Tx3 Services: Delivering Efficient IT Solutions to Life Science Companies

“Headquartered in Blue Bell, Pennsylvania, Tx3 began its journey with a combination of Life Science industry expertise and a deep understanding of technology.”

 Tx3 Services develops ITsolutions targeted at the specific requirements of Life Sciences clients. Founded in 2014, they’ve

become recognized leaders in software development and quality lifecycle management, for FDA-regulated companies. Combining extensive Life Sciences expertise with best-in-class technology from partners such as Hewlett Packard Enterprise and Tricentis, Tx3 equips their clients to meet demanding regulatory requirements in a more efficient and cost-effective manner.

The Tx3 Story
Tx3 Services is a technology company providing regulatory compliance services such as: computer systems validation; 21 CFR Part 11 solutions; and consulting services for the Pharmaceutical, Biotechnology, and Medical Device industries. They focus on providing cost-effective, practical validation solutions to companies regulated by the US FDA or European EMA. Tx3 offers both “out of the box” and customized solutions for implementing validation lifecycle management tools, working with each client separately to satisfy requirements of their specific quality process.

The management team at Tx3 Services began working together at Genilogix, an IT consulting firm based in Pennsylvania. Realizing an opportunity to better serve the Life Sciences IT market, they formed the Healthcare & Life Sciences practice in 2005, and developed the Genilogix “eSignature” and “eApprove” offerings. Genilogix was subsequently acquired by Avnet, Inc. in November, 2012. With support from Avnet’s executive management, Tx3 Services spun off from Avnet in August of 2014 as an independent Vertical Specialist Partner focused on Life Sciences industries. Tx3 Services remains a software reseller and systems integration partner of both Avnet and Hewlett Packard Enterprise.

For the past 15 years, the management has relied heavily on their Client Advisory Board to understand the evolving needs of clients, and to set the direction for future solutions.  This CAB is composed of representatives from a range of Life Science companies meeting 4-6 times a year to collaborate and share information, and is certainly a major contributor to the success of Tx3 Services.

Solutions & Services Offered
Tx3 Services has deep expertise in utilizing HPE’s ALM Software as a tool for validation lifecycle management. This ALM software has the basic structure and core functionality to support business requirements, but it lacks essential process controls required by the FDA for the software to be validated and relied upon as a true system of record. As a result, the team developed eApprove software to provide HPE ALM with the electronic signatures and controlled workflow features needed to meet regulatory requirements. Tx3 builds on the eApprove platform by providing enhanced features and functions through the Tx3 Vera (Validated Electronic Record Approval) template that addresses very specific usability and long-term maintainability needs identified by clients.

The company’s Tx3 Helios solution is a Platform as a Service (PaaS) solution designed to meet the regulatory compliance requirements of Life Sciences organizations. This qualified platform enables Life Sciences companies to deploy their regulated/GxP applications into a hosted environment, including the infrastructure, software, (i.e. OS and middleware), database, and supporting procedures.  The platform is qualified independent of the validated GxP applications installed on the hosted site.

In addition to Tx3 Helios and Tx3 Vera (their own IP), the company resells many of its partners’ solutions (HPE’s suite of tools, Avnet’s eApprove and Archive Manager, and Assure’s Total View, to name a few).

They also offer services in the following areas:

• Validation Lifecycle Management Automation Strategy
• Integration of Agile software  development with traditional computer system validation processes
• Adoption of hosted cloud SaaS solutions
• Testing COE (Center of Excellence)
• Test automation frameworks
• Computer systems validation
• Regulatory compliance
• Software implementation
• Performance testing
• Test automation

The Future
Tx3 Services anticipates an ongoing need in the industry, globally, for its solutions and services. As the company develops and provides products and related services to an expanding range of global Life Sciences companies, it is also identifying new, complementary offerings.

Future offerings include:

• Expansion of Helios service for project-based and long-term hosting of HPE ALM, eApprove, and Vera Next generation of Vera as a web service oriented architecture.
• An integrated, qualified application delivery platform that utilizes best-in-class tools along with  industry best practices and  process for use of these tools
• End-to-end software lifecycle services leveraging the company’s paperless validation technology and software quality processes, complemented by near- and off-shore presence

Meet the Key Executives

Eric Toburen, Managing Partner
Eric is the co-founder of Tx3 Services and is currently serving as its managing partner. He is a man with a lot of experience up his sleeve. Prior to Tx3 Eric co-managed the Healthcare and Life Science Practice at Genilogix/Avnet for 12 years. Following which he led a sales team for a Computer Systems Validation company, 3 years in the Pharmaceutical Center of Competence for a large global process automation company, 5 years managing Latin American Sales and distribution, and 2 years in Singapore managing sales and distribution in Asia. He focuses on developing client and partner relationships to provide best in class technology driven IT solutions to the Life Science industry sector.

Jason Tepfenhardt, Managing Partner
Jason is a Managing Partner and co-founder of Tx3 Services. Jason spent 12 years co-managing the Healthcare and Life Science Practice at Genilogix/Avnet. Over the past 19 years Jason has been successfully applying technology to deliver innovative solutions that derive real value from the computer systems validation life cycle. He has experience as an Analytical Chemist, IT Engineer, Validation and Compliance Specialist, Quality Systems Manager and Director of Quality, Vice President of Operations for the Life Sciences Practice at Genilogix and Sr. Director for the Life Sciences Practice at Avnet.

He is responsible for business operations and developing strategic solutions and services that enable Life Sciences companies to meet regulatory requirements for computerized systems in a more cost effective and efficient manner.