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Computerized system validation

Computerized system validation (CSV) (Computerised system validation in European countries, and usually referred to as "Computer Systems Validation") is the process of testing/validating/qualifying a regulated (e.g., US FDA 21 CFR Part 11) computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner…

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System requirement

System requirementsUser Requirements Specification
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Overview

FDA21 CFR Part 11
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System requirement

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Computerized system validation

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Triples0
Avg. degree1.71
Density0.285714
Components1

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system testing requirements validation computerised computer systems 11 documented definition computerized european process regulated part used activities rules required csv

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