The Challenges of Remote Auditing Faced by the

Level 3 Level 3

Volume 15 Issue 2 Article 10

2020

The Challenges of Remote Auditing Faced by the Pharmaceutical The Challenges of Remote Auditing Faced by the Pharmaceutical

Industry Industry

Megan Hannon Technological University Dublin, [email protected]

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Recommended Citation Recommended Citation Hannon, Megan (2020) "The Challenges of Remote Auditing Faced by the Pharmaceutical Industry," Level 3: Vol. 15: Iss. 2, Article 10. doi:https://doi.org/10.21427/yj8x-cm05 Available at: https://arrow.tudublin.ie/level3/vol15/iss2/10

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Level3 Issue17,December2020 TechnologicalUniversityDublin

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AuthorMeganHannon,TechnologicalUniversity(atDublin

Abstract

Onthe11thofMarch2020,theWorldHealthOrganisation(WHO)declaredtheCOVID-19outbreak as a global pandemic. The way companies operated had to change and manypeoplearenowencouraged towork fromhome. Companieshavehad toadaptmanyoftheir work practices and in some cases adopt new ways conducting activities suchconducting and hosting of audits. The paper seeks to investigate the challenges andpotentialbenefitswithconductingremoteaudits.

Anindustry-basedsurveywasconductedtoidentifythechallengeswithconductingremoteauditsfromthepharmaceuticalindustry’sperspective.Toovercomesomeofthechallengesidentifiedanactionplanisproposedtofacilitatecompaniesinpreparingforremoteaudits,asitappearsthis“newnormal”maybesomethingthatweallhavetoadapttointhefuture.

IntroductionOnthe11thofMarch2020,theWorldHealthOrganisation(WHO)declaredtheCOVID-19

outbreak as a global pandemic(WHO, 2020). COVID-19 is a highly contagious virus that

attacks the lungs and airways. There is currently (at the time of writing this paper,

November 2020) no vaccine approved for COVID-19. Due to the fast spread of the virus

throughout the world, governments are developing and enforcing plans to control the

spreadoftheviruswithintheircountries.ThefirstcaseofthevirusinIrelandwasconfirmed

on the28thofFebruary. International travelbans formanycountrieswereenforced inan

efforttocontrolthespreadofthevirus.Thistravelbanhasimpactedmanyindustrysectors,

includingthepharmaceuticalindustry.Oneimpactofthistravelbanwasthepostponement

of on-site ‘GoodManufacturingPractice’ (GMP) audits.Auditorswouldnormally travel to

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Hannon: remote auditing

Published by ARROW@TU Dublin, 2020


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manufacturing sites to inspect facilities; this is no longer possible with such travel bans.

Companieshavehadtocomeupwithnewapproachesandwaysofconductingsuchaudits.

Equally,regulatoryagentshavehadtodevelopplansonhowtoconductGMPcompliance

auditsutilisingstaffina‘remoteworking’environment.

TheEuropeanMedicinesAgency(EMA,2020)hasreleasedupdatedguidanceonauditsand

has deemed remote auditing acceptable.While travel bans are being rescinded by some

countries, rulesandgoodhygieneetiquette regarding socialdistancingwill still apply into

the future. Social distancing is definedmaintaining safe space (typically about 2metres)

fromsomeonenotfromthesamehousehold(CentersforDiseaseControlandPrevention,

2020). This is been termed the new ‘normal’; furthermore, it is anticipated that social

distancing will be in place until a successful vaccine is found. This ‘social distancing’

etiquettewillhaveamajor impactonGMPauditingon-site,evenwhenalltravelbansare

lifted.Thishasresultedincompanieswithintheindustry,conductriskmanagementplans

foralloftheiroperationsincludingauditingactivities.

With such restrictions and operational requirements now in place, companies and

regulatorsarenowexploringtheconceptofremoteGMPauditingtoreplacethetraditional

on-siteaudit.Onepossiblesolutionisremoteauditsperformedoff-sitethroughtheuseof

information and communication technology (FDA, 2020). When the European Medicines

Agency (EMA) issuedguidance toassist the industryduring theCOVID-19Pandemic; they

extended thevalidityperiodof currentGMPCertsandstated that ‘Ifneeded, inspections

willbecarriedoutremotelytosupportsuchextensions,withon-siteinspectionscarriedout

assoonasfeasible’(EMA,2020).

RemoteAuditingRemote/digital auditing is a form of accessing a company for compliance by

teleconferencing, phone calls and emails. Traditionally in the pharmaceutical industry

regulatory and supplier audits are held on site. The COVID-19 pandemic has forced both

companies and regulatory agents to think about the auditing process in a different way.

Withtheadvancesintechnologyitisnowpossibleforauditstobeheldremotely.

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Remote auditing is one of the audit methods described in International Standards

Organisation(ISO)guidancedocumentISO19011:2018AnnexA1(ISO,2018).However,this

waspublishedbeforetheoutbreakofCOVID-19.AnupdatedISOguidancedocument“ISO

9001AuditingPracticesGroupGuidanceon:REMOTEAUDITS”(ISO,2020)wasissuedinApril

2020andgivesextraguidanceonremoteauditingasaresultoftheglobalpandemic.The

guidancedocumentoutlinesdifferent areas that need tobe consideredwhen conducting

remoteaudits.Italsodetailssomepotentialrisksandlimitationswithremoteauditing.

‘The first step to ensure feasibility is determining what technology may be used, if

auditorsandauditeeshavecompetenciesandthatresourcesareavailable’

(ISO,2020)

Without the correct technology remote auditing is not possible. One pressing area of

concernthatmustbeaddressedbeforeremoteauditsaredecided is thatofdatasecurity

and protection. In terms of data security and protection there should be appropriate

agreements put in place between the auditee and the auditor. Before COVID-19 it is

possible that the use of screensharing and video recording many not been covered in

agreementsand thisneeds tobe rectified inany futurearrangements.The ISOdocument

states‘whenanalysingfeasibility,thedigitalqualityofthedatatobereviewedshouldalso

beconsidered’(ISO,2020).Thisisanimportantfactortobeconsideredasremoteauditing

maynotbefeasibleifacompany’sdocumentationisnotcompletelydigitised.

RegulatoryAuditsTheEMAcoordinatestheinspectionsformedicalproductsthataremanufacturedandsold

within the EuropeanUnion (EU). The EMAdoes not conduct audits itself, the competent

authorities of EU member states must conduct these audits, in accordance with EMA

guidance and regulations. The Health Products Regulatory Authority (HPRA) conducts

Regulatory GMP audits on behalf of the EMA in Ireland. Typically, these audits are done

every2to3years,usingarisk-basedapproach.

TheEMAhavestatedthatcurrentGMPcertificateswillbeextendeduntiltheendof2021

forcompaniesintheEuropeanEconomicArea(EEA).However,itshouldbenoted;thisdoes

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notcoveranychangestotheGMPCertificate.IfacompanyislocatedwithintheEEAbutthe

facility has never been inspected before, therewill be a need for a ‘distant assessment’.

This is identified as a remote audit, with the provision that ‘on-site inspection should be

conducted when circumstances permit’ (Medicines Agency, 2020). The EMA have stated

thattheywillconduct‘distantinspection’ifrequiredsocompaniesneedtopreparetohost

theseinspectionsifrequired.

SupplierManagementEveninthemiddleofaglobalpandemicthesafetyofdrugsdeliveredtopatientsisapriority

fortheregulatoryagents.Thismeanscompaniesmuststillensurethecompetencyoftheir

supplierandcontactmanufacturers. Itwasmadeclear in theEMAQ&Adocument issued

April2020that‘thattheobligationofmanufacturersandimporterstocomplywithGMPis

notwaived’(MedicinesAgency,2020)’.Companieshavehadtoadoptnewwaysofworking

andstillensuretheyhaveoversiteoftheirsuppliersandcontractmanufacturers.TheEMA

also identify and explain some regulatory flexibility during the COVID-19 pandemic in

relation to this aspect of suppliermanagement. Temporary changes arepermittedwhen

requirede.g.‘Onsitesre-auditsofsuppliers,andreplacementbyremoteaudits’(Medicines

Agency,2020).

An assessment using an appropriate risk-based approach and the use of a Quality Risk

Management system is recommended. ‘Remoteaudits shouldprovide confidence that the

contractedparty is fit-for-purposeandwillnotnegativelyaffect thewholesaledistribution

process’ (Medicines Agency, 2020). This requires companies to develop remote auditing

plans using a robustmethodology and framework. To explain, each situation should be

assessed,documented,andauthorisedusingarisk-basedapproach.

InJanuary2009ICHguidelineQ9onQualityRiskManagementwasreleased.Thisguidance

documentenablesmanufacturerstobuildinqualityriskmanagementtotheirprocessfrom

developmenttopackingandshippingwithinthestagesofproductlifecycle.Themainfocus

ofriskmanagement is toproduceasafeandeffectivedrugforpatients.ThetermQuality

RiskManagementisdefinedbytheICHas‘Asystematicprocessfortheassessment,control,

communication,andreviewofriskstothequalityofthedrug(medicinal)productacrossthe

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product lifecycle’. The term ‘risk’ is described as ‘The combination of the probability of

occurrenceofharmandtheseverityofthatharm(ISO/IECGuide51)’.Riskassessmentsare

usedtodeterminetherisksandhowtoeliminateormitigateagainstthem.

ICHQ9 identifies that quality risk management can be integrated into auditing and

inspections planning ‘To define the frequency and scope of audits, both internal and

external’Riskassessmentsconsiderdifferentfactorswhendeterminingtheauditschedule

suchas:perviousinspectionreports;and,thecomplexityoftheproduct.Riskmanagement

isusedbymanufacturersandtheregulatoryagentstoplantheirinspections‘Toassistwith

resource allocation. including, for example, inspection planning and frequency, and

inspection and assessment intensity’ (ICH, 2015). Bothmanufacturers and regulators are

advised to use riskmanagement tools to assess the risk in conducting audits during the

globalpandemic.Thegoalisalwaystoreducetherisktopatientsbutalsoduringaglobal

pandemic, theeliminationormitigationof this risk for inspectors tovisitamanufacturing

facility needs to be considered.Whilemindful of the recommendation that non-essential

travelshouldbeavoided;iftheriskassessmentscanjustifyeitherextendingtheperioduntil

theauditorperformingremoteaudits,thisrecommendationshouldbeobserved.

RemoteWorkingTheCOVID-19globalpandemichasimpactedtheworkinglivesofpeopleinmanydifferent

ways. Some of these impacts include people encouraged towork from home, the Irish

government as part of the ‘Plan for Livingwith COVID-19’ has stated remoteworking is

encouraged where possible across all levels of the plan (Ireland, 2020) . Equally, many

childcare facilities were forced to close or suspend services which in turn added greater

pressures on parents. The workplace and the childcare facility were now the home for

manypeople.Moreover,whiledifficulttohavepredictedaglobalpandemic;manypeople

werenotreadyforthischangeintheirdailylivesofworkandchildcare.Thesechangesin

lifestyleconditionshaveaffectedpersonnelintermsofpersonalstressintheirlives.

Studieslookingintothepsychologicaleffectsofremoteworkinghavefoundthatitcanlead

personneltofeeloverwhelmed,uncertaintyandsocialisolation(Allen,2020).Itissuggested

that thosewho primarilywork fromhome face isolation and are less able to collaborate

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effectively with colleagues (Allen, 2020). To overcome feelings of isolation people are

comingupwithnewideassuchasavirtualcoffeedate;assigning30minswithcolleaguesto

talk about issues other than work. Furthermore, it is found that often training for

teleworking/remoteworkingislacking,resultinginstaffstrugglingtodevelopacompetent

levelofefficiency(Grant,WallaceandSpurgeon,2013).Theglobalpandemic’sswiftspread

across the globe further tested organisations’ capabilities to deliver remote working

training. The main issue with remote working for staff members is finding the balance

betweenworkandhome life. More importantly,with technology there isa linkbetween

workandthehomeenvironment;boundariesareoftenblurredmakingithardforworkers

toswitchoff(Grant,WallaceandSpurgeon,2013).

There are also the technical difficulties with working remotely. Personnel need to have

accesstobroadbandwhileathometobeabletoconducttheirroleseffectively.Companies

alsoneed to ensure that their staff have the correct technology at home such as screen,

keyboards etc. Companies should also put in place procedures for security and

confidentially agreements while working remotely, these procedures and policies should

detailthecorrectprocessforworkingfromhometoensuretheconfidentialityofwork.The

procedures should include detail on topics such as paperwork being removed from the

manufacturingsiteandbroughttoapossiblylesssecurehome.Riskassessmentsshouldbe

conductedtoensurerisksofworkingremotelyarecapturedandmitigated.

Non-Verbal Communication Non-verbal communication involves the unspoken word, interactions between people

through body language, facial expressions, hand movements and eye contact. This non-

verbalcommunicationislostduringremoteaudits.Theexistenceofavisualchannelwhile

talkingfacetofaceincreasesthesocialpresencebyallowingforvisualcluesthatcanalter

themeaningoftheaudiochannelalone,often inunconsciousways(Short,J.,1976).Non-

verbalcommunicationhasaninfluenceoverthewholecommunicationprocess.

‘Peopleassumethatnon-verbalactionsdonotlieandthereforetheytendtobelieve

thenon-verbalmessagewhenaverbalmessagecontradictsit’(Bessonetal.,2005).

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Non-Verbalcommunicationcangiveawaydetailsthatmaynotbeexpressedduringverbal

communication. Body language is important during audits as it can relay or convey a

messagee.g.ifsomeone’slegisshakingitmaymeantheyarenervous.Orwhenanauditee

is moving their hand when explaining a process, it may mean they are passionate and

confident. Eye contact is another form of non-verbal communication and it is also

particularly important during audits. The frequency of eye contact may suggest either

interestorboredomormayevenbetraydishonesty(Bessonetal.,2005).Facetofaceaudits

by their very nature can reveal more non-verbal forms of communication to both the

auditor and the auditee. However, not all non-verbal communication is lost during

telecommunication.

Thetoneofanindividual’svoiceisconsideredanon-verbalcommunication.Toneofvoice

can communicate if a person is aggressive, critical, nervous, disappointed, monotonous,

friendly,enthusiastic,vivid,andpersuasive;thesedifferenttonescanbecuestotheauditor

aboutasituationinquestion.

Methodology – Industry Survey Asurveywascreatedtoprovidebothqualitativeandquantitativedataonperspectivesheld

on this research topic within the pharmaceutical and biopharmaceutical industry. This

surveywascreatedusing‘SurveyMonkey’;itconsistedof10questionsthatweredesigned

toobtaintheappropriatequalitativeandquantitativedataneeded.Conductingthissurvey

allowedtheauthortodiscoverandidentifycurrentopinionheldonremoteauditing.Data

gatheredalloweda“snapshot”ofopinionintheearlystagesofthe“workingfromhome”

situation we have found ourselves in and to draw some preliminary conclusions on the

impactsthisishavingonthepharmaceuticalindustry.

The survey was completed by seventy-six (76) personnel who work within the Irish

pharmaceuticalandbiopharmaceuticalindustries.ThesurveywassharedonLinkedIn,alsoa

numberofpersonnelwhohaveexperienceintheareaof‘RemoteAuditing;werecontacted

directlytocompletethesurvey.Oneaimofthesurveywastoidentifytheirperspectiveon

currentchallengestheyarefacingwithremoteauditing.

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Results1. Whatindustryareyouworkingin?

FromtheresponsesreceivedmajorityofpeoplewhorespondedworkedintheBio-

pharmaceutical industry (46%) or the pharmaceutical industry (37%) the other

respondentswhereinthemedicaldeviceindustryorother.

Figure3:INDUSTRYSECTOR

2. Whatdepartmentareyouworkingin?

Ofthe76respondents67workedintheQualityDepartmentintheircompany.Theother9

respondentsworkedbetweenQC,ManufacturingandValidation.

3. Hasyourcompanyconducted/hostedanyremoteaudits?

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This was asked in order to determine the number of remote audits that have been

conducted.Fromtheresponses,67%ofcompanieshaveconductedremoteaudits.22%of

respondents answeredNOwhile 10%DIDNOTKNOW if their companyhad conductedor

hostedanyremoteaudits.

Figure4:FREQUENCYOFREMOTEAUDITS

4. Have your company’s auditing procedures been updated to manage remote

auditing?

Question4wasaskedinordertodetermineiftheindustryhadconsideredremoteauditing

before the COVID-19 pandemic. 25% ALREADY HAD INFORMATION on remote auditing.

While 37% said YES, their procedures needed to be updated and 37% said NO their

procedureshavenotbeenupdated.

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Figure5:UPDATEOFAUDITINGPROCEDURES

5. Rank these remote auditing challenges in order ofwhat you think are themostchallenging1beingthemostchallenging5beingtheleastchallenging

Thisquestionwasaskedinordertodeterminetheindustry’sopiniononthechallenges

withremoteauditing.Thefollowingchallengeswererankedfrom1-5.

a. ConductingVirtualToursb. SharingofDocumentationc. DataSecurityConcernsd. InsufficientITPlatformse. ConductingPersonnelInterviews

All of the challengesprovidedwere identifiedwithbyall respondents. Conductingof

virtual tourswas ranked themost challengingby 29 respondents,whileData Security

Concernswasidentifiedby22respondentsasbeingmostchallenging.Furthermore,the

least challenging aspect was identified by 35 respondents as Conducting Personnel

Interviews.Overall,thepriorityofchallengesbytheirScoreMarkingwasidentifiedas:

1. ConductingVirtualTours. 3.67.

2. DataSecurityConcerns. 3.49.

3. SharingofDocumentation. 2.86.

4. InsufficientITPlatforms. 2.81.

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5. ConductingPersonnelInterviews. 2.16.

*Thescoremarkingiscalculatedbycalculatingtheaveragerankingforeachanswerchoice

Figure6:RATINGOFREMOTEAUDITINGCHALLENGES

6. Doyouthinkthereareanybenefitsofremoteauditing?

Thisquestionwasaskedtoidentifytheindustry’sattitudetowardsremoteauditing

and if it could returnbenefits. Respondentswere asked to choose ‘Yes’ or ‘No’; if

theychose‘Yes’theywereaskedtoidentifytheperceivedbenefits.

61 respondents answered YES to this question. Of the 61 that responded YES, 55

commentedtowhattheythoughtwerethebenefitstoremoteauditing.Ofthese55

comments, 21 respondents stated that ‘Reduced Travel’ as a benefit. There were

also respondents believing the benefit of easier pre-planning for remote audits

exists.Anotherrespondentstatedthatabenefitwas:thatit‘Allowsamorefocused

review and make optimal use of auditors time thereby potentially increasing the

samplesizeforaudits.

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Figure7:BENEFITSTOREMOTEAUDITING

7. Isallyourcompany’sdocumentationavailableelectronically?

This questionwas asked to determine howmuch of the industrywas paperless. Remote

audits can by their nature involve no paper and relies on the review of electronic

documents,so ifcompaniesdonothavetheseavailable itwillbehardertoplanforthese

audit types.Of the75respondentsonly3%havenodocumentsavailableelectronically.A

majorityofrespondents,54%identifiedtheircompanyashavingahybridofbothpaperand

electroniccopies;43%ofrespondsidentifiedalldocumentsareavailableelectronically.

Figure8:AVAILABILITYOFELECTRONICDOCUMENTS

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8. Doyouthinktherearecomplianceriskstoremoteauditing?

This question was asked to gain the industry’s opinion on compliance risks. 53% of

respondentsbelievedtherearecompliancerisksassociatedwithremoteauditing.With46%

believing there are no compliance risks. Respondents that answered yes, were asked to

identifythesecompliancerisks.

Figure9:COMPLIANCERISKSWITHREMOTEAUDITING

Manyoftherespondentsbelieveitisdifficulttogainanoverallimpressionofacompanyvia

remoteauditing.Whileclearthatreviewofdocumentationiseasierremotely,otheraspects

ofauditingarenotandthereforeconsideredariskforthefollowingreasons.

‘Auditsampleismorecontrolledbyauditee’

‘Itiseasiertohideissuesinaremoteaudit’

‘Youonlyseewhatyouareshownwithremoteauditing’ ‘Somethingscouldbehiddenfromcamerathatcompanydoesn’twanttobeseenbyauditor’

‘Virtual tours reliant on the auditee to provide a true representation of theareaunderreview’.

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9. DoyouthinkyourcompanyhastheITcapabilitiestoconduct/hostremoteaudits?

Themain factor to a remote audit is the IT capabilities without such technology remote

audits are not possible. When identifying how many of the respondents believe their

company has the capability, of the 76 respondents that answered 67 believed their

companyhadthecapabilitieswhileonly9believedthattheydidnot.Therespondentswho

answered‘No’tothisquestionwerefurtheraskedwhytheybelievedthistobethecase.Of

the 9 that answered ‘No’, 3 common responses identified the lack of virtual tour

capabilities.

• ‘Virtualtoursneedworkinmycompany’

• ‘VirtualTourscapability’

• ‘Capabilitytoperformalivetourofourfacilities.Iwouldalsobeconcernedabout

poorqualityofvideo-callswhichcouldmakeinterviewsalittlemoredifficult.’

Figure10:ITCAPABILITIESFORREMOTEAUDITING

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10. Howdoyouthinkvirtualtoursshouldbeconducted?

Thisquestionwasusedtodeterminewhatrespondentsconsideredhowtoconductvirtual

tours. This question provided 4 identified options and provided an opportunity for

respondents to identify a specific opinion.Of the 76 respondents, 62 identified that ‘Live

videowalking around the site’ is the bestway to conduct a virtual tour. 12 respondents

selected‘pre-recordedvideos’asawayofconductingvirtualtours.

Figure11:THECONDUCTOFVIRTUALTOURS

Ofthe13specifiedopinions,7suggestedusingacombinationofmethodstoconductthat

virtualtourswhile4suggestedtheuseof‘smartglasses’asameansof‘livetour’toseethe

operatorsperforming.

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11. Doyouthinkthereisenoughguidancedocumentsonremoteauditing?

This question was asked to determine the industry’s perspective on remote auditing

guidancedocuments.Ofthe76peoplewhoansweredthisquestion47believedthereisnot

enoughguidancedocumentsfortheindustry.While21oftherespondentsdidnotknowif

there were enough guidance documents. Only 7 of the respondents believed there is

enoughguidancedocumentsonremoteauditing.

Figure12:REMOTEAUDITINGGUIDANCE

DiscussionRemote auditing has become more relevant since the onset of the global COVID-19

pandemic. Regulations on auditing in relation to GMP audits by regulators and the

regulationsinrelationtooutsourcedactivitiesidentifiesthelegalrequirementforauditsto

ensure the safety of drugs. However, the traditional approach of onsite audits is not

possibleatthistime.Thisrequirescompaniesandregulatorstoadoptnewwaysofworking

andauditingforcompliance.Asaresult,muchoftheguidanceonremoteauditingforthe

Pharmaceutical Industry was published the past year as the industry grappled with the

situationitfounditselfin.

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This researchhasshownthat the industrybelieves that there isa lackofguidanceonthe

topic.Duetoanunexpectedglobalpandemic,regulatorsandcompaniesmayhavebeenill-

prepared in their contingency plans to deal with its impact on auditing operations.

Regulatory agencies responded in short-term and published Q&A documents to address

someoftheindustryconcerns.

Sharingofdocumentationduringremoteauditingwasoneofthekeychallengeshighlighted

bytheindustry.Fromtheresultsoftheindustrysurvey42%ofrespondentsidentifiedtheir

companyhaving documentation available electronically,while 52%had a hybrid of paper

andelectronic copies. For thecompanies thathaveahybrid format, theywill still require

time tobe fullyprepared for remoteaudits. Thismay involve scanningofanydocuments

thatarenotavailableelectronically.

Sharing of documentation links into the challenge of data security concerns for industry.

28% of the respondents identified this as their biggest challengewhile 22% respondents

identified this as their second biggest challenge. Companies need to ensure confidential

information is not revealed unnecessarily through processes such as screen sharing. The

regulations for outsourcing activities state that contracts are required between two

companies, these contracts may now require an update to align with a remote auditing

process. These contracts will require addressing items such as confidentially agreements

andincludeinformationfortheremotesharingofdocumentation.

Conducting tours of a facility is an obvious challenge with remote auditing. It was

highlightedasachallengeintheindustrysurvey.Conductingofvirtualtourswasrankedthe

mostchallengingaspectof remoteauditingduring the IndustrySurvey.Fromthe industry

survey‘livevideo’wasexpressedasbeenthebestwaytoconductavirtualtour.‘Livevideo’

isputforwardasamethodtogivearealtimereviewofinspectedareasandmayallowfor

auditorstocommunicatewithpeoplewhoareonthetour.

Anotheraspectoftheresearchwastohighlightanybenefitsofremoteauditing.Thesurvey

highlighted the obvious benefits such as no requirement to travel to different countries,

reductionincostofanauditandenvironmentallymorefriendlyduetoreductionincarbon

footprint due to less air travel. Respondents during the survey also stated that remote

auditscanbemoreplannedinnature,whichcanleadtomoreefficientuseoftime.

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In summary, there aremany challenges faced by companies required to conduct or host

remoteaudits.Preparationwillbekeytominimisingsomeofthesechallenges.Tofacilitate

thisan‘ActionPlan’isproposed,thisactionplanjustfocusedonaidingcompaniesprepare

forremoteaudits.Theactionplanisdiscussedbelow.Itisalsoevidentthattechnologyisa

key enabler to conducting remote audits, without the correct technology and familiarity

withthistechnology,remoteauditswillnotbeeffective.Companiesandregulatorsneedto

move forward with this approach as a priority to ensure patients continue to receive

medicineswhileensuringcompliance.

ActionPlanInordertosuccessfullyconductaremoteauditonaserviceprovider/contactmanufacturer

thefollowingkeyactionsdetailedbelowneedtotakeplacethekeymessageispreparation

iskeytoasuccessfulaudit.

QualityRiskManagement tools suchas riskassessments shouldbecarriedoutbefore the

remoteaudit.Riskassessmentscanbeused todetermine ifanaudit isneedede.g.when

wasthepreviousauditandwhatwastheoutcome?Theriskassessmentshouldalsobeused

todeterminethescopeoftheaudit.

Once thescope isdefined theaudit teamshouldmeetanddiscuss the ITplatforms tobe

usedandifthereneedstobeavirtualtour.Asdiscussed,QualityAgreementsmayneedto

be updated if time permits, they should be updated prior to audit. If needed a

‘Memorandum of Understanding’ should be in place to define the confidentiality

agreement.

An important task to prepare for a remote audit is to ensure the training of staff on the

technologytobeused.Technicalissuescanhappen,andthemorefamiliarstaffarewiththe

ITplatformthesmoothertheauditingprocesswillbe.

A full actionplan canbe seenbelow. The tableoutlines a roughestimateof timelines to

adheretowhenplanninganaudit.Ideallyplanningshouldstartassoonasanotificationof

anauditisreceived.

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Action Timeline

RiskAssessmentØ Conduct Risk Assessment to determine if

anauditisrequiredorifanextensioncanbeconsidered.

Ø IncludethecriticallyoftheproductØ Lookatthelastauditreport.

Atleast8weeksoutfromaudit

HostPreagendameetingØ DiscussauditscopeØ DiscussLogistice.g.ITplatformsØ Discussifvirtualtoursarepossible.Ø DiscussQualityAgreements

6weeksoutfromaudit.

UpdateQualityAgreementØ Cover the scope of remote audits i.e

Screensharing, sharing of documentationelectronically.

Ø IncludeconfidentialityagreementØ If specific detail is included on frequency

ofauditingupdate.

6 weeks or as soon as there is an agreementbetweenbothsides.

PrepareAuditPlan/ScheduleØ Prepare a detail audit plan to provide to

theauditeeØ Provide the list of pre request

documentationwherepossible

4weeksoutfromaudit.

SiteAuditTeamMeetingØ Host training session with audit team to

discussITplatformØ Discussthescopeindetail

4/3Weeksoutfromaudit.

FinalPre-MeetingØ SendMeetinginvitesØ Trial Technology – Demo any technology

newtotheauditee.Ø Sharedetailedaudittimetable

1weekoutfromaudit.

Table1:RemoteAuditActionPlan

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Conclusion

In conclusion, there are many challenges faced by the pharmaceutical industry when

conducting/hostingremoteaudits.Withinthepharmaceuticalindustry,theauditingprocess

hashadthesameapproachformanyyearsandthesuddenimpactoftheglobalpandemic

forced the industry to adapt new ways of working. While remote auditing will not

completelyreplaceonsiteaudits,therewillnowbeanoptiontoconductremoteauditsviaa

risk-basedapproach.Itislikelythatthiswillbethe‘NewNorm’untilavaccineisapproved

forCovid-19,additional guidanceand legislation covering remoteauditswill benecessary

forthepharmaceuticalindustry.

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Level 3, Vol. 15, Iss. 2 [2020], Art. 10



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ReferencesBesson,C.etal.(2005)Theimportanceofnon-verbalcommunicationinprofessionalinterpretation.

CentersforDiseaseControlandPrevention(2020)SocialDistancing,Quarantine,andIsolation.

Availableat:https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/social-

distancing.html(Accessed:11November2020).

EMA(2020)UpdatetoguidanceonregulatoryexpectationsinthecontextofCOVID-19pandemic|

EuropeanMedicinesAgency.Availableat:https://www.ema.europa.eu/en/news/update-guidance-

regulatory-expectations-context-COVID-19-pandemic(Accessed:4July2020).

FDA(2020)Manufacturing,SupplyChain,andDrugInspections|COVID-19|FDA.Availableat:

https://www.fda.gov/drugs/coronavirus-COVID-19-drugs/manufacturing-supply-chain-and-drug-

inspections-COVID-19(Accessed:4July2020).

Grant,C.A.,Wallace,L.M.andSpurgeon,P.C.(2013)‘Anexplorationofthepsychologicalfactors

affectingremotee-worker’sjobeffectiveness,well-beingandwork-lifebalance’,EmployeeRelations,

35(5),pp.527–546.doi:10.1108/ER-08-2012-0059.

ICH(2015)CommitteeforHumanMedicinalProductsICHguidelineQ9onqualityriskmanagement.

Availableat:www.ema.europa.eu/contact(Accessed:23June2020).

Ireland,G.of(2020)gov.ie-ResilienceandRecovery2020-2021:PlanforLivingwithCOVID-19.

Availableat:https://www.gov.ie/en/publication/e5175-resilience-and-recovery-2020-2021-plan-for-

living-with-COVID-19/(Accessed:11November2020).

ISO(2018)ISO-ISO19011:2018-Guidelinesforauditingmanagementsystems.Availableat:

https://www.iso.org/standard/70017.html(Accessed:11November2020).

ISO(2020)ISO9001AuditingPracticesGroupGuidanceon:REMOTEAUDITS.Availableat:

https://committee.iso.org/files/live/sites/tc176/files/documents/ISO9001AuditingPracticesGroup

docs/AuditingGeneral/APG-Remote_Audits.pdf(Accessed:7July2020).

MedicinesAgency,E.(2020)‘QUESTIONSANDANSWERSONREGULATORYEXPECTATIONSFOR

MEDICINALPRODUCTSFORHUMANUSEDURINGTHECOVID-19PANDEMIC’.Availableat:

https://ec.europa.eu/health/sites/health/files/human-

use/docs/guidance_regulatory_covid19_en.pdf.

Short,J.,E.W.andB.C.(1976)‘TheSocialPsychologyofTelecommunications.’,Londan:Wiley.

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22

TammyAllen(2020)APSBackgrounderSeries:PsychologicalScienceandCOVID-19:Working

Remotely–AssociationforPsychologicalScience–APS.Availableat:

https://www.psychologicalscience.org/news/backgrounders/backgrounder-COVID-19-remote-

work.html(Accessed:22June2020).

WHO(2020)WHODirector-General’sopeningremarksatthemediabriefingonCOVID-19-11March

2020.Availableat:https://www.who.int/director-general/speeches/detail/who-director-general-s-

opening-remarks-at-the-media-briefing-on-COVID-19---11-march-2020(Accessed:11November

2020).

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Documents

The Challenges of Remote Auditing Faced by the