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Jira for Agile GxP Part 5 of 5: Eureka!

For software teams in a regulated environment that are serious about adopting and implementing Agile workflows by utilizing solutions like Jira, breaking away from the document, whether paper or electronic, is a crucial component.  To accomplish this, teams should be looking instead at moving validation and compliance relevant tasks and associated electronic signatures to the data level.

Enabling these activities at the data level vs managing a static document is really where organizations are effectively able to drive validation activities to integrate much more seamlessly into an Agile workflow and thus will unlock the full scope of the desired functionality of solutions like Jira.

Controlling validation relevant elements at the data level also allows for the achieving of standardizing approval lifecycles, implementing uniformed or dynamic workflow controls and capturing end-to-end lifecycle and audit history trail.  With all this enabled, teams are now able to remove the manual effort required to maintain a document-centric approach (and the human error that comes with it) and allow validation and compliance activities to stay on track with larger organizational requirements demanded by business and software teams in today’s landscape. 

The process is sound and efficient, but appropriate solutions are required to bring it to life.  This is where VERA for Jira comes into the picture and where we begin to achieve drastic process refinements to meet modern SDLC standards, while still satisfying regulatory requirements.

Developed to align with modern technologies and methodologies, VERA provides all the necessary validation and compliance components needed for teams working in a regulated environment, but without bringing any of the traditional baggage associated with these requirements.   

With VERA already utilized by top global Life Sciences organizations in their software-related solutions and practices, we have now extended that functionality to integrate with Atlassian Jira.  This addition further extends the ability to streamline regulatory compliance-related activities across an organization’s SDLC tool stack beyond previously supported solutions like Tricentis qTest, Tricentis Tosca and Micro Focus ALM.

In addition to core VERA functionality (found here), this tight integration embedded in a Jira workflow enables: 

  •  Jira app to view approval routes and perform approval tasks 
  • Approve Jira issues with electronic signatures 
  • Prevent the modification of issues routed for approval or approved 
  • Prevent cloning of issues with electronic signatures
  • Reject Jira issues and document reasons
  • Withdraw approval routes to allow correction

Couple this tight workflow governance with the ability to standardize workflow best practices, simplify record retrieval capabilities and complete end-to-end data lifecycle traceability, and users now have a truly Agile capable, GxP ready solution. With much more than just electronic signatures enabled, now teams are able to bring their validation and regulated software quality efforts up to the pace that business and software teams demand, all while shoring up gaps in compliance found in legacy processes and solutions. 

If you would like to see more about this, check out the recording of our VERA for Jira webinar here.

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