Atlassian Jira has become a cornerstone for teams shifting to Agile. With a simple and intuitive UI, feature rich capabilities and ability to integrate not only to other SDLC tools in the Atlassian stack but also other popular tools, it has been widely embraced from the user level all the way through to CIO’s.
Generally, teams utilizing Jira will at least have hopes of achieving Agile in some capacity, and many will leverage its capabilities to great success in achieving a truly Agile adoption. However, Life Sciences teams working under regulatory compliance requirements will have a much more difficult time maximizing the benefits that Jira allows software teams.
After all, modern demands on software teams require that they achieve faster, higher quality releases and added compliance and Computer Systems Validation constraints don’t lend themselves to Agile adoption, or at least not in the way in which validation requirements have historically been satisfied. Requirements often fluctuate throughout a project’s lifecycle. Users are less and less singularly focused in their roles and very often wear multiple hats for more of a hybrid role. Constant reporting and visibility is required across the SDLC landscape.
To fit these needs, Agile focused tools like Jira offer a lot to enhance productivity for software teams through tight integrations, automation, synchronization and advanced reporting capabilities. In a non-regulated environment, this is enough to alleviate good practice requirements and achieve high quality builds and releases in an Agile framework, but in a regulated environment there is an added layer of process, complexity, compliance and documentation that must be accounted for by software teams and the tools they use.
At the bare minimum, some type of 21 CFR Part 11 compliant solution will need to be put in place to manage approvals across an Agile/DevOps tool stack to avoid the highly disruptive CSV approach of printing and applying wet signatures to paper validation documentation, but simply utilizing compliant electronic signatures is not enough to maximize the Agile focused feature set of tools like Jira. In fact, most solutions offering Part 11 compliant electronic signatures are basically just taking the same methodology behind the old school paper validation approach and shifting it to the computer screen.
They will allow for “achieving” compliance in the context of an already familiar process, but not much else and they certainly don’t enable achieving Agile processes or utilizing Agile focused tools. For software teams in Life Sciences that are serious about leveraging Jira to achieve Agile, the pursuit really requires a truly Agile GxP solution, rather than a solution that adds a bare minimum GxP component to an Agile tool.
Before we get there, let’s focus a bit on what teams are currently doing and why simply applying bare-bones compliant electronic signatures isn’t enough…..
Check out a webinar we did on enabling Jira for Agile GxP here.
Jason Secola is the Support Sales Manager at Tx3 Services and has been with the company since 2016. Jason began working with the larger portion of the existing Tx3 team dating back to 2007 when he got his first start in the world of application testing and later began a focus on testing in a regulated environment.
He currently resides near Sacramento, CA.