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Regulatory Compliance Technology for Life Science Industry from Tx3 Services

Regulatory Compliance Technology for Life Science Industry from Tx3 Services

Innovative drugs and medical devices have the potential to improve and extend our lives. However, regulatory oversight of the Life Science industry is required to safeguard patient safety. When applied appropriately, these regulations actually foster innovation; this is where Tx3 Services can assist. Tx3 helps clients focus on their core business by improving methods for meeting regulatory requirements.

In FDA parlance “validation” refers to the process which ensures that software applications function correctly for their intended use. Early validation efforts depending on paperwork were cumbersome and stifled the adoption of new technologies. Tx3 Services is a recognized leader transitioning Life Science companies to efficient “paperless” validation methods. “Homegrown offerings range from specific point product solutions to large-scale service engagements. Delivering this vision involves partnering with leading technology companies and developing our own Intellectual Property when necessary to augment partners’ capabilities,” explains Jason Tepfenhardt, co-founder of Tx3 Services.

Tx3 Services Journey

It all started with two friends, Jason Tepfenhardt and Eric Toburen, working on a common goal: bringing real value to the computer system validation practices of FDA-regulated companies. Both Eric and Jason were seeking ways to harmonize emerging software lifecycle validation tools with important FDA regulations. Things began taking shape in 2005 when they created the life sciences practice at Genilogix and developed tools which enabled pharmaceutical companies to utilize HP Quality Center.

Five years later, Genilogix was established as a premier HP partner with a strong reputation for applying their practical knowledge of 21 CFR Part 11 to the software development lifecycle. After Avnet acquired Genilogix in 2012, Jason and Eric were given the responsibility of managing the life sciences vertical.

A couple of years later, with the approval of Avnet’s executive management, Tx3 Services was formed as an independent Vertical Specialist Partner focused on life sciences. Even today, Tx3 Services remains a software reseller and systems integration partner of both Avnet (now TechData) and HP (now Micro Focus). Tx3 Services is also a Micro Focus SVI partner, providing technical support of the Micro Focus tools.

Suite of Solutions

Tx3 Services is a Regulatory Compliance Technology Company which provides Life Sciences industry specific services & solutions focused on leveraging technology and leading-edge methodologies to enable our Clients to meet regulatory requirements in a more efficient and cost effective manner. Our solutions range from large scale service engagements to customized product solutions.

Tx3 Services focuses on providing cost-effective, practical validation solutions to companies operating within an FDA-regulated environment. We offer both “out of the box” and customized solutions for the implementation of validation lifecycle management tools by working with each Client to satisfy the requirements of their specific software quality process.

One of the company’s newest offerings is VERA (Validated Electronic Record Approval). Based on years of industry experience, VERA is a leading software solution for validation testing at life science companies. VERA simply makes the process of validating computer systems easier. It is deployed either on-premise or hosted in a qualified cloud environment.

Future VERA enhancements will apply electronic signatures across DevOps tools like JIRA, TFS, Jenkins and ALM Octane; provide convenient dashboard views into the testing process; implement risk-based testing methodologies; and trace entities throughout the lifecycle and across tools and applications.

The Success Story

Since Tx3 Services was founded in 2014, it has experienced 60% revenue growth in each of the last 3 years. A major contributor to this success is the company’s ability to learn from peers and clients.

Regularly scheduled CAB (Client Advisory Board) meetings have been an effective feedback platform. The CAB consists of members from a range of life science organizations. “We share success stories and struggles in a forum where all can learn from one another.” explains Eric Toburen. The CAB has played an important role in shaping product development efforts by providing insights that address the unique challenges of this highly regulated sector.

Another reason for this success is Tx3’s focus on teamwork. By remaining nimble and entrepreneurial, and hiring only people who share those qualities, we strive to maintain this remarkable growth trajectory,” Eric adds. This is also why Tx3 Services encourages all employees to be innovative, positive, resourceful, responsible, to over-communicate, and exceed expectations. For years to come, Tx3 Services will continue to service a widening range of life science companies.

Meet the Forerunners of Tx3 Services

Eric Toburen is a Managing Partner and co-Founder of Tx3 Services. He is passionate about building lasting client and partner relationships, to provide IT solutions to the life science sector. Prior to Tx3, Eric spent 12 years co-managing the life sciences Practice at Genilogix/Avnet. He has also led the sales team for a computer systems validation company and managed Pharmaceutical sales and distribution for the Latin American and Asian markets of a process automation company. Eric holds a BS in Mathematics from Gettysburg College.

Jason Tepfenhardt is a Managing Partner and Co-Founder of Tx3 Services. He is responsible for business operations and strategic solutions. With over 20 years of life sciences industry experience, Jason was previously the VP of Operations for life sciences at Genilogix/Avnet. Some of the other positions he held include Analytical Chemist, IT Engineer, Compliance Specialist, Quality Systems Manager, and Director of Quality Management. Jason holds a BS in Environmental Science from William Patterson University and an MBA in Technology Management from Drexel University.

“Tx3 Services provides services and solutions for the life sciences industry that are

specifically focused on leveraging technology and deep industry expertise.”

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