GAMP 5 - Good Automated Manufacturing Practice
Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 4.2.5.4: 4.2.5.4 Traceability

Traceability links requirements to the configuration or design elements that fulfil them and to the verification that demonstrates they are met, so that all applicable elements of specification have been verified and the impact of a proposed change and the scope of regression testing can be judged. The approach is chosen and documented at planning based on risk and complexity, from common numbering across requirements, design and tests for simple systems, through links to configuration items for configured products, to full multi-level traceability for custom applications, with automated tools recommended over manually maintained matrices, as detailed in Appendix M5.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • 5.7.4 5.7.4 Evaluate software system testing

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice

Query this from an agent

The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.