agile in highly regulated environments
November 15, 2016

Agile Integration in Regulated Product Development

Agile
Application Lifecycle Management

Many organizations are considering adopting Agile — if they haven't already. But many highly-regulated organizations are hesitant.

That's because there are five common barriers to Agile adoption for these organizations. 

In this blog, we'll cover Agile integration — and how to approach it across development.

Agile Integration Doesn't Meet Every Need

You want the development team to be as creative as possible. But what they do needs to be directed by the strategic priorities and requirements that are defined by the business.

The development team must use tools that allow for traceability and compliance. But the team still needs to be flexible enough to realize the benefit of an Agile process.

The Problem With Scrum and Kanban

Dedicated Scrum tools are good for providing flexibility, but not great at meeting traceability and compliance needs.

Scrum and Kanban processes are deliberately designed to be simple. Therefore, it doesn’t take much effort to create an easy-to-use software tool that does only the things you need to do for Scrum and Kanban.

Agile Integration for Regulated Industries

If you’re in a regulated, quality-critical, or functional safety development organization, Scrum and Kanban tools can’t meet your needs.

You might be struggling with the mindset: 

“We want the development team to be as creative as possible, but what they do needs to be directed by the strategic priorities and requirements that are defined by the business. But it's impossible to find a tool that allows for traceability and compliance, as well as the flexibility of Agile processes.”

How to Succeed at Agile Integration

For a successful Agile integration, you need an ALM tool that can satisfy both needs.

Helix ALM (formerly TestTrack) is flexible enough to accommodate your entire process, including Scrum or Kanban delivery. And it has the traceability you need in all your earlier design and approval stages.

So, you can create a fully integrated, end-to-end scalable process that properly records all the approvals and steps necessary to pass an audit.

4 More Barriers to Agile Adoption

There are four other common barriers to Agile adoption in regulated environments. Learn how to overcome them:

Transition to Agile Successfully

Transitioning to Agile can be tricky for any organization. And it's trickier for organizations in highly-regulated industries. 

Until now. 

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