Tx3 VERA for Tricentis qTest: An Agile Solution for Computer Systems Validation
It’s no secret that in recent years, Tricentis qTest has emerged as the leading test management platform for Agile-focused software teams. With a robust feature set geared towards enhancing test management and testing in the modern DevOps landscape, qTest has caught the attention of growing organizations looking for a test management platform to help them scale, as well as Fortune 500 organizations looking to shift away from legacy solutions that have been slow to adapt to modern testing methodologies. Add to that the integration of the test management capabilities of Tricentis qTest with the powerful test automation functionality of Tricentis Tosca, and customers truly have access to a “best of breed” Agile testing solution.
However, due to regulatory compliance requirements, Life Sciences organizations have had a more difficult time than most fully adopting Agile-focused methodologies. The compliance demands of operating in a regulated environment requires that Life Sciences teams create workflows that go beyond the boundaries of even the best test management tools.
Life Sciences teams have very niche regulatory compliance and validation needs that are difficult to support in an industry-agnostic solution. In an FDA regulated environment, a wide variety of application types require very specific validation testing to be performed. This essentially means that those applications must be verified via ample documentation to be considered “tested” according to defined policies and SOPs that have been built around regulatory compliance guidelines. This process requires that rigorous amounts of review, approvals and documentation be captured to verify proper application validation.
To satisfy these requirements, Life Sciences teams need a solution that enables:
- Configurable approval routes, with the ability to define approvers and approval types, configure global project approvers, and configure approvers by issue type
- Approving records with electronic signatures
- Standardized workflow and best practices
- Rejecting records and documenting rejection reasons
- Maintaining record versions and audit history
- Verifying validity of records and signatures
- Record retrieval capability for inspections
- End to end data lifecycle traceability
Without these components, teams are forced to either print and sign physical documents at each step or push the data to an outside tool to capture signatures on an electronic document to be stored elsewhere. Unfortunately, neither option lends itself to an Agile approach. This ultimately proves inefficient, costly, time consuming and risk heavy. Moreover, it also pulls users outside of the core functionality and workflows of qTest.
The good news for Life Sciences organizations currently using or evaluating qTest is that Tricentis continues to push the solution forward. Through a strategic partnership with Tx3 Services, LLC, Tricentis addresses the needs of the Life Sciences vertical with a truly niche and industry-specific solution.
Leveraging Tx3’s longstanding expertise in working with the world’s top Pharma, Biotech and Medical Device teams and their existing computer system validation solution, VERA (Validated Electronic Record Approval), the Tricentis and Tx3 teams have been able to develop and release a truly compliant validation solution for organizations wanting to leverage qTest in a regulated environment.
VERA for qTest provides all the components Life Sciences organizations need to allow qTest to meet computer system validation requirements. 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. Through this joint solution, qTest users can leverage VERA as a validation portal for all review and approval tasks, as well as generate audit history and traceability with simple record retrieval capabilities.
If your team would like to learn more about implementing an all-in-one Agile CSV solution:
View the Webinar: Agile Testing in Regulated Environments: Challenges and Best Practices
Jason Secola manages content marketing and channel activities 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 which ultimately led to a focus on testing in a regulated environment. He currently resides near Sacramento, CA.
Jason Secola manages content marketing and channel activities 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 which ultimately led to a focus on testing in a regulated environment. He currently resides near Sacramento, CA.View all posts by Jason Secola