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Achieving GxP compliance with SAP S/4HANA in the AWS Cloud


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Learn how you can achieve full GxP compliance when moving to SAP S/4HANA in the AWS Cloud. In the session, you’ll hear learnings and best practices for securing FDA approval in order to fully reap the benefits of cloud transformation.

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Achieving GxP compliance with SAP S/4HANA in the AWS Cloud

  1. 1. In collaboration with 1The information contained in this document is proprietary. Copyright © 2019 Capgemini. All rights reserved. Cloud Within Reach: Achieving GxP Compliance with S/4HANA on AWS Rémon Hogguer and Jason Hatch, Capgemini Tuesday, May 7th, 3:00 to 3:30 pm
  2. 2. In collaboration with 2The information contained in this document is proprietary. Copyright © 2019 Capgemini. All rights reserved.  Intercompany Stock Transfers  Direct Procurement Supplier Qualification  UDI Compliance Common challenges for Medical Device companies Sales  Rebates, Charge-Backs  Configure-price-quote  Deferred Revenue Recognition for Device Install / Rentals / Leases  Incentive compensation  Customer segmentation Supply Chain  GxP Validation  Batch Release with Genealogy Checks  Compliant manufacturing  Device History Record  NCMR / CAPA / Complaints Handling  In-House Repairs  Manufacture-at-Risk  Product Expiry Management Manufacturing/Quality/Regulatory Customer Service  Returns, Repairs, Refurbishment  Product Recall  Spare Parts Inventory Management  Trunk Stock Management  Product Recall  Samples Management Development  R&D Portfolio and Project Tracking  Product Innovation and Connected Care Patients Contract Care Organizations Payers PhysiciansChambers WholesalersLifeSciencesPath
  3. 3. In collaboration with 3The information contained in this document is proprietary. Copyright © 2019 Capgemini. All rights reserved. Capgemini’s LifeSciencesPath accelerates your journey to the Life Sciences Intelligent Enterprise AI/ML | IoT | Analytics Intelligent Enterprise Suite Customer Experience Manufacturing & Supply Chain Digital Core People Engagement Network & Spend Management Intelligent Technologies Digital Platform Data Management Cloud Platform LifeSciencesPath
  4. 4. In collaboration with 4The information contained in this document is proprietary. Copyright © 2019 Capgemini. All rights reserved. SOP-driven business operations, Change Controls Business users “day in the life” acceptance testing (CSV PQ) Functional testing against approved requirements (CSV OQ) Installation verification (CSV IQ) Integration testing Security testing Unit testing Code and Configuration Reviews LifeSciencesPath: Our validation-ready solution Our CSV and Testing approach is based on GAMP® V framework Validation Master Plan (VMP) User Requirement Specification (URS) Functional Requirement specification (FRS) Technical requirement specification (TRS) Site Acceptance Test Maintaining state of validation Performance Qualification (PQ/UAT) Operation Qualification (OQ) Installation Qualification (IQ) LifeSciencesPath
  5. 5. In collaboration with 5The information contained in this document is proprietary. Copyright © 2019 Capgemini. All rights reserved. Client Overview Publicly traded global company delivering infection prevention products (endoscopy, water purification and filtration and healthcare disposables) and services for patients, caregivers, and healthcare providers Success at Cantel Medical Global Medical Device Manufacturer “Greenfield” implementation of ERP backbone on LifeSciencesPath  Reliable ERP backbone needed to run business and drive standardization and commonality across the enterprise  Flexibility needed to quickly absorb acquisitions and realize synergies  “Greenfield” deployment of LifeSciencesPath powered by SAP S/4HANA 1610  Business process scope: Finance to Manage, Demand to Settle, Procure to Pay, Order to Cash, Service to Cash  Incorporated CSV expertise from the start to confirm that the systems were to be operating as intended  Provisioned all SAP environments through AWS cloud  Managed deployments and transitioned to Capgemini’s application management team  Standardized processes across all divisions and geographies  Ability to quickly absorb integrations of new acquisitions  Easy maintenance / optimized cost of ownership for new state-of-the-art ERP platform  Seamless end-user experience through integration of Salesforce and ServiceMax with ERP backbone  Deployed technologies that are fulfilling its purpose in line with the regulatory guidelines Business Issue Capgemini’s Approach Benefits
  6. 6. In collaboration with 6The information contained in this document is proprietary. Copyright © 2019 Capgemini. All rights reserved. RecognitionCapabilities  Expansive AWS Offerings – Cloud Strategy – SAP & Mass Migrations – Cloud-native development – Digital Cloud Platform – VMware on AWS – Data & Analytics Intelligent Applications – Sector-specific solutions – Managed Services  Executing AI prototyping for AWS Digital Innovation team  AWS Cloud Adoption Framework embedded in Capgemini methodologies  AWS MAP program Partner  AWS Premier Consulting Partner since 2012  Over 200,000 people in backed by state-of-the-art on-shore and off-shore centers of expertise in more than 40 countries.  700+ certifications ramping to 5,400 in 3 years  AWS Migration Center of Excellence in India  Bringing to life the future with Capgemini Invent and Applied Innovation Centers  Insights & Data Practice 1,000 people over three years  AWS Managed Service Provider (MSP) First to get certified on the new Partner Program  Customer Experience Leader in Gartner January 2018 Magic Quadrant for CRM and Customer Experience Implementation Services Worldwide  SAP Application Services Leader in Gartner February 2018 Magic Quadrant for SAP Application Services  Business Agility Forrester: Now Tech: API Strategy and Delivery Service Providers; Integration and Strategy Delivery Service Providers, Microservices Strategy and Delivery Service Providers, Q1 2018  AWS Transformation Award  AWS Partner Network Ambassadors Relationship RelationshipADOPT TRANSFORMDESIGN MANAGE
  7. 7. In collaboration with 7The information contained in this document is proprietary. Copyright © 2019 Capgemini. All rights reserved. We help make digital agility a reality Building your dream house faster  Migrated Louisiana Pacific’s entire SAP landscape to the AWS platform in 3 months  LP’s CIO Don Walker described the migration as “flawless”  Capgemini’s Digital Cloud Platform on the AWS Cloud is transforming diabetes care management  Building a B2B and B2C e- commerce engine to drive revenue from $200M to $500M  Capgemini is McDonalds strategic disruptive innovation provider  Transforming customer experience from their e- commerce platform, to mobile ordering and in- store kiosks, and we run their entire IT operation  Created serverless environment for petabytes of DNA data  Rapidly scaled secure processing pipeline that cut genomics processing from 30 days to one day Improving crops with DNA analysis Reinventing insurance, by the mile  Delivering flexible and scalable claims platform enabling expansion of Metromile’s pay-per- mile model across the U.S. Breaking boundaries in diabetes care Helping you skip the line
  8. 8. A global leader in consulting, technology services and digital transformation, Capgemini is at the forefront of innovation to address the entire breadth of clients’ opportunities in the evolving world of cloud, digital and platforms. Building on its strong 50-year heritage and deep industry-specific expertise, Capgemini enables organizations to realize their business ambitions through an array of services from strategy to operations. Capgemini is driven by the conviction that the business value of technology comes from and through people. It is a multicultural company of over 200,000 team members in more than 40 countries. The Group reported 2018 global revenues of EUR 13.2 billion (about $15.6 billion USD at 2018 average rate). About Capgemini Learn more about us at This message is intended only for the person to whom it is addressed. If you are not the intended recipient, you are not authorized to read, print, retain, copy, disseminate, distribute, or use this message or any part thereof. If you receive this message in error, please notify the sender immediately and delete all copies of this message. This message contains information that may be privileged or confidential and is the property of the Capgemini Group. Copyright © 2019 Capgemini. All rights reserved. Rightshore® is a trademark belonging to Capgemini.