By: Henrik Jensen, Senior Director, Strategic Engagement

The life science industry has been living with CSV (computer system validation) for 36 years if you can believe it. The first major guidelines the FDA published on CSV dates back to 1987, when life science was called… well, just science, usually, and when computer systems were limited to a PC or two.

But as the industry evolved, the validation process essentially did not. CSV is the same as it ever was a process/methodology to ensure that computerized systems used in life science are compliant with FDA requirements, and that they work as they’re supposed to.

CSV was designed with the quality and security of computer systems in mind. Ideally, said systems should also be able to create/deliver an audit trail that demonstrates compliance.

Today, CSV applies to a range of specific FDA regulations—such as Title 21 CFR Part 11, which goes all the way back to 1997, and concerns how life science companies manage electronic records and electronic signatures. And it’s not just in the USA where CSV comes into play: international standards, such as EU Annex 1, EudraLex Volume 4, ISO 13485,and ISO 14971  help standardize validation processes across the globe, creating a more universal —and universally understood — CSV process.

No matter where it takes place and what regulations are in play, CSV is typically a time-consuming process resulting in reams of archived documentation, never to be seen again. But better than to be out of compliance and subject to fines or far worse. 

Microsoft Dynamics, the game-changer for CSV (almost)

Here’s the thing: when CSV guidelines were established, most companies were using — to put it mildly — ad hoc computing systems: on-premises, non-integrated beasts requiring “one-by-one” validation of each station, system, and device (causing the aforementioned reams of documentation).

However, with Microsoft Dynamics 365 and other cloud-based operational back-end systems, CSV has become simpler. The consistency of the solutions, the connectivity through the cloud… these factors among many others have made CSV processes faster to execute.

But as solid a foundation as Dynamics is, when it comes to CSV, it’s somewhat akin to the adage of “putting lipstick on a pig.” The CSV process is still heavily manual, still requires reams of documentation, and still involves testing of all hardware, software, firmware, and more to ensure guidelines are met.

Technology alone can’t solve the CSV challenge. Solving it means rethinking the issue from the ground up. And because we’re past the days of ad hoc systems (thanks, Dynamics!), the FDA has revised guidelines to focus on far-more targeted Computer Software Assurance (CSA) rather than CSV.

CSA: CSV 2.0?

First off, we don’t think CSA is CSV 2.0. We think it’s more like: CSV = Ford Escort; CSA = Tesla (but that was too long for a headline).

CSA should be a game-changer for every life science company. No more shotgun approach to validation (CSV, in which the whole system is targeted and documented). CSA is more of a sniper approach, zeroing in on the software, focusing on the most critical parts of the process that could impact the safety of products, treatments, and devices being made in life science, as well as systems operation.

Additionally, CSA is leaning into automation in a very big way, which will drive further increases in productivity and reductions in costs. Think about it: manually validating a system from top to bottom could take days, weeks, longer, and is incredibly error prone. And it’s not a one-and-done task. It has to be done over and over over the lifetime of a company.

But in automated systems, the mechanics involved in validation don’t typically change over time. Enacting automated, up-to-code processes wherever you can in your operational systems helps ensure said processes stay within the guidelines by default. The FDA, in effect, has nothing to worry about as your automated system is validated and will remain so.

The FDA also calls CSA “a risk-based approach to establish confidence in the automation used for production or quality systems, and identify where additional rigor may be appropriate.” CSA is about troubleshooting the issues, not about scanning the whole system. Also a HUGE time- and money-saver.

The next step in systems validation

The crazy thing is that even though CSV has been with us for 36 years, many life science companies are still not caught up, still outside those very old guidelines. And now, here comes the next big thing (CSA) before they’ve even figured out the last big thing.

Here’s where Argano can help. We have teams of solution architects and life science industry business consultants who know their way around the regulations and the mechanics in equal measure. We can help equip your life science business with a CSA compliant system even if you’re still not up to speed with CSV.

Not only that, but with Argano and Microsoft (and the Healthcare Cloud), you’ll benefit from an operational backend with nearly endless flexibility. So that no matter what may come next from the FDA (CSABCDEFG?), you’ll be ready.