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Don't worry about computer software validation

This white paper looks at standards, rules and laws for software validation and shows a risk-based validation approach for software used in the quality management system. Published in March 2020.

GMP-gerechte Computer/-Softwarevalidierung

What are the regulatory requirements with regard to the validation of software used in the quality management system and how can such validation be implemented pragmatically and risk-based? The white paper by our industry manager Marc Mettenberger and our subject matter expert for computer/software validation, Dr. Susan Spiller, provides answers to these questions. 


  • Differentiation between software types  
  • Standards, rules and laws for software validation  
  • Risk-based validation approach according to GAMP 5® 

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