As part of the medical device industry, you face significant regulatory pressures. FDA compliance is key in ensuring your products pass clinical trial phases and come to market. The cornerstone of FDA compliance is the Current Good Manufacturing Practices (CGMP). The CGMP emphasizes the necessity of having a quality management system (QMS) in place to track, monitor, and review all of your production and management processes. Using spreadsheet software like Excel may seem like a good fit for your quality management solution at first. However, as time goes, it’s likely that:
- Your business will grow and mature beyond the scope of what a spreadsheet can handle.
- Additional regulations, compliance burdens, and paperwork will become part of the quality management process.
- Your organization will seek to adopt more rigorous quality management standards such as ISO 13485 (if working with vendors and purchasers outside of the United States) or IEC 60601.
These changes can happen fast, adding additional layers of complexity and uncertainty to your quality management process. If you’re still using spreadsheets as your QMS, here are a few reasons to consider adopting a digital QMS solution today.
A Digital Quality Management System for Scalability
The need to scale presents a host of new quality management issues. If you’re entering into a new category of the medical device market, adopting new standards, onboarding new employees, or making changes to your purchasing pipeline, your quality management system needs to be able to adapt to your new processes and controls. Spreadsheets and paper-based quality management systems can’t grow with your functional QMS needs.
When you need to rapidly scale, and the scope of your processes and controls need to easily expand to meet your new KPIs, having a digital QMS in place ensures a seamless transition between business phases. A digital QMS turns process and control management into a process of itself, giving your organization analytical insights it never had before.
More importantly, you’ll save time on paperwork, document signature procedures, and document tracking. You can also automate many of the tasks associated with paper and spreadsheet entry, giving you even more focus on improving the KPIs associated with .
A digital QMS gives your organization the management and process tools required to ensure that the creation of new products and business relationships match your goals for growth and standards compliance.
Digital Quality Management Systems for Risk Mitigation
Risk mitigation is the ultimate focus of any quality management practice, especially for life saving medical devices. Risk management through the use of a quality management system is shared across all levels of your organization. Without a digital QMS solution in place, information can’t easily travel, or be retrieved, across stakeholders and departments.
This limits your ability to assess compliance with the risk management standards your organization has adopted as well as the processes involved with using internal risk assessment tools.
A digital QMS lets you easily track and implement your risk management procedures across all of your processes. You’ll be able to create and visualize a risk management trail for internal and external auditing purposes. Furthermore, a digital QMS makes it simple to store and categorize risk management documentation for multiple levels of internal and external stakeholders, including vendors and device purchasers.
However, simply tracking and managing risk doesn’t mean compliance. A paper or spreadsheet based QMS makes it difficult, time consuming, and expensive to accurately assess compliance. The right configuration of a digital quality management system houses risk policy, procedure, and audit into one location that makes risk mitigation an intuitive, integrated process.
Documentation Update and Storage
Making sure your quality management documentation is up to date is a critical. The paper or spreadsheet based QMS makes updating the right documents and the correct time nearly impossible without stretching already strained staff resources. A digital solution makes document changes across all of your processes possible in a fraction of the time it would take without a digital QMS.
The same document storage possibilities also allow for sharing of data with those outside of your organization. Rather than having to upload, scan, email, and manually track all the data you share with external stakeholders and regulators, you can share the necessary documentation from within your digital QMS. This greatly speeds up your flow of critical communication. Quicker sharing with external stakeholders makes for faster approvals and sign-offs, letting you proceed with your core operations without constantly having to check on the status of document distribution.
Digital Quality Management Systems and Design Process Control
Your design process is crucial in ensuring that each product is consistent and fits a defined user need. Designs are also the foundation of your intellectual property and patents, making their storage and safety an important part of the competitive longevity of your organization. digital quality management solution can safely contain all of your design documentation in an on-premises or cloud storage, making version control an integrated process.
Moreover, your digital QMS can categorize and store all of the documents required for your design iteration files including: user defined needs, design safety content, design audits, and stakeholder validation procedures. Should your designs procedure require review from auditors or regulators, a single design iteration file that lives in your digital QMS can quickly provide the necessary information. And should you ever decide to sell your medical device patents, you’ll be able to supply buyers with a clear, consistent history on the controls and processes surrounding the design.
A Digital Quality Management System Supports Your Business
A properly configured and deployed digital QMS is made to address your risk, compliance, process, control, and documentation needs. Spreadsheets and paper, even when pushed to their limits, simply weren’t made to handle growing – and always changing – quality management scenarios.
If you’re considering adopting a digital QMS, or need a customized digital QMS for your medical device organization, download our free ebook, 7 Critical Steps that Will Help You Select the Right Quality Management System for Your Organization.
General Networks has helped numerous organizations transition from paper and spreadsheet based QMS to digital QMS. Contact us today for a free consultation on how a digital QMS can be a business asset to your medical device organization.