A team of experts consisting of Dr. Dennis Sandkühler, Markus Roemer and Dr. Siegfried Schmitt has successfully published an article entitled “9.D System Classification and Risk Management” (German: “9.D Systemklassifizierung und Risikomanagement”) in the “GMP compliance adviser” of the GMP publishing house Peither.
In it, you will find answers to the following questions, among others:
- What criteria can be used to classify computer systems?
- What are the ISPE GAMP®5 categories?
- What is the role of risk management in the validation of computerized systems?
- What are the special features to be considered in the risk assessment of computer-based systems?
Furthermore, our colleague Dr. Dennis Sandkühler again succeeded in placing an editorial with the GMP publisher Peither with his second technical article “9.B Requirements of the AMWHV for computerized systems” (German: “9.B Anforderungen der AMWHV für computergestützte Systeme”). In this article you will learn more about the requirements of the regulations for computer-based systems and their validation. In addition, the applicable regulatory requirements for computerized systems and computer system validation in Germany, Europe and the USA are analyzed.
Recently, Dr. Doris Borchert (editor) was able to write an interesting article for the German GMP magazine “Logbuch” together with Dr. Dennis Sandkühler. Under the title Risikobeurteilung computergestützter Systeme” (English: “Risk assessment of computer-based systems”) you will gain exciting insights around the risk assessment and evaluation of computer-based systems.
The GMP compliance adviser
The GMP compliance adviser is the world’s largest standard reference for quality management in the pharmaceutical industry. It combines ongoing updates of global regulations with recommendations from experts in the field. This means that the world’s largest GMP knowledge portal is at your side when implementing Good Manufacturing Practice.