GHP Q4 2019

GHP / Q4 2019 11 Driving Innovation in Regulatory Compliance process faster, more efficiently and with less cost. “Its uniqueness in product con- figuration, integration capabilities with market-leading DevOps tools, low-cost structure and flex- ibility enables it to compete with – and surpass -- any offerings from our closest competitors,” says Troy. VERA extends process au- tomation across the DevOps tools landscape, leveraging an increasing number of ecosys- tem partners to help maintain on-going compliance with FDA regulations. The TX3 offering is complemented by industry-lead- ing partners such as MicroFocus and its Application Lifecycle Man- agement (ALM) software tool. ALM software was developed to provide a standardized environment that integrates all the disciplines of the software development process – from specification and design to de- velopment and testing to delivery and servicing of the application. It has become a key element in the CSV toolkit, helping to improve quality management by using consistent, repeatable application testing processes, while tracking release progress and quality to foster greater collaboration and visibility. VERA enhances automated testing tools such as MicroFocus ALM by providing electronic sig- nature capabilities and workflow processes (required for validation testing) to comply with 21 CFR Part 11 and related regulations. “Regulatory compliance is built into everything we do,” adds Troy. “And that includes the develop- ment and on-going maintenance of our compliance platform, as well as the administration and support for MicroFocus ALM tools. The Tx3 Services approach is one of “continuous validation”. This means ongoing management and monitoring of all applications and solutions to ensure compliance with FDA requirements – throughout the ALM process.” “We take on the risk, so our clients don’t have to,” he states emphatically. The partnership between Tx3 and MicroFocus has yielded great results. Troy referenced a recent customer that was challenged with a major corporate soft- ware upgrade. The client was a multinational pharmaceutical and biopharmaceutical company with a portfolio of products for major disease areas including cancer, cardiovascular, gastrointestinal, infection, neuroscience, respira- tory and inflammation. Under extremely tight deadlines, the company needed to upgrade close to 60 ALM projects with minimal disruption to the user community. “There were a number of challenges,” says Troy. “System owners and administrators were new to the ALM tool. The new process required an enhanced approval and signature process. In addition to this, up to 60 pro- jects had to be converted in just 11 short weeks, with the majority being handled during off busi- ness hours. We came through with flying colors.” Industry analysts predict that sales of global prescription drugs will grow at an annual compound rate of 6.5% over the next five years. Worldwide sales are expected to reach $1.06 trillion by the year 2022. Of course, cost reduction is becoming increas- ingly critical – especially when the estimated cost of bringing a new drug to market can easily exceed the $1B dollar threshold. The ability to increase flexibility and address costs in a rapidly evolving digital world is helping to fuel the technology debate. As for Tx3, the cloud is beginning to take center stage. “Cloud computing technolo- gy is currently being used by life sciences companies of all shapes and sizes. However, in today’s competitive world, the cloud can be considered the equalizer for small-to-medium size life sciences companies that want to play with the “big boys”. Working with smaller budgets and limited resources, the SMB players can now compete directly with the larger organizations, taking full advantage of the cost-effectiveness, scalability and reliability of new hosting platforms,” adds Troy. Tx3 Helios is their qualified host- ing platform. It represents the optimum framework for maintain- ing a variety of applications and solutions, including validation and compliance testing. It sup- ports and maximizes the benefits of the Tx3 VERA product and the MicroFocus ALM tool. The Tx3 Helios platform ensures the quality, integrity, reliability and performance of systems to miti- gate risk and drive greater agility and flexibility. “It is becoming clear that compli- ance modernization is no longer an optional exercise,” states Troy. “The ability to leverage innovative technologies and methodologies can reap big rewards in today’s regulatory environment.” Company: Tx3 Services Inc Web Address: www.tx3services.com