Traceability Analysis (TRA)
In the SaMD risk management framework, traceability analysis is used to ensure that all requirements are correctly implemented in the software and that potential risks are identified and mitigated. By maintaining traceability throughout the development process, it is possible to verify that the software meets all of the requirements and to ensure that any changes made to the software are properly documented and tested.
Controls related to this risk category are listed as below:
- TRA 01 - Logging Capabilities
- TRA 02 - Logging Traceability
- TRA 03 - Full Track of Mitigation Measures
- TRA 04 - Traceability Matrix