fme compliance-center solves validation challenges

by David Gwyn |
Apr 18, 2023 |

At last! An end to many of the onerous software validation activities will boost innovation in Life Sciences.

It’s been a long time coming, but a new risk-based approach to computer software assurance looks set to spur new digital advancement in Life Sciences. After a quarter of a century of the rigidly comprehensive Computer Software Validation (CSV) model, in which each and every tweak to an IT system led to a whole raft of testing and documentation, the FDA has published new draft guidance with an emphasis which is more fit for purpose.

Rather than enforce a checklist of no-exceptions tests, the new Computer Software Assurance (CSA) model will be geared to the impact of any changes to a system. It will require new testing and associated documentation only if there is likely to be a direct effect on the product or on patient safety. Indiscriminate testing of logins and similar low-risk processes will no longer be required – or incur the risk of a failed inspection if not completed.

Removing the validation-related barriers to digital transformation

The update to the FDA requirements comes just in time. Over-zealous requirements have caused a reticence to upgrade systems in a Life Sciences Regulatory context because the cost of validation is often two to three times the original cost of the software. While a large company with a sizeable budget and ample internal resources might be able to weather this comfortably, the same hasn’t always been true and cannot always be said for small businesses along the supply chain. Neither size company wants this added cost.

This is one of the reasons Life Sciences has lagged behind other industries in digital innovation. Years ago, analyst firms put the sector at 17th for innovation, a barely altered ranking. If a mundane transactional system had to be put through its paces each time an adjustment was made, consider how much more of a barrier introducing an AI-based capability would have been under the outgoing regime would be.

Although the new approach is still only at a draft guidance stage, the excitement around the change is palpable. Suddenly, even the regulators are pushing for digital innovation in how Life Sciences companies manage their processes, and this impetus for change is now driving the FDA’s new approach to software assurance.

Reducing complexity & cost of validation

The new emphasis on risk-based and ad-hoc software assurance checks and documentation could reduce the time and cost burden by as much as 80%. Instead of resigning themselves to weeks of writing scripts and capturing screens, IT teams will be able to explore the potential for concepts like:

  • AI-based safety signal detection;
  • advanced use of Regulatory intelligence to drive pipeline development and submission strategies;
  • and adopting more innovative interfaces (e.g., voice assistants) to drive complex RIM queries.

At last, companies will be able to reduce their reliance on Excel spreadsheets without worrying about adding to an already overwhelming validation worklist.

Cultivating greater cloud use

Next-level cloud adoption is likely to increase because there won’t be the same requirement to track down and physically visit hosting data centers to check on fire alarms and the like. Instead, third-party assessments will usually be acceptable, opening new opportunities to embrace the latest remote capabilities.

It might be the best part of another year before the new provisions apply, but knowing that the FDA is altering its approach to software assurance paves the way for bolder tech-based ambitions today – whether that’s around AI capabilities or enhanced inter-system data integration.

And fortunately, we’re fme poised to help companies chart and respond to these opportunities. Our new compliance-center solution encapsulates the FSA’s new CSA approach in a digital platform, delivering a fit-for-purpose QMS capability for companies in a paperless cloud platform.

Read more about the advantages of CSA over traditional CSV here and keep an eye out for the compliance-center webinar in May. We’d be delighted to share more about it – so why not get in touch?

Read more and watch the fme compliance-center™ webinar here

Learn more about CSV and CSA

Learn more about the challenges and new solutions for software validation in this recording from fme’s David Gwyn. 

About the author

David Gwyn is a strategic, creative, and data-driven Business Development and Technology Specialist with extensive expertise in building key partnerships, implementing business strategies, and deploying solutions across the life science and emerging technology industries. In October 2021 he joined fme US as the Business Unit Director for Business Consulting. For the past 30 years, he has led teams in the delivery of content management, clinical, and quality solutions with a recent focus on end-to-end Regulatory Information Management (RIM). His practice has evolved in parallel to the Life Sciences industry, moving from custom-developed software solutions to packaged-based implementations, and the development of methodologies and best practices to guide practitioners in realizing the greatest return on investment. Mr. Gwyn is passionate about helping organizations evolve from traditional to digital businesses and increase their ability to act with speed and agility.


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