agile in highly regulated environments
November 10, 2016

Agile in Highly Regulated Product Development, Part 3

Agile

Part One of this series gave an overview of the barriers to Agile adoption in highly regulated product development environments, and examined the first barrier: the lack of documentation. Part Two discussed how to overcome the loss of traceability, which is another major barrier.

This segment explores the issues with enforceability and auditability of an Agile process, including sign-offs.

One of the key benefits of Agile is that the design is expected to evolve. As the development team gets feedback on each iteration, they gain more insight into how the product should function, and can alter the design to accommodate those changes. Iterative development is central to Agile’s ability to accelerate product development and drive quality.

If you are developing a product that consists of more than just software, your feedback iterations are different. You can’t have a two-week iteration with a fully finished product if it takes six weeks to manufacture it. The principle, however, remains the same: figure out the best way to build something that you can get feedback on as early as possible, whether that is just a design, mock up, or prototype. Agile is about principles, so how you choose to organize an iterative process to get that early and continuous feedback can only be determined by you.

Allowing iterative development and early feedback to evolve your design is vital if you want to gain the benefits of an Agile process. In a safety-critical environment, you also need to be able to demonstrate that changes to the product and design are properly reviewed, authorized, and tested by qualified persons. This is often a challenge with some product development technologies, and can deter Agile adoption.

Helix ALM (formerly TestTrack) overcomes that barrier by making user stories a part of your approval and review process. With Helix ALM, you can define, enforce, and record all the decisions and approval processes that you need — including electronic signatures to approve user stories. All of this control and auditability is established automatically, even when you are moving items around on the task board. Also, because user stories are automatically linked to earlier artifacts (requirements, for example), you can easily determine and manage the impact of any changes before you make them.

Helix ALM even makes reviews of work feasible for an Agile process. The heavy-handed approach — where everything needs a sign-off, no matter how small — doesn’t work in any process, but it’s especially bad for Agile. Helix ALM's workflow capabilities allow you to be very specific about when, where, and who performs these sign-offs. And each sign-off is recorded and fully auditable.