When doing a system design we are often asked to design the system such that the system meets multiple standards. Many times the desired standards overlap or are specific to more than one commercial segment. For example, we may have to meet a set of government standards for one market place and a set of commercial industry standards for another. How do we demonstrate our system design to these two regulatory agencies?
We have an app for that! Or should I say we have a solution for this situation. There is an extension to the CORE and GENESYS schema distributed with the software that provides support for industry standards. The extension is named “StandardComplianceSchema” and can be found in the Extensions folder under the CORE 9 or GENESYS 4.0 folder installed with the software.
This schema extension provides an alternative method to track system-level requirement traceability by allowing the user to show traceability of a system requirement to more than one source document, namely more than one standard. The schema extension adds the Standard class to the schema and two new relationship pairs: “compliance with / satisfied by” and “clarified by / clarifies”. The “compliance with / satisfied by” relation pair demonstrate that a particular Program Activity or Requirement complies with a Standard. The “clarified by / clarifies” pair indicate the relationship between Standards.
Adding this extension to an existing project is easily accomplished by importing the schema extension. The base schema is modified to provide the following arrangement:
And now we can write one system-level requirement to satisfy requirements from more than one standard.
Once this schema extension is in place and the model populated, several traceability tables can be developed to trace from the standard, through the standard requirement, to the system requirements. Alternatively, traceability can be demonstrated from the system requirements to the standards being satisfied.
And, if you have developed a set of verification requirements, you can trace from the standard, to the system requirements, and thru to the verification requirements; essentially creating a verification cross reference demonstrating system performance to the standard.
The result is objective evidence available as ready reference as part of the system design repository to ease the burden of managing and demonstrating regulatory compliance.