The Cloud, Cold Chain, and Compliance

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