M.M. Abdeen and T. Maibaum (Canada)
Software Validation; Medical Software Certification; Sys tems Modelling; Process, Product Evaluation.
Certification has been a concern amongst the software en gineering community for the past few decades and is be coming a major concern today. Several organisations, in charge of certification, have published guidance documents to describe this crucial activity. Indeed, these organisations, through their documents, aim to establish a common under standing between software producers and certifiers (eval uators). These guidance documents use natural language in specifying recommendations, because of the wide audi ence to which they are addressed and the consequent need for simplicity. However, the specification is not sufficiently explicit and precise to be able to impose a contract (obliga tion) between the two parties. In this paper, we illustrate this problem as it ap pears in the guidance documents published by the US Food and Drug Administration (FDA) to validate medical de vice software. By bearing in mind the clear distinction be tween products and processes, we use the Product/process (P/p) method to model the “Quality Planning” activity of the FDA validation approach. By using P/p modelling, we present a simplified representation for the FDA validation activities. In essence, the P/p methodology takes a general systems approach. It is appropriate to a variety of areas and has proven its applicability in many fields.
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