Tx3 Services: Automated Computer Systems Validation Solutions for Life Sciences Industry

Jason Tepfenhardt, Managing Partner
In Life Science companies, Application Lifecycle Management (ALM) software has an increasingly dominant role in managing the computer system validation lifecycle beginning at project inception and continuing through application retirement. ALM tools provide the capability for organizing and managing the computer system validation process including requirements definition, requirements traceability, test planning, test script development, review and approvals, test execution, and managing test defects. These tools offer a central repository for all testing assets and provide the framework for a standardized process that can be repeated throughout the application lifecycle.

When leveraging ALM tools for computer system validation, it is vital to assure any computerized system that impacts patient safety, product quality, or data integrity is thoroughly tested and risks mitigated throughout the entire system lifecycle. Tx3 Services, headquartered in Blue Bell, PA, specializes in providing industry specific solutions combining best in class technology and industry expertise to optimize the computer system validation lifecycle and reduce cost throughout the lifecycle.

Jason Tepfenhardt, Managing Partner, Tx3 Services, explains, “We provide ALM solutions that increase IT business processes efficiency and compliance for Life Science companies, primarily focusing on the lifecycle for validated applications.” Many companies still employ manual methods for ALM processes, using tools such as MS Word and Excel; these methods are paper-intensive, prone to human error, and difficult to manage with geographically dispersed teams. Leading organizations are adopting web-based solutions to manage their computerized system lifecycle. “We help companies define, design, and implement changes which transform their computer system validation lifecycle from a manual process to a more efficient and cost effective automated process,” further states Tepfenhardt.

Tx3 Services has partnered with Hewlett- Packard and Avnet to provide automated computer system validation solutions to the Life Sciences industry. These solutions combine partner technology with Tx3 methodology designed to be compliant with 21 CFR Part 11 and Annex 11. Tx3 tool-based validation solutions have proven to be extremely cost-effective. Typically, Tx3 clients report savings of 35 to 40 percent when automating their manual validation practices. These solutions also integrate development tools such as JIRA and Microsoft TFS to offer additional efficiency gains throughout the application lifecycle.
Tx3 Helios is a qualified and dedicated cloud solution for hosting of FDA-regulated applications. Initially focused on hosting HP ALM with Avnet eApprove, the solution is being expanded to host other validated applications as well. By leveraging the existing platform qualification and an infrastructure designed for the industry, Helios greatly accelerates deploying validated applications and reduces the ongoing maintenance costs associated with maintaining the system in a validated state; freeing valuable resources to focus on core competencies of their company.

We provide ALM solutions that increase IT business processes efficiency and compliance for Life Science companies, primarily focusing on the lifecycle for validated applications

Having acquired a collective team of life science professionals from within the industry, Tx3 employees possess a strong base of subject matter expertise across Pharma, Medical Device, and Bio Tech. This advantage allowsTx3 Services to serve as a bridge between IT and the application owners within Life Science organizations and to play an advisory role, guiding clients when choosing solutions to satisfy specific business requirements.

Innovation is a hallmark of Tx3 Services, as they continually develop new technologies and expanded use cases. Their long-term vision for the Helios platform is to expand its use to include all phases of the validation lifecycle.

Tx3 Services

Blue Bell, PA

Jason Tepfenhardt, Managing Partner and Eric Toburen, Managing Partner

Tx3 Services provides Life Sciences industry-specific services and solutions focused on leveraging technology and proven methodologies to enable our clients to meet regulatory requirements in a more efficient and cost effective manner