Every time you (a pharmaceutical or medical device company) change your QMS, you must have it revalidated with the FDA. Continuous improvement, however, means that you may need to update your QMS periodically.
In 2019, the FDA started the discussion to create a new Guidance on Computer Software Assurance to help life sciences companies speed the uptake of new and improved QMS systems.
How can you start optimizing your validation to make sure that your quality management system remains at the state of the art?
Is the Need to Validate Holding Back QMS Adoption in the Medical Device Industry?
As soon as software began to form a major component of the software industry, the FDA was on the case. In 2002, the FDA released “General Principles of Software Validation; Final Guidance for Industry and FDA Staff.” This document stated that software must be validated whether it represented a part of a medical device, whether the software was a medical device in and of itself, or whether it was “used in production of the device or in implementation of the device manufacturer’s quality system.”
Further FDA and ISO regulations reinforced the point. Not only should the manufacturer ensure that its system is validated, it should also validate any software changes before they’re approved (per FDA 21 CFR 820.70(I)).
The problem with validation mostly arises from the fact that it can be an intensive process, and from the fact that validation itself must be assessed prior to every patch and upgrade. This process can be so burdensome that it deters medical device manufacturers from buying into QMS as a digital concept
This reluctance is something that’s borne out by surveys showing that over 80% of medical device manufacturers are still using legacy quality management tools—including clipboards and spreadsheets.
What’s more, this lack of investment in up to date quality tools has had a measurable impact on the industry at large. Research from McKinsey indicates that medical device manufacturers could recover up to $11 billion in costs every year by making quality investments.
Prior to 2019, medical device manufacturers felt that their efforts to improve on quality were restricted by the need to validate. When this guidance takes effect—how will it change the industry?
New Computer Software Assurance Guidelines for Manufacturers
Effectively, the FDA has admitted that its previous guidance regarding software in the medical device industry—and EQMS specifically—has been both vague and over-prescriptive. With that in mind, the new guidance to be released, known as Computer Software Assurance for Manufacturing, Operations and Quality Systems Software, will address this ambiguity and make it easier for manufacturers to patch, update, and implement QMS systems.
Although this guidance has yet to be finalized, we can expect a sea change in the way that computer system validation is performed—in fact, the change may be broad enough that computer system validation (CSV) may be replaced as a term of art with a new term, computer software assurance (CSA) taking its place.
The previous CSV framework involved ensuring that the computer system did exactly what it was designed to do, and then providing documented evidence of this. This entailed a rigorous, lengthy, and complicated testing process which relied heavily on manual processes and discouraged automation. Because of this, human error became a huge factor in deviations, because it’s nearly impossible to repeatedly implement a complex manual process without making a few mistakes.
The new FDA’s CSA framework will differ strongly and in many respects:
- Encouraging Automation:
Whereas the previous CSV process discouraged automation, the agency now recognizes that automation and the tools that support it are critical in terms of their ability to reduce human error while generating labor savings in the workforce. In other words, developers and operations can spend less time testing the QMS and more time optimizing it, which will ultimately result in products that are safer for patients.
- Streamlined Documentation Process
The CSV approach is to document everything—AKA document the process without understanding the reason why you’re documenting them. This approach creates snowdrifts of documentation that can obscure real risks to patient safety. You still need to test and document under CSA, of course, but the documentation process is much more focused on risk—which once again results in a safer final product. In addition, manufacturers no longer need to reproduce vendor documentation (as long as it’s in good order), which should shorten the documentation process considerably.
- Risk-Focused Analysis
Under CSA, companies only need to document risks as they relate to a device’s intended use. These risks take the form of two categories: risks to patient safety, and risks that the device may not perform as intended. More complex forms of risk documentation, such as the Failure Mode Effect Analysis, are no longer required.
These changes make using and adopting a quality management system much easier for companies in the medical device industry—at least in theory. From a close reading of the CSA, however, it’s clear that narrowing the scope of risk analytics means that companies will no longer have to revalidate their QMS after every patch—especially if the patch deals with quality-of-life issues that aren’t central to the core functionality of the product.
ETQ and Validation
ETQ offers a validation approach and solution options to deliver expedited validation with minimal disruption. Our solution looks at defining the intended use and potential risk in a system, while minimizing the validation effort by using the “least burdensome approach.” ETQ’s validation offerings for life science companies are fully aligned with regulations and industry guidance and offer a comprehensive approach based on guidance like GAMP 5.
A New Kind of Quality Management System for a New Kind of Validation
The new CSA guidelines won’t just make it easier to update your QMS—they’ll also make it easier to adopt new technologies. Here at ETQ, we embrace automation, machine learning, and artificial intelligence as core to our philosophy of improving quality across industries. If you’d like to learn more about how to apply the capabilities of our Reliance QMS to the medical device industry, sign up for a demo today!