Tx3 Services
Life Sciences Technology for Seamless Compliance

The life sciences industry, which includes the pharmaceutical, biotechnology, and medical device sectors, undergoes constant scrutiny by regulatory agencies such as the Federal Drug Administration (FDA). The FDA regulates a wide range of products and processes in its mandate to safeguard the general public. This includes a process called computer system validation (CSV) which is used to ensure that computer-based systems (both hardware and software) are performing as intended within the regulatory guidelines of the industry.

Since 2011, Tx3 Services—a technology company that offers compliance consulting solutions and services for the life sciences community—has been addressing the challenges of CSV. Through its flagship product, VERA (Validated Electronic Record Approval), Tx3 provides a 21 CFR Part 11 compliant solution for automating computer system validation within an FDA-regulated environment.

Tx3 Services is launching the next generation of VERA in 2Q 2019—which will offer an array of benefits designed for the small-to-mid-tier life science companies. According to Eric Toburen, co-founder and managing partner of Tx3 Services, this market has been underserved by many technology firms. In this interview with CIO Applications, Toburen explains how this new product will impact the agile management space, and a whole lot more.

What changes are being made to your VERA product?

VERA currently provides all the technical controls to facilitate full compliance with the FDA regulation 21 CFR Part 11 in one major test management tool—MicroFocus ALM. Our goal this year is to further expand the VERA platform to allow users to connect to the best-of-breed DevOps tools. It is quite common for life science companies to use ALM for test management, but leverage other tools for defects or requirements. To help address this issue, VERA will provide the workflow controls and electronic signatures across a diverse tools landscape with the ability to capture end-to-end lifecycle traceability of data flowing between the tools.
To help facilitate this effort, we are creating a quality and compliance software platform that will enable our customers to achieve 21 CFR Part 11 compliance by securing electronic records with VERA workflow controls and electronic signatures. This solution will include an approval queue that will display for each approver—in a simple, easy-to-read format—a complete listing of their review and approval tasks across their DevOps tools landscape. It doesn’t matter whether they are using an agile management tool, a requirements tool, or an ITSM tool. The key is that quality approvers will have a single user interface for all their review and approval tasks.

What about Waterfall vs Agile Methodologies? What works better for life sciences?

The life sciences industry— like many other industries—is focusing on releasing software early and better addressing their business requirements. Because of this trend, we see an increasing transition from a waterfall to an agile methodology. This is a challenge for many life sciences companies. They have grown up over the years with a host of manually-developed, paper-intensive linear processes that are unable to utilize or fully adopt an agile methodology. Hence, they are finding it much more difficult to deliver software in the time frame the business requires. We work with our clients to help them transition from their document-laden systems and guide them to a more dynamic, data-driven approach. By changing the focus from documents to data, specific tasks from different sprints can be tagged as validation relevant and used to support the validation requirements while leveraging this iterative approach for faster and more effective software releases.

How do you work with new customers?

After engaging with new clients, we analyze their CSV approach to understand the different approval processes, and the dependencies between the various tools they use. The goal is to break the document paradigm they have become dependent on and unlock the inherent value of the data lifecycle. Once we understand the manual process, we create the mapping to an approach that focuses on data, continually looking for opportunities to improve the process along the way. We can begin to drive efficiencies into the process by creating reusable libraries, dashboards that provide real-time insight into their validation projects, and automatically manage the end-to-end traceability of the data. Most of our clients inherently understand that the manual process is not effective; however after years of following this process, a cultural shift is required. Training helps address this shift in thinking and once users see a better way, adoption takes care of itself.

Why do you focus so much on data?

In essence, the VERA platform is the governance piece that sits on top of the ALM process. However, there are also significant benefits to integrating data between the tools. For example, if a life sciences company is leveraging VERA to meet compliance needs on an application in production, and a user places an enhancement request in their service management tool, that request could turn into a requirement in the requirements management tool. That requirement could turn into a user story in an Agile tool, which could turn into a test case in the testing tool, and that could eventually turn into a defect. All of this data needs to be integrated between all the various tools, reviewed, and approved. The VERA platform manages this entire process.

How is Tx3 different from other tech companies?

For starters, we have an amazing reputation in the industry which has led to outstanding relations with longstanding clients. This is something we are very proud of. Secondly, our Tx3 development team comprises people from all sectors of life sciences, be it medical devices, biotech, or pharma. Our true value comes from the fact that we understand the industry, the CSV process and the technologies our clients rely on.

What lies ahead for Tx3?

Since 2016, our business has nearly doubled. Our flagship product, VERA, continued to gain market acceptance being deployed in some of the largest life science companies in the world. In 2019, we are focused on expanding the capabilities of the VERA platform and will continue to evangelize the benefits of data-driven validation. We are forecasting aggressive growth in the U.S. and expect further growth in the Global market by leveraging re-sale partners and working closely with our technology vendors.