The Dot helps medical device companies solidify their supply chains

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About the company
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Headquarters
California

The Dot is a contract manufacturing firm that manages test kit assembly, relabeling, fulfillment, logistics, and distribution for clients and also offers printing, direct mail, and creative design services. The company, which was founded more than 35 years ago and is headquartered in Irvine, California, began working closely with medical device manufacturers and healthcare businesses in 2010, but saw a huge spike in interest in the aftermath of the COVID-19 pandemic.

Question
The Challenge

As the pandemic began shutting down the world, The Dot experienced an increase in the mission-critical nature of the organization. Several key healthcare and medical device clients began enlisting the company’s services to help secure their supply chains and ensure they could continue bringing life-saving products to market.

To give these clients peace of mind, The Dot needed a quality management solution that would give customers visibility into their manufacturing processes so they could determine whether the CMO’s approach to quality met their standards.

“We needed to develop a formalized system to document our processes and procedures and assign responsibilities for achieving our quality policies and quality objectives within the organization,” explains Edgar Gimenez, Quality Assurance Specialist at The Dot.

Setting
The Solution

At this point, The Dot began looking for a quality management system that was easy to use, reliable, and could scale to meet the needs of their operation. After doing their due diligence, the team ultimately decided that Qualio, the electronic quality management system (eQMS) built for life sciences companies, was most able to meet their needs.

“Qualio seemed most appealing because of the nature and size of our organization,” Gimenez says, comparing the platform to feature-heavy solutions designed for massive companies.

Gimenez focus is continual improvement and building quality processes. The old system required him to spend too much time on document management vs. system improvement. To help lighten his load, The Dot decided to invest in Qualio Plus, which gives Gimenez access to Qualio’s powerful quality as a service solution that delivers best-in-class eQMS software along with expert QA support from the Qualio team.

Star
The Results

While Gimenez wasn’t part of the decision-making process that led The Dot to Qualio Plus, he’s worked with other quality management systems in previous roles  and is thoroughly impressed by Qualio.

“I find Qualio more appealing because it helps us achieve a high level of deployment in such a short amount of time,” he says. “It’s very visual, very easy to understand, and very intuitive.”

Here are some of the ways The Dot has benefitted from its decision to trust Qualio Plus for quality management.

1. Formalized processes

Qualio gives The Dot a formalized system where they document their processes and manage the organization’s knowledge in one place.

“We can track our processes now and achieve the consistency we need, which brings value to our organization,” Gimenez says. “I don’t have to worry about versions; everything is done automatically.”

2. Rapid onboarding

The Dot was able to get up and running on the eQMS quickly thanks to the impressive onboarding support the Qualio team delivered.

“All the support that I’ve gotten from the Qualio team has been extremely helpful,” Gimenez says. “They were there every step of the way to answer every question I had, offering solutions and ways to overcome obstacles. I’m truly thankful because they have been amazing throughout the whole deployment process.”

3.  Less IT resources

Due to Qualio’s cloud-based nature, The Dot doesn’t have to invest precious IT resources in making sure software works as it’s supposed to — enabling them to redirect resources into other important areas of operations.

“There aren’t a lot of IT requirements for the deployment,” Gimenez continues.

4. Top-notch support

Thanks to The Dot’s decision to invest in Qualio Plus, the Qualio team essentially acts as Gimenez’s own team, providing dedicated support when it’s needed.

“I think that’s the most valuable thing,” Gimenez says. “It’s allowed me to deploy an eQMS across an organization in a record amount of time.”

As he was just starting out with the eQMS, he had some questions about regulatory standards, and those questions were quickly answered by the Qualio team.

“They were there 100 percent of the time, offering solutions for the success of our initiative here,” he continues.

5. Ready to scale

As The Dot makes further inroads into the healthcare and medical device industries for fulfillment and assembly, the team is confident they have an eQMS that can support their mission at scale and help them pass customer audits with ease.

“Qualio shows that we are taking quality seriously and investing in quality improvement initiatives,” Gimenez concludes. “We plan to keep growing with Qualio, offering visibility, continuous improvement, and knowledge management to our current and potential customers.”

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