The Safety Case provides a reasoned argument, supported by identified evidence, which justifies that the system is safe and fit for purpose.
The Safety Case demonstrates that overall safety requirements, both contractual and derived, have been achieved. It provides design safety, health hazard, and operational and maintenance safety assurance to the customer.
The Safety Case consists of 9 major sections.
Preparation of the Safety Case requires the use of the concepts of claims, arguments and evidence. It has become popular these days to use Goal Structuring Notation (GSN) as a graphical argumentation notation within the Safety Case.
If you work for FDA (e.g., Infusion Pumps Total Product Life Cycle, Guidance for Industry and FDA Staff), you most likely refer to the Safety Case as the Safety Assurance Case.
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