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Justification Factory : de l'élicitation d'exigences de justification jusqu'à leur production en continu

Abstract : In many areas where it exists human risks, such as medicine, nuclear or avionics, it is necessary to go through a certification stage to ensure the proper functioning of a system or product. Certification is based on normative documents that express the justification requirements to which the product and the development process must conform. A certification audit then consists of producing documentation certifying compliance with this regulatory framework.To cope with this need for justifications to ensure compliance with the standards in force and the completeness of the justifications provided, it must therefore be able to target the justification requirements to be claimed for a project and produce justifications during the development of the project. In this context, eliciting the justification requirements from the standards and producing the necessary and sufficient justifications are issues to ensure compliance with standards and avoid over-justification.In these works we seek to structure the justification requirements and then help to produce the associated justifications while remaining attentive to the confidence that can be placed in them. To address these challenges, we have defined a formal semantics for an existing model of justifications: Justification Diagrams. From this semantics, we have been able to define a set of operations to control the life cycle of the justifications to ensure that the justifications regarding the justification requirements. Through this semantics, we have also been able to guide, and even automate in some cases, the production of justifications and the verification of conformance.These contributions were applied in the context of medical technologies for the company AXONIC, the bearer of this work. This made it possible to i) elicitate the justification requirements of the medical standards and company's internal practicals, ii) automatically produce the justifications associated with the IEC 62304 standard for medical software, iii) automate the verification and validation of the justifications as well as the production of documents that can be used during the audit.
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Submitted on : Friday, January 11, 2019 - 12:58:06 PM
Last modification on : Thursday, July 1, 2021 - 3:08:26 AM
Long-term archiving on: : Friday, April 12, 2019 - 2:03:13 PM


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  • HAL Id : tel-01978192, version 1



Clément Duffau. Justification Factory : de l'élicitation d'exigences de justification jusqu'à leur production en continu. Modélisation et simulation. COMUE Université Côte d'Azur (2015 - 2019), 2018. Français. ⟨NNT : 2018AZUR4094⟩. ⟨tel-01978192⟩



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