Validation Suite

Validation Suite

Phoenix WinNonlin Validation Suite 8.0 As required by US FDA’s 21 CFR Part 11, International Conference on Harmonization of Technical Requirements (ICH), EudraLex Annex 11, and other regulatory agency guidance documents, computer systems used in the pharmaceutical industry and output from software used in regulatory submissions must be validated to assure proper performance. This necessitates […]

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