White Papers

GxP regulated industry assessments of SoftMax Pro Software and microplate readers

Laboratories operating under GMP or GLP regulations must follow guidelines set by agencies to protect scientific integrity or demonstrate quality assurance of manufactured products.

In these white papers, we discuss the implementation of SoftMax Pro GxP Data Acquisition and Analysis Software, and assess the implementation of Molecular Devices microplate readers, in regulated environments.

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White Paper: GxP regulated industry assessments of SoftMax Pro Software
 
White Paper: GxP regulated industry assessments of microplate readers
  • 21 CFR Part 11 and EudraLex Annex 11 overview 
     
  • Whose responsibility is it to validate the system?
     
  • Impact of compliance vs. non-compliance
  • 21 CFR Parts 58, 211 and 820 and EudraLex Vol. 4 (Annex 15) overview
     
  • Whose responsibility is it to validate the system?
     
  • Impact of compliance vs. non-compliance