Cloud computing occurs when a program is run on many computers at the same time, referring to a server connected through the internet. This presentation from Sparta Systems describes how cloud technology can be an integral part of the Enterprise Quality Management Systems (EQMS).

1. Jim Attardi
Vice President, Cloud Services
Cloud Technology and Its Implication
for Quality Services

2. E-Mail
Clouds
Games
Pictures
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3. Clouds
E-Mail
Games
Pictures
Software as a Service
Hybrid Cloud
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4. Cloud Technology
Proven over time
 Increases the ability to manage capacity
 Reduce the cost of the environments
 Reduces Downtime
 Enables High Availability Solutions
 Automate infrastructure deployment
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5. What To Look For In A Quality Partner
 Proven Market Leader
 Experience operating in a Global
Market
 Strong Organizational Framework
 Proven Facility Controls
 Redundant Environmental Controls
 Business Continuity and Disaster
Recovery Options
 Logical Access Management
Criteria:
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6. Secure Services
• Business Value
• Performance Levels
• Support Levels
Security
Software layer
IAAS
SAAS
Customers
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7. Policy Driven Security
 Integrity
 Authenticity
 Confidentiality
 Availability
 Non-repudiation
Security Policy Mandatory Staff
Training
Certification
 SSAE 16 - ISSAE 3402
 ISO
 Safe Harbor
Compliant
 21 CFR Part 11
 GMP/GXP
Reviewed Regularly
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8. Layered Security
Physical
Security
 24 by 7 Physical Security onsite
 Video Surveillance on a 24 by 7 basis
 Authorized access managed through key cards and
biometrics
Logical
Security
 Users are Identified and
Authenticated
 Access is Logged & audited
 Tiered access controls
 Firewall manages Inbound & Outbound
traffic
 Firewall controls access to the internet
 Firewall Access Defaults deny mode
Application
Security
 Password Controls
 Data Encryption
 Routine Penetration Testing
 Code Scanning and 3rd Party Security Audits
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9. Service Development
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10. Unified Development Team
Providing Quality services to users in a SaaS model:
• Agile / Iterative development methods
• Frequent checkpoints to verify requirements
• Entire team focused on delivering customer value, security of assets and defined service
levels
Cloud Services Development Testing
Product Management
Customers
QA

11. Comprehensive Testing
Service Based Testing
 Service Levels are defined early in the
design phase and tested throughout the
Service delivery process
 Business and technical requirements are
tested jointly as part of the Service
delivery process.
Cloud
Services
Business
Goals
Testing Monitoring
Application Service
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12. Quality Certification
Installation
Qualification
Operational
Qualification
Performance
Qualification
Is the environment built properly?
Do the services meet requirements?
Does the application achieve business goals?
Quality Certification?
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13. Service Support
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14. Release
Management
SDLC
Validation and
Certification
Deployment
Management
Change
Management
Event
Management
Incident
Management
Problem
Management
Quality Service Controls
Emergency
Response
Disaster
Recovery
Access
Management
Data
Management
Environment
Management
Security Policy
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15. Quality Services
 Service Availability – No Less then 99.5%
 Performance – No greater then 2 second page turns
 Customer Support - Customer Selected Option
Service Levels
 Monitoring 24 hours a
day 7 days a week
 Regulatory Compliance
 Service Level Reports
 Security Focused Service
Delivery
 Continuous Improvement
 TrackWise Integration
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16. Service Support - Monitoring

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Sparta Systems
We Help Protect Millions of Lives Everyday
www.spartasystems.com
609-807-5100