Deciding when to invest in a QMS (Quality Management System) can be a time-consuming endeavor. It’s important to choose the right time for your organization to ensure a smooth implementation and return on investment. Here are some considerations to help you navigate this process.

What Stage is Your Organization In?

One advantage of investing early is that you can use certain modules now and add modules for additional processes as your organization grows. While the best time to invest in a QMS can be debated, there are benefits to implementation while in the clinical stage. Implementation in Phase II or Phase III, prior to FDA approval, is beneficial in that it allows you to prepare for an FDA audit and subsequent commercialization.

Preparing for an FDA audit necessitates an assessment of your current systems as well as your documentation to determine if everything is complete and address any existing gaps. Performing this activity is, in effect, a wellness check for your current operating system.

Impending commercialization allows you to predict what the needs of your organization will be to plan for which modules to implement immediately, as well as which modules to add at a later time.

Where Should You Begin?

An electronic document management system (EDMS) is recommended to be developed and maintained immediately. Having an EDMS in place is imperative to keeping your documents in order and readily available.

After your EDMS is implemented, focus should move toward training, as it is a key part of inspection readiness and often a focus of FDA investigators. When implementing a QMS, a training module will ensure that all training records are up to date, complete, and documented. If you’re in the clinical space, having document management and training systems implemented will ensure all your records are complete and available as you prepare for FDA review.

If you’re already a commercial stage organization, you can definitely benefit from implementing a QMS. In addition to document management and training, you would want to think about including Deviation, Corrective and Preventive Actions, Change Controls, and Product Complaints modules.

How Would Your Organization Benefit from Investing in a QMS?

The decision to invest in a QMS can help refine your existing processes. The process of implementing a QMS will require careful analysis of the quality processes currently in use and identify areas for improvement. Moving from a paper system to an electronic QMS will also ease management of the quality processes. Records can be tracked, sorted, and searched easily with a single source of truth. Additionally, longevity is an important aspect of selecting the right QMS and you are encouraged to invest in a system that will grow with your organization.

Implementing a QMS can be an arduous task, but one that can bring immense value to your organization. Clarkston Consulting has a team of dedicated quality and compliance consultants who can help you develop and implement the right system for your organization.

Contributions from Dinesh Srinivasan