- Why Us
A quality management system (QMS) is simply a formalized system for documents, policies, procedures, and processes that companies in many industries—including MedTech—use to ensure their products are safe and effective.
However, the way in which a company maintains that system and its records is often anything but simple. This is especially true when it comes to enterprise companies that may easily have hundreds of products and thousands of employees in many different countries.
At that point, the types of QMS solutions that may have worked for a smaller company are no longer the best option. Enterprise-size companies require enterprise quality management software for their QMS.
Enterprise quality management software is a type of software solution that large companies often use to streamline their quality processes, manage documentation, and maintain their quality management system according to relevant regulations or standards like the FDA’s Quality System Regulation (QSR) or ISO 13485:2016.
In MedTech, quality management systems are shaped by ISO 13485:2016. This standard establishes the requirements for a quality system—what the policies and procedures should cover—but it doesn’t specify the tools you should use to create or maintain your QMS.
This means that a lot of smaller companies (and some larger ones) choose to use free or low-cost tools like Excel, DropBox, or Google Drive to manage their QMS. And for small companies with a handful of employees and one or two devices, this can be a workable solution for a while.
But because of the complexity of operations within larger companies, an enterprise quality system can’t really be maintained this way while staying on the right side of regulations.
These companies need an electronic quality management system (eQMS) that can grow with them and handle both the design and development of new devices and the post-market requirements of devices already on the market.
Enterprise quality management software is different from what smaller companies use to manage their QMS in a number of ways.
Only a comprehensive solution will allow an enterprise company to eliminate the use of disconnected tools like Excel or DropBox. An all-in-one solution allows the quality management software to be woven into the fabric of a company’s operations.
Enterprise companies are also different from smaller organizations in that they need quality management software that can connect quality data to other essential software tools they may be using, such as enterprise resource planning (ERP) and customer relationship management (CRM) tools.
This essentially disqualifies any disconnected, general-purpose software like Excel, Dropbox, or Google Drive. These tools can be useful in limited capacities, but for an enterprise quality system, they’ll typically fall far short, creating more work than they help accomplish.
An enterprise QMS is a comprehensive solution. Any good QMS solution at the enterprise level will, at minimum, include features like:
Corrective and preventive action (CAPA) management
Customer feedback and complaint management software
Any good enterprise quality system should provide a single source of truth, ensure traceability, and help employees correctly follow the policies and procedures set out in their QMS—regardless of where they’re located geographically.
The benefits of an enterprise quality system can be enormous, and include:
Medical device companies are subject to a variety of stringent international regulations, such as FDA's Quality System Regulation (QSR) and the European Union's Medical Device Regulation (MDR). An enterprise QMS helps in maintaining compliance with these regulations by providing a framework for standardizing processes and documentation.
Enterprise quality management software automates and organizes document management, making it easier to maintain, retrieve, and update essential documents. An enterprise QMS solution will also help ensure compliance with document-related regulations like the FDA’s 21 CFR Part 11 regarding electronic records and electronic signatures.
An enterprise QMS will include purpose-built tools for risk assessment and management, which are crucial for identifying potential issues in device design, manufacturing, and distribution, thus minimizing risk, preventing costly recalls, and ensuring patient safety.
With an enterprise QMS, preparing for and conducting audits becomes more efficient, as all necessary information is organized and easily accessible. This streamlines the audit process, saving time and resources.
Keeping track of the training requirements and completions for thousands of employees is practically impossible to do manually, which is why enterprise quality management software will include dedicated training management to help ensure compliance and competency within the organization.
All of that probably sounds great, however, making the most of these features depends on choosing and successfully implementing the right enterprise QMS software for your company.
When it comes to selecting the right enterprise quality management software, there are several key factors that organizations must consider.
The chosen system should be scalable, adapting to the growing needs and complexities of the business. User-friendliness is another critical factor; the system should be intuitive and easy to use to ensure wide adoption across the entire organization.
But the QMS solution you choose should also be able to handle your specific business needs without an enormous amount of customization. Purpose-built solutions—like Greenlight Guru Quality, built specifically for MedTech companies—are often faster to implement and easier to use than general-purpose software that requires extensive customization.
(If you’re concerned about how to get internal executive buy-in for a new enterprise quality system, check out our free eQMS Buyer’s Guide).
Successfully implementing an enterprise quality management system is a journey, not a destination.
It involves careful planning, stakeholder engagement, and meticulous execution. Best practices include defining clear objectives, involving both quality and product development teams from the start, and ensuring there is a solid change management plan in place.
Post-implementation, it is essential to measure the success and ROI of the enterprise quality system. This involves tracking key performance indicators such as reduction in defects, improvement in compliance rates, and overall efficiency gains.
Continuous monitoring and iterative improvements ensure that the QMS evolves in tandem with the business, delivering sustained value over time.
There's plenty of general-purpose enterprise quality management systems out there to choose from. But if you're in MedTech, there's only one enterprise eQMS that is built specifically for your needs: Greenlight Guru Quality.
At Greenlight Guru, our quality management system software is built with everything MedTech companies need to be successful. From design and development to post-market surveillance (and everything in between), we have you covered throughout the entire device lifecycle.
Not to mention, our dedicated customer success team will help you build a custom implementation plan, and be with you every step of the way.
If you're ready to see why enterprise MedTech companies trust us as their medical device QMS provider, then get your free demo of Greenlight Guru today!
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...