GxP regulated industry assessments of microplate readers

GxP regulated industry assessments of microplate readers

This document outlines references to 21 CFR Parts 58, 211 and 820 and EudraLex Annex 15 to assess the implementation of Molecular Devices microplate readers in regulated environments

• 21 CFR and EudraLex Vol. 4 overview
• Whose responsibility is it to validate the system?
• Impact of compliance vs. non-compliance