computer system validation


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computer system validation

The certification that a computer is operating according to specification. It includes the observation of the hardware, software, connected instruments, as well as the practices trained staff employ while running the system. See software validation.
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About the Speaker: Founder of Computer System Validation (CSV), David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIP and Computer System Validation.
Another important piece to include is the location of the computer system validation documentation, as this is not only important from a storage aspect, but also an access point of view.

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