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Articles With This Tag: 21 cfr part 11

Meeting the 21 CFR part 11 requirements with Quality Window 5

The US Federal Drug Administration (FDA) requirements under the regulation 21 CFR part 11 states all manufacturers of regulated brands must comply to these standards. Meeting these requirements for Quality Window Applications involves employing an number of features available in the standard version of the product. They are: Use of the Protected setting for a […]