Current SOP Index Updated 170613 2017 - Integrated … Analytical Solutions, Inc. GxP Division...

Integrated Analytical Solutions, Inc.GxPDivision

CurrentSOPIndex

CurrentSOPIndexUpdated170613_2017.docx Page1of2

SOPNo. VersionNo. SOPTitle CPS-ComputerSystemsCPS-001-0011 5 GoverningPolicyforComputerSystemsCPS-002-0011 5 ComputerSystemValidationCPS-003-0011 3 CPSValidationMasterPlanCPS-004-0011 4 UserRequirementRiskAssessmentCPS-007-0011 3 Security,Backup,andDisasterRecoveryforComputerSystemsCPS-008-0011 2 ChangeControlforComputerSystemsCPS-011-0011 3 PeriodicReviewofComputerSystemsCPS-012-0011 2 RetirementandDecommissioningofComputerSystemsCPS-013-0013 2 SystemAdministrationofComputerSystemsandITInfrastructureEQP-EquipmentEQP-001-0011 4 OperationoftheShimadzuHPLCSystemUsingClass-VP

EQP-002-0011 5 Qualification,Operation,andMaintenanceofShimadzuHighPerformanceLiquidChromatography(HPLC)Components

EQP-003-0011 3 OperationoftheAPI4000MassSpectrometerUsingAnalystEQP-004-0011 3 QualificationandMaintenanceoftheAPI4000MassSpectrometer

EQP-005-0011 4 Calibration,Operation,andMaintenanceoftheMettlerAG285BalanceandtheMettlerAX26Balance

EQP-006-0011 3 OperationandMaintenanceoftheMilli-QWaterSystemEQP-008-0011 3 ChangeControlofLaboratoryEquipment

EQP-009-0012 0 Qualification,MaintenanceandUseofthePurair5-48XTDuctlessChemicalFumeHood

EQP-013-0013 1 Installation,Operation,andPerformanceQualification(IOPQ)ProceduresforEquipment

EQP-014-0015 1 QualificationandOperationoftheUV-VisSpectrophotometer

EQP-015-0015 0 Certification,Operation,andMaintenanceoftheBakerVBM-400BiologicalSafetyCabinet

EQP-016-0016 0 MeasurementofOsmolalityUsingtheAdvancedInstrumentsMicro-Osmometer

EQP-017-0016 0 MeasurementofpHUsingtheThermoOrion230A+pHMeter

EQP-018-0016 3 Qualification,Operation,andMaintenanceoftheSpectraMaxM2PlateReader

EQP-019-0016 0 QualificationandUseofTimersEQP-020-0016 1 QualificationandUseofThermometers

EQP-021-0016 1 OperationoftheMolecularDevicesM2PlateReaderusingSoftMaxProGxPSoftware

EQP-022-0015 0 QualificationandUseofHygrometersFAC-FacilitiesFAC-001-0011 2 WashingGlasswareFAC-002-0011 1 FacilityManagementFAC-003-0012 1 HazardousMaterialsLOP-LaboratoryOperationsLOP-001-0011 3 Operation,Maintenance,andCalibrationofMicropipettesLOP-002-0011 4 SampleTrackingandManagementLOP-003-0011 4 ReferenceStandardsandStandardSolutionsLOP-004-0011 5 ReceiptofLaboratoryChemicalsandReagentsLOP-005-0011 2 PreparationandLabelingofReagentsandSolutions

Integrated Analytical Solutions, Inc.GxPDivision

CurrentSOPIndex

CurrentSOPIndexUpdated170613_2017.docx Page2of2

SOPNo. VersionNo. SOPTitle

LOP-006-0011 5 OperationoftheTemperatureMonitoringSystemusingDataCaptureSoftware

LOP-009-0013 2 IncurredSampleReanalysisLOP-011-0013 1 NonclinicalDoseFormulationAnalyticalMethodValidationLOP-012-0013 2 ValidationandUseofBioanalyticalTestMethodsLOP-013-0013 1 StabilityStudiesLOP-014-0013 1 PreparationofTestMethodsandTestMethodWorksheets

LOP-015-0013 9 QualificationofTemperatureGuardTemperatureMonitoringUnitandStorageChambers

LOP-016-0014 0 ValidationofAnalyticalTestMethodsLOP-017-0016 0 TransferofAnalyticalTestMethodsORG–OrganizationandPersonnelORG-001-0011 3 TrainingProceduresORG-004-0016 0 Non-GxPOperationsQAU–QualityAssuranceUnitQAU-001-0011 2 LaboratoryOOSResultsInvestigation

QAU-008-0011 3 GoodDocumentationPracticesandLaboratoryNotebookProcedures

QAU-010-0011 2 MaintenanceoftheStudyMasterScheduleQAU-011-0011 4 StandardOperatingProceduresQAU-014-0011 0 ManagingRegulatoryInspectionsQAU-017-0012 3 CorrectiveandPreventiveActions(CAPA)SystemQAU-018-0012 2 InternalAuditsQAU-019-0012 2 CustomerComplaintsQAU-020-0012 2 UseofElectronicSignaturesinAdobeAcrobatQAU-021-0012 2 DeviationsQAU-022-0013 1 GoodLaboratoryPractice(GLP)ComplianceQAU-023-0013 1 ResponsibilitiesandAuthorityoftheQualityUnitQAU-025-0013 0 SupplierQualificationQAU-026-0013 2 DocumentControlQAU-027-0013 3 BioanalyticalOOTRetestProceduresQAU-028-0014 1 RecordsManagementQAU-029-0014 3 DataReviewProceduresQAU-030-0014 1 ElectronicLogsUpdatedbyQA/Date:____________________________________