DATA INTEGRITY THE FOUNDATION OF GOOD S … · FDA has defined data integrity as the completeness, consistency and accuracy of data3. Complete, consistent and accurate data have the
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Sounddataisthefoundationtogooddecisionsandgoodscience.IntheLife-Scienceindustrypatientoutcomes,productquality,safetyandefficacyallrelyuponvastamountsofdatathatisgeneratedthroughouttheproductlifecycle.Thismeansthatpatients,brandequityandreputationshavethepotentialtosuffergreatlywithoutastrongdataintegrityfoundation.Inrecentyears,regulatorsaroundtheworldhaveincreasinglyobservedcGMPviolationsinvolvingdataduringinspections.AccordingtoFDA’sdata,14of23warninglettersissuedbytheOfficeofManufacturingQualityreferenceddataintegrityintheperiodfromJanuary2015toJanuary20161.Dataintegrityfindingshaveledtowarningletters,importalertsandconsentdecrees.OneFDAwarningletterspecificallycalledout,“seriousCGMPviolationsdemonstratingthatyourqualitysystemdoesnotadequatelyensuretheaccuracyandintegrityofthedatageneratedatyourfacilitytoensurethesafety,effectiveness,andqualityofthedrugproductsyoumanufacture.2”Thisisproofthatthelackofdataintegrityhasthepotentialtocallintoquestionanorganization’sentirequalitysystem.TheMedicinesandHealthcareproductsRegulatoryAgency(MHRA)hasalsoreportedthatdataintegrityhasbeenatoppriorityfortheLifeScienceindustryintheUKoverthepasttwoyears.Noteworthyistheoftenmisconceivednotionthatactsofdeliberatefraudaretherootcauseofdataintegrityissues.However,theMHRAInspectoratehasdeterminedthatbadpractices,poororganizationalbehaviorsandweaksystemshavecreatedopportunitiesfordatamanipulation.Toaddressthesetypesofissues,companiesshouldconsiderleadingfromthetopandempoweringfrombelow,understandingthedatalifecycleandgivingspecialconsiderationstoorganizationalandtechnicalcontrolswithinthequalitysystemleveraging the technologies provided by the industry.
3 Source: FDA Data Integrity and Compliance with CGMP, Guidance for Industry. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm495891.pdf >
TherearenewFDAinitiativesbeingpromulgatedtoindustrysuchastheCaseforQuality(see: http://mdic.org/cfq/) to consider compliance as a baseline and quality as aninvestment.Collectingdocumentedevidenceofcompliancewithregulatoryrequirementsisanoverheadcost–itdoesnotaddvalue.Beinginbusinesstobecompliantisdifferentfrombeing in the compliance business. Life Science companies are in business tomakehighquality,life-sustainingproducts,notdocuments.Qualityistheinitiativethatdrivesimprovements,tostreamlineprocessesresultinginoperationalefficienciesandreducedwaste.Therefore,investinginimprovingproductqualitycanactuallylowercostsandimproveprofitability.TosupportthistransitionfromcompliancetoQuality,itisnecessarytotransformdataintoTruth.WiththeimplementationofFDASIATitleVIISection7066,theFDAisshiftingitsfocustorequestinginformationinadvanceof,orinlieuof,aninspectionineitherelectronicorphysicalform.Thisshifttoe-Inspectionsofdrugmanufacturersrequiresmassiveamounts
Forsounddatatobethefoundationforgooddecisionsandgoodscience,therecanbenoquestionswithregardstoitsintegrity.Patientoutcomes,productquality,safetyandefficacyofproductsrelyuponvastamountsofdatathataregeneratedthroughouttheproductlifecycle.Muchofthisdataisoftenproducedbyamultitudeofdisconnectedstand-aloneorredundantsystemsthatweregenerallyimplementedbyfunctionalareastoaddressspecificneeds.Thisdisconnectcanresultinalackofdataintegrityandconsistency.Thereforepatients,brandequityandreputationshavethepotentialtosufferwithoutastrongfoundationfordataintegrity.Bytakingaplatformapproach,companiescanintegratedataconsumingapplicationsthatsupportbusiness,manufacturing,laboratoryandqualityareas.Dataintegrityisultimatelytheresponsibilityofexecutivemanagement.Theseteamsmustbecommittedtoensuringthatamasterdatamanagementsystemsupportsgovernancearounddatainordertosupportitsintegrity.However,forthesystemtohavevalue,participationandcommitmentbystaffatalllevels(bothinternalandexternalresources)isnecessaryinordertosupportasinglesourceoftruth.Isyourcompanydoinggoodscience?Withoutdataintegritytheresultsofthatsciencecanbeinquestion. This white paper was written by Axendia, Inc. and was sponsored by BIOVIA, a brand of DassaultSystèmes. TheopinionsandanalysisexpressedinthisresearchreflectthejudgmentofAxendiaatthetimeofpublicationandaresubjecttochangewithoutnotice.Informationcontainedinthisdocumentiscurrent as of publicationdate. Information cited is notwarrantedbyAxendiabuthasbeenobtainedthrough a valid research methodology. This document is not intended to endorse any company orproductandshouldnotbeattributedassuch. AboutAxendia:Axendia,Inc.isaleadingtrustedadvisortotheLife-ScienceandHealthcareindustries.WeprovidetrustedcounseltoindustrystakeholdersonBusiness,RegulatoryandTechnologyissues.Formoreinformation,[email protected]