Historical safety data has demonstrated that projects often miss or do not address requirements and/or the impact of change, and that small changes to a system can create significant safety and reliability problems. This has caused some regulatory agencies to mandate that traceability be an integral part of the development process.
For example, the latest U.S. Food and Drug Administration (FDA) guidance for traceability in medical
software development activities is contained in the FDA Office of Device Evaluations (ODE) Guidance Document (1996b). In addition, the Design Controls section of the medical Current Good Manufacturing Practices (CGMP) document (FDA 1996a), Subpart C of the CGMP, defines the obligations of the system designers to be able to trace relationships between various work products within the lifecycle of the product's development.
Defines standard
Replaced/Superseded by document(s)
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| File | MIME type | Size (KB) | Language | Download | |
|---|---|---|---|---|---|
| TraceabilitySep02.pdf | application/pdf | 196.85 KB | English | DOWNLOAD! |
Provides definitions
Cover images
Introduction
Experience has shown that the ability to trace requirements artifacts
through the stages of specification, architecture, design, implementation,
and testing is a significant factor in assuring a quality software
implementation.
The ability to track these relationships and analyze the
impact when change occurs is common to many modern, high-assurance
software processes -- particularly in the life-critical medical products area
and in business- or mission-critical activities.