Configurability: The Agile Approach to Quality Management
The words “configuration” and “customization” are often used interchangeably, but when it comes to quality management software, they have wildly different definitions. A customized eQMS is one built from scratch to meet the specific needs of a life sciences organization. It’ll do exactly what you want it to do, but at a cost.
Customized solutions require a lot of work from the QMS software vendor, your internal IT team, and often, an outside consultant. You’ll need to know exactly what you want at the outset because you’ll be writing your own requirements, and once they’re established, making changes can be difficult and costly. Additionally, a customized eQMS takes longer to design, test, and implement, and it requires a hefty validation effort.
A configurable eQMS is a little more straight-forward. Think of it like your smartphone. Just as you personalize the home screen with your favorite, most used apps, a configurable quality management tool allows you to build out your workflows to match your quality processes, without being locked into one choice forever.
When needs change, not only is the process flexible, but you can do it yourself, without having to wait for the consultant, IT team, or vendor. Add, delete, and move things around, just like your apps.
As far as validation goes, the effort required on the customer’s end is much less than that of a customized solution. It’s limited to testing specific high-risk configurations while the core functionality is maintained. The customer can leverage the eQMS vendor for design, requirements-gathering, and the majority of the validation (which the FDA encourages).
This is a huge advantage because the vendor has already built the system and is familiar with the market requirements. The heavy lifting has already been done.
Configurability Reigns Supreme
While a customized electronic quality management system might seem appealing at first blush, it introduces complexity, delays, and costs. Custom-built features can trap you in a cycle of dependency, where each minor change adds additional time and expense. Customization might offer a wide range of flashy, exciting options when you’re first prospecting, but when it comes to managing quality in the long run, it's a rigid approach.
Configurability, on the other hand, is about sustained adaptability. It’s about aligning your QMS software with the specific demands of your environment – from document control to training to CAPA management – and allowing for change when the need arises. (This is especially important for CROs and CMO/CDMOs.)
This flexible approach significantly reduces the learning curve for quality admins and general users alike, fostering faster adoption of your quality management processes. Here’s what sets it apart:
- Rapid Implementation: Configurable quality management software can be implemented in approximately 90 days, a stark contrast to the 6+ months often required for fully-customized solutions.
- Cost-Efficiency: Avoid the hidden costs of customization, from initial development to long-term maintenance.
- Less Work: Smaller validation projects, as they are maintained by the vendor, not the customer. (Confirm that your eQMS vendor shares their validation data ahead of time.)
- User Empowerment: Place control in the hands of those who use the system daily, ensuring changes can be made swiftly and efficiently, aligning with evolving needs without dependency on IT or vendor support.
Imagine if an internal audit raised some red flags. Do you really want to wait for your IT team or the eQMS vendor to fit those changes into their schedule before a regulator shows up, or would you prefer the ability to immediately make changes yourself? We know which option we’d choose.
Opt for Ongoing Flexibility
Flexibility shouldn't be a one-time feature but rather an ongoing capability. A customized eQMS, built from the ground up, might offer you 100% customization from the start, but unless that flexibility remains embedded and accessible to stakeholders who actually use your eQMS, that promise of flexibility is an empty one.
Our advice? Ask about continued flexibility that gives your team autonomy to adapt to new cGMP, cGCP, and other GxP regulations, as well as organizational changes without the constraints of custom-coded systems.
By choosing configurability over customization, you invest in a solution that grows with you, ensuring your quality management system remains a robust, responsive ally in your quest for excellence and compliance.