ELM and Regulatory Compliance

I’ve often been asked about whether or not the IBM Engineering Lifecycle Management tools comply with various regulatory standards, such as ITAR, DoDAF, DO-178B/C, IEC 62304, ASPICE and others. I think the best answer is – wrong question.

Compliance means “being in accordance with,” so compliance is the state of being in accordance with established guidelines or specifications, or the process of becoming so. Software, for example, may be developed in compliance with specifications created by a standards body, and then deployed by user organizations in compliance with a vendor’s licensing agreement. Compliance with any kind of standard is nearly always going to be the responsibility of whoever has undertaken the project work. For example, when referring to ITAR, its very important to understand that compliance with ITAR means in essence that access to either physical materials or technical data related to defense and military technologies is restricted to US citizens only. With that understanding then, if a US defense contractor purchases an engineering tool to enable the design and development of a fighter jet, and sources the administration of that engineering tool to an offshore organization, it is now non-compliant with ITAR – but the tool itself has nothing to do with that, it’s the fact that anyone in that offshore organization now has the ability to access any of the design elements within the Engineering tools by virtue of the fact that they now have admin access to the repository of technical data being developed

When considering compliance with these various standards then, the right question to ask about Engineering tools is, do they facilitate, or, do they support the processes we have to maintain compliance with the established standards. The answer to that is, YES, they DO. ELM enables out-of-the-box tailoring to simplify ELM adoption and accelerate compliance with key standards (ASPICE, ISO, etc.) and drive common industry working patterns. IBM templates and processes make it easier to “fast start” a company’s compliance integration.

There are a number of Solution Process Assets that have been created for the ELM tools by IBM and made available via the IBM support pages.

These process assets, or method configurations were created using the IBM Engineering Method Composer, and can be customized using that tool.

In summary, the IBM Engineering Lifecycle Management tools support the integration of engineering processes with compliance and regulatory requirements.