Introduction to the Computer System ValidationWord文档格式.docx

Introduction to the Computer System ValidationWord文档格式.docx

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ProcessValidation

In1987theFoodandDrugAdministrationpublishedadocumententitled

‘FDAGuidelinesonGeneralPrinciplesofProcessValidation’.

Itstatesthefollowing:

Processvalidationisestablishingdocumentedevidencewhichprovidesahighdegreeofassurancethataspecificprocesswillconsistentlyproduceaproductmeetingitspredeterminedspecificationsandqualityattributes.

Note:

Thisdefinitionindicatesthatvalidationcanapplytoanyprocessincludingprocessmanaged/controlledbycomputersystems.

Validation

Validationisappliedtomanyaspectsofthehealthcareandotherregulatedindustriesandbusinesses.

Examplesinclude:

∙services∙ 

equipment∙ 

computersystems∙ 

processes∙ 

cleaning

Ineachcase,theobjectiveofvalidationistoproducedocumentedevidence,whichprovidesahighdegreeofassurancethatallpartsofthefacilitywillconsistentlyworkcorrectlywhenbroughtintouse.

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.

TheGlossaryconsistsofalexiconofvalidationterms.

UseofStandardterms

ThetermsandmeaningsintheGlossaryhavebeenadoptedasastandardforusewithinthisguide.

ConsistentuseofthesetermswillfacilitatecommunicationaboutcomputersystemvalidationthroughouttheCompany.

Chapter1

ValidationResponsibilities

Overview

Computersystemvalidationmustbesupportedatdifferentlevelswithintheorganizationthroughpolicies,standardsanddocumentation.

Thischapterdescribestheresponsibilitiesforvalidationatthefollowinglevels:

∙ 

Validation,Qualification,andProtocolDevelopmentandExecuting（D&

E）Personnel

BusinessSector/Unit

Siteordepartmentalpersonnel（EndUsers）

QualityAssuranceandRegulatoryUnits

CorporateManagement

InformationManagement,ITorISdepartments

CorporateResponsibilities

ThistopiclooksatDevelopmentandExecution（D&

E）PersonalandBusinessUnitvalidationresponsibilities.

D&

EPersonnelresponsibilities

ComputerSystemValidationandComputerSystemValidationPolicy

The（CSV）ComputerSystemValidationandComputerSystemValidationGuide（thisdocument）,providesguidanceonhowtoachieveconformancetotheabovepolicy.

BusinessUnitresponsibilities

Eachbusinessunitisresponsibleforestablishingapolicyoncomputersystemsvalidationrequirements.

BusinessUnitpolicy

TheBusinessUnitpolicymayapplytoanentireBusinessUnit,ortosomeotherlogicalbusinessgrouping,forexample,siteordepartment.

TheBusinessUnitpolicyshouldbebasedonandcomplywiththe（CSV）Corporatepolicyasaminimumrequirement.

ThepolicyshouldalsotakeintoaccountadditionalBusinessUnitspecificvalidationrequirements.TheseadditionalrequirementsmayresultfromotherpolicieswithinaBusinessUnitoraregulatoryrequirement.

IfaBusinessUnitpolicyrequireshigherstandardsthanthe（CSV）Corporatepolicy,thentheBusinessUnitpolicyshouldbefollowed.

SiteorDepartmentalResponsibilities

Thistopiclooksatsiteordepartmentalvalidationresponsibilities.

Responsibilities

Sitesordepartmentsareresponsiblefor:

ComputersystemvalidationStandardOperatingProcedures（SOPs）

Systeminventoryandassessment

Systemspecificvalidationprotocols

Systemspecificvalidationdocumentation

StandardOperatingProcedures（SOPs）

SOPsprovidespecificproceduresforvalidatingcomputersystemsatasiteorwithinadepartment.

SOPsmust:

ComplywiththeComputerSystemsValidationPolicyandanyBusinessUnitpoliciesthatmayapply

beapprovedbytheappropriatemanagementforthatsiteordepartment

Systeminventoryandassessment

Siteordepartmentalmanagementisresponsibleforcompilingandmaintainingdetailsabouttheircomputersystems.Thisinformationincludesidentifyingthesystemsthatarebeingusedandforwhatpurposesthosesystemsarebeingused.

Thesysteminventoryandassessmentinformationisusedtodeterminewhichsystemsneedtobevalidated.

SeeChapter2-BeforeYouPerformSystemValidationfordetailsonhowtoperformthesysteminventoryandassessment.

ThesystemsthatrequirevalidationwillbeincorporatedintotheSiteorDepartmentalValidationMasterPlan.

Aftertheinitialsite/departmentalinventoryhasbeencompliedamechanismmustbeestablishedtocapturenewcomputersystems（preferablypriortopurchase/development）andtoaddthemwiththeinventoryandValidationMasterPlan.

Systemspecificvalidationprotocols

Validationprotocolsaredocumentsassociatedwitheachsystemidentifiedasrequiringvalidation. 

Theprotocoldescribesthescope,proceduretobefollowed,responsibilitiesandacceptancecriteriaforthevalidation.

ValidationprotocolsshouldcomplywiththeSOPs.

Systemspecificvalidationdocumentation

Documentationthatverifieseachvalidationactivitymustbegeneratedandstoredwiththevalidationprotocolintheappropriatearchive.

Validationdocumentationmayinclude:

testdata

summaryreports

procedures

certificationformsproducedduringthevalidationprocess

Chapter2

BeforeYouPerformSystemValidation

Thischapterlooksatthethingsyouneedtodobeforeyouperformsystemvalidationonaspecificcomputersystem.

Youneedto:

∙SetuptheValidationCommittee

∙Under21CFRPart11Requirements

∙Identifysystemsthatrequirevalidation

∙Conductappropriatetraining

Note

Thefollowingtopicsarethefourstepsinvolvedinidentifyingsystemsthatrequirevalidation:

CreatinganInventory

IdentifyingtheSystems

AssessingEachSystemforValidation

DeterminingValidationPriority

SettingUptheValidationCommittee

ThistopiclooksatsettinguptheValidationCommittee.

Thisisoneofthefirstactivitiesthatyoumustdobeforeyoucanvalidateasystem.

RoleofValidationCommittee

TheValidationCommitteeoverseesallofthecomputersystemvalidationprojectsatasite,orwithinadepartment.

Itshouldbenotedthatinsomeinstancesthiscommitteewouldberesponsibleforallvalidationproject