Case Studies > The Dot uses Qualio to help medical device companies solidify their supply chains

The Dot uses Qualio to help medical device companies solidify their supply chains

Customer Company Size

Mid-size Company

Region

America

Country

United States

Product

Qualio
Qualio Plus

Tech Stack

eQMS
Cloud-based software

Implementation Scale

Enterprise-wide Deployment

Impact Metrics

Productivity Improvements
Customer Satisfaction
Digital Expertise

Technology Category

Functional Applications - Enterprise Resource Planning Systems (ERP)
Functional Applications - Enterprise Asset Management Systems (EAM)

Applicable Industries

Healthcare & Hospitals
Life Sciences

Applicable Functions

Quality Assurance
Business Operation

Use Cases

Supply Chain Visibility
Regulatory Compliance Monitoring
Remote Asset Management

Services

Cloud Planning, Design & Implementation Services
System Integration
Training

About The Customer

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.

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.

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 their organization. Gimenez, who focuses on continual improvement and building quality processes, found the old system required too much time on document management versus 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.

Operational Impact

Qualio gives The Dot a formalized system where they document their processes and manage the organization’s knowledge in one place. This allows them to track their processes and achieve the consistency needed, bringing value to the organization.
The Dot was able to get up and running on the eQMS quickly thanks to the impressive onboarding support the Qualio team delivered.
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.
The Dot received top-notch support from Qualio, with quick answers to regulatory standards questions.
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.

Quantitative Benefit