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GxP @ AWS

Bertram Dorn – Specialized Solutions ArchitectSecurity/ComplianceAmazon Web Services EMEA

©Amazon.com, Inc. and its affiliates. All rights reserved.

Healthcare and Life Sciences customers are rapidly adopting AWS

Initial usage concentrated in Research, Digital Marketing and core IT

GxP solutions are now incredibly important to our customers

Development and Manufacturing are beginning the adoption curve

AWS’s GxP approach comes directly from our customers and partners

We want to educate, engage and deliver further value to our customers

Business Context of AWS and GxP

The Benefits to Using the AWS Cloud

?Move from operational to

variable costLower variable cost than most companies

can achieveNo need to guess

capacity

Agility, speed & innovation

Remove undifferentiated heavy lifting

Go global in minutes

AWS Service Build

Tennant Isolation Deep Network Security Scaling Crypto Services Detailed Monitoring Access Control

Mandatory Fine Grade MFA Possible

AWS Global Infrastructure

Application Services

Networking

Deployment & Administration

DatabaseStorageCompute

Inherit

Control

Identity Management

Key Management & Storage

Monitoring & Logs

Assessment and reporting

Resource & Usage Auditing

SECURITY & COMPLIANCE

Configuration Compliance

Web application firewall

Access Control

12 Regions

33 Availability Zones

54 Edge Locations

Coming Soon:

5 Regions

11 Availability Zones

AWS Operates Globally, as do our Customers

ENTERPRISE APPS

DEVELOPMENT & OPERATIONSMOBILE SERVICESAPP SERVICESANALYTICS

DataWarehousing

Hadoop/Spark

Streaming Data Collection

Machine Learning

Elastic Search

Virtual Desktops

Sharing & Collaboration

Corporate Email

Backup

Queuing & Notifications

Workflow

Search

Email

Transcoding

One-click App Deployment

Identity

Sync

Single Integrated Console

PushNotifications

DevOps Resource Management

Application Lifecycle Management

Containers

Triggers

Resource Templates

TECHNICAL & BUSINESS SUPPORT

Account Management

Support

Professional Services

Training & Certification

Security & Pricing Reports

Partner Ecosystem

Solutions Architects

MARKETPLACE

Business Apps

Business Intelligence

DatabasesDevOps Tools

NetworkingSecurity Storage

RegionsAvailability Zones

Points of Presence

INFRASTRUCTURE

CORE SERVICES

ComputeVMs, Auto-scaling, & Load Balancing

StorageObject, Blocks, Archival, Import/Export

DatabasesRelational, NoSQL, Caching, Migration

NetworkingVPC, DX, DNS

CDN

Access ControlIdentity Management


Monitoring & Logs






HYBRIDARCHITECTURE

Data Backups

Integrated App Deployments

DirectConnect

IdentityFederation

IntegratedResource Management

Integrated Networking

API Gateway

IoT

Rules Engine

Device Shadows

Device SDKs

Registry

Device Gateway

Streaming Data Analysis


MobileAnalytics

ENTERPRISE APPS


DataWarehousing

Hadoop/Spark


Machine Learning

Elastic Search

Virtual Desktops


Corporate Email

Backup


Workflow

Search

Email

Transcoding


Identity

Sync


PushNotifications



Containers

Triggers

Resource Templates


Account Management

Support




Partner Ecosystem


MARKETPLACE

Business Apps





Points of Presence

INFRASTRUCTURE

CORE SERVICES





CDN

Access ControlIdentity Management


Monitoring & Logs






HYBRIDARCHITECTURE

Data Backups


DirectConnect

IdentityFederation



API Gateway

IoT

Rules Engine

Device Shadows

Device SDKs

Registry

Device Gateway



MobileAnalytics

ENTERPRISE APPS


DataWarehousing

Hadoop/Spark


Machine Learning

Elastic Search

Virtual Desktops


Corporate Email

Backup


Workflow

Search

Email

Transcoding


Identity

Sync


PushNotifications



Containers

Triggers

Resource Templates


Account Management

Support




Partner Ecosystem


MARKETPLACE

Business Apps





Points of Presence

INFRASTRUCTURE

CORE SERVICES





CDN

Identity Management


Monitoring & Logs






HYBRID ARCHITECTURE

Data Backups


DirectConnect

IdentityFederation



API Gateway

IoT

Rules Engine

Device Shadows

Device SDKs

Registry

Device Gateway



MobileAnalytics

Access Control

The main AWS Compliance Frameworks of today

Certificates: Programmes:

ISO27000

ISO9001

GxP SDLC and Deployment Scenarios

Develop Validate Operate

COTS App

Virtual

Infrastructure

Custom App

Virtual

Infrastructure

AWS Products AWS Products

Scenario 1 Scenario 2

AWS Account AWS Account

SaaS

Virtual

Infrastructure

AWS Products

Scenario 3

AWS Account

GxP End Users

Pharma,

DeviceAWS ISV PartnerRoles:

User Needs

Application Requirements &

SLA

Server Requirements

Amazon EC2 Instance

Amazon EC2 Product Spec &

SLA

Solution Architecture

Database Requirements

Solution Architecture

Amazon RDS DB Instance

Amazon RDS Product Spec &

SLA

Customer

AWS

Development Starts with Your User Needs

AWS Shared Responsibility Model in GxP

Human

Interface Support

Equipment

Interface Support

Instrument

Interface Support

Application

Data

Software-defined Infrastructure

AWS Account

Amazon IAM Amazon VPC Amazon EC2 Amazon S3 Amazon RDS Other AWS Products

Manual I/O Automated I/O

Step 1 Step 2 Step 3

Customer

AWS

Automated I/O

GxP Process Validation

GxP Software Validation

GxP Infrastructure Qualification

Commercial IT Standards

G o o d L a b o r a t o r y , C l i n i c a l , M a n u f a c t u r i n g P r o c e s s

On-Premises Infrastructure

Products

AWS’s New GxP Compliance Resources

GxP Cloud on AWS FAQ

Considerations for Using AWS Products in GxP Systems

AWS Quality Management System Overview (available to NDA-holders)

Technical Product Documentation

Introduction to Auditing the Use of AWS

Security by Design Program

Cloud Technology

Software-defined infrastructure? Cloud users replace physical IT infrastructure with

virtual IT infrastructure

SDI can be managed like any other software code

Users control their virtual infrastructure and data via web service API, CLI, GUI

Users integrate applications with virtual infrastructure through SDKs and APIs

Users and applications interact with SDI programmatically with .json scripts instead of manually with .doc files

{API}

AWS Cloud Advantages

IT Benefits Trade capital expense for

variable expense

Benefit from massive economies of scale

Stop guessing capacity

Increase speed and agility

Stop spending money on data centers

Go global in minutes

Compliance Benefits Designed for Security & Quality

Constantly Monitored

Highly Automated

Highly Available

Highly Accredited

ISO 9001:2008, ISO 27001:2013ISO 27017:2015, ISO 27018:2014

Cybersecurity of AWS Products

Security Features Built-in

Security Bulletins

Security Guidance

AWS Trusted Advisor

Penetration Testing/Scanning

Vulnerability Reporting

AWS Professional Services

AWS Partner Network

"The financial service industry attracts some of the worst cyber criminals. We work closely with AWS to develop a security model, which we believe enables us to operate more securely in the public cloud than we can in our own data centers."

-Rob Alexander, CIO, Capital One

Data Integrity with AWS Products

API

service

web

API Request

API Response includes a Message Digest, a unique fingerprint for each API request

AWS Product Features for Data IntegrityEnd-to-end authenticated encryption, API message digests, file object hashing, file object integrity monitoring, log file integrity validation, account configuration rules and alarms, fine-grained access controls, VPC flow logs, application deployment and testing tools to enforce application input validations, multi-region redundancy and backup capability, multiple methods of bulk data transfer to and from the AWS cloud…

Supplier Assessments of AWS

Customers with GxP systems have completed their supplier assessments of AWS based on our performance history,

compliance reports, and extensive documentation of our products.

Product Documentation

Product Training Materials

Customer Support

Service Health Dashboard

Security & Compliance Whitepapers

Quality Management System Overview

Supplier Questionnaires & RFIs

ISO Certification

SOC Auditor Reports

FedRAMP Compliant Status

Public Company Reporting (AMZN)

Agreements with AWS

Customer Agreement

Service Terms

Acceptable Use Policy

Customer Support Agreement

Product SLAs

Addendums:o Security

oData Processing

oBusiness Associate

Change notification

Security notification

Your data

Data privacy

Support case SLA

No minimum spend or term

Customer responsibilities

Cloud Solution Validation (CSV)

Hardware Era Cloud EraVirtualization Era

Protocol-driven manual activities

Procedure-driven manual activities

Code-driven automated activities

Application Validation

Software Defined Infrastructure Qualification

Web Service API Qualification

AWS qualifies our products to commercial IT standards like ISO, SOC and NIST,Customers qualify their use of AWS Products to industry-specific standards like GxP, QSR and Part 11.

Operations of GxP Systems

Reduce human access to your production IT environment through deployment automation

Track and monitor 100% of your assets, changes, and configurations

Software-defined infrastructure makes synchronizing environments easy

Feed end user requests back into the development process.

GxP end usersGxP engineers

production

Auditing GxP Systems

An IAM user, Alice, employed the CreateUser action to create a new user account for Bob.

AWS CloudTrail

Resources

https://aws.amazon.com

https://aws.amazon.com/compliance/

https://aws.amazon.com/security/

https://aws.amazon.com/premiumsupport/

http://status.aws.amazon.com/



https://aws.amazon.com/security/

https://aws.amazon.com/premiumsupport/

http://status.aws.amazon.com/

Thank you!

Documents

GxP @ AWS - aws-de-media.s3.amazonaws.comaws-de-media.s3.amazonaws.com/images/Webinar/Life Science Webd… · Products in GxP Systems ... application deployment and testing tools