While some medical device companies may be able to get by with a paper QMS, most (especially those looking to maximize efficiency) should look to make the swap to an electronic quality management system, or eQMS.
Kapstone is well-versed in both traditional “paper-based” QMS and newer eQMS. We’ll work with your company to determine which is right for you, assess the software platform most appropriate for your company, and, if you choose to move forward with an eQMS, assist the transition and implementation as seamlessly as possible.
There are many benefits to implementing a technologically-advanced eQMS.
Traditional eQMS systems may be comfortable, but they are also incredibly vulnerable to risk. Losing just one document or signature—or filing it in the wrong place—can cause unexpected project delays that prolong your path to approval and drive your costs way up.
eQMS software solutions store everything on the cloud. No more rifling through file cabinets or disorganized server folders; with an eQMS, everything you need will be organized and accessible, no matter where you’re working from.
The FDA and other regulatory bodies take a rigorous approach to quality management. Both require a designated Quality Manager to have reliable access to all project documentation, where they can review it for adherence and validate with their signature.
Most eQMS platforms facilitate the signature and approval process through automated features and electronic signatures. No need to chase down your internal resources for a physical signature, or validate that they’re seeing the latest version of a document. The system can handle it—leaving you free to focus your time, energy, and resources elsewhere.
Our eQMS vendors use features and workflows built specifically for the medical device industry. That means they’re built to comply with international regulatory standards like ISO 13485 and FDA 21 CFR Part 820. Some solutions are ready right out of the box without a need to build custom workflows, create documents and forms, or go out of your way to prove compliance—the system can handle it right from the start. Other platforms are more customizable to meet your needs and workflows.
Kapstone partners with the following eQMS software vendors to deliver the best possible QMS for your company. Click the logo links below to learn more about these partners and schedule a demo. Or, feel free to contact us for any questions. We’re happy to show you the benefits of going electronic for your QMS.