January 23, 2020

Experience shows that out-of-the-box configured software only works for businesses with limited resources or standardized business processes. Unfortunately, quality management systems are rarely standard due to unique product/service, regulatory compliance, and business nuances. When evaluating a software platform, consider the differences between configuration and customization for enterprise QMS software.

Enterprise QMS Software: Configuration or Customization?

If you are evaluating QMS software, be wary of vendors that tell you that their QMS software works “right out-of-the-box.” This is a strategy used to impress you with what the system can do while cloaking the things it can’t do.

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 wish to call it – is a misnomer, especially when it comes to the complex nature of quality and compliance management systems.

In reality, most manufacturers are falling somewhere in the 80/20 rule for quality processes (complaint management, change management, CAPA, etc.).  They are using software with an 80% out-of-the-box usability and using custom configurations for the rest of the functionality they need.

Unfortunately, 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 often have to use  customization.

The Configuration vs. Customization Conundrum

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 application’s framework.

The inherent problem with customization is that it means you will forgo future software updates with new features. That is, unless you have more budget and extra time for the QMS software vendor or a highly savvy IT staff to implement modifications.  High levels of customization can cause you to miss out on evolving technology and functionality in future releases.

Enterprise QMS systems that are truly configurable will not need to entertain core code changes. 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.


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Resource Allocation and the Impact of Change

Customization means extensive time and investment in software development ̶ writing lines of code, 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.  While configuring a quality management solution can be a very complex process, it will always be more efficient than writing code and validating the system.

Furthermore, factor in the always looming potential of change in your business.  Customized solutions require a higher budget line item for implementing new code or re-coding existing enterprise software every time a business requires change. Configuration solves that issue by allowing quick modifications without the need to start over.

Experience + Software Design is Key

Implementing a robust yet adaptable QMS requires a combination of flexible software and expertise in workflow design based on your industry’s specific needs. A best practice approach is to map out and streamline workflows that maximize out-of-the-box features easily to accommodate configurable elements into the workflows.

The right partner has a robust, configurable QMS solution that is designed based on extensive knowledge of common process gaps and design shortfalls common in other solutions. They use a development approach that builds systems based on the unique needs of each organization, yet still aligns quality processes and regulatory requirements with specific industry criteria.


It would be negligent to say that customization is avoidable at all costs. However, a  configurable enterprise QMS platform takes away that concern and makes the best sense in terms of implementation and maintenance. When unique or regulatory-driven business challenges and changes occur, there is rarely an out-of-the-box solution to solve them without at least some level of configuration. A quality management software vendor with proven experience and highly configurable workflows can minimize the complexity and provide quality processes that easily adapt to future demands.