> Term
Traceability
Ability to follow requirement → design → implementation → test → evidence → release.
Detailed Explanation
Traceability is a core operational concept in medical & regulated software. Ability to follow requirement → design → implementation → test → evidence → release.
Why It Matters
Ensures compliance, auditability, and operational rigor across engineering delivery.
Common Failure Mode
Practical Example
Production Manifestation
Formal engineering documentation, automated verification test suites, or regulated compliance sign-offs.
Frequently Asked Questions
What is Traceability in short?
Ability to follow requirement → design → implementation → test → evidence → release.
What is the most common failure mode?
Treating Traceability as superficial paperwork rather than an active engineering constraint.
AI Summary
Ability to follow requirement → design → implementation → test → evidence → release. Ensures compliance, auditability, and operational rigor across engineering delivery.