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FDA Compliance

Qualio Focuses on Building a New, Collaborative Life Sciences Ecosystem

Delivers time, cost, and efficiency savings while streamlining compliance activity

Published: Thursday, June 23, 2022 - 12:01

(Qualio: San Francisco) -- Qualio, a trusted cloud quality management system for the entire life sciences ecosystem, announced significant growth during the first half of 2022, including expanded business and technology integration capabilities, and an enhanced consulting partner program.

“As the emerging life sciences ecosystem evolves post-pandemic, companies and the organizations that support them run up against silos of data and broken processes that impede their ability to get critical products to market,” says Robert Fenton, Qualio’s CEO and founder. “We take our mission to enable life sciences companies to launch and scale lifesaving products faster very seriously, and that’s why we’ve doubled down on product, people, and partner growth over the last few months.”

Today, fragmented data and workflows, information gaps, and disconnected platforms continue to slow the path to market for life sciences products and services. Development, regulatory, and go-to-market processes have become more complex as these companies specialize and increasingly rely on partnerships. In fact, a recent survey of Qualio customers uncovered that life sciences companies rely on a minimum of five business-critical supplier partners for product development, delivery, and support stages of the product life cycle. Each of these companies has its own processes and silos of information, which leads to lost time and resources if they aren’t effectively connected.

To address these collaboration and data integration challenges, Qualio has built API integration capabilities. Integrating Qualio with other business systems can deliver time, cost, and efficiency savings while streamlining compliance and bringing quality, account management, customer success, and development teams into lockstep. Integrations available today include Asana, Azure DevOps, ComplianceWire, Jira, Salesforce, TestRail, and Xray—as well as single sign-on functionality for Azure/Office 365, Google Suite, and Okta.

Qualio customers are already benefiting from these integrations, including Empatica, which integrated Jira and Qualio to streamline collaboration between its software development and quality management teams. As a result, Empatica was able to reduce time to submission by 90 percent, a significant milestone for a company that is helping to build the future of decentralized clinical trials.

In just the last six months, Qualio also launched its Partner Program. The Qualio Partner Program already has nearly 200 members, all of whom are qualified quality management consultants with decades of process and regulatory experience. Qualio will also launch an enhanced Partner Program later this summer. These enhancements will benefit Qualio partners—and the medical device, pharmaceutical, and biotech companies they serve—by providing quality and regulatory resources, educational assets. and helping to speed up collaborations.

Fifth Eye is a software as a medical device company that provides clinicians unique, real-time information on patient status. Its CEO Jen Baird offered this insight on the business value of the Qualio partnership: “For us and those who use Fifth Eye, speed means everything. Partnering with Qualio has allowed us to accelerate regulatory approvals and certifications while also maintaining a strong culture of quality, which is absolutely essential in an industry that is focused on saving patient lives.”

About Qualio

With nearly 500 life sciences customers worldwide, Qualio is a trusted quality management software for teams launching and scaling lifesaving products. Leading pharmaceutical, biotech, medical device, and clinical research organizations leverage Qualio’s cloud-based quality management system software to unite their teams’ processes and data. Qualio enables customers to deliver on the promise of quality and meet the complex regulatory compliance requirements without sacrificing speed.

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For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.