Managing Regulatory Requirements through Semantic Analysis and Requirements Architecture (SAMRA)

Speaker: Eckhard Jokisch
Venue: Local Speaker in Hamburg

Standards and also regulations are binding requirements towards systems throughout their life cycle. In development projects obviously standards could be treated in the same way systems engineers usually treat customer requirements.

Until now the reality shows that there are many things that make handling of standards as requirements nearly impossible. Different legislation prescribe the conformance to different standards. To some degree those standards contain commonalities but also contradictions towards each other. Additionally the standards contain cross-references which are hard to resolve. For many engineers this turns into some kind of nightmare when it comes to traceability and conformance approval. Too much effort, lack of time, too complex, too expensive … . The result often is “we know what we are doing and this is the way it works for us”. Really? What happens in case of audits or assessments?

Consolidated traceability often cannot be ensured and time consuming discussion and argumentation loops are the result.

What if regulations where to meet faster and reliable by breaking the habitual thinking of “complex”, “expensive”,”exhausting” and instead using a Semantic Analysis Model for Requirements Architecture (SAMRA) to transform the regulation into clean, unambiguous requirements and test cases?

Using case studies for ISO-13485:2003 to ISO-13485:2016 transition and from the train industry regulation environment in Europe this presentation demonstrates how Semantic Analysis is done and how the results lead into a clean requirements architecture. In fact the output of using this method can instantly be used as input for system architecture. For example: The predicates of the requirement statements feed the activity diagrams, the conditions feed the constraint diagrams and the other semantic components also are used to engineer the model.

From clean requirements architecture there is just one simple step to semi-automatically generate verification / test cases. The complexity of legal paperwork can be deployed into a system model of the legislation. This makes the complexity manageable by formalization.