Risk Management / Analysis

In the automotive industry, risk analyses and comprehensive risk management are a self-evident fact. This is because they accompany continuous change. Whether as part of routine work or during model changes - the tools of risk analysis are used consistently. In the life science industry their application should become part of daily practice today as well. Nevertheless, there is always resistance to this supposed extra effort. The risk management system and the associated risk analyses can be used sensibly and efficiently in daily GMP practice. And save time! GMP risk management and risk analyses - doing the right thing moderated by know-how and experience!

GMP risk analyzes as a joint task

Risk analyses make sense when all sectors, all participants, discuss together at the round table. In this way, risk analysis is also a platform for knowledge exchange. They bring about a deeper understanding of the process among all those involved, raise awareness, and draw attention to starting points for continuous quality assurance.

Risk management system as part of quality assurance

The basic idea of a risk management system is the life cycle idea.

Part 3 of the EU GMP Guide & ICH Q9 require a transparent assessment, evaluation and continuous tracking of the possible risks for the product and process. As an essential element of quality assurance, risk analyzes must therefore be embedded in a holistic risk management system. Medcycle supports the development and implementation of tailor-made, pragmatically realizable risk management systems. Life cycle oriented.