In the heavily regulated world of life sciences, computer system validation (CSV) continues to be a crucial element of the compliance 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 regulatory 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), computer system validation verifies that computer systems and their associated applications operate in a consistent fashion and yield reliable results based on their intended use. CSV directly impacts the development, manufacture and delivery of pharmaceutical, 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 technologies and process modifications can have a significant impact on product quality. It is for these reasons that many life sciences organizations continue to struggle 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 Logan, Director of Global Business Development for Tx3. “Our team is comprised of technology professionals 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 ensure effectiveness and regulatory compliance on an on-going basis.“

Headquartered in idyllic Blue Bell, Pennsylvania, Tx3 is instrumental in providing innovative technologies around quality control, workflow management and electronic signature capabilities for a wide range of application lifecycle tools and methodologies. These solutions help life sciences 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, manually-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 validation 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 landscape, literally capturing all the necessary information and data for rigorous, comprehensive testing, 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 dramatic 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 development into essentially a sequence of pre-defined phases,” he says. “The agile methodology presents 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 validation, providing clients with personalized, 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 Approval). This quality and compliance 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 process faster, more efficiently and with less cost.

“Its uniqueness in product configuration, integration capabilities with market-leading DevOps tools, low-cost structure and flexibility enables it to compete with – and surpass — any offerings from our closest competitors,” says Troy.

VERA extends process automation across the DevOps tools landscape, leveraging an increasing number of ecosystem partners to help maintain on-going compliance with FDA regulations. The TX3 offering is complemented by industry-leading partners such as MicroFocus and its Application Lifecycle Management (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 development 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 signature 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 development 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 software 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, respiratory 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 projects had to be converted in just 11 short weeks, with the majority being handled during off business 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 increasingly 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 technology 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 hosting platform. It represents the optimum framework for maintaining a variety of applications and solutions, including validation and compliance testing. It supports 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 mitigate risk and drive greater agility and flexibility.

“It is becoming clear that compliance 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