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.
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®