Control the development and test process through Risk Management
The validation and test activities must focus on the critical aspects related to patients/people, product quality, data integrity and risks. And always consider the benefit and the risk for your company.
In accordance with GAMP5 our risk approach shows in five steps
- The initial risk of the system is defined based on the system’s domain, context and its most important capabilities. The impact of the risks on your system is identified.
- The characteristics and functions, which could harm the people/patients, the product quality and the data integrity or your company are identified.
- The functions are analyzed and evaluated for risks in detail. Appropriate counter-measures for risk minimization, risk avoidance and early detection are defined, such as defensive development, detailed testing, additional or changed functionality or training.
- The effects of the counter-measures is monitored on an ongoing basis
- The residual risk will be assessed before release and documented