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The Development and Validation of a Roadmap for Traceability.

McCaffery, Fergal and Flood, Derek and Regan, Gilbert (2015) The Development and Validation of a Roadmap for Traceability. Communications in Computer and Information Science, 526 (526). pp. 45-57. ISSN 1865-0929

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Abstract

Organisations who operate in the safety critical domains such as the medical device, avaition, and automotive domains must ensure their software is safe and provide objective evidence to this effect. One way of achieving this is by adhering to domain specific regulations and guidelines which specify a comprehensive implementation of traceability. However there is a gap between regulatory traceability requirements and what is implemented in practice. This lack of compliance means that organisations find it difficult to assess the safety of their software and thus ensure its safety. One reason for non-compliance with regards to traceability is a lack of guidance on what traceability to implement or how to implement it. In this paper we present the development and validation of a roadmap for the implementation of traceability in the medical device domain. The roadmap will provide medical device organisations with a pathway for effective traceability implementation.

Item Type: Article
Uncontrolled Keywords: Software traceability; Medical device; Roadmap; Compliance; Safety critical software; Standard; Guideline.
Subjects: Computer Science > Computer Software
Research Centres: Regulated Software Research Centre
Depositing User: Enda Kelly
Date Deposited: 28 Nov 2018 14:14
Last Modified: 28 Nov 2018 14:14
License: Creative Commons: Attribution-Noncommercial-Share Alike 4.0
URI: http://eprints.dkit.ie/id/eprint/600

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