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It was a breezy morning in late November 2019 in Miramar, FL. The Director of Regulatory Affairs and Quality Systems of an exciting software-based medical device company received a phone call from the executive leadership and board members. They got straight to the point.

“We need a robust, automated software solution to meet our quality, safety, and regulatory requirements.” The board members then put down an aggressive timeline: “This needs to be ready for use by April 2020.”

The Director of Quality had no time. He immediately got to work and jotted down on his notepad a set of requirements he would use to evaluate several QHSE solution providers. One criterion was non-negotiable – a solution that would work out of the box or with minimum customization. His timelines demanded that.

With that as the first requirement, he invited several EQMS and QHSE solution providers for a pitch. One of the companies he invited was ComplianceQuest. Eventually, the software-based medical device company decided to go with our solution for the following reasons:

  1. The scalability of the ComplianceQuest solution was a deal clincher. While the company was a young startup, it was formed through a collaboration between two of the largest blood centers in the country. The company was launching an FDA 510(k) cleared medical device that would eventually serve customers that will be assisting organizations that fulfill over 50% of North America’s blood supply needs. The customer’s suite of software solutions was designed to process approximately 10 million products across 56 states and territories. A combination of these solutions track each unit of donated blood from collection to transfusion and is designed to help its customers improve the overall efficiency, quality, and safety of the blood donation process. With that goal in mind, the customer needed a QHSE solution that was highly scalable and cloud-based.
  2. In addition to the requirement of scale, the deadline was non-negotiable. The company was opening its doors for end-users and customers in April 2020. The software had to be ready for use to automate quality and regulatory-related processes by then. Specifically, document, training, and change control modules had to be ready at launch. Right after that was the need to automate supplier quality management workflows. The ComplianceQuest solution worked out of the box, thanks to our experience of serving a wide range of customers in the life sciences industry. It also helped us do the end-user validation on time. Overall, we knew what it took to offer a solution that was ready to meet both quality and regulatory requirements in life sciences and that was critical for the customer.
  3. Ease of collaboration with multiple stakeholders: The common perception associated with quality and regulatory compliance is that it is a separate workflow that adds complexity to operations. But with the right software and process, that need not be the case. In fact, with ComplianceQuest, companies are able to seamlessly integrate the quality management system with the rest of the organization’s ERP, CRM, and other business processes. This was also an important requirement for the customer, simply because the nature of its product and solution demanded deep integration and collaboration with various departments.
  4. “When we saw the out-of-the-box supplier configuration, it was better than what we could have customized and deployed,” said the Director of Regulatory Affairs and Quality Systems. This was a crucial requirement since the company needed to automate the process of supplier quality evaluation, onboarding, and ongoing supplier performance management.

It has been over a year and a half since we deployed ComplianceQuest at various locations across the country. While the initial goal was to launch on time and move from a paper-based system to automation, today the company uses our QHSE solution to deliver competitive advantage and drive-up customer satisfaction. The executive leadership team at the customer organization is also extremely satisfied with ComplianceQuest’s analytics capabilities and the robustness of our Complaints Solution.

“The out-of-the-box features help us determine if an event is reportable. If it is, a task is created, and you are prompted to fill in details that the FDA requires. Once that’s complete, it will create the XML file to load into the FDA’s reporting system. This was wild to me.”

Director of Regulatory Affairs and Quality Systems, Arc One

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To request for a demo or talk to one of our experts in quality management for life sciences, click here: http://www.compliancequest.com/online-demo

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