GHP Q4 2019

10 GHP / Q4 2019 , Sep19385 Driving Innovation in Regulatory Compliance Tx3 Services is a software development compliance company, providing workflow controls and electronic signature capabilities for a vast range of application lifecycle tools andmethodologies. Troy Logan, Director of Global Business Development for Tx3 takes the time to provide us with a detailed insight into Pennsylvania’s leading life sciences technology firmof 2019. In the heavily reg- ulated world of life sciences, computer system validation (CSV) continues to be a crucial element of the com- pliance process. CSV is designed to help ensure patient safety, product quality and data integrity throughout the entire lifecycle of a regulated product. Additionally, it is in this exciting arena of regula- tory compliance that U.S.-based software technology company, Tx3 Services has positioned itself as a catalyst for change. Mandated by the U.S. Food and Drug Administration (FDA), com- puter system validation verifies that computer systems and their associated applications operate in a consistent fashion and yield reliable results based on their in- tended use. CSV directly impacts the development, manufacture and delivery of pharmaceuti- cal, biological and healthcare products. Failure to comply with regulatory requirements can result in severe penalties and financial damages. Pressures have been mounting for life sciences companies. The rise of digital transformation increased regulatory mandates, and pricing pressures are challenging these companies to be quicker, nimbler, and more cost-effective. However, change is difficult when new technolo- gies and process modifications can have a significant impact on product quality. It is for these reasons that many life sciences organizations continue to strug- gle with modernization in the IT compliance arena. It is also the reason that life sciences companies have come to rely on Tx3 and their extensive knowledge and experience in helping to manage the complex and sophisticated CSV process. “We are experts at computer system validation,” says Troy Lo- gan, Director of Global Business Development for Tx3. “Our team is comprised of technology pro- fessionals with deep experience and expertise in the life sciences industry. By utilizing industry best practices, Tx3 helps to confirm the accuracy and integrity of data in computerized systems – and en- sure effectiveness and regulatory compliance on an on-going basis.“ Headquartered in idyllic Blue Bell, Pennsylvania, Tx3 is instru- mental in providing innovative technologies around quality con- trol, workflow management and electronic signature capabilities for a wide range of application li- fecycle tools and methodologies. These solutions help life scienc- es companies achieve regulatory compliance in their GxP (Good Practice) systems. “While compliance technologies have improved dramatically, many life sciences companies still contend with antiquated systems and onerous, manual- ly-laden processes,” says Troy. “A large portion of the industry still relies on document-driven validation which has been proven to be rife with inefficiency, higher costs and greater risk. In our opinion, document-based valida- tion is dead.” “Our approach is different,” he adds. “Tx3 is a champion of data-driven validation – and it’s one of the keys to our success. A data-driven validation approach reduces most compliance risk by moving away from the structure of static documents. We break information down into more granular data elements, which enables us to better control and manage the workflow across the entire Software Development Life Cycle (SDLC). The data centric approach provides a panoramic view of the entire CSV land- scape, literally capturing all the necessary information and data for rigorous, comprehensive test- ing, analysis and reporting.” “It improves process efficiency, helps increase speed of delivery and reduces system costs,” he states. “It’s a ‘win-win-win’ arrangement.” Troy suggests that data-driven validation is forcing another dra- matic change in the life sciences industry. This focuses on the shift from the traditional waterfall methodology to an iterative, agile process. “Many life sciences companies have traditionally utilized the waterfall methodology, which segregates software develop- ment into essentially a sequence of pre-defined phases,” he says. “The agile methodology pre- sents a flexible framework that is designed to drive rapid delivery of an application in complete functional components. This means that agile can effectively handle changes based on new requirements throughout the development process. More importantly, new software code can now happen in days or even hours. Waterfall methodology can’t perform with that flexibility or at that speed.” Tx3 offers both “out-of-the-box” and customized solutions for implementing DevOps lifecycle management tools to support val- idation, providing clients with per- sonalized, individual support and guidance. Companies across the life sciences industry have come to rely on Tx3’s flagship product called VERA (which stands for Validated Electronic Record Ap- proval). This quality and compli- ance management platform uses an end-to-end approval system that is 21 CFR Part 11 compliant, allowing pharmaceutical, biotech, and medical device companies to move through the FDA approval