Six Must-Have Atlassian Apps for MedTech Companies

Which tools should I pick from the Atlassian stack? Jira? Jira Software? Jira Core?

And then there is a marketplace full of apps that sit on Jira and Confluence. Can I pick one from there or do I need apps at all?

These and many similar questions are asked by almost all new Atlassian users and it is especially hard to create a simple setup if you are operating in the regulated domains like MedTech, Pharma, Aerospace or Automotive.

This blog post aims to describe a basic setup of tools you might need to get started. Please keep in mind that this is not the final list of tools and you can always add additional apps to automate more and make your life even easier.

Requirements, Project & Documentation Management

First we need to cover Atlassian’s own applications. Which ones to use?

There are many applications to choose from: Jira Software, Jira Core, Confluence, Trello, Bitbucket, etc. Let’s say your basic needs are the following:

• Requirements management
• Project management
• Documentation management

In order to fulfill those needs we suggest you select Jira Software and Confluence.

Jira Software is used for issue tracking, project management and virtually anything else involving a workflow. So ideal for both project management and requirements management.

Small note about Jira Software vs Jira Core – if you do agile software management then you get all those useful backlog and active sprint views with Jira Software. Backlogs and active sprint views are widely used in other domains also, not just software development. Jira Core, on the other hand, is just a basic issue tracking tool without useful project management views. So our suggestion for project and requirements management is to go with Jira Software.

Confluence is a platform for collaboration where teams can build their content and share knowledge. For more traditional terms – it’s a tool to create and manage documentation across your organisation.

We now have the cornerstones of Atlassian tools: Jira Software and Confluence. Let’s look at the pricing of those tools for starters (up to 10 people team) and for a growing company (up to 50 people team).

NB! Information that you need to know about prices before making a decision:

• We are listing only the self hosted (server) platform prices because most of the regulated domains have strict rules about hosting and being in full control of the instance. Cloud platform is therefore not a compliant option yet.
• Please note that these prices can change over time. It is just a snapshot at the time of writing this blog post, so make sure to check them again when budgeting for the tools.
• The prices are for the new licences only. The price for subsequent years, i.e. beyond Year 1, is 50% off the first year’s price! Read more about Atlassian pricing model here → https://www.atlassian.com/licensing/purchase-licensing

Application	Number of users	Price 1st year
Jira Software	up to 10	$ 10
	up to 50	$ 6’800
Confluence	up to 10	$ 10
	up to 50	$ 5’300

Electronic Quality Management System

Now that we have basic Atlassian tools in place, let’s add some more features to our setup. What are the tools that support us in:

• Document workflows (FDA 21 CFR 11 compliance);
• Quality management system (ISO13485, IEC62304, ISO14971, FDA 21 CFR 820 compliance).

These requirements can be solved by adding features on top of Confluence, in other words we need to add Confluence apps.

For document workflows we would recommend Comalatech’s apps which together with SoftComply’s eQMS app support you in establishing an electronic Quality Management System.

These apps are:

• SoftComply eQMS
  • Provides a complete Quality Management System content based on ISO 13485, IEC 62304, ISO 14971 and FDA 21 CFR 820
• Comala Document Management
  • Supports creating custom document management workflows with reviews, approvals, tasks, and read confirmations. All that you need to control your documents lifecycle.
• Comala Publishing
  • Silently controls your approved/published documents so that the right people see the right content.

The pricing of those apps is following:

Application	Number of users	Price 1st year
SoftComply eQMS	up to 10	$ 2’400
	up to 50	$ 2’700
Comala Document Management	up to 10	$ 200
	up to 50	$ 1’000
Comala Publishing	up to 10	$ 100
	up to 50	$ 500

Test, Risk & Access Management

Finally, we may want to look into automating test, risk and access management.

1. According to ISO 14971 we need to manage the risk of our safety-critical products to ensure that they are safe for the patient and the user;
2. Our development team needs an easy automated way to manage tests;
3. We should make sure that accessing of our system is compliant with regulations, e.g. password expiration and complexity, account lockdown, maximum number of attempted logins, etc.

To summarise, we need tools for:

• Risk management
• Access management
• Test management

The following are our suggested list of tools for them:

• SoftComply Risk Manager
  • ISO 14971 compliant risk management tool to track and report software product risks.
• Atlassian Crowd
  • Atlassian’s own user management tool for self-managed environments, especially useful for regulated domains.
• Xray Test Management for Jira
  • Powerful test management app that integrates seamlessly with other tools like the SoftComply Risk Manager in order to establish traceability.

Application	Number of users	Price 1st year
SoftComply Risk Manager	up to 10	$ 100
	up to 50	$ 2’400
Atlassian Crowd	up to 10	$ 10
	up to 50	$ 10
Xray Test Management for Jira	up to 10	$ 10
	up to 50	$ 1’250

Compliant setup on Atlassian stack – recommended apps for a MedTech Company

To summarise, this is the list of apps needed for a compliant and paper-free setup on Atlassian stack:

1. Jira Software
2. Confluence
3. Crowd

and some apps on top:

1. SoftComply eQMS on Confluence
2. Comala Document Management on Confluence
3. Comala Publishing on Confluence
4. SoftComply Risk Manager on Jira
5. Xray Test Management for Jira

 

The prices of the Server version of these tools are provided below:

Application	up to 10 people team	up to 50 people team
Jira Software	$ 10	$ 6’800
Confluence	$ 10	$ 5’300
Atlassian Crowd	$ 10	$ 10
SoftComply eQMS	$ 2’400	$ 2’700
Comala Document Management	$ 200	$ 1’000
Comala Publishing	$ 100	$ 500
SoftComply Risk Manager	$ 100	$ 2’400
Xray Test Management	$ 10	$ 1’250

 

Note that after the first year all the prices go down by 50%!

In case of any questions, please don’t hesitate to contact us.

Happy usage & smooth compliance!