The simple fact is that no enterprise QMS software will ever meet 100% of a company’s needs “as is.” Experience shows that unless you’re a small business with limited resources, you can’t work around limitations and restrictions in your software platform. When evaluating a software platform, consider the differences between configuration and customization for enterprise QMS software.

Enterprise QMS Software: Configuration or Customization?

Obviously, any sales rep will tell you that their QMS software is the best on the market.  It can do everything you need and more.  The strategy is to impress you with what the system can do and distract you from what it can’t do.

According to recent LNS Research findings, manufacturing companies are striving to reach the “80% out-of-the-box threshold with the remainder of functionality being delivered through configurations and an out-right elimination of customization.”

Evidently, then, when it comes to EQMS, there is no such thing as out-of-the-box software if you need to configure it or customize it. Off-the-shelf, OOTB – whatever you call it – is a misnomer, especially when it comes to the complex nature of quality and compliance management systems.

The vast majority of quality management software on the market is not as configurable as you’d be made to believe.  In order to meet your critical business requirements, a vendor may have to to resort to customization.

The Configuration vs. Customization Conundrum

So, what’s the difference between configurable vs. customized software? It’s extensive. Configuration is the ability to work within the framework of an application. Alternatively, customization requires changes to the underlying code, therefore altering the framework.

The inherent problem with customization is that it means you will forgo future software updates to take advantage of new releases, unless you have more budget and extra time for the QMS software vendor to reapply all of your changes.  Unfortunately, you might be in for a serious surprise when the vendor announces their next release includes new and impressive functionality that you can’t dive into.

Enterprise QMS systems that are truly configurable will not even entertain core code changes.  They don’t need to. This is because their architecture allows you to simply set up the program according to your exact needs. New functionality can be added and improvements can be made ̶ all without having to reconfigure what you’ve already done. This will allow for seamless upgrades without affecting your quality management system.

Resource Allocation and the Impact of Change

Customization means extensive time and investment in software development ̶ writing lines of code, testing, debugging, rewriting, testing and repeating.  On the other hand, configuration normally involves point-and-click, drag-and-drop building of pages and business rules all within the existing application.  By comparison, configuring a quality management solution is not easy ̶ it can be a very complex process. But it will always be more efficient than writing code.

Furthermore, factor in the always looming potential of change in your business.  No one wants to spend the kind of money it takes to implement new or re-code existing enterprise software every time your business requires change. Configuration can solve that issue. Truly configurable applications will allow for quick modifications without the need to start over.


The next time you’re in the market for any type of enterprise software and you’re viewing a demonstration that misses some of your core requirements, ask the question: configuration or customization?  Configurable systems that are designed based on years of industry experience and best practices can address the majority of your needs without an additional line of code.

Inevitably, you have to make the decision whether to allocate resources to manage your business or manage your quality management software. And if the latter, how much are you willing to spend and potentially keep spending?

Choose a QMS software vendor like AssurX that has considerable experience with clients facing the configuration vs. customization conundrum.


With decades of expertise built into our quality management and regulatory compliance software platform, AssurX helps medical device manufacturers maintain quality and FDA compliance, streamline workflow, control risk and better manage any enterprise. Our incredibly configurable software and deep understanding of users’ needs produce a unique system that easily adapts as your business evolves. AssurX is an ideal partner for FDA regulated companies looking for better operational control and efficiency while staying compliant.

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