Expertise in Risk Analysis
Risk Analysis
Accurate process risk analyses are indispensable in life sciences and high-tech industries. Whether it concerns initial risk analyses as part of a validation or risk analyses of existing but modified processes, our experts make sure every detail is covered.
Minimising risks
Within the world of GMP (GxP), risk analyses are a standard component. All GMP processes and linked processes are subjected to analyses of:
The risk
The seriousness of the risk
The frequency of the risk
There are several risk analysis methods, including the FMEA (Failure Mode & Effects Analysis), which we conduct in a structured way. The necessary documentation and actions are also provided to reduce the risk to an acceptable level. A multidisciplinary team gathers input to approach all aspects of risk. In the new regulations (e.g. Eudralex Vol. 4, Annex 1 implementation August 2023), conducting risk analyses and managing risks is discussed in detail. It is a regular point of review during inspections by regulatory bodies.
Risk analysis
Conducting risk analysis studies
Implementing actions after risk analysis
Writing risk analysis procedures and documentation
Risk analysis methods training
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