New Technology & Data
Management
The Cloud, Cold Chain & Compliance
Matt McNamara
What is “The Cloud”
• Something we hear about often, but cannot
see or touch
• Remote vs Local
• Ultimately: where the
computing occurs
What is “SaaS”
Software as a Service
• Renting the software
• Little to no infrastructure
• As needed
Examples of Cloud Services / SaaS
Considerations of Cloud Computing
Performance
Security & Control
Long Term Costs
Reliability
Isolated Data
Benefits of Cloud Computing
• Cost Benefits
Benefits of Cloud Computing
• Cost Benefits
• Quick Implementations
Benefits of Cloud Computing
• Cost Benefits
• Quick Implementations
• Access to Data & Networked Systems
Benefits of Cloud Computing
• Cost Benefits
• Quick Implementations
• Access to Data & Networked Systems
• More Powerful Features
Benefits of Cloud Computing
• Cost Benefits
• Quick Implementations
• Access to Data & Networked Systems
• More Powerful Features
• Implement New Features Faster
Benefits of Cloud Computing
• Cost Benefits
• Quick Implementations
• Access to Data & Networked Systems
• More Powerful Features
• Implement New Features Faster
• More User Friendly
Benefits of Cloud Computing
• Cost Benefits
• Quick Implementations
• Access to Data & Networked Systems
• More Powerful Features
• Implement New Features Faster
• More User Friendly
• Easier Administration
Cloud + Cold Chain
Why are the cloud and the cold chain
better together?
Cloud + Cold Chain
Global Supply Chains
Cloud + Cold Chain
Data Comes to you
Automatically
Cloud + Cold Chain
Critical Products
Require
Real-Time Data
Cloud + Cold Chain
Ease of Use
Compliance & Validation
Why do we need to comply?
Compliance & Validation
Because someone says to!
• In the US:
• FDA, CDC, etc
• 21CFR11
• In the UK:
• GMP - Annex 11
How do we validate
software?
Compliance & Validation
1st . . . are we building the right thing?
• Accuracy & Precision
• Repeatability (Reliability)
• Curve - Fitting
• System Sustainability
Compliance & Validation
Next, are we building it correctly?
• Outputs Meet Requirements
• Requirements consistently fulfilled
Compliance & Validation
Ultimately:
• Make a system that is more reliable than paper
• Make records more:
• Legible
• Accessible
• Secure
• Be able to prove it!
New Technology = Change
But change isn’t a bad thing!
• Requires new SOPs
• Faster implementations & Validations
• Greater Security
• Easier to use
• Easier to manage
• Flexibility
