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Research findings from an industrial trial of a traceability assessment and implementation framework

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dc.contributor.author Regan, Gilbert
dc.contributor.author Flood, Derek
dc.contributor.author Mc Caffery, Fergal
dc.date.accessioned 2017-01-06T11:56:58Z
dc.date.available 2017-01-06T11:56:58Z
dc.date.issued 2016
dc.identifier.uri http://hdl.handle.net/10344/5431
dc.description peer-reviewed en_US
dc.description.abstract Software systems are becoming increasingly complex. Within safety critical domains such as medical device software, this increasing complexity is placing growing demands on manufacturers who must ensure their software not only meets functional requirements but is also safe and reliable. However, the Food and Drugs Administration who regulate medical device software in the United States report a significant increase in recalls between years 2003 and 2012 and have cited software difficulties as one of the frequent causes of recalls. Furthermore a recent analysis of traceability documentation submitted to the Administration has revealed that the traceability data was incomplete, incorrect, and conflicting in many cases. This is problematic as traceability plays an important role in the development of safe and reliable software. In this paper we present the validation, through industry trial, of a traceability assessment and implementation framework which we have developed to assist medical device organizations implement traceability in an efficient and regulatory compliant manner. Our findings show that implementation of the framework within two organizations improved their traceability process and that both organizations found the framework to be both useful and usable. en_US
dc.language.iso eng en_US
dc.publisher Association for Computing Machinery en_US
dc.relation.ispartofseries ICSSP '16 Proceedings of the International Conference on Software and Systems Process;pp. 91-95
dc.relation.uri http://dx.doi.org/10.1145/2904354.2904365
dc.rights © ACM, 2016. This is the author's version of the work. It is posted here by permission of ACM for your personal use. Not for redistribution. The definitive version was published in ICSSP '16 Proceedings of the International Conference on Software and Systems Process, pp. 91-95, http://dx.doi.org/10.1145/2904354.2904365 en_US
dc.subject process assessment en_US
dc.subject roadmap en_US
dc.subject software process improvement en_US
dc.subject medical device en_US
dc.title Research findings from an industrial trial of a traceability assessment and implementation framework en_US
dc.type info:eu-repo/semantics/conferenceObject en_US
dc.type.supercollection all_ul_research en_US
dc.type.supercollection ul_published_reviewed en_US
dc.identifier.doi 10.1145/2904354.2904365
dc.contributor.sponsor SFI en_US
dc.relation.projectid 10/CE/I1855 en_US
dc.relation.projectid 13/RC/20194 en_US
dc.rights.accessrights info:eu-repo/semantics/openAccess en_US


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