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.