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.
Benefits of eQMS
There are many benefits to implementing a technologically-advanced eQMS.
- Accessibility & Consolidation: All documents (old and new) are accessible in the system, whenever and wherever you need them. Nothing gets lost in file cabinets or on stray Post-It notes.
- Cross-Linking: State-of-the-art eQMS subsystems can link up with other subsystems, allowing for a more seamless development process.
- Error Reduction: Avoid loss, duplication, mishandling, and other human error through eQMS automation.
- Signature Capture: Feel confident that all required approval signatures have been captured and preserved in the electronic system.
- Transparency & Traceability: The entire history of your project will live in one consolidated place. Need to access a document for reference? Anyone can pull it up. Need to compile a set of documentation to meet a regulatory milestone? It’s organized and ready for review.
- Version Control: All employees can access and work from the most up-to-date version of every document, wherever they are.
Reduce Risk By Storing QMS Documents in the Cloud
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.
Streamline and Store Signatures and Approvals
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.
Utilize Pre-Built QMS Workflows for ISO 13485:2016 Compliance
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.
eQMS Software Providers
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.
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