Pursuing Paperless in an Medical Device Landscape - Part 4

Master Quality Management

In part 1 of this blog series, we established the clear benefits a transition to paperless offers for capturing medical device marketing requirements. Part 2 followed, focused on the benefits paperlessness offers for tackling testing and part 3 for risk assessment. But what about quality management? Speaking from several decades of experience in this space, I can share that historically, quality management in a medical device company has been synonymous with stacks of procedures and endless shelves of bulging binders. With the highly regulated industry requiring all documentation to be saved, outdated files pile up despite their “obsolete” stamp.

Despite the efforts of even the most organized quality team, maintaining a streamlined and efficient quality system is challenging. Rapid design iterations can lead to documentation gaps and non-compliance, wreaking havoc on timelines and derailing regulatory milestones.

How can the transition to paperless help medical device companies master quality management? Again, it all comes down to selecting the right tool.

Here are a few stories from my experience to help illustrate how impactful the power of paperless can be in this stage:

Story 1: “Off to collect signatures again, wish me luck!”

Documents are updated, new version printed and you’re just about to begin the rounds to track down reviewers to capture their signatures. The first reviewer you encounter signs haphazardly on the way to a meeting without so much as a glance at the changes. Well, at least you have one down!

On to locate the next reviewer, who you learn is out of the office for the next week. You consider the best course of action and decide to leave the document in an obvious spot on their desk with a post-it note.

A week later, the document is lost, buried under a stack of other pressing items. The usually remote third reviewer is finally in the office, so you seize the opportunity to reprint and reinitiate the rounds to finally capture the signatures needed. So much time wasted circulating and tracking signatures on paper.

Story 2: “Why are you using version C of that procedure when we are at version E?”

Despite best efforts, keeping up to date with current document versions can be tricky when relying on paper systems. Employees can have outdated copies of procedures, completely unaware that the procedure they are following is now obsolete. This can be quite the quality management headache as it opens the door for errors and non-compliance.

Story 3: "Where is my blue pen?"

This is one of my favorites. Per policy, all documents were required to be signed in blue ink, not black. While the rationale makes sense so that the color signature would not look like a copy, in practicality, it seemed a bit ridiculous. Was it really true or just a RA/QA joke? Either way, that blue pen was very precious and seemingly always hiding when it was time to sign off on necessary documents!

I bet you can relate.... but what is the alternative you ask? Not printing! Managing these documents digitally allows you to eliminate the hassle of tracking down colleagues to sign documents, keeps the latest versions easy to find while avoiding the risk of error from obsolete versions, and allows you to finally swap that elusive blue pen for the flexibility and ease of electronic signatures.

These examples, and many others like them, are what drove us to develop MatrixQMS. It simplifies and digitizes quality management documentation, allowing teams to work efficiently and collaboratively. With MatrixQMS in place, users have dynamic information at their fingertips. The latest version of each document is easily accessible to anyone in the company and electronic signatures provide the flexibility to streamline approvals from anywhere on any device.

Worried about transferring existing documentation? Not a problem, we have you covered. Our experienced team has helped hundreds of customers successfully integrate their historical data into the Matrix platform seamlessly.

So, if you want to master quality management with the power to customize your documentation and ensure compliance at every step so your disruptive technology can go-to-market faster, look no further. Sign up for one of our online demos or view our recorded webinar Introducing MatrixQMS to see the functionality, flexibility, and power of MatrixQMS.

About the Author
Arnaud Alberts
Head of Customer Success & Product