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Non Product and FDA Software Validation

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Non Product and FDA Software Validation

  1. 1. Email:info@automationandvalidation.comTel.(tollfree):1-877-ADB-CCRO Tel.(local):954-517-1970 8569PinesBlvd,Suite215Hollywood,FL33024 Supporting manufacturing and logisticssystems, such as those that involve SAP,PeopleSoft, MicrosoftDynamics,andQAD. RunningRunningclinicaldatabasesystemssuchasOracle Clinical,ClinTrials,MetaData,SAS,RDC,DataFax, image managementsystems,labs management systems,adverse event management systems, coding management systems, thesaurus management systems, MEDDRA, WHODRUG, WHOART,clinicalstudy management,and trial management.management. Incorporating System development life cycle assessment comprising concepts, design, implementation, installation, integration, and maintenance. Standardizingoperatingprocedureandqualification protocoldevelopment. Validating packaging lines,Assembly,Automated TestingSystems,manufacturingsystems,endof line testers,reliability systems,and in-process systemswhichincludevalidationofoxygenlevel pacemakerswith8-bitmicro-controllers. ImplementingImplementingdocumentationtestingandevaluation standardspursuanttoIEEE,FDA& ISO standards, suchasISO13485. Meeting FDA product development and manufacturing regulations for diagnostic, implantable,ClassI,II,IIImedicaldevices,Biologics andmeetingrelatedindustryregulationssuchas AAMI,AIMD,ICH,MDD,ISO,CFRandIEC. MaintainingMaintainingdocumentationrevisioncontrolusing object oriented control systems including Documentum®,Agile PLM®,SharePoint®,Scripts, andMasterControl. SupportingSupportingqualityassuranceprocesses,corrective andpreventativeactions,complaints,issues,field service, non-conformance, supplier, receiving inspection,anddeviceaccountability,packagingand transportation,producttraceability,return goods systems, manufacturing, audits, and training systems. AdheringAdheringtoFDAwarningmitigations,includingFDA 21CFRPart11,FDA21CFRPart211,49CFRand FDA21CFRPart820. Automationand ValidationGroup www.automationandvalidation.com Automationand ValidationGroupADBADB Non-ProductSoftwareValidation ADBAutomationandValidationGroupoffersourexperienceintheestablishmentandexecutionofnon-productsoftwarevalidationprocessestosupportMedicalDeviceand PharmaceuticalCompanies,amongothersectors.Tothisend,wepossessknowledgeandexperienceinthefollowingareas: 10 20142004EST.

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