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The Development and Validation of a Roadmap for Traceability.
McCaffery, Fergal; Flood, Derek; Regan, Gilbert
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.
Keyword(s): Computer Software; Software traceability; Medical device; Roadmap; Compliance; Safety critical software; Standard; Guideline.
Publication Date:
Type: Journal article
Peer-Reviewed: Yes
Institution: Dundalk Institute of Technology
Citation(s): 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
Publisher(s): Springer
File Format(s): application/pdf
Related Link(s):
First Indexed: 2018-11-29 06:55:04 Last Updated: 2018-11-29 06:55:04