KPIT Agile PLM Accelerator For Life Sciences

Agile PLM Accelerator forLife Sciences ManufacturersPre-Configured for Rapid ImplementationPre-Configured for IndustryBest PracticesManufacturers of medical devices & pharmaceuticals must complywith rigorously enforced standards. Frequently changinggovernment directives require changes in product classifications,identifiers and other variables reflected in the workflow process.Knowledge of Agile PLM is simply not enough – yourimplementation partner needs to understand industryrequirements.With our extensive industry understanding and robust solutions,we deliver a differentiated customer experience at every step ofthe customer life cycle.Designed for all sizes of Life Science companies, our Agile PLM LifeSciences Accelerator solution, based on Oracle’s Agile ProductSuite comprises:Pre-configured workflowsData modelsTest scriptsOptional pre-configured integration to Oracle E-Business SuitePrepared with a ‘Straw Man’ configuration, our best practicesassure faster implementations and improved processes, all at amuch better price.Accelerated BenefitsReduction in development and process discovery timeReduced need for dedicated or full time customer resourcesImmediate execution of best practice validation techniquesImmediate implementation of PC/PQ best practicesengineered and configurable to how you do businessReduced implementation schedulesYou Have Our SupportSupport is provided for the identified business processes.Examples:Engineering Change OrderProcess Item Master and BOM ManagementPart NumberingDistinguished FeaturesOur Agile PLM Accelerator for Life Sciences can be used withthe Agile FDA Validation Protocol Package (written by USDM)for handling:Installation Qualification (IQ)Operation Qualification (OQ)Performance Qualification (PQ)The Accelerator is engineered for compliance with 21 CFR Part11, which can result in decreased audit time and increasedauditor confidence.Accelerated implementation means we rapidly bring AgileProduct Lifecycle Management (PLM) and Product QualityManagement (PQM) solutions into production to ensure youachieve low-risk, high-impact, cost-effective implementationthat directly addresses your business needs.Structured WorkshopsBusiness process discovery and requirements are completelytailored for Life Sciences. A structured workshop brings arelevant starting point for documenting key business processes,item template restructuring, revision control, and part numberrestructuring.Implementation Deliverablestailored for Life SciencesExamples:Item MastersFile Attachments –Drawings, Artwork, Labels,MFG and MFG Part Numbers considering FDA & EUclassification systemsDHF –Design History FileDMR –Design Master RecordDHR –Device History Recordwww.kpit.com

“KPIT's Oracle Accelerate solution for Life Sciences combines our world-class product lifecycle managementapplications with KPIT’s expertise to deliver an affordable, rapidly implemented industry-focused solution.”- Dan Scheib,Vice President, Channels - North America Applications, OracleKPIT Oracle Practice provides Oracle and process-basedexpertise to Manufacturing, Automotive and Energy industries.More than 2,000 Oracle professionals deliver a powerful combinationof industry experience and Oracle knowledge in the following areas:E-Business SuiteJD EdwardsAgile PLMCRM On DemandValue Chain PlanningValue Chain ExecutionOracle ConfiguratorWarehouse ManagementOracle Transportation ManagementKPITholds20+OracleSpecializationsand5 Advanced SpecializationsBusiness Intelligence and HyperionFusion MiddlewareGlobal Services and Supportinfo@kpit.comwww.kpit.comChina | France | Germany | India | Japan | Singapore | South Africa | South Korea | UAE | UK | USA