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Agile & Process Control in Safety-Critical Device Development

Adopting Agile in Safety-Critical DevelopmentA lot of companies working in highly regulated safety-critical industries still rely on the Waterfall/V-model development method when creating software embedded in their end products. While this doesn't allow them to take advantage of more modern Agile methods, they choose to stick with these tried and tested processes because these allow them to enforce certain processes and simplify documentation, both key to achieving compliance. Process control is simply easier to do in a Waterfall environment – but that doesn't mean that Agile is not compatible with safety-critical development.

Adhering to the regulations of industry standards can also be ensured in an Agile development environment. Adequate process control measures can be implemented, which is best proven by FDA's 2013 endorsement of Agile practices. If it can be used in medical software development, where rigorous standards apply to various processes, Agile is surely compatible with development in other regulated industries.

Related reading:

Agile + IEC 62304: Using Agile in Medical Device Development

Agile + ISO 26262: Adopting Agile in Automotive Development

So how should Agile be used in safety-critical development, and what tools provide advantages when it comes to transitioning to Agile in a regulated environment?

Switching to Agile while maintaining process control

Indeed, more and more companies in various industry sectors are coming to the conclusion that Agile is fit for their needs while providing added benefits. Agile helps dev teams reduce risks by letting them work on smaller chunks of the software at a time. Agile also helps reduce the time of development, and improve the quality of software products. However, aligning Agile techniques with the requirements of relevant industry standards and regulations takes a bit of effort.

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Therefore, if you're looking to adopt Agile while maintaining the same control over your processes that you had using Waterfall, you will first need to map Agile practices and the stipulations of standards that apply to your industry or product. Any inconsistencies between these two will have to be addressed at an early stage of planning your Agile implementation. The end product of this analysis is hugely important: it's going to be the set of (compliant) processes that you'll need to enforce throughout the development lifecycle. Any deviation from these will likely result in non-compliance, and could increase the risk levels of your end product. This task is difficult enough, but there's more to compliance than this.

Traceability down to source code will have to be ensured and proven along the lifecycle. The processes that you have set in stone in the first step should help achieve this – but proving it means that all the links between all work items will need to be recorded, documented, and shown during audits. This is where you'll realize that adequate Application Lifecycle Management tools such as codeBeamer ALM are simply necessary when it comes to implementing and scaling Agile in safety-critical development.

Design, verification, documentation & development with ALM

The reason is simple: not only do such solutions help enforce set processes through preconfigured workflows for each item, they can also automatically record all changes, and generate documentation to help compliance audits. Agile favours "working software over comprehensive documentation", which is why it's so much faster than Waterfall – but regulators in safety-critical sectors still require thorough, complete documentation regardless of the development method you decide to use.

ALM tools like codeBeamer take the burden of documentation off the shoulders of your team by automatically recording a comprehensive change history on all artifacts, and letting you customize reports that can be simply exported, taking care of documentation without requiring manual effort from your team. What's more, codeBeamer's cutting-edge workflow engine also allows you to connect various processes (with preconfigured workflows provided via our templates for the medical, automotiveavionics, and pharma industries). Thus, it enables you to maintain control over all processes throughout the entire development lifecycle.

Pro tip: Find out more about the Audit Trail Reports feature set introduced in codeBeamer ALM 9.0!

Once you understand the basics, unlocking the benefits of Agile for safety-critical applications really isn't that tricky. Granted, it requires a bit of initial investment in terms of purchasing and configuring an adequate ALM solution. After you start using it, however, that investment is returned in more than one ways: total control over all processes, reduced time to market, increased efficiency & product quality, and comprehensive documentation created automatically. All that simply translates into one fundamental goal: increased profitability. It's no wonder that more and more safety-critical development companies are making the transition to Agile with the help of ALM solutions.

Interested in finding out how codeBeamer ALM can help you adopt Agile & align your processes with regulations? Drop us a line and ask for a 1-on-1 demonstration so that we can show you how our clients (global enterprises in safety-critical development) are using codeBeamer every day. Ready to start? Sign up for a free trial of codeBeamer ALM to see what it could do for you!