Hybrid Agile Regulated
March 30, 2020

How to Do Hybrid Agile: Where to Start in a Regulated Industry

Agile

The appeal of Agile’s flexibility is simple: get products to market faster. But when you have to prove compliance, you need the accountability of a more structured methodology.

The good news is that you can create an efficient process by using a hybrid methodology, or hybrid Agile.

Hybrid Agile combines pieces of Agile methodology with elements of other methodologies — like Waterfall — to tailor the most efficient development process possible.

Creating a hybrid methodology can also help you go paperless. Learn more in this white paper about digital transformation solutions >>
 

Steps to a Hybrid Agile Approach

The goal of creating a hybrid methodology is to get both speed and accountability. If you don’t know how to get started, these tips can help you create a successful plan:

1. Start small.
Eventually you may have a giant workflow that accounts for every possible occurrence, but it’s hard to anticipate that up front. So even though you may have multiple products or projects, start small with your workflow. Rely on person-to-person communication to gradually build in your steps, automation, and processes as the team matures and grows.

2. Play it safe.
If you’re in a position to choose between speed and accountability, err on the side of accountability. It’s better to do things the right way so that when it’s released, you’re confident you have a well-documented development and a quality product.

3. Don’t force the fit.
You want to strike the right balance based on your own team’s natural cadence, so don’t put in something that doesn’t fit. What works for you will depend on what you’re building — hardware, software, firmware, etc. — and how your team is already working.

4. Create a change management loop.
You don’t want just anyone to be able to take something that’s been approved or implemented and roll it back. Create a change management loop and notifications so that only the right people — like team leads — are able to take action. This will also help with your traceability. When changes are made after testing or development has already started, dependencies downstream can be impacted, so you want to establish some control.

5. Ensure a Comprehensive Audit Trail
You should be able to track who is taking which actions when, so you can tie verification and validation activities to the people who performed them.

6. Communicate.
There is no substitute for good team communication. Any time you ask a team to modify their process, they should always know why. Communicate what the end goal is and convey good reason for the new process to be in place.

7. Consolidate tools wherever possible.
If you use many separate tools that can’t communicate with each other, you may not be able to get information you need. It might take hiring an integration specialist just to get your tools to talk to each other in meaningful way. Avoid this by consolidating your tools. Then you can compile development activities into overall hierarchal plans — like requirement documents — while simultaneously grouping activities in agile fashions, like Kanban boards and work in progress limits. Then you can see what your team is up to at any given time without losing sight of the overall plan.

Dive into more detail on the above steps. Watch the Hybrid Development Technology in a Regulated World webinar >>
 

Keep Traceability in Your Agile Approach

Speaking of tools, remember that you also want to set yourself up for traceability. Activities can get disconnected with too many tools trying to work together. If something changes somewhere, you won’t always know the impact of the change. And when an auditor comes, you have to try to form tracing at the time. By maintaining all your different activities within just a couple of tools that work harmoniously, you avoid forcing everyone to drop everything to manually create tracing.
 

Hybrid Agile Methodology Tool

There are a number of tools on the market that make hybrid Agile much easier for you. One of them is Helix ALM — a modular suite that tracks requirements, issues, and testing. It’s highly configurable, and it’s easy to use with distributed teams.

Helix ALM can facilitate end-to-end activities without forcing your teams to stop using the programs they’re good at. It integrates with a number of tools — like Jira — out of the box.

It also has hosting capabilities ideal for regulated companies like medical device manufactures. We know you’re validating on a specific version of the software, and you don’t want to be automatically upgraded to the newest release. Perforce will flag the account and hold off on upgrading until you’re ready.

Try Helix ALM free for 30 days and see if it’s the tool to best support your hybrid Agile development.

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