Introduction to the Computer System Validation.docx

Introduction to the Computer System Validation.docx

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IntroductiontotheComputerSystemValidation

IntroductiontotheComputerSystemValidation

ThisguidewasdevelopedasaresourcedocumenttoassistregulatedindustryValidation,QualityAssurance,TechnicalServices,andregulatedindustryprofessionalstoidentifyandadapt"bestpractices"intheirmanagementofvalidationandqualificationofcomputersystems,software,hardwareanddevelopmentalpracticesandactivities.

Thisguidewasdevelopedtobeaconcise,step-by-stepsetofmanagementaids,whichareconsistentwithindustrystandards.Theyaredesignedtoguideimplementationtotheminimumrecommendedlevelofpracticesandstandards.Localmanagement,atitsdiscretion,maydecidethattheserecommendedlevelsareinsufficientforlocalconditionsandneedsandthereforerequiremorestringentpracticesandcontrols.

Thepracticeswithintheguides,whenfullyimplementedwillservetoensuresecureandcosteffectiveoperationandevolutionofprotocolimplementation.

Suggestionsforimprovementtothisguidearealwayswelcome.Thisdocumentisintendedtobelivingdocumentandwillbeupgradedandadaptedas‘betterpractices’emerges.  EmailAllComments

JohnFCuspilich,SeniorEditor,GMPPublications,Inc.

SeniorConsultant,FDA.COM

 Introduction

ThisintroductionprovidesanoverviewoftheComputerSystemValidationCorporateComputerSystemValidation（CSV）Guide.

ProcessValidation

In1987theFoodandDrugAdministrationpublishedadocumententitled

‘FDAGuidelinesonGeneralPrinciplesofProcessValidation’.

Itstatesthefollowing:

Processvalidationisestablishingdocumentedevidencewhichprovidesahighdegreeofassurancethataspecificprocesswillconsistentlyproduceaproductmeetingitspredeterminedspecificationsandqualityattributes.

Note:

Thisdefinitionindicatesthatvalidationcanapplytoanyprocessincludingprocessmanaged/controlledbycomputersystems.

 Validation

Validationisappliedtomanyaspectsofthehealthcareandotherregulatedindustriesandbusinesses.

Examplesinclude:

∙services∙     equipment∙    computersystems∙    processes∙    cleaning

Ineachcase,theobjectiveofvalidationistoproducedocumentedevidence,whichprovidesahighdegreeofassurancethatallpartsofthefacilitywillconsistentlyworkcorrectlywhenbroughtintouse.

Note:

Validationrequiresdocumentedevidence,ifthevalidationprocessisnotdocumentedthenitcannotbeprovedtohaveoccurred.

 Scope

Thisguidelooksatcomputersystemsvalidationonly.Computersystemsvalidationincludesvalidationofbothnewandexistingcomputersystems.

 Definitionofcomputersystem

Forthepurposesofthisguide,acomputersystemisdefinedas:

anyprogrammabledeviceincludingitssoftware,hardware,peripherals,procedures,users,interconnectionsandinputsfortheelectronicprocessingandoutputofinformationusedforreportingorcontrol.

 Examplesofcomputersystems

Examplesofcomputersystemsinclude:

·automatedmanufacturingequipment

·controlsystems

·automatedlaboratoryequipment

·laboratorydatacapturesystem

·manufacturingexecutionsystems

·computersrunninglaboratory,clinicalormanufacturingdatabasesystems

 Purpose

Thepurposeofthisguideistohelpyou:

·identifycomputersystemsthatrequirevalidation

·determinehowtovalidate,andtheextentofvalidationrequired,forthecomputersystemsthathavebeenidentified

·complywiththevalidationrequirementsdocumentedinthe（CSV）inaccordancewithyourCompany'sSoftwareSystemsDevelopmentMasterPlan（SDMP）. 

 Audience

Thisguideisintendedfor:

·InformationResources,ServicesandTechnologymembers

·allconcernedmanagers,auditorsandregulatorypersonnel

·alldevelopersofcomputersystemsapplications

·allpersonnelinvolvedincomputersystemsprocurement

·allusersofcomputersystemsinvolvedinvalidationactivities

 Structure

Thisguideisdividedinto:

·11chapters

·Referencematerial

Chapter1looksatwhoisresponsibleforvalidationactivities

Chapter2looksatthethingsyouneedtodobeforeyouperformasystemvalidation

Chapters3outlinesthevalidationprocess

Chapters4to11takeamoredetailedlookatthevalidationprocess

TheReferencematerialconsistsofaglossary,referencesandstandards.

Note:

TheGlossaryconsistsofalexiconofvalidationterms.

 UseofStandardterms

ThetermsandmeaningsintheGlossaryhavebeenadoptedasastandardforusewithinthisguide.

ConsistentuseofthesetermswillfacilitatecommunicationaboutcomputersystemvalidationthroughouttheCompany.

 Chapter1

ValidationResponsibilities

Overview

Introduction

Computersystemvalidationmustbesupportedatdifferentlevelswithintheorganizationthroughpolicies,standardsanddocumentation.

Thischapterdescribestheresponsibilitiesforvalidationatthefollowinglevels:

∙        Validation,Qualification,andProtocolDevelopmentandExecuting（D&E）Personnel

∙        BusinessSector/Unit

∙        Siteordepartmentalpersonnel（EndUsers）

∙        QualityAssuranceandRegulatoryUnits

∙        CorporateManagement

∙       InformationManagement,ITorISdepartments

CorporateResponsibilities

 Introduction

ThistopiclooksatDevelopmentandExecution（D&E）PersonalandBusinessUnitvalidationresponsibilities.

 D&EPersonnelresponsibilities

∙        ComputerSystemValidationandComputerSystemValidationPolicy

The（CSV）ComputerSystemValidationandComputerSystemValidationGuide（thisdocument）,providesguidanceonhowtoachieveconformancetotheabovepolicy.

 BusinessUnitresponsibilities

Eachbusinessunitisresponsibleforestablishingapolicyoncomputersystemsvalidationrequirements.

 BusinessUnitpolicy

TheBusinessUnitpolicymayapplytoanentireBusinessUnit,ortosomeotherlogicalbusinessgrouping,forexample,siteordepartment.

TheBusinessUnitpolicyshouldbebasedonandcomplywiththe（CSV）Corporatepolicyasaminimumrequirement.

ThepolicyshouldalsotakeintoaccountadditionalBusinessUnitspecificvalidationrequirements.TheseadditionalrequirementsmayresultfromotherpolicieswithinaBusinessUnitoraregulatoryrequirement.

Note:

IfaBusinessUnitpolicyrequireshigherstandardsthanthe（CSV）Corporatepolicy,thentheBusinessUnitpolicyshouldbefollowed.

SiteorDepartmentalResponsibilities

 Introduction

Thistopiclooksatsiteordepartmentalvalidationresponsibilities.

 Responsibilities

Sitesordepartmentsareresponsiblefor:

∙        ComputersystemvalidationStandardOperatingProcedures（SOPs）

∙        Systeminventoryandassessment

∙        Systemspecificvalidationprotocols

∙        Systemspecificvalidationdocumentation

 StandardOperatingProcedures（SOPs）

SOPsprovidespecificproceduresforvalidatingcomputersystemsatasiteorwithinadepartment.

SOPsmust:

∙        ComplywiththeComputerSystemsValidationPolicyandanyBusinessUnitpoliciesthatmayapply

∙        beapprovedbytheappropriatemanagementforthatsiteordepartment

Systeminventoryandassessment

Siteordepartmentalmanagementisresponsibleforcompilingandmaintainingdetailsabouttheircomputersystems.Thisinformationincludesidentifyingthesystemsthatarebeingusedandforwhatpurposesthosesystemsarebeingused.

Thesysteminventoryandassessmentinformationisusedtodeterminewhichsystemsneedtobevalidated.

SeeChapter2-BeforeYouPerformSystemValidationfordetailsonhowtoperformthesysteminventoryandassessment.

Note:

ThesystemsthatrequirevalidationwillbeincorporatedintotheSiteorDepartmentalValidationMasterPlan.

Aftertheinitialsite/departmentalinventoryhasbeencompliedamechanismmustbeestablishedtocapturenewcomputersystems（preferablypriortopurchase/development）andtoaddthemwiththeinventoryandValidationMasterPlan.

Systemspecificvalidationprotocols

Validationprotocolsaredocumentsassociatedwitheachsystemidentifiedasrequiringvalidation. Theprotocoldescribesthescope,proceduretobefollowed,responsibilitiesandacceptancecriteriaforthevalidation.

ValidationprotocolsshouldcomplywiththeSOPs.

Systemspecificvalidationdocumentation

Documentationthatverifieseachvalidationactivitymustbegeneratedandstoredwiththevalidationprotocolintheappropriatearchive.

Validationdocumentationmayinclude:

∙        testdata

∙        summaryreports

∙        procedures

∙        certificationformsproducedduringthevalidationprocess

Chapter2

BeforeYouPerformSystemValidation

Overview

Introduction

Thischapterlooksatthethingsyouneedtodobeforeyouperformsystemvalidationonaspecificcomputersystem.

Youneedto:

∙SetuptheValidationCommittee

∙Under21CFRPart11Requirements

∙Identifysystemsthatrequirevalidation

∙Conductappropriatetraining

Note

Thefollowingtopicsarethefourstepsinvolvedinidentifyingsystemsthatrequirevalidation:

∙        CreatinganInventory

∙        IdentifyingtheSystems

∙        AssessingEachSystemforValidation

∙        DeterminingValidationPriority

SettingUptheValidationCommittee

Introduction

ThistopiclooksatsettinguptheValidationCommittee.

Thisisoneofthefirstactivitiesthatyoumustdobeforeyoucanvalidateasystem.

 RoleofValidationCommittee

TheValidationCommitteeoverseesallofthecomputersystemvalidationprojectsatasite,orwithinadepartment.

Itshouldbenotedthatinsomeinstancesthiscommitteewouldberesponsibleforallvalidationproject