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Navigating eQMS with Enzyme
April 20, 2021

The use of electronic Quality Management Systems (eQMS) is becoming standard technology in Medtech startups. They offer the promise of automation, improving compliance, reducing cost, increasing productivity, enhancing traceability, and reducing documentation burden.

As a full-service outsourced quality management company, we get asked quite frequently what is the best eQMS platform on the market and what eQMS we would recommend.

Given the number of platforms available today, there is a varying range of features, benefits, and price points, so the best solution for Startup A might not be the best solution for Startup B.

Initially Cannon Quality Group founder Nicolle Cannon wanted to set up a recurring learning session for her staff where each session, a different eQMS vendor would present their platform. “And then I thought why should we stop there, let’s open it up to our clients and our community so they can have opportunities to talk through and learn about the different options,” Cannon said.

Now it’s a recurring webinar open to anyone in the Medtech community who wants to kick some tires from the comfort of the home office. Each session, a new vendor will present their product and take Q and A from webinar participants and Nicolle Cannon. To make comparisons clear, Cannon will walk each vendor through a similar list of topics:

  • When to take the eQMS plunge
  • How to evaluate platforms based on your business or product type
  • How to ensure a successful eQMS implementation
  • Key functionality of the platform and any upcoming product rollouts

CQG partnered with Jared Seehafer, CEO of Enzyme, to kick off the series on March 25th. You can view the webinar in its entirety here: https://youtu.be/DKwgIXGywyQ

Seehafer advocates for an early plunge into eQMS, and recommends prospective buyers to consider customization, integration, and data movement as key decision points. He emphasizes the need for full organizational buy-in and team training. Seehafer asks prospective customers if they intend for the eQMS to talk to internal systems.

One tip shared is to make sure the most tech-phobic person on staff is involved in selection/evaluation process; buy-in across the team from cross functional departments to management will make it easier to get compliance to everyday things like training requirements with fewer headaches.

“Enzyme was built from the ground up to work within your existing technology stack. As more teams in bio and Medtech make use of various software tools, having an eQMS that can integrate with those tools is crucial” Seehafer noted. “It’s lean enough for a 5 person startup but flexible, and can easily scale to teams of 1000+ users.”

In addition to a clear understanding of the workflow, Seehafer says “it’s really in the execution of the procedures, but users have to know what they are doing, and just using eQMS does not make you compliant.”

Another tip emerging from the webinar was to tell your vendor what they need to do to help the eQMS implementation be successful, as they are vested in getting you up and running efficiently and seeing the move to eQMS as successful throughout the organization.

The consensus is that the first one or two quarters are critical: are you sticking with the system or are people deploying work-arounds? Are new people being on-boarded properly?

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