Tx3 Services was recognized among 4 and 3 vendors respectively in both the Paperless and Digital Category in CSA Solutions section

DOYLESTOWN, PA, UNITED STATES, February 10, 2022 /EINPresswire.com/ -- Tx3 Services, a leading solution provider of FDA compliance solutions in software quality and software testing, today announced that it has been identified as Representative Vendor and Solution in the 2022 Gartner ^® Life Science CIOs™: Use Computer Software Assurance to Modernize Your GxP Validation Practice report. Tx3 Services was named in both the Paperless and Digital category in CSA Solutions sections. [1]

In response to years of overly burdensome CSV practices implemented at many Life Science organizations, the FDA is in the final stages of completing their draft guidance for CSA (Computer Software Assurance) aimed at streamlining and reducing effort around non-product CSV. Although not officially published yet, the industry has a fairly good idea of what it will entail and what the intent is.

While there is an interest in updated approach and the benefits it offers, many organizations are struggling to understand how to incorporate CSA into their CSV programs and what technologies can be used to facilitate this shift away from years of traditional validation mindsets and documentation practices.
According to the report, “Life Science firms have long been challenged by computer system validation requirements and the accompanying increase in deployment costs. CIOs can use this research to understand the forthcoming FDA guidance on Computer Software Assurance and optimize deployments with new digital solutions.” [1]

While the formalization of a CSA guidance from the FDA may be new, this approach to software validation is one that Tx3 has been advocating and implementing amongst our Life Science clients for years. Through the utilization of paperless, digital solutions which enhance - rather than hinder - the validation process, many organizations have already begun to achieve compliance as the byproduct of good software quality practices and streamline their validation projects to meet business demands.

“Our core goal as an organization has been to build and provide the tools our clients need to shed traditional processes around CSV and instead implement modern, forward-thinking approaches to enhance software testing and quality for regulated systems,” said Eric Toburen, Managing Partner at Tx3 Services. “We believe that being listed as a Representative Vendor and Solution in both the Paperless and Digital CSA Solutions section of this article helps reinforce our faith in our vision and place in the Life Sciences industry.”

[1] Gartner, “Life Science CIOs: Use Computer Software Assurance to Modernize Your GxP Validation Practice”, Jeff Smith, Michael Shanler, 25 January 2022.

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