Even though there are multiple ways to manage documents today, most medical device companies (especially small companies or startups) still use paper for documentation and QMS. By paper, here, we are referring to physical paper-based documents or digital papers in the form of spreadsheets.
While these methods might seem appealing and easy, the process has many flaws that can be risky for the product’s QMS.
Risks associated with Paper-based QMS for Medical Device companies
With decades of experience and after having used both paper-based QMS systems and electronic documentation systems we can effectively pinpoint why paper-based medical device quality management systems are riskier.
Here are a few things that we’ve noticed while using a paper-based system:
⦿ Missing Documentation: You’ll inevitably face situations where important documents and records go missing. These critical pieces of evidence can sometimes disappear, never to be recovered again, leaving you scrambling.
⦿ Difficulty In Keeping Documents Up-To-Date: Another major headache is dealing with outdated documents. In a paper-based system, managing document revisions can quickly turn chaotic. As revisions pile up, the likelihood of an old version being mistakenly used increases. Over time, ensuring all your documents are up-to-date and correctly managed becomes a daunting task.
⦿ Missed Approvals: Another common issue is missed reviews and approval signatures on key documents. With paper records, you need physical signatures or a compliant method for electronic documents. When tracking signatures manually, especially with paper or generic software, you’re almost guaranteed to encounter missing approvals at some point.
The worst part here is that these issues can remain hidden to you until a serious consequence comes your way. Even a minor issue in the documentation can become a reason for a warning letter and believe us when we say that dealing with warning letters, conducting audits, and rechecking the paper-trail and documentation can cause a major setback in your product’s approval and launch.
So, if you ask us whether paper-based medical device quality management system documentation is better than electronic one, we will hands down say “NO”.
Luckily, there are several QMS tools available specifically for the medical device industry, like Qualio, Greenlight Guru, MasterControl Quality Management System, TrackWise, etc.
Remember! It’s not just enough to have e-QMS tools, you need a dedicated individual part time or full time or a team, based on the volume of documentation. At Elexes, we have acted as the Document Controller or the Quality and Regulatory Specialist for several medical device companies and can help you as well in this journey of transition to an e-QMS and its maintenance thereafter.
Benefits of using electronic QMS for medical devices
Now that we have discussed that paper-based QMS is not very effective, let’s list some reasons why you should consider electronic QMS for medical devices.
1. Staying Compliant
Using eQMS software, you can ensure that your company is in compliance with all the necessary regulatory requirements. Many of these software have a predefined workflow that can guide you through the correct process of documentation and auditing.
2. Improved overall process efficiency
An eQMS also helps streamline the workflows and automates all the repetitive tasks, making the whole process more efficient and accurate.
3. Improved Product Quality
eQMS software plays a crucial role in ensuring that quality procedures are consistently followed across established workflows. By automating and standardizing these processes, electronic QMS systems contribute to producing higher-quality products with greater consistency. This leads to a significant reduction in deviations and nonconformances.
4. Cost-Reduction
Since these systems reduce quality issues and streamline all QMS processes, including documentation, the operational cost is significantly reduced. Medical device companies can then also use data-driven decision-making processes to optimize resource allocation.
5. Enhanced Communication
eQMS software strengthens collaboration and communication within teams by offering a unified platform where information, feedback, and updates can be easily shared. This centralized system ensures everyone stays informed and connected.
6. Data-driven decision making
By delivering quality data and KPI reports, eQMS software allows companies to track performance, identify trends, and pinpoint areas for improvement. This data-driven approach enables informed decision-making, supporting continuous improvement and strategic planning efforts.
7. Audit Readiness
Since eQMS software keeps accurate, up-to-date records of quality activities, companies are always audit-ready. It simplifies access to documentation, retrieval, and compliance evidence, providing seamless traceability and smooth audit processes.
e-QMS tools are just the beginning—you need a dedicated expert or team to manage the load. At Elexes, we’ve been the go-to Document Controllers and Quality Specialists for many medical device companies. We’ve guided companies and facilitated a smooth transition to e-QMS and have kept it running seamlessly.
Conclusion
In the end, we’d recommend every medical device company to consider switching to an eQMS, if they have not already. With tons of pros, the eQMS is hands-down a more effective Medical device quality management system. It might seem a daunting task to switch to the new system but luckily, there are teams like Elexes who are there to help you set up an efficient eQMS system.
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