Tx3 Services
Redefining Electronic Records in Life Sciences

Pharmaceutical and medical device companies depend on a range of software applications to deliver products which are both safe and effective. To safeguard consumers, these software applications undergo careful scrutiny by regulatory agencies such as the FDA, utilizing a process known as computer system validation. The basic goal of validation is to ensure the software functions correctly for its intended use. Unfortunately, the validation methods commonly employed are often cumbersome and inefficient, relying upon reams of paperwork which must be printed, reviewed, and hand-signed (often, by groups distributed across the globe) to authenticate the software was tested satisfactorily.

Modern companies are demanding a better way. To test software more quickly without jeopardizing quality, many companies utilize web-based test management tools to enable teams to collaborate around the globe and provide real-time insight across projects. For FDA-regulated companies, this means addressing two key considerations: 1) applying technical controls on the use of the test management tool, and 2) adopting a new paradigm for how the software testing is performed.

While most test management platforms have comprehensive features for conventional software testing, they lack quality controls required by regulations such as FDA’s 21 CFR Part 11. Tx3 Services’ flagship product VERA (Validated Electronic Record Approval software) extends the capabilities of industry-leading test management tools such as ALM by Micro Focus, and adds the necessary electronic record controls and electronic signatures which enable compliance with FDA regulations.

VERA provides a configurable review and approval workflow, giving project teams the flexibility to tailor their validation process based on corporate policies, including but not limited to incorporating risk based validation methodologies. To fully appreciate the benefits offered by a paperless validation process, companies must break the document-centric validation paradigm, adopting instead an approach that centers on individual electronic records. Instead of simply attaching digital signatures to traditional paper documents, VERA provides approvals of individual data, whether its requirements, tests, test results, or other test elements. As Henry Farris, CTO at Tx3 Services states: “Our clients have seen significant benefits abandoning antiquated traditional computer systems validation documentation and adopting green electronic records approved immediately with electronic signatures. This greatly expedites the validation process and gives (clients) the ability to reuse approved assets.”

VERA can either be deployed straight into a customer’s environment or on Tx3 Services’ qualified hosting platform called Helios. Helios is available as a fully controlled PaaS and can be used by life sciences companies to host GxP applications. It is integrated with scalable cloud technology and quality controls that can accelerate software development while meeting the regulatory compliance requirements of the life sciences industry.

As new technologies emerge, Tx3 Services will continue to build upon the VERA platform to optimize our clients’ quality and compliance efforts. For example, coming versions of VERA will be entirely cloud-based, and will connect to applications across the Dev/ Ops landscape. This will enable Quality Approvers to quickly review and approve or reject whatever is in their queue without the need to log into individual applications.

Tx3 Services offers more than just software solutions. The employees at Tx3 have many years of experience working in the life sciences sector, providing valuable insights to clients and devising effective business strategies. This expertise also enables Tx3 to offer a comprehensive range of services such as implementing testing centers of excellence (TCOE), performance testing, functional test automation, and other Quality and Validation services for life science companies. As testament to their success, Tx3 has seen remarkable growth, achieving 58 percent year-on-year growth for the last two years.