Recently CQG partnered with Qualio to host a webinar on using electronic Quality Management Systems (eQMS) in MedTech. CQG’s Regional Director of Quality Josh Tucker teamed up with Qualio SMEs Tamara Burch-Williams and Ashley Sherrick to talk about the benefits and challenges MedTech startups face when implementing an eQMS.
Benefits and Challenges
Traditional QMS management was through paper-based systems, which slowly evolved to incorporate a variety of solutions, from spreadsheets and Word docs to SharePoint and DropBox.
Unfortunately, traditional QMSs were complex and overly burdensome. Luckily, eQMS systems have evolved by combining the best features of traditional systems and offering a single source of truth.
eQMSs like Qualio organize the quality system into pillars – documents, design controls, suppliers, training, events, and reports. This structure allows for better control, speed, and efficiency. It also allows data-driven decision making and a strong focus on quality.
Choosing the Right eQMS
While pharma and medtech giants like Merck and Medtronic used custom-built eQMSs in the past, recent fragmentation of the life science ecosystem has provided options for MedTech start-ups. The major challenges for these small start-ups are:
- Time to market
- Usability
- Integration
To choose the right eQMS, Qualio recommends asking these questions:
- What are the requirements?
- What needs to be achieved?
- Can this eQMS meet our needs now and in the future?
Seek Experienced Help for Success
As a full-service outsourced quality management company, CQG gets asked quite frequently what is the best eQMS software platform on the market and what eQMS we would recommend. After helping multiple clients right-size their quality systems, Josh has seen how eQMS platforms can empower teams to achieve their business goals.
Josh commented, “Several of Cannon’s clients are in the submitting/waiting stage. Those that use an eQMS are really more efficient in developing the necessary documentation when submitting evidence to FDA or notified body. We’ve found having an eQMS helps the management of documentation and data to be prepared to submit faster.”
Tamara Burch Williams, Senior Solutions Consultant with Qualio agrees. “It’s really nice to see organizations that get documentation up and running for one product and hear later they’re already able to scale to move forward with submission and shift gears with other potential products and markets.”
Often startups aren’t sure where to start with implementing an eQMS. Josh advises them to seek experienced help. “At CQG, we help organizations not only implement eQMS tools, but we provide processes and SOPs that work with the eQMS, like Qualio.”
“It can be intimidating reading regulations. It’s one thing to know what they say, but another thing to implement them. Cannon implements regulations regularly, ensuring clients right size their quality to use it effectively and efficiently,” he concluded.
Conclusion
Implementing an electronic Quality Management System (eQMS) in your MedTech startup can bring numerous benefits, such as improved control, efficiency, and data-driven decision making.
By partnering with an experienced eQMS provider, you can navigate the challenges and leverage their expertise to right-size your quality system effectively. Streamlining documentation and data management with an eQMS empowers your team to meet regulatory requirements, accelerate submission processes, and scale your operations.
Contact us at quality@cannonqg.com to learn more about the benefits of an eQMS and how to implement one at your organization.
