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How Pharmaceuticals Are Securely Embracing The Cloud
AMAZON WEB SERVICES (AWS) PREMIER
PARTNER with 6+ years of success in onboarding and
migrating over 175 customers to the AWS Cloud
CHAIRED AND INFLUENCED many of the
standards our customers use today
Recognized by 451 Group – 8K MILES CROSSES
THE CHASM IN CLOUD-BASED IDENTITY
FEDERATION
Built a powerful TEST DRIVE FRAMEWORK for
AWS to move enterprise software customers onto
Cloud – E.g., Alfresco, CA, Red Hat, Trend Micro
Enabled over 10 MILLION federated user transactions
and enabled 300+ SaaS and enterprise applications
MARKET LEADERSHIP
8KMiles is a leading
provider of end to end
Cloud Solutions that
meet the unique needs
of the Pharmaceutical,
Life Science and
Healthcare Markets
Panelists
Shah Nawaz
Senior Director, Enterprise Architecture
Shire Pharmaceuticals
https://www.linkedin.com/in/nawazshah
3
Sudish Mogli
VP, Engineering
8KMiles Software Services
https://www.linkedin.com/in/sudishmogli
Disclaimer: All content and opinions expressed in
this presentation are solely those of the presenters
and not necessarily those of Shire Pharmaceutical.
References made in the slides are for informational
purposes only. It doesn’t claim to be any current or
past employers strategy and/or position. Shire
Pharmaceutical does not guarantee the accuracy
or reliability of the information provided herein.
The panelists or speakers will not be liable for any
errors or omissions in this presentation nor for the
availability of this information.
• Trends
• Drivers
• Inhibitors & Considerations on overcoming those
• How 8KMiles is helping Clients
4
Topics
Trends
Life sciences companies
will engage with other
members of the value
chain (for example,
patients and clinicians) to
improve patient
outcomes.
6
New Medicines and
services will be
developed using an
entirely new paradigm
drawing on external
innovation and data from
multiple sources
Convergence of
Technologies, enabled
and driven by the cloud,
will further enable life
sciences companies to
act globally and open the
door to new partnership
and expanded markets
Source: GigaOm, Accenture
Credit : Shutterstock
DRIVERS
Cost Scalability Agility
•SECURITY
•CULTURE
•COMPLIANCE
•OPERATION
INHIBTORS
Security, by far remains the biggest concern, however numerous
Technology advancement made in the last 3 years that can help
mitigate these gaps.
Security
Recommendation
Build a Security
Architecture in the context
of Cloud
Maintain Security Heat
Maintain Manageability
Deployment Model
Source: Mckensie, 8KMiles
Culture is still the King. Cloud is Distributive and it will affect the
organization culture, the way things are developed, run, operated &
delivered. Every organization adoption will vary.
Culture
Recommendation
Focus on the Business
Outcome
Traditional Mode
Nonlinear Mode
Accept Instability
DevOps
Automation
Agile Development
SOA Method
(ITIL, CMMi, COBIT)
Required Reliability
Ops
Minimum Automation
System of Innovation
System of Differentiation
System of Record
Loosely Coupled
Tightly Coupled
Iterative Development
Sequential Development
Non-Iterative Development
Cost Scalability Agility
Adopt Bi-Modal IT
Establish Governance
Model
Define required
outcome
Define Require
Control
Test Outcomes
and controls
Hold owners
accountable
Operate and end-to-end view of
GRC across entire environment
Ensure all decision consider
holistic risk and Impact of Cloud
to IT Function
Ensure Governance input into
cloud transformation lifecycle
Deliver
Infrastructure
outcome
Monitor and
Manage
Infrastructure
Control
Deliver
Application
Outcome
Monitor and
Manage
Application
control
Shared Responsibility
Shared Governance Functions
Infrastructure and Operations
Application Development
Requirement
Compliance
GxP Electronic Record
Keeping Control
Qualified Infrastructure
Standard Operating
Procedures ( SOPs)
Trained personnel (
Including IT )
System Validations
Record Availability Record Integrity Record Retention
Traceability
Design
Specification
User
Requirement
Specification
Test
Specification
Deployment
Specification
Adopt DevOps ( Automation )
User
Acceptance
 Codify your Infrastructure
 Pre-Qualify your environment prior to
loading GxP Workloads
 Build Pre-validated images for Cloud
Usage
 Adopt a version control & release
methodology
 Automate your stack as much as you can
 Automate your Testing
 Adopt V-Model by Design )
http://en.wikipedia.org/wiki/V-Model_(software_development))
Specification Verification Acceptance
Agree on Data
Center
Certification level (
i.e SAS 70, ISO / )
Decide how IQ &
OQ Portion of the
Part 11 Guidelines
will be supported
in Cloud
Environment
Integrate Provider
Auditing part of
VMP ( Validation
Master Plan )
Recommendation
Org Dependent
Regulatory consideration for use of cloud computing will
matter depending on the services you consume. Not all
services are created equally to satisfy compliance requirements.
Operation will be different, Tower Concept will not work, hence
consider adopting capabilities that can provide the appropriate
assurance and governance to operate your cloud services
Operate
Operational Capabilities Considerations
“As cloud services and user consumption model continue to evolve, so must capabilities for
effective management of this environment”
CloudEzRx ™ Framework
“Framework designed for Life Science, Pharmaceutical and Healthcare Industry that are
considering running highly sensitive/regulated workloads in the Public Cloud”
13
Enterprise Cloud Engagement Platform
Manage and Operate your Cloud Lifecycle
Self-Service Portal
IAM Control Service Market Place
Financial Management Security | Audit | Compliance
Validated Platform
ServiceExtensible
Validated Security Architecture
Validated Service Development & Qualified Network Reference Architecture
GxP|HIPAA|Reporting
AcceleratedQualifiedTemplates
Cloud Control
(Operate)
Key Benefits To Our Customers
Documented Design |
Test & Verification
Specification
Validated Platform
to consume any
Cloud IaaS/PaaS
Services
Qualified Solutions
Stack
Proven SIEM for
Life Science in a
Cloud
Operating Best
Practices
Selected use Cases
14
Use
Cases
Resource
Provisioning
Automation
Implementing
Analytical Platform
in a Public Cloud
Drug trial analysis
Efficient data
sharing and
management
HPC Workload
Processing
Cloud Operational
Platform
Development
Lifecycle
Disaster Recovery
Data
Retention/Archive
www.8kmiles.com
15
Thank You
For More Information:
Tom Crowley
Director of Sales
tom.crowley@8kmiles.com
630.863.8406
Anand Kumar
Vice President
ak@8kmiles.com
708.289.5111
www.linkedin.com/company/8kmiles.com
www.facebook.com/8KMiles
twitter.com/8kmiles

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8 k miles embracing the cloud webinar

  • 1. How Pharmaceuticals Are Securely Embracing The Cloud
  • 2. AMAZON WEB SERVICES (AWS) PREMIER PARTNER with 6+ years of success in onboarding and migrating over 175 customers to the AWS Cloud CHAIRED AND INFLUENCED many of the standards our customers use today Recognized by 451 Group – 8K MILES CROSSES THE CHASM IN CLOUD-BASED IDENTITY FEDERATION Built a powerful TEST DRIVE FRAMEWORK for AWS to move enterprise software customers onto Cloud – E.g., Alfresco, CA, Red Hat, Trend Micro Enabled over 10 MILLION federated user transactions and enabled 300+ SaaS and enterprise applications MARKET LEADERSHIP 8KMiles is a leading provider of end to end Cloud Solutions that meet the unique needs of the Pharmaceutical, Life Science and Healthcare Markets
  • 3. Panelists Shah Nawaz Senior Director, Enterprise Architecture Shire Pharmaceuticals https://www.linkedin.com/in/nawazshah 3 Sudish Mogli VP, Engineering 8KMiles Software Services https://www.linkedin.com/in/sudishmogli Disclaimer: All content and opinions expressed in this presentation are solely those of the presenters and not necessarily those of Shire Pharmaceutical. References made in the slides are for informational purposes only. It doesn’t claim to be any current or past employers strategy and/or position. Shire Pharmaceutical does not guarantee the accuracy or reliability of the information provided herein. The panelists or speakers will not be liable for any errors or omissions in this presentation nor for the availability of this information.
  • 4. • Trends • Drivers • Inhibitors & Considerations on overcoming those • How 8KMiles is helping Clients 4 Topics
  • 5. Trends Life sciences companies will engage with other members of the value chain (for example, patients and clinicians) to improve patient outcomes. 6 New Medicines and services will be developed using an entirely new paradigm drawing on external innovation and data from multiple sources Convergence of Technologies, enabled and driven by the cloud, will further enable life sciences companies to act globally and open the door to new partnership and expanded markets Source: GigaOm, Accenture Credit : Shutterstock
  • 8. Security, by far remains the biggest concern, however numerous Technology advancement made in the last 3 years that can help mitigate these gaps. Security Recommendation Build a Security Architecture in the context of Cloud Maintain Security Heat Maintain Manageability Deployment Model Source: Mckensie, 8KMiles
  • 9. Culture is still the King. Cloud is Distributive and it will affect the organization culture, the way things are developed, run, operated & delivered. Every organization adoption will vary. Culture Recommendation Focus on the Business Outcome Traditional Mode Nonlinear Mode Accept Instability DevOps Automation Agile Development SOA Method (ITIL, CMMi, COBIT) Required Reliability Ops Minimum Automation System of Innovation System of Differentiation System of Record Loosely Coupled Tightly Coupled Iterative Development Sequential Development Non-Iterative Development Cost Scalability Agility Adopt Bi-Modal IT Establish Governance Model Define required outcome Define Require Control Test Outcomes and controls Hold owners accountable Operate and end-to-end view of GRC across entire environment Ensure all decision consider holistic risk and Impact of Cloud to IT Function Ensure Governance input into cloud transformation lifecycle Deliver Infrastructure outcome Monitor and Manage Infrastructure Control Deliver Application Outcome Monitor and Manage Application control Shared Responsibility Shared Governance Functions Infrastructure and Operations Application Development
  • 10. Requirement Compliance GxP Electronic Record Keeping Control Qualified Infrastructure Standard Operating Procedures ( SOPs) Trained personnel ( Including IT ) System Validations Record Availability Record Integrity Record Retention Traceability Design Specification User Requirement Specification Test Specification Deployment Specification Adopt DevOps ( Automation ) User Acceptance  Codify your Infrastructure  Pre-Qualify your environment prior to loading GxP Workloads  Build Pre-validated images for Cloud Usage  Adopt a version control & release methodology  Automate your stack as much as you can  Automate your Testing  Adopt V-Model by Design ) http://en.wikipedia.org/wiki/V-Model_(software_development)) Specification Verification Acceptance Agree on Data Center Certification level ( i.e SAS 70, ISO / ) Decide how IQ & OQ Portion of the Part 11 Guidelines will be supported in Cloud Environment Integrate Provider Auditing part of VMP ( Validation Master Plan ) Recommendation Org Dependent Regulatory consideration for use of cloud computing will matter depending on the services you consume. Not all services are created equally to satisfy compliance requirements.
  • 11. Operation will be different, Tower Concept will not work, hence consider adopting capabilities that can provide the appropriate assurance and governance to operate your cloud services Operate Operational Capabilities Considerations “As cloud services and user consumption model continue to evolve, so must capabilities for effective management of this environment”
  • 12. CloudEzRx ™ Framework “Framework designed for Life Science, Pharmaceutical and Healthcare Industry that are considering running highly sensitive/regulated workloads in the Public Cloud” 13 Enterprise Cloud Engagement Platform Manage and Operate your Cloud Lifecycle Self-Service Portal IAM Control Service Market Place Financial Management Security | Audit | Compliance Validated Platform ServiceExtensible Validated Security Architecture Validated Service Development & Qualified Network Reference Architecture GxP|HIPAA|Reporting AcceleratedQualifiedTemplates Cloud Control (Operate) Key Benefits To Our Customers Documented Design | Test & Verification Specification Validated Platform to consume any Cloud IaaS/PaaS Services Qualified Solutions Stack Proven SIEM for Life Science in a Cloud Operating Best Practices
  • 13. Selected use Cases 14 Use Cases Resource Provisioning Automation Implementing Analytical Platform in a Public Cloud Drug trial analysis Efficient data sharing and management HPC Workload Processing Cloud Operational Platform Development Lifecycle Disaster Recovery Data Retention/Archive
  • 14. www.8kmiles.com 15 Thank You For More Information: Tom Crowley Director of Sales tom.crowley@8kmiles.com 630.863.8406 Anand Kumar Vice President ak@8kmiles.com 708.289.5111 www.linkedin.com/company/8kmiles.com www.facebook.com/8KMiles twitter.com/8kmiles