacttheirworkforce.Supportingany
outsourcingsolutionisadedicatedteamof global compliance consultantswhostayinformedon
legislative andregulatorychanges.These consultantsmonitorlegislative changesthroughoutthe
governmental,legal andpharmaceutical industriesall overthe world.Whennew lawsorregulations
arise,thisteamleveragesthe company’sHRtechnologiestoimplementthe necessaryprocessesand
proceduresintothe payroll systemwithoutinterventionfromthe company.
Examplesof the importance and usefulnessof compliance oversightrelatedtopayroll isillustrated
inrecentlegislative changesinAustraliaandBelgiumregardingthe minimumwage increaseand
olderworkersupportmeasures.ForcompanieswithworkforcesinAustraliaandBelgium, ensuring
that theirpayroll processesaccommodatethese regulationsiskey,aswell asunderstandinghow
these changesaffecttheiroverall global employeebase.Forthisreason,outsourcedpayroll
technologiesare vital astheymarry legal compliance expertise andcompensationneedstohelp
companiesmanage local changesinaneffective andefficientmanner.
Notonlydo HR technologiesallowforstrongercompliance controlsastheyrelate tofinancialsand
legislative changes,theyalsosupportacompany’sHR and compliance activitieswithemployees.For
example,dataresultingfromthese technologiescanbe usedto ensure all employeesare
participatinginthe compliance activitiesandtraining,asthe datacan reveal whichemployeeshave
confirmedtheirknowledge of the code of conductand participatedincompliance learningevents.
Additionally,these toolsprovidea“one stopshop” of resourcesrelatedtocompliance,empowering
employeestotake ownershipintheirunderstandingof andactivitiesregardingcompliance.
AnalyzingHRdata can alsohelpquantifythe makeupof aworkforce (percentage of employeesin
sales,forexample).Bycomparingthisinformationagainstdataoncompliance breachesandSLA,
companiescanbetterunderstandwhichdepartmentsmay needstrongeroversightandavoidfines
and feesrelatedtolate payroll andtax filings.
CertifiedinCompliance
In additiontoremainingcomplianttolocal payregulations,pharmaceuticalcompaniesmustalsobe
aware of requirementsregardingfinancial reportingtoavoidheftyfinesoradditional audits.
Complimentsof the Sarbanes-OxleyAct–whichrequiresacompany’sannual confirmationthatits
internal controlsoverfinancialreportingare effective –accuracy andtransparencyaroundfinancial
reportingcontinuestobe criticallyimportant.Underestimatingoroverlookinghumanresources
expensescanleadtoextremelyskewedfinancial reporting –a majorrisk forthose inthe
pharmaceutical industry.Assuch,itisvital thatorganizationshave anaccurate picture of their
workforce andthe expensesrelatedtothe outsourcingof humanresources.
WhenselectingaHR outsourcingprovider,one of the firstthingsthatpharmaceutical companies
shouldinquire aboutisthe provider’sServiceOrganizationControl ReportsorSOC1.The SOC1
reportverifiesthataservice organization(HROprovider) hascompletedanin-depthauditof its
internal control processes,includingITandenterprise wide controls,relatedtoitsoutsourced
services.Thisreportassuresoutsourcedservicesare beingproperlyperformedandmonitoredin
orderto ensure the successful presentationof the client’sfinancial reports.
The audit specifically:
>providesanindependent,third-partyassurance aroundthe adequacyof internal controls
>demonstratesasoundinternal control environmentoverfinancial reportingdata
3. >establishesanavenue foridentifyingopportunitiesforimprovementinbusinessprocessesand
managementof informationtechnologyoperations
Ensuringyourproviderhassuccessfullycompletedthe SOC1iskeytoa compliantHRoutsourcing
engagement.Othercertificationspharmaceutical companiesshouldlookforinclude:
SSAE16- the more advancedauditevolutionof SAS70, whichrequiresawrittenassertionregarding
operatingeffectivenessandbetteralignswithinternational standards
ISO9001- to ensure efficientandeffective qualitymanagementprocessesare inplace
ISO27001- regardinginformationsecuritytovalidate thatanemployeepopulation’spersonal datais
safe
BS 25999- focusedonbusinessensure the resiliencyof service operationsdespite disruptions
beyondourcontrol
KeepanEye onCompliance
Pharmaceutical,bioscience andmedical device companiesface anumberof challengesincludinga
tougheconomy,continual changesinthe healthcare space andarise in generics.The lastissue they
needtocontendwithiscompliance.Withsomanychallengestotackle,companiesmustmanage
compliance inastreamlinedandefficientway,toallow time andresourcestobe spenton
addressingmarketplace andindustrychanges.ByleveragingHRtechnologiesandoutsourcing,
organizationscanefficientlymanage numerousfunctionsof HRwhile keepingaclose eye on
compliance
Source : Pharma blog
Recommendedby:
CHRISTOPHERT. ANDERSON,SPHR,CBS
Vice President,HumanResources
Mölnlycke HealthCare, Atlanta,GA
email:ctanderson209@sbcglobal.net
https://www.linkedin.com/in/chrisandersonsphr
Mölnlycke HealthCare,AbbottLaboratories,HospiraInc.,Hill-Rom,The Ertl Company
Pharma,Pharmaceuticals,Biopharm, Biopharmaceuticals,Medical Devices,Biotech,Biotechnology
http://www.zoominfo.com/z/ChrisAnderson
http://www.yatedo.com/p/CHRISTOPHER+ANDERSON/normal/e23ed9da3ff1b552ba6fcd85dff79f0c
