the cloud, cold chain, and compliance
DESCRIPTION
A presentation on the Cold Chain, Cloud Computing, and Validation from the DicksonOne Product Manager, Matt McNamara, presented at the Cold Chain Conference in Dubai. Matt walks you through the different advantages to using cloud computing in the cold chain, and how new technology currently complies with regulatory agencies such as the FDA. Questions? Send us an email at [email protected], and for more content on temperature, visit our blog at www.blog.dicksondata.com. Enjoy!TRANSCRIPT
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