FDA 21 CFR Part 11

FDA 21 CFR Part 11 , the American Food and Drug Administration (FDA) specifies requirements for electronic documents, electronic signatures and handwritten signatures applied to electronic documents regarding trustworthiness, reliability,…

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Functional specification

Definition of the term („What is a functional specification?“) A functional specification contains a contractor’s detailed description how he intends to solve the customers requirements. As the preceding instance, however,…

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