Achieve Test Traceability For Compliance Requirements

Test Traceability For Compliance Requirements

Showing traceability in software testing is not just good practice. In the case of adhering to regulatory requirements, such as the FDA Validation Guidelines and other software safety standards and guidelines, it is the law!

In addition, some contracts require adherence to standards that also have requirements for traceability of tests even in non-safety contexts. Or, a contract may include a set of acceptance criteria that must be achieved. To demonstrate the fulfillment of acceptance criteria, traceability to tests and test results are needed.

In this paper, we show why traceability in testing must be considered early in test design, along with specific examples from some major standards and guidelines such as:

- IEC 62304 – “Medical Device Software – Software Lifecycle Processes”
- FDA Validation Guidelines (USA)
- ISO 26262-1:2018 – “Road vehicles — Functional Safety”
- FAA System Safety Handbook (USA)
- Sarbanes-Oxley Regulations (USA)

Article outline:

  • Example of Traceability Found in Standards and Regulatory Requirements
  • What is Test Traceability?
  • Why is Bi-directional Test Traceability Important?
  • The Benefits of Traceability
  • Challenges in Expressing Traceability
    • Establishing Traceability
    • Maintaining Traceability
    • Showing Evidence of Traceability at Any Time
    • Understanding the Limitations of Test Coverage
  • How Traceability is Achieved in PractiTest
  • Summary

By Randall W. Rice

Randall W. Rice is a leading author, speaker, consultant and practitioner in the field of software testing and software quality, with over 40 years of experience in building and testing software projects in a variety of domains, including defense, medical, financial and insurance.
You can read more at his website.

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