The Quick Start Guide to Creating a QMS With Jira & Confluence

Not everyone chooses Jira and Confluence for creating their QMS system, as they are not marketed that way. Atlassian doesn’t provide step-by-step manuals as a use case, and at first glance, it’s not intuitive.?

However, many life sciences companies consider using Jira and Confluence for quality management systems for?many good reasons. The question they all have is,?“Where do I start?”

Thanks to Cloud technology, you don’t even have to install the software. Five minutes after going to?Atlassian’s website, you can have your site up and running —?without even providing a credit card.?

Sounds simple right? And in some ways, it is. If you were a software developer, you could immediately start running your sprints on the platform. However, you are a QA manager in need of an eQMS. Maybe you need a system for?document management or a system for your?design controls. In all cases, to support your QMS, Jira and Confluence must be tweaked before putting in your first electronic approval or your first user need item.?

So, what does “tweaked” actually mean, and how can you get your system customized for your company’s needs? Here’s a quick survival guide for the newbie that helps you on your journey from installation to eQMS epiphany.

What you get with out-of-the-box Jira and Confluence

In many cases, you can use Jira and Confluence as soon as your site is launched. For example, if your team wants to set up Kanban and sprint boards and start defining their stories, you just need to create a new project, and you are ready to go.

However, you also now have the full power of a flexible and extensible platform. We need to leverage this fact as we transform a “system for software developers” into a quality management system.?

The three levers available are configuration options, the Atlassian Marketplace, and custom extensions.

I will explain what each provides, but first, keep in mind, you must use your options in the order I wrote them:

• Use configurations first, as the software comes programmed with a solid set that can solve many needs.
• Once you’ve exhausted your configuration options, you should check the Atlassian Marketplace to see if there’s an app that fills the gap. (This entails paying for another license, so that’s why this is your second step.)
• Finally, if configuring your system and employing apps still leaves you with an unmet need, you can develop an app to solve the challenge. This is by far the most expensive option. We are all aware of the high costs of good developers, and believe me, you do not want to hire a cheap developer to mess up with your eQMS.?

Configuring Jira & Confluence

A wide range of configurations

Configurations are the changes you can make to the platform without writing code. One of the reasons for Jiras’ success is how much power it gives each team to tailor the software without writing code. By the way, I am focusing here on Jira because Jira configurations play a significant role in adopting it to new use cases. In Confluence, the configurations are straightforward.

These are the main areas:

1. Issue types:?Out-of-the-box Jira can have Stories, Tasks, and a few other issue types. With configurations, you can create new types such as Nonconformities, User Needs, and Training tasks.
2. Fields:?Each Jira issue has a set of fields. You can add whatever fields you need, and there are a few dozen formats to choose from, such as:
3. A field called “Acceptance criteria,” which will be a long text field (as this criteria may be very detailed)
4. A field called “owners” that will hold the group of users responsible for an issue
5. A field called “Root cause” that has two linked select options: the main category (system, process, competence) and the subcategory (electrical infrastructure failure, undefined process, and so on)
6. Workflows, Kanban, and Sprint boards:?The processing of issues from created to done can vary significantly. In particular, Quality processes tend to be long-winded: a Nonconformity is created, then it’s reviewed by the QA team, considered by the committee, and so on.

Whatever your process, the steps can be modeled in Jira. Also, the business logic of the transitions can be defined, such as who is allowed to close a nonconformity issue.?

There are many more configuration areas in Jira, but these are the key ones.?

Workflows are also the first area where you may run into a wall. Despite the plentiful options available, you may still want to construct a workflow step that cannot be configured. For example, when a nonconformity issue is closed, and you need it to be electronically signed and filed as a PDF. Jira cannot do that on its own.

The Atlassian Marketplace

The?Atlassian Marketplace?contains thousands of extensions to help streamline, automate, and optimize various Jira functions — some that are free or have free versions, some for purchase.?Just like installing Jira in the first place, it’s just a click of a button to install an app on your instance. Also, like Jira, many apps and plugins provide additional configuration options.?

Here are a few of the apps I frequently use and recommend:

1. ScriptRunner for Jira?is so ubiquitous that it’s hard to imagine a Jira site without it. It provides a Swiss army knife of options to extend workflows and other aspects of Jira.
2. Structure – Project Management at Scale?is the easiest way to see the hierarchy and connections between many issues in Jira. And it’s very useful to track traceability right inside Jira.
3. Document Control for Confluence Cloud?is a great app to get you eSigning Confluence pages. It’s even compatible with CFR 21 part11.

It is not a surprise, certainly not for frequent readers of my blog posts, that we too developed apps to help you implement your QMS with your Jira & Confluence. You can find them on our?Atlassian Marketplace page:

• Speedy PDF Sign-Offs for Jira Cloud: An electronic signature app that helps fast-moving teams capture sign-offs and archive Jira issues at lightspeed.
• Jira Snapshots for Confluence: This is Jira and Confluence integration on steroids; the app provides you with time-stamped static Jira reports in Confluence, including multi-level reports.?
• Read & Understood Training Genius: Automate and ease Read & Understood training and compliance burdens in the pharmaceutical, MedTech, and BioTech industries.

Custom development

Jira’s Application Programming Interface (API) allows you to write specific code that extends the platform’s capabilities. It’s the same technology that marketplace vendors use to create their apps. Jira’s API enables you to write your own scripts, extending its functionality.?

For?example, you can create an interface between your Service Management system and Jira for passing tickets from first-line support (working with the Service Management system) to second-line support (working with Jira).?

Another example?is if you’re committed to automated tests and have also built a fluent Continuous Integration (CI) pipeline. Each commit triggers the pipeline and runs a set of automated tests. Since your development cycle starts in Jira, and you would like to close the loop in Jira, with the automated test cycles reported into Jira, providing greater visibility into the development status. This also helps compliance with better traceability. A custom-coded solution would ensure your Jira traceability is always current.

To sum up, the procession of creating an eQMS that works for your needs flows looks like this:?

• Explore configuration options.
• Check out the Atlassian Marketplace for apps that can fill any gap between existing configurations and how you need your system to work.
• Develop tailored apps to take your system to the next level and solve any challenges that configurations and apps alone cannot resolve.

Out-of-the-box Jira is a great starting point, and best of all, you can tailor it to suit your needs. If you have questions on how to create a QMS with Jira & Confluence, please don’t hesitate to?give us a shout.?