GxP regulated industry assessments of SoftMax Pro Software

GxP regulated industry assessments of SoftMax® Pro Software

This document outlines references to 21 CFR Part 11 and EudraLex Annex 11 and how they apply to the implementation of SoftMax Pro GxP Data Acquisition and Analysis Software in regulated environments.

• 21 CFR Part 11 and EudraLex Annex 11 overview
• Whose responsibility is it to validate the system?
• Impact of compliance vs. non-compliance