Traditional document-based approaches to CSV can now be a thing of the past. In a world of ever-evolving technology and methodologies, it no longer makes sense to allow outdated processes to handcuff Life Sciences teams and they no longer have to. Paperless, risk-based, data-driven validation is the future of CSV and achieving it is finally well within reach.
After years of honing efficient and industry leading CSV solutions and processes, Tx3 Services introduced VERA (Validated Electronic Record Approval)As the latest flagship in an evolution of CSV solutions, VERA picked up where previous iterations left off and brought with it a number of improvements, but the evolution has not stopped. In fact, VERA continues to rollout it’s biggest functionality and integration leaps to date.
In crafting a data-driven approach to CSV, Tx3 has really taken aim at bringing a truly Agile capable regulatory compliance solution to the Life Sciences market. With VERA, customers now have the ability to integrate to best of breed SDLC solutions to act as the centralized review and approval portal, complete with features like workflow governance, dynamic approvals, traceability, audit history and the capturing of 21 CFR Part 11 compliance electronic signatures at the data level, rather than at the end of a static requirements or validation document.
With this versatile workflow engine in place and compliant electronic signature capturing at the data level across a number of SDLC tools, Life Sciences teams are finally able to utilize a CSV solution that actually flows with the software development lifecycle, rather than hindering it. The availability of configurable workflow controls and approval chains also means that teams can set up VERA in a way that is conducive to pre-existing internal requirements, ensuring that compliance focused quality and validation procedures are adhered to and documented properly.
Out of the box, customers will be able to leverage such benefits as:
- Configurable approval routes
- Approve records with electronic signatures
- Standardize workflow and best practices
- Reject records and document reasons
- Maintain record versions and audit history
- Verify validity of records and signatures
- Record retrieval capability for inspections
- End-to-end data lifecycle traceability
As it currently stands, VERA can add this functionality to cornerstone solutions like Micro Focus ALM (formerly HPE), Tricentis qTest (formerly QASymphony) and Atlassian Jira, but development continues to enable VERA to be extended to additional Agile focused, SDLC solutions.
With a number of top Pharma, Biotech and Medical device organizations already utilizing VERA and with a growing number of partnerships with industry leading technology providers, VERA has already begun to bring CSV processes and methodologies up and into the modern era of the Agile and DevOps landscape for a number of organizations.
If you would like a bit more detail on the methodologies behind VERA, or the technology itself, you can click the link below to download a VERA data sheet as well as a white paper we published on the topic of paperless validation to gain and understanding of the thought behind the development of VERA.
Request VERA Data Sheet here.
Request Agile, Data-Centric Validation White Paper here.
Join us for our VERA for Jira Webinar here.
Of course, you can always reach out to firstname.lastname@example.org if you would like to work with someone directly to learn more about VERA.
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.