Your Digital Quality Management Roadmap

Digital quality management is on everyone’s mind. It helps you automate your quality processes and get products to market sooner. Wanting to go digital in quality management is one thing — figuring out how to do it is a bit more complicated. To help you do that, we’ve created a quality management maturity model to gauge digital maturity and conducted research with your life sciences peers. Based on that research, we’ve also created a quality management assessment.

After taking the quality management assessment, you’ll know where you fall in the quality management maturity model, the benefits of increasing your digital quality management maturity, and how to overcome the blockers that are holding you back.

The 4 Tiers of the Quality Management Maturity Model

The best overview of the quality management maturity model is in our recent research report. But, here’s a TLDR version:

Manual:

We do things the old-fashioned way here. We don’t need none of that there fancy tech.

Digital:

We have an electronic quality management system (eQMS), but it’s giving our other enterprise systems the cold shoulder.

Connected:

All of our software systems speak nicely to each other, don’t fight, and never have to go to time out.

Intelligent:

We’re fancy. Our artificial intelligence (AI) overlords take care of everything.

Benefits of Increasing Digital Quality Management Maturity

The benefits of increasing maturity will be different depending on how advanced your digital quality management currently is. This part of your results section will vary greatly. If you’re really curious you can always take the assessment multiple times so you can learn the benefits of each tier. The results page specifically dives into benefits of each tier, but there are some more general benefits that apply across the board.

One of these is increased efficiency. This is true no matter where you are in the quality management maturity model. Using better, more advanced technology in your digital quality management will always save you time and money in the long run. The difference is how it makes you more efficient. If you’re moving from the manual to digital tiers, you’ll be more efficient because you’ll save so much time in hunting down documents. If you’re moving from the connected tier to the intelligent tier, you’ll save time because prescriptive analytics will point you in the right direction.

Another universal benefit of digital quality management is real-time access to quality data and insights. Until all of your systems are interconnected and you can easily access and analyze your data, it’s of limited use. More advanced analytics and AI functionality is only possible when your data is centralized and up to date. This lets you easily see the state of quality in your organization, identify where improvement is needed, and track those efforts.

Your Barriers to Digital Quality Management

While becoming more mature in your digital quality management sounds great, making it a reality is more difficult. Part of that is because it requires change and investment, which means you have to convince the leadership at your company that it’s a good idea. That’s always a fun conversation. Our research found that the number one reason companies don’t progress on the quality management maturity model is cost, followed by time and possible disruption.

These issues were the topic of a recent article from MasterControl Chief Strategy Officer Matt Lowe. He shared that when he worked in the medical device industry, “The company I worked for used a paper-based system, and although I could see the benefits of digitizing, I wasn’t able to convince my superiors. It was only when we had a run-in with the U.S. Food and Drug Administration (FDA) and received a Form 483 that things started to change.”

A Form 483 is quite the wakeup call, but it shouldn’t have to come to that. After you take the quality management assessment, you’ll get customized help to convince your superiors that investing in digital quality management is a good idea — without any regulatory action.