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In the recent years, there has been a rush towards highly autonomous systemsoperating in public environments, such as automated driving of road vehicles,passenger shuttle systems and mobile robots. These systems, operating inunstructured, public real-world environments (the operational design domain canbe characterized as open context) per se bear a serious safety risk. Theserious safety risk, the complexity of the necessary technical systems, theopenness of the operational design domain and the regulatory situation pose afundamental challenge to the automotive industry.  Many different approaches to the validation of autonomous driving functionshave been proposed over the course of the last years. However, although partlyannounced as the solution to the validation challenge, many of the praisedapproaches leave open crucial parts.  To illustrate the contributions as well as the limitations of the individualapproaches and providing strategies for 'viable' validation and approval ofsuch systems, the first part of the paper gives an analysis of the fundamentalchallenges related to the valid design and operation of complex autonomoussystems operating in open contexts. In the second part, we formalize theproblem statement and provide algorithms for an iterative development andvalidation. In the last part we give a high level overview of a practical,holistic development process which we refer to as systematic, system view basedapproach to validation (in short sys2val) and comment on the contributions fromISO26262 and current state of ISO/PAS 21448 (SOTIF).

On the validation of complex systems operating in open contexts