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