Atlassian and QbD

Atlassian has many applications that are suitable for business operations and processes. JIRA and Confluence in particular are frequently used as collaboration or project management software. For instance, JIRA Software is often used for software development. This application makes sure new features, issues, bugs, planning releases and release notes can easily be created, prioritized, monitored, assigned and tracked. Confluence allows for knowledge documenting and sharing.

atlassian logo

There can be some confusion about the names Atlassian, JIRA and Confluence. Atlassian is the the software provider that offers applications such as JIRA Software, which focuses on project management. It’s an issue tracker. In addition, Atlassian provides additional plug-in applications such as Comala Document Management and CFR Part 11 E-Signatures (FDA Compliance) for Atlassian JIRA [¹], in order to assist in complying with FDA regulations[²] or quality management systems ISO 9001[³]. Confluence is a collaboration/document tool to share knowledge[].

QbD possesses the knowledge and the expertise to provide support in the creation of a streamlined process within JIRA and/or Confluence. This way, you can meet your business needs while being compliant. QbD has experience dealing with common mistakes and hurdles when it comes to implementing Confluence in GxP environments.

atlassian software validation and qbd infographic
Figure 1 Atlassian software validation

In order to realise and uphold a validated system, the customer’s needs and knowledge, current legislation (e.g. FDA, national laws), relevant guidelines (e.g. GAMP5, GMP) and the supplier’s expertise are essential. This Our synthesis approach enables customers to deploy their system rapidly, safely and consistently.
QbD offers multiple services to assist, support, lead or govern in system validation, data integrity, training, change management, and regulatory compliance.

Atlassian and the lifecycle

After the system is validated for use it must stay validated. Atlassian applications will require regular updates. Therefore, it is critical to have a systematic approach in order to remain compliant in GxP environments, in which QbD’s expertise lies.

Using Atlassian Cloud ensures you are working with the latest version. The roadmap of updates are not made public in advance but there are options to test new functionalities in test environments[]. Changes of the software in the cloud are pushed every week[]. Component applications of Atlassian are updated within days if it concerns a critical update, such as a security issue or if a production application is down[].

If your business runs Atlassian applications on your own controlled servers it is possible to choose to update the application or not. Atlassian also provides a so-called enterprise release which contains a cumulation of updates performed once a year[]. There is a possibility to create a test environment for JIRA applications to conduct tests with the same database set as in the production environment[].

Contact us for any questions concerning Atlassian.

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