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“As producers of a variety of biotech vaccines, we must adhere to the statutory requirements in the pharmaceutical industry (GMP), which often explicitly call for risk analysis. Other regulators (occupational safety, environmental protection, and biosafety) do not require this method but have so far reacted very favorably to the systematic analysis and comprehensible evaluations of the relevant risks.
In addition, more and more customers are requiring risk analyses. Since greater scope and detail are being required in all areas, any other kind of risk management than the existing database-supported FMEA is no longer imaginable for our company given our specific risk management needs.

Since we can easily draw on existing causal chains and their evaluations, we're achieving resource savings of around 80% when it comes to risk analysis!

For multiple-use buildings, plants, and systems (e.g. central ventilation or water supply), the savings potential is nearly 100%. As part of project management, the systematic approach based on experience from previous projects helps us streamline project planning considerably.

We have had no complaints related to risk management in the last inspections by authorities and customers – and even earned some compliments.”
Statement from Denis Nienhueser, Head of risk management, Berna Biotech, Switzerland