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.

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. 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. 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. 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. 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. 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. 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

9. 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
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