This course covers use of Phoenix WinNonlin version 7.0. Updated validation template documents are aligned with the latest regulatory guidance computer system validation such as ICH E6 Good Clinical Practice (GCP) R2 and can be readily modified to fit individual user/organizational policies and procedures. The Phoenix® WinNonlin® Validation Suite is integrated into Phoenix and provides software validation in less than 30 minutes with non-editable PDF reports containing links to saved reference files, user output files, and difference files. This necessitates companies to invest significant time and resources to manually write and perform the validation steps used in software execution. This short tutorial video shows you how to use the Phoenix® WinNonlin® Validation Suite.Īs 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. Phoenix WinNonlin Validation Suite Tutorial
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