agile in highly regulated environments
November 18, 2016

Agile in Highly Regulated Product Development, Part 5


This is the final installment in our discussion of the barriers to Agile adoption in highly regulated product development environments. In the other four parts, we looked at the lack of documentation, the loss of traceability, the issues with enforceability and auditability, and the inflexibility of Scrum tools to integrate into the broader development process. This time, we look at the difficulty of integrating formal testing into an Agile process.

Agile is often perceived to be great for developers, but with a big gap — testing. Some organizations transitioning to Agile struggle to understand where traditional testing teams fit into the new process. Agile teams often focus on user stories and tasks, keeping testing as a separate activity outside of the sprint or iteration. In a functional safety environment, however, that separation doesn’t work. Testing and development need to remain integrated and traceable, so you know that what was developed was tested, and all defects were addressed.

Helix ALM (formerly TestTrack) helps you to manage this disconnect by allowing everyone to work in the same system, with user stories, tasks, and test cases all given the same importance. With Helix ALM, the testing team can easily view and filter in a sprint to only see the testing activities (test cases and runs) they need to focus on. The project can still be tracked as a whole, with burn down or burn up reports available for all activities or just testing activities, depending on what you need to know at the time.

The team can also use Helix ALM’s task boards as Kanban or Scrum boards to track testing activities. Taking it a step further, Helix ALM helps establish a more integrated development process and stronger traceability, because you can create a test from a user story or task and they are automatically linked. With traceability across the user stories, your teams won’t have to use separate tools for their testing activities and their Scrum or Kanban activities.

Overcome the Barriers to Agile with Helix ALM

You should have a good idea of how Helix ALM can help you adopt an Agile process and still satisfy internal or external regulatory, quality, or functional safety needs. Hopefully, this series has at least dispelled some of the misconceptions about Agile’s suitability within safety-critical environments. With the right tools and technology, it is possible to overcome each of the barriers.