Struggling with your QMS? If your MedTech company relies on paper-based documentation systems, you’re likely familiar with the drawbacks of traditional paper or hybrid quality management systems. Recently Cannon’s Regional Director of Quality Josh Tucker and Qualio discussed going paperless in the webinar “How to Build a Paperless Quality Management System.”
Teamed with Qualio’s experts, the group emphasized three key points for a successful transition from a traditional QMS to a paperless one.
1. Find the Best Vendor for You
Each eQMS vendor differs slightly, so it’s crucial to align your processes with the most suitable provider. Some systems might offer too many bells and whistles for a MedTech startup, leading to a poor return on investment. In contrast, mature companies can integrate multiple systems, automating workflows to minimize waste.
2. Validation & Migration
Compliance with regulatory requirements requires eQMS validation. Ensure your eQMS vendor adopts an agile, risk-based assurance approach to ensure the system is fit for use. A well-structured migration plan should include discovery, mapping, and population of target documents into the eQMS.
3. Elect a Champion
Change can be challenging. Despite the benefits of a paperless eQMS, colleagues might resist adoption. Before implementing, appointing an eQMS champion with senior management support can raise awareness and encourage participation.
Reaping the Benefits
Transitioning from a paper-based or hybrid QMS may seem daunting, but the benefits of eQMS are clear. It ensures compliance to the data integrity principles of ALCOA through audit trails, electronic signatures, and security. Furthermore, an eQMS offers precise metrics and user-friendly dashboards, allowing you to easily track and monitor your quality status at a glance. It also provides significant time and financial savings by automating error-prone and inefficient manual workflows.
Ready to learn more about our ongoing Navigating eQMS in Medtech Today webinar series? We’ve created a webinar series where you can engage with different eQMS platform solutions in a safe, non-selling environment, or reach out to us at quality@cannonqg.com.
