FDA 21 CFR Part 11 Explained
13 June, 202221 CFR 11 sets out what Life Sciences organizations in the US must do to safely use software that handles e-signatures and electronic records.
21 CFR 11 sets out what Life Sciences organizations in the US must do to safely use software that handles e-signatures and electronic records.
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Maren Nelson has developed multiple medical devices during her career. Her projects have included internal and external resources for both the development and manufacturing of new products and product changes. Maren currently consults on medical product development strategy and Quality Management System implementation and improvements.