Introduction to the Computer System Validation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