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Tag: CFR 21

Cloud Infrastructure and FDA Compliance

May 5, 2010 |

Talking today about the infrastructure services side of cloud computing. I will also discuss how the aspects of public versus private cloud impacts the approach for implementing cloud computing in the life sciences.

Negotiating IT in the FDA Regulatory Environment

Apr 26, 2010 |

The FDA, like many other regulatory bodies does not issue standards; instead it provides guidelines on what must be done to be considered compliant but not on the execution of how it is accomplished.