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Operational Qualification Protocolfor the XXXDocument Revision HistoryRevisionDateAuthor / CompanyDescription of Revision Changes001Initial VersionTable of Contents TOC \o "1-2" 1.Purpose/Scope PAGEREF _Toc219602512 \h 32.Description PAGEREF _Toc219602513 \h 33.References PAGEREF _Toc219602514 \h 33.1Definitions PAGEREF _Toc219602515 \h 34.Responsibilities PAGEREF _Toc219602516 \h 35.Execution Materials And Equipment PAGEREF _Toc219602517 \h 36.Execution Instructions PAGEREF _Toc219602518 \h 37.Protocol Deviations Resolution PAGEREF _Toc219602519 \h 37.1Signature Record PAGEREF _Toc219602520 \h 48.Operational Qualification PAGEREF _Toc219602521 \h 58.1Technical Requirements Testing PAGEREF _Toc219602522 \h 68.2User Functional Requirements Testing PAGEREF _Toc219602523 \h 88.3Electronic Records / Compliance Requirements Testing PAGEREF _Toc219602524 \h 109.Approvals PAGEREF _Toc219602525 \h 12Purpose/ScopeThis protocol covers the Operational Qualification for the XXX. Describe any specific functions of the system that are to be tested i.e. workflow.DescriptionSee Validation Plan for details (If a Validation Plan was written otherwise, reference an appropriate document with the system description or include it here.ReferencesSupporting Documentation (All validation documents written that are associated with the system)Document IDTitleDefinitionsTermDefinitionResponsibilitiesIt is the responsibility of XXX to execute this protocol and XXX, XXX to approve the executed results.Execution Materials And EquipmentList any items that may be required to complete execution i.e. temperature/humidity gauge. Execution InstructionsRecording of data or other required information in any test document must be done pee, Good Documentation Practices. Blue or Black ink must be used (no pencil). If an error is made in the documentation, use one line to line out the error and write in the correct information along with a reason for the change and initial and date the correction.Protocol Deviations ResolutionAll protocol deviations must be documented using VAL008_01.Signature RecordPrinted NameSignatureInitialsDateOperational QualificationTest Purpose:The purpose of this test is to verify the operation of the XXXTest Method:Record the results in the appropriate row of the test table. Where possible, screenshots or other documented evidence may be included as supporting evidence and attached to the test protocol and marked with the appropriate protocol number, attachment page number (as x of y), test page number, test step number references, and initials and date.Acceptance Criteria:All Expected Results must match the Actual Results for each test step.Technical Requirements TestingStepTest StepExpected ResultActual ResultPass / FailReferenceInitial and Date8.1Technical Requirements TestingComments/Additional Information:Conclusion:Did the Actual Results for each test step match the Expected Results listed?YesNoCompleted By:Date:Reviewed By:Date:User Functional Requirements TestingStepTest StepExpected ResultActual ResultPass / FailReferenceDate and Initial8.2User Functional Requirements TestingComments/Additional Information:Conclusion:Did the Actual Results for each test step match the Expected Results listed?YesNoCompleted By:Date:Reviewed By:Date:Electronic Records / Compliance Requirements TestingStepTest StepExpected ResultActual ResultPass / FailReferenceDate and Initial8.3Electronic Records / Compliance Requirements TestingComments/Additional Information:Conclusion:Did the Actual Results for each test step match the Expected Results listed?YesNoCompleted By:Date:Reviewed By:Date:Approvals ................
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