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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)?        

1 comment

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.



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