Agile Software Development Practices for Regulated Industries

In 2001, gathered together in Snowbird, Utah, a group of 17 like-minded software developers brainstormed ways to quickly build software and get it into the hands of end-users. Out of this meeting the Agile Manifesto was born.

The iterative and incremental methodology of Agile has generally been accepted as a modern approach to software development and has high adoption rates across many industries. However, with fluidity and responsiveness to change at the forefront of Agile’s methodology, many organizations believe that Agile is not compatible with highly regulated industries. Lack of planning and documentation, they wrongly believe, are reasons why Agile cannot work for those building products under regulatory compliance.

The truth is that using Agile for product development within regulated industries is actually true to the Agile Manifesto. Here’s why:

Agile is a Set of Values, Not a Set of Rules

The full Agile Manifesto is a succinct and comprehensive overview of the framework’s principles, and the gist is quite simple. Agile is a methodology that encourages teams to iterate; to communicate with stakeholders, customers and suppliers; to not go crazy with documentation; and to be good human beings at work. Pretty simple, right?

So why do many organizations in regulated industries believe that Agile is not feasible?

While dealing with audit requirements and regulatory compliance, the idea of fluidity and “responding to change over following a plan” may have those in regulated industries cringing. But where in the Agile Manifesto does it say that planning and documenting have no place in your software development process? It doesn’t.

The truth is, adopting Agile values just means you are agreeing to open communication, iterating and focusing on delivering a product. Values are just one part of the product development process – organizations in highly regulated industries can adopt Agile values but still select a stricter framework and strategy to adhere to regulatory standards and document their processes.

And while documentation is not discouraged in Agile, teams are encouraged to view working software as a better indicator that the product meets requirements rather than reams of documentation.

Why Choose Agile for Regulated Industries?

Waterfall has traditionally been a popular choice for highly regulated industries. And yet, the number of organizations adopting Agile now due to very low success rates with Waterfall is rising. With fixed requirements and rigidity as the basis for Waterfall processes, there’s very little room for change and flexibility as requirements evolve.

On the other hand, teams who have adopted an Agile methodology are highly focused on creating products that meet end-users’ needs. And Agile gives them the flexibility to be both iterative and fluid.

Agile methodologies also allow for (and encourage) communication between customers, stakeholders and suppliers. You’ll be able to see in real time what’s working and what’s not and, in turn, keep tabs on what your customers want. By constantly reexamining customer needs and wants, Agile teams are more likely to deliver a product that meets users’ expectations. This, simply put, can be your competitive advantage.

Agile not only makes good business sense but may also help your employees feel happier and more fulfilled at work. Adopting the Agile methodology empowers your engineering and product development teams to change as they need and to use their professional judgement. It allows them to have open communication, to know that what they’re building is useful, and to feel that they are being respected and heard.

Leveraging Jama Connect™ for Agile Documentation

When adopting Agile in highly regulated industries, it’s important that you work closely with auditors — internal or external — to clearly communicate your documentation processes. This is where Jama Connect™ comes in.

Jama Connect is your single source of truth when it comes to complex product development. It allows you to document and communicate your requirements and what you’re setting out to build, and gives you a record of who, what and why things changed along the way. Plus, if you decide to make a change or switch directions, everything is fully reversible.

Real-time collaboration within Jama Connect gives you a platform to discuss change by connecting comments, decisions and reasoning throughout the project. With closer communication (in accordance with Agile methodology), teams experience increased productivity, a shorter design process and critical context for improved decision-making.

Jama Connect provides your team with valuable information to help them decide when and how to make changes.

Is Agile Right for Your Team?

While Agile is compatible with all industries — even those with strict regulatory standards — it all comes down to choosing a methodology that is right for your team. A good place to start is by identifying what values are most important to you and your organization and examining your processes to understand what you want to achieve.

Download our whitepaper, Agile for the Enterprise, to learn more about successfully implementing Agile in regulated and governed industries.