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Using Jira Cloud or Data Center with new pricing scheme in a regulated environment

We are a small enterprise with 80 employees/Jira users working in a regulated environment (medical device development regulated by FDA). Regulations require us to validate process software and configurations before it is used in a productive setting. We were able to address all requirements by using the on-premise server version of Jira, so that we can control the time point a new version is rolled out and also can take care of e.g. the data retention requirements. Now Atlassian forces us to switch in a - for us - ridiculous short time frame to either Data Center or Cloud.

Data Center would result due to our size in a crazy cost increase by approx. factor 10x, but we would be probably able to address all requirements - at least if we are willing to pay the full price until the retention time (usually 10 years) of the last project using Jira has ended. So at least 0.5 million USD for a period where probably nobody is actually working with the system and data.

Cloud would be slightly more expensive than today, but I don't see how we can fulfill our regulatory requirements if we cannot control when and how often new features are rolled out by Atlassian. Data retention is probably ok as long as Atlassian keeps up operations of Jira Cloud. However, also during the 10 year phase out the system probably continuously needs maintenance resources, because of frequent changes triggered by Atlassian. Instead, we could freeze an on-premise server during the phase-out and just fire it up if it is required, e.g. for audits. 

I would be interested to hear from users working in regulated domains (medical, aerospace,  pharma, ...) how they use in Jira Cloud or Jira Data Center and what their experience is regarding aligning regulatory requirements with the Atlassian products and operations.

Has the time Atlassian products can be used in regulated environments ended (at least for small and medium enterprises)?        


Hello @Tuelle ,

Sorry for the late reply.

At the moment the biggest problem with Atlassian cloud products is that they are very dynamic. It is frequently updated so any validation is difficult to defend. We are working with Atlassian to find a solution, but it will probably be the towards the end of the year.

Other than that, the system is compliant to most of 21 CFR 11.

Get in contact with us if you need more info.


We are in a very similar position.  We are a small pharmaceutical company of about 65 employees and have been using Confluence and Jira for almost 10 years to manage many of our GMP processes.  We are able to do this in this highly regulated space as we are using the server version of these Atlassian products and we can control the updates.  A move to Cloud is not possible as it would put us in a continuous revalidation cycle and becoming impossible to remain in compliance.  A move to Data Center would be preferable, but the minimum user count of 500 users makes it cost prohibitive.  I am hopeful that Atlassian can provide Data Center at a lower user count (100 users).  As it stand, this announcement has significant impact to our needs.  I would love to hear feedback from anyone else in this or similar regulated spaces and know your path forward.

Same situation on our side. We are a small medical IT device producer with 95 employees. We introduced Jira/Confluence a few months before Atlassian announced end of support for our server-based system.

Our architecture in Jira is based on Jira Insight to connect company assets and digital twins with procedures/documents. Smart Attachments and goEdit apps are in use to control “file-based” approvals. Structure for Jira is our powerful issue-browser to support multi project management and inter-department projects/workflows.

In Confluence we are using Document Management for Confluence to provide ISO 13485 QM documentation and technical documentation for our products.

In addition to former posts in this thread we are faced with two more critical problems:

  1. Insight for Jira is no longer available as Jira (Software) addon in cloud. Now it is contained in Jira Server Management licenses. We are using Insight for a lot of asset types maintained in different departments like product configuration, terminology, HR files, digital twins, etc. To get the same features as before we have to “upgrade” a lot of users to “Jira Service Management licenses” and that is a huge price difference to Jira Software. I don´t know why Insight is not available horizontally as before because it was (and still is) a database to store other thinks than “service assets”.
  2. A lot of features of our add-ons listed above are not available in Cloud (like GoEdit) or its functionality is (still) limited to a “unusable level” for us.

We are now looking for a way to continue using the server installation after Atlassian support has been discontinued. This is not a long-term perspective, but we need much more time to find a solution for these massive problems.


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