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Strategic Traceability for Safety-Critical Projects

Published: 01 May 2013 Publication History

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.

Cited By

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  • (2024)TRIAD: Automated Traceability Recovery based on Biterm-enhanced Deduction of Transitive Links among ArtifactsProceedings of the IEEE/ACM 46th International Conference on Software Engineering10.1145/3597503.3639164(1-13)Online publication date: 20-May-2024
  • (2024)Recovering Trace Links Between Software Documentation And CodeProceedings of the IEEE/ACM 46th International Conference on Software Engineering10.1145/3597503.3639130(1-13)Online publication date: 20-May-2024
  • (2022)Using Consensual Biterms from Text Structures of Requirements and Code to Improve IR-Based Traceability RecoveryProceedings of the 37th IEEE/ACM International Conference on Automated Software Engineering10.1145/3551349.3556948(1-1)Online publication date: 10-Oct-2022
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Published In

cover image IEEE Software
IEEE Software  Volume 30, Issue 3
May 2013
85 pages

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IEEE Computer Society Press

Washington, DC, United States

Publication History

Published: 01 May 2013

Author Tags

  1. Product safety
  2. Safety
  3. Software architecture
  4. Software development
  5. Software reliability
  6. assessment
  7. documentation
  8. requirements traceability
  9. safety critical
  10. software and system safety
  11. traceability strategies

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Cited By

View all
  • (2024)TRIAD: Automated Traceability Recovery based on Biterm-enhanced Deduction of Transitive Links among ArtifactsProceedings of the IEEE/ACM 46th International Conference on Software Engineering10.1145/3597503.3639164(1-13)Online publication date: 20-May-2024
  • (2024)Recovering Trace Links Between Software Documentation And CodeProceedings of the IEEE/ACM 46th International Conference on Software Engineering10.1145/3597503.3639130(1-13)Online publication date: 20-May-2024
  • (2022)Using Consensual Biterms from Text Structures of Requirements and Code to Improve IR-Based Traceability RecoveryProceedings of the 37th IEEE/ACM International Conference on Automated Software Engineering10.1145/3551349.3556948(1-1)Online publication date: 10-Oct-2022
  • (2022)Retrieving data constraint implementations using fine-grained code patternsProceedings of the 44th International Conference on Software Engineering10.1145/3510003.3510167(1893-1905)Online publication date: 21-May-2022
  • (2022)An empirical study of data constraint implementations in JavaEmpirical Software Engineering10.1007/s10664-022-10175-w27:5Online publication date: 1-Sep-2022
  • (2022)How assurance case development and requirements engineering interplay: a study with practitionersRequirements Engineering10.1007/s00766-022-00375-727:2(273-292)Online publication date: 1-Jun-2022
  • (2021)TracIMo: a traceability introduction methodology and its evaluation in an Agile development teamRequirements Engineering10.1007/s00766-021-00361-527:1(53-81)Online publication date: 29-Aug-2021
  • (2020)Managing Assurance InformationProceedings of the XXXIV Brazilian Symposium on Software Engineering10.1145/3422392.3422454(580-585)Online publication date: 21-Oct-2020
  • (2020)Improving the effectiveness of traceability link recovery using hierarchical bayesian networksProceedings of the ACM/IEEE 42nd International Conference on Software Engineering10.1145/3377811.3380418(873-885)Online publication date: 27-Jun-2020
  • (2020)A novel approach to tracing safety requirements and state-based design modelsProceedings of the ACM/IEEE 42nd International Conference on Software Engineering10.1145/3377811.3380332(848-860)Online publication date: 27-Jun-2020
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