Computer+Validation+Plan.docx

Computer+Validation+Plan.docx

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Computer+Validation+Plan

s

ComputerValidationPlan

[SystemName]

AcronymSpelledout,ifapplicable

SystemVersion:

[X.X]

DocumentRevision[0]

SystemOwner:

BusinessArea:

SystemResponsible:

BusinessArea:

[SystemName]AcronymSpelledout,ifapplicableSystemVersion:

[X.X]

Author:

Theauthor’ssignatureindicatesthatthisdocumentwaswrittenforthenamedsystemtomeetthe[CompanyName]QualityStandardforComputerValidation（docno.XXX,rev.X）requirementsforcomputervalidationplanningandexecution.

Signature

Initials

Date

[Typed/PrintedName]

[Sinceapprovalsdifferfrombusinessareatobusinessarea,theapprovalsshownaretheminimumthatshouldbeconsideredonaComputerValidationPlan.Thebusinessareamayaddorsubtractsignaturesasrequired.]

ReviewandApprovalSignatures

Thesignaturesbelowindicatethatthisdocumentmeetsthe[CompanyName][validationstandarddocno.andname]requirementsforvalidationplanningandexecutionwhileaccuratelydetailingtheplanforvalidatingthenamedsystem.

ReviewedbyITResponsible（Ifrequiredbythebusinessarea.）

Signature

Initials

Date

[Typed/PrintedName]

ApprovedbyQualityAssurance（Required）:

Signature

Initials

Date

[Typed/PrintedName]

ApprovedbySystemResponsible（Ifrequiredbythebusinessarea.）

Signature

Initials

Date

[Typed/PrintedName]

ApprovedbySystemOwnerorDesignee（Required）:

Signature

Initials

Date

[Typed/PrintedName]

TableofContents

1.0

Purpose

ThepurposeofthiscomputervalidationplanistoensurethatCompanyName’s（policyandstandard）aresufficientlyaddressedfor[SystemName],version[x.x],andtoidentifytheapproachtobeusedtocomplywitheachoftheelements.

AsdefinedintheXXXXStandard,acomputersystemincludesthecomputerplatformandapplicationsoftware,assembliestoperformaspecificfunctionorgroupoffunctions,andalldocumentationthatisrequiredtosupportthecomputersystem.Thecomputerplatformincludesthehardwareandsystemsoftwareusedaspartofoneormorecomputersystems.Becauseacomputerplatformmaybepartofseveralcomputersystems,itisqualifiedseparatelytoensurethatitisproperlyinstalledandtested.Additionaltestingofthecomputerplatformisaccomplishedthroughtheuservalidationtestingthatisexecutedbytheusersofbusinessapplications.

2.0SystemDescriptionandScope

[Provideanoveralldescriptionofthesystem.Besuretoindicateconsiderationsforwhatwillbeperformedgloballyandwhatwillbeperformedlocally.]

3.0CriticalityandComplexity

[UsingtheguidelinesinSOPXXX,definethecriticalityandcomplexityofthesystemandhowthisratingwillaffectthevalidationplandetailedinthisdocument.Ifpossible,useeither“high”or“low.”Avoidtheterm“medium.”Includerationaleforyourdecision（orreferencetherationaledocumentasanattachment）.]

[Criticalityisbasedon:

1.Thepotentialconsequencesoffailure.

2.Theprobabilityoffailure.

Complexityisbasedonwhetherthesystem:

1.Containsdetailedalgorithmsorcalculations.

2.Interfaceswithothercompanysystems.

3.Performsextensivedatainputchecking.

4.Performslargenumbersoftransactions.

5.Hasalargenumberofusers.

6.Requiresextensivesupporttomaintainthesystem.

7.Requiressignificantcustomizationofastandardsoftwarepackagethroughconfigurationand/ormodificationofthesourcecode.]

4.0ValidationApproach

ThetwelveStandardRequirementsaddressedbelowarespecifiedin[CompanyName]documentXXXX.

4.1ComputerValidationPlan（StandardRequirementNo.1）

Intent:

Toensurethattherequiredcomputervalidationactivitiesareproperlyplanned,performed,anddocumented.

Deliverables:

Responsible:

ComputerValidationPlan

[ValidationCoordinator

SystemOwner

SystemResponsible]

[EdittheabovetoreflectthetitleoftheRoleresponsibleforthedeliverable.]

ValidationActivitiesTable

[Sameasabove.]

Comments:

TheComputerValidationPlanistheintendedapproachtovalidating[versionnumber]of[systemname].TheSystemOwnerandQualityAssurancewillapprovethisplanpriorotthestartofformaltesting.Duringtheearlystagesofvalidation,membersofthevalidation/projectteamwillagreetotheactivitiesandinitialtargetdatesdetailedintheValidationActivitiesTable（VAT）.[TheVATisatrackingtoolthatwillbeusedforthedurationofthevalidationprojectandlistsdeliverables,personsresponsibleforthedeliverables/activities,theassociatedtarget/completiondatesforeachactivity,andtheresourcerequirementsintermsoftimeontheproject.]TheVATwillbeupdatedonanongoingbasistotrackvalidationactivities,aComputerValidationReportwillbecreatedthatsummarizesthevalidationprocessandlistsan