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Issue No.03 - May-June (2013 vol.30)
pp: 58-66
Patrick Mader , Ilmenau Technical University
Paul L. Jones , US Food and Drug Administration
Yi Zhang , US Food and Drug Administration
Jane Cleland-Huang , DePaul University
ABSTRACT
To support any claim that a product is safe for its intended use, manufacturers must establish traceability within that product's development life cycle. Unfortunately, traceability information submitted to regulators and third parties is often weak, casting doubt rather than confidence in a product's integrity. This article evaluates traceability information for 10 submissions prepared by manufacturers for review at the US Food and Drug Administration. The authors observed nine widespread traceability problems that affected regulators' ability to evaluate the product's safety in a timely manner. To address these problems, the authors present a set of guidelines for implementing strategic traceability in a way that supports safety assessments.
INDEX TERMS
Safety, Software development, Software reliability, Software architecture, Product safety, documentation, requirements traceability, safety critical, assessment, traceability strategies, software and system safety
CITATION
Patrick Mader, Paul L. Jones, Yi Zhang, Jane Cleland-Huang, "Strategic Traceability for Safety-Critical Projects", IEEE Software, vol.30, no. 3, pp. 58-66, May-June 2013, doi:10.1109/MS.2013.60
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