Modernize and Accelerate Validation Processes

by The fme Team |
Aug 24, 2023 |

The speed at which software and computer technology are advancing is accelerating at an astounding pace. But in highly regulated industries like life sciences, strict requirements slow the pace of system innovation and can add substantial costs to any efforts to adopt new and improved solutions. Of course, these requirements’ underlying and essential purpose is ensuring that the software performs as expected. Still, there have been times when the rigidly comprehensive Computer Software Validation (CSV) approach has triggered a whole raft of testing and documentation for even small tweaks to an IT system.

CSA is accelerating validation for modern business

This overzealous requirement is one of the main reasons the life sciences sector is reticent to adopt new technology, hindering improvements across the industry. To help address this issue, the FDA is developing new guidance that promises to reduce software assurance and documentation’s time and cost burden by as much as 80%. Still in draft, the new risk-based Computer Software Assurance (CSA) approach is focused on the impact of any changes on the product or patient safety. Testing and associated documentation are adjusted according to the perceived risk, introducing new concepts of ad-hoc testing, not testing low-risk requirements and relying on vendor-performed testing as part of the overall validation effort.

Learn more about CSA on September 6

It might be another year before the new provisions are fully approved and adopted, but knowing that the FDA is altering its approach to software assurance paves the way for bolder tech-based ambitions. The advantages of CSA over traditional CSV promise to open new opportunities to accelerate validation processes and encourage Life Science companies to explore and implement new and innovative technologies without being encumbered by burdensome validation requirements.

On September 6, fme’s David Gwyn will be sharing critical insights in a live presentation with Paul Ireland, VP Life Sciences at DocShifter, entitled “CSV vs. CSA: How to accelerate business speed”. In this session, they will delve into the potential of Computer Software Assurance (CSA) as a tool to accelerate the validation process in line with the pace of modern business operations. They will compare CSA with the traditional Computer System Validation (CSV) approach, discussing its primary limitations, and then explore how the risk-based approach of CSA can potentially overcome these challenges.

As specialists in content and document management in highly regulated life sciences environments, the historic knowledge of Mr. Gwyn and Mr. Ireland is sure to deepen anyone’s understanding of the challenges of CSV, and the exciting possibilities of the new CSA guidelines.

Use the link below to learn more and sign up to attend this unique LinkedIn Live session, and please review fme’s previous posts on CSA, validation challenges, and our newest solution fme compliance-center™.


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Tracey King
Technology Success Manager