agile in highly regulated environments
November 7, 2016

Agile in Highly Regulated Product Development, Part 2


Part One of this series gave an overview of the barriers to Agile adoption in highly regulated product development environments. This installment discusses the how traceability can be impacted by the adoption.

Many companies can’t create high-level design or requirements specifications with Agile user stories or epics. For these organizations, user stories and epics simply aren’t suited to earlier-stage requirements gathering and high-level design activities, or they’re not a feasible cultural fit. For those activities, you still need documents that subject matter experts can easily create and review—like market requirements, high-level requirements, and so forth.

Once development work is ready to begin, early-stage system specification documents must be broken down into user stories and tasks. The most common way to manage user stories and tasks in sprints is with sticky notes on a physical task board, or by using a standalone software tool — both of which breaks your end-to-end traceability. After all, how do you track a bunch of pieces of paper stuck to a whiteboard (or digital cards in a standalone tool) in a way that will be compliant?

With Helix ALM (formerly TestTrack), you can break down a requirement specification or test specification document into user stories and tasks. Helix ALM automatically links the user story to the requirement it was created from, and links tasks to the user stories they were created from. The magic of Helix ALM is that it allows you to create a user story that can be a part of your documentation set, while simultaneously appearing in your backlogs and sprints as required.

But what about that much-beloved whiteboard with all the sticky notes? Helix ALM has you covered there, too, with task boards. Task boards are interactive, alternate views of folder contents that look and work just like a physical task board, only better.

Items in a Helix ALM folder are displayed as cards in a virtual task board. Cards are organized vertically in columns mapped to your workflow, and horizontally in swim lanes by folder, user, relationship, or requirement document. You can drag cards between columns to change item status as work progresses, and perform other actions—such as creating new related items, entering hours, and viewing time-tracking information. You can even set work in progress (WIP) limits for each column to help identify bottlenecks.

Helix ALM task boards are interactive, alternate views of folder contents.


With Helix ALM, you can have the best of both worlds. Do your high-level requirements gathering in documents (where each paragraph is a traceable record), and then create user stories, which can be automatically linked and added to backlog/sprints and to your document set at the same time. Helix ALM takes the stress out of creating and maintaining traceability.

Explore Helix ALM