agile in highly regulated environments
November 10, 2016

Agile Workflows for Audits

Agile
Application Lifecycle Management

Adopting Agile is inevitable for many organizations. But for highly-regulated organizations, there's a lot of risk involved.

That's because these organizations face five barriers to Agile adoption. 

In this blog, we'll cover Agile workflows — and how they can be used in audits. 

Agile Workflows Can't Pass Audits

One of the key benefits of Agile is that the design is expected to evolve. Iterative development is central to Agile’s ability to accelerate product development and drive quality.

As the development team gets feedback on each iteration, they gain more insight into how the product should function. So, they can alter the design to accommodate those changes. 

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. That might be a design, a mock up, or a 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.

How to Make Your Agile Workflow Audit-Ready

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 it can deter Agile adoption. Many struggle with the mindset:

“Ultimately, we need to be able to demonstrate to an auditor that we have control of our process. This means that every change needs to be made in accordance with our process and must be signed off by an authorized person. Agile does not allow this.”

Unless you have the right Agile ALM tool.

Get Audit-Ready With Helix ALM

Helix ALM 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.

This control makes your Agile workflow audit-ready. And it's 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 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 ready to be audited.

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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