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.
![Computer/-Softwarevalidierung GMP-gerechte Computer/-Softwarevalidierung](/fileadmin/_processed_/6/a/csm_reinraum-softwarevalidierung-gxp_594e8cef04.jpg)
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.
Contents:
- Differentiation between software types
- Standards, rules and laws for software validation
- Risk-based validation approach according to GAMP 5®
Download now
You can find more information in our Knowledge Center.