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.
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.
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 was most able to meet their needs.
Quality Assurance Specialist Edgar Gimenez' focus is continual improvement and building quality processes. The old system required him to spend too much time on document management, and not enough on system improvement. To help lighten Edgar's load, The Dot decided to invest in Qualio+, which gave him access to expert QA support from the Qualio team alongside the software itself.
While Edgar wasn’t part of the decision-making process that led The Dot to Qualio, he’d worked with other quality management systems in previous roles and was quickly and thoroughly impressed by Qualio.
I find Qualio more appealing than other systems because it helped us achieve a high level of deployment in such a short amount of time.
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 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.
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,” Edgar notes. “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.
4. Top-notch support
Thanks to The Dot’s decision to invest in Qualio+, the Qualio team essentially acts as Edgar's own support network, providing dedicated help when it’s needed.
As Edgar was starting out with his eQMS, he had some questions about regulatory standards which were quickly answered by the Qualio team.
I think Qualio+ has been the most valuable thing. It’s allowed me to deploy an eQMS across an organization in a record amount of time.
They were there 100% of the time, offering solutions for the success of our initiative here.
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 we're taking quality seriously and investing in quality improvement initiatives.
We plan to keep growing with Qualio, offering visibility, continuous improvement and knowledge management to our current and potential customers.