Over the last two decades, the lack of clarity around FDA computer system validation (CSV) has created several major hurdles for life science companies.

First, it has driven manufacturers to take a compliance-centric approach when it comes to their quality management system (QMS) software.

This approach can be extremely time-consuming for those who are tasked with managing the system and can inhibit their ability to upgrade and take advantage of valuable new features as the typically lengthy upgrade process needs to be balanced alongside other priorities.

Second, it has inhibited the ability of companies to adopt newer QMS technologies that provide better integration with other systems to help drive automation and digital transformation across the value chain.

A clear example of this was the industry’s initially slow adoption of cloud QMS platforms (though thankfully the industry is now quickly catching up).

However, without a new approach to CSV, it’s clear that being overly focused on compliance threatens to undermine the speed at which industry can adopt new solutions that can help improve product and device quality and safety.

That is what the FDA’s upcoming Guidance on Computer Software Assurance for Manufacturing, Operations, and Quality System Software will finally aim to resolve when it is released later this year.

Sparta recently partnered with Axendia, a leading analyst and strategy advisory firm focused on life science and healthcare, to talk about the upcoming changes on a webinar entitled Understanding the FDA’s New Approach to Computer System Validation.

What we learned is that in order to overcome the roadblocks created by traditional CSV, the FDA and industry are driving the shift toward computer system assurance (CSA).

Traditional CSV prioritizes documentation, followed by testing activities, assurance needs, and critical thinking.

In contrast, CSA flips this model on its head by focusing first on critical thinking and then on assurance needs, testing activities, and documentation.

We also discussed the four major steps within the CSA process. It begins with identifying your intended use of the software and determining a risk-based approach that is appropriate based on the intended use for each function within the software.

Companies must then decide on the appropriate methods and activities for determining risk, and the appropriate level of record keeping for this process. 

To learn more, watch this webinar Understanding the FDA’s New Approach to Computer System Validation.