Compliance in Agile Testing: Tx3 VERA for Xpand IT Xray

Compliance in Agile Testing: Tx3 VERA for Xpand IT Xray

Agile tools and methodologies have certainly taken the SDLC landscape by storm over the course of the last decade or so. Even in our generally more conservative life sciences industry, in recent years we have really begun to see adoption increase dramatically. While a fully agile approach may not be what is required or even desired for many life sciences teams, the reality is that with the business requiring higher quality builds and releases at faster speeds than ever before, some variant of agile and agile tool adoption is essentially becoming a requirement.

One such tool that we have seen becoming more prevalent amongst our customer base is Xpand IT Xray. With very powerful and nimble agile oriented capabilities and workflows for test management, the uptick in adoption over the last couple of years has been impressive. Coupled with its extremely tight integration and relationship with Jira (which is essentially used at almost every organization at this point) and teams basically have a fully functioning, easy to purchase and install agile development and testing platform that can be utilized both by smaller teams, as well as scale for full enterprise use cases.

However, while adoption of these tools and methodologies may have started with teams not necessarily utilizing them for the development and/or testing of their GxP systems, the use case and adoption is certainly bleeding over to regulated systems at this point. This is leaving many teams with a very common problem of trying to manage regulatory compliance while leveraging tools that weren’t really designed to operate within traditional CSV amd documentation frameworks. In fact, agile tools and processes are drastically inhibited by traditional validation and compliance processes. 

Have you ever heard the sayings “FDA compliance and agile just don’t go hand-in-hand” or “The ‘A’ in ‘FDA’ doesn’t stand for agile”? Well, I’m not surprised if you haven’t heard either of them. I just thought I’d try to write them here and pass them off as if they were common phrases.

Okay, enough of that. Back to the point…….

Luckily for the fine organizations that we get to work with, the disparity between what tools like Xray and Jira offer relative to legacy validation practices are something that we addressed long ago. Through our VERA (Validated Electronic Record Approval) solution, we are able to provide a centralized quality and compliance platform for standardizing compliance across tools and teams - which is a crucial component for regulated teams attempting to move into a more agile form of operating.

Through the automation and electronic capturing of compliance deliverables, we are able to embed compliance requirements seamlessly into controlled workflows leveraging 21 CFR Part 11 compliance functionality - which is a stark contrast from trying to manage wet signatures on physical documents, or even electronic signatures on electronic documents. In fact, when it comes to agile tool and process adoption, this approach is almost a requirement if teams do not want to limit the efficacy of agile practices.

With VERA already supporting Jira, we have now extended the platform to support Xray for agile test management. Combined, not only do organizations now have a potent combination of leading agile solutions for software development, testing, and quality, but now they can add the missing regulatory compliance functionality to bring compliance into the fold.

With these combined solutions, teams can tightly control Jira and Xray data, without requiring customization or disruptive compliance and documentation practices. Amongst other things, users can expect:

  • 21 CFR Part 11 compliance capabilities
  • Seamless record revision process
  • Controlled workflows per defined process
  • Single UI to manage review and approvals across tools and teams
  • SDLC records traceability
  • Configurable approval routs
  • Ability to automate regulatory compliance tasks
  • Seamlessly capture compliance deliverables
  • Replace the use of paper or electronic documents with true electronic records
  • Lock records in Xray and Jira

In short, VERA for Xray provides all the components life sciences organizations need to allow Xray to meet computer system validation requirements in a modern fashion that supports agile. From pre and post-test execution review and approval capabilities to 21 CFR Part 11 compliant electronic signatures captured at the data level, life sciences teams can now achieve an agile-focused, paperless, data-driven approach to CSV.  

If your team would like to see this solution in action, we will be hosting a webinar “Tx3 VERA and Xpand IT Xray: Compliance in Agile Testing” on 2/17/2021. Click the link below to register.

Register for the webinar HERE.

In the meantime, please feel free to download this datasheet to learn more:

Download datasheet HERE.

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