The medical device industry has been undergoing a major shift for the past 20 years, and now that shift is accelerating.
1. Compliance is built-in with Greenlight Guru so you can focus on True Quality.
The number of regulations and organizations that companies have to deal with on a daily basis can seem overwhelming. Compliance requirements aren’t always well understood, and companies without subject matter experts can find themselves at a disadvantage.
But with Greenlight Guru, you’re covered – from FDA 21 CFR Part 820, to ISO 13485:2016, and criteria for EU MDR – all the specific workflows are built into the system. The compliance components are captured as part of the steps customers follow when initiating workflows like document management, design control, risk management, CAPA, and more.
It gives medical device professionals peace of mind because they no longer have to worry about whether the systems and tools they’re using are up-to-date with current regulations and industry best practices. Let Greenlight Guru worry about that – it’s what we we spend our time, energy, and resources doing on a daily basis.
For instance, the ISO 14971 standard has a new revision in draft, which is likely to be published soon, and we’re already devising a plan so the risk management workflows within Greenlight Guru eQMS are in alignment with the changes. We build the software to stay in alignment with regulations. Achieve and maintain regulatory compliance, so you can put the focus squarely on the quality of your devices.
2. We enable better audit and inspection readiness.
Our objective to help you be better ready for audits and inspections is connected to quality. Because Greenlight Guru is a quality management software solution built specifically for the medical device industry, it means the solution aligns with current medical device regulations out of the box putting you in a much better position from an audit perspective.
Every medical device company is subject to routine regulatory audits and inspections. That means having a system that’s always one step ahead of regulatory changes is a huge step toward audit readiness on its own.
But we’ve also used our decades of experience in the medical device industry to guide how we created the solution. We’ve been across the table from FDA investigators and ISO auditors, so we know what an auditor is looking for within a QMS, documents, and records and how they expect information to be presented.
It’s how one of our customers, SOLIUS, cut down their typical audit preparation time from three weeks to three days. The advantage of Greenlight Guru is having constant visibility — no matter how long you have to prepare for an audit or inspection, whether that be months, weeks, or even days.
3. We get your devices to market faster.
The conventional approach to quality management systems in the medical device industry has always been through just a compliance lens, not quality. And that has made it very inefficient.
Compliance is critical, but it’s possible to stay compliant and save time while also focusing on true quality of your products and processes. With Greenlight Guru, companies can streamline their processes and focus on serving their customers with better devices.
The Greenlight Guru workflow saves hundreds of hours per project during the design process. Imagine getting more than a hundred hours of time back on every project you complete each year – time spent tracking down documents or updating spreadsheets – and translating that to time you can use on other projects.
That means you can get your product submitted to FDA faster and you can get to market faster, which ultimately means you can generate revenue faster.
MYOLYN, a company in Florida, cut more than 90 days from their 510(k) clearance with Greenlight Guru. Those 90 days added up to a real competitive advantage for MYOLYN.
4. Greenlight Guru provides design control and risk management integration.
This is just one of the things that sets us apart from our competition: no one else integrates design control and risk management like Greenlight Guru.
We’ve witnessed a great deal of evolution on design control in the 20 or so years since the original regulation was published– but the changes in risk management have been revolutionary. And for medical device companies, it’s not just the regulators we have to worry about; it’s the litigators.
Medical device professionals, design devices that can save lives; and patients deserve companies that have completed due diligence and reduced risk as much as possible. Common sense dictates that the design and development processes are means of risk mitigation.
It’s not just that risk mitigation is a best practice; it’s also required in many new regulations. When we saw ISO 13485:2016 published a couple years ago, there was a much heavier emphasis placed on risk-based approaches. And regulatory bodies across the world have embraced and adopted ISO 14971 as the medical device industry standard for risk management.
The fact that Greenlight Guru’s design control workflow aligns with what’s required from FDA and ISO 13485:2016, and the risk management workflow aligns with ISO 14971, gives medical device companies yet another competitive edge.
5. Greenlight Guru increases visibility and control.
How many medical device professionals really know the state of their quality management systems?
Just knowing where the binder is or what the procedures include doesn’t mean you have visibility into what’s really happening with those processes and procedures.
Often times, the quality management system has been maligned a great deal, but it’s because people misunderstand the intent behind a quality management system. Too many companies can’t achieve the visibility they need, don’t understand which processes are working and which aren’t, and don’t have the solutions and tools in place to enable that kind of detailed control — which is absolutely necessary in the medical device industry.
With the ability to link anything built right into the Greenlight Guru platform, customers gain direct visibility into where their documents are, as well as the state of those documents. Our platform gives companies built-in workflows to manage events like CAPAs, complaints, and nonconformance.
Our most important focus is on providing a single source of truth — the place where the executive management team can make the best decisions. Making decisions with fragmented data just increases business risk. But knowledge is power; and providing executives with more knowledge about the health of their business is a powerful thing.
The other part of that power is accessibility, having up-to-date information at your fingertips. Within a few clicks, you know with certainty that the document you’re looking for is the right version, where it’s being routed, who approved, and what stage it’s in. No more uncertainty around the right folder of a server, or whether a signed document got transferred over. That visibility is important to everyone: executives, middle managers, and VPs alike. It’s what helps them make better, more informed decisions about the state of their products and processes.
6. Greenlight Guru enables you to better manage business risk.
Managing risk is important – not just from a product standpoint, but from a business standpoint as well. A high-efficiency quality management system is a good thing because it defines the critical business processes. It gives you visibility and control of your product and process documents and data, the analytics to track and trend what’s happening with those key processes, and the insight to forecast and mitigate risk.
You’re able to see what’s happening before it becomes a problem so that you can be proactive instead of reactionary.
At Greenlight Guru, we work with you to develop solutions that establish risk controls early in the product development process, reducing overall risk and creating visibility between requirements. Customers can link risk artifacts with product management artifacts, providing context during risk mitigation. Companies can avoid expensive rework and save valuable time, identifying issues before they become problems.
7. We help accelerate implementation.
There’s no denying that technology has helped accelerate the medical device development process. But it’s also clear that most of the general purpose tools out there weren’t designed for the medical device industry; they’re clunky, they’re not ready out of the box, and they get you stuck focusing on just compliance.
Recently, I worked with an executive who chose a general purpose provider. I warned him that his organization would spend about six months evaluating, configuring, customizing, and testing the tool, all without expertise from that company while implementing it. I followed up with him a few months later, and he told me he was frustrated: he was no more than one step closer to implementation than when I talked to him initially.
In the 90 days between our conversations, Greenlight Guru would’ve been implemented, we’d have trained the team, and legacy documents and records would have all been transferred. That’s because Greenlight Guru is ready out of the box – in fact, there is no “box”. Greenlight Guru is deployed via cloud, so there’s none of the IT infrastructure or heavy IT support involved that traditional software requires.
8. Audit-tested SOPs and templates.
Technology moves quickly, but there’s still only about 20 years of history when it comes to quality system regulations, and eQMS is even more recent. Many companies end up choosing a QMS that’s bloated with unnecessary details and procedures, but missing the kinds of templates and compliance forms that can help save time and ensure compliance.
An effective QMS should have only what it needs to keep documents and procedures up-to-date. Quite some time ago, we established a library of forms, templates, and procedures that allow customers to find and create the documentation they need. The Greenlight Guru QMS also helps create the Design History File, the last step in the design controls process mandated by the FDA in 21 CFR Part 820.
9. Save time and improve operational efficiency.
The more time you can save, the more money you can make. That’s why the Greenlight Guru workflows were all designed around saving time and improving efficiency. The design control workflow is a great example: product development project teams can save hundreds of hours per year with a single source that simplifies information and aligns with regulations. That can lead to a serious boost in productivity, improve response times for audits and required changes, and improve collaboration.
But how does a system like this save so much time? Think about companies with paper-based processes: they send emails with attachments, then those files might sit on someone’s desk for a week, waiting for someone’s signature. Conventional approaches rely on sending documents back and forth via email, with no way to see where a document is or whether it’s been signed. Greenlight Guru’s cloud-based workflow means there’s no waiting on signatures or wondering where a document is. Companies also have an opportunity to eliminate unnecessary emails and meetings, saving even more valuable time.
10. Ease of Use.
From day one, Greenlight Guru has been focused on delivering a seamless experience; we want our solution to become an invisible part of your team getting things done. In fact, we’ve focused thousands of hours on user interface and user experience alone, with a full time team. That commitment goes a long way towards aligning our product from a compliance standpoint as well: we understand how to apply the FDA and ISO quality system requirements to improving overall UI/UX. Ease of use is key to any of these workflows – and we’re devoted to ensuring Greenlight Guru works exactly as it’s supposed to.
Being ready out of the box is just one part of making our QMS easy to use, day in and day out. The other part is making quality a foundational element of the platform. Too many solutions take a piecemeal approach to building a platform. Greenlight Guru has taken the opposite approach: we take a high-level view of the entire QMS universe, considering the entirety of all the workflows that one might need to do. That gives us the strategy to be both granular and big-picture at the same time.
11. Zero Effort Part 11 Validation with Validation Package.
21 CFR Part 11 is one of the most ambiguous topics in medical device regulations. That’s because there’s varying levels of experience and expertise, both at medical device companies and among auditors and inspectors who evaluate documentation on the topic. We’re working closely with FDA’s Case for Quality, and we’ve learned that the historical approach to Part 11 is very dated.
That’s led to companies looking for a Part 11 validation package to search for something that simply checks a box. Box-checking can lead to even more problems if a solution doesn’t provide reliable validation. For companies, that might mean having to pay even more to validate a solution – on top of the money, resources, and time invested in the original solution. The Greenlight Guru team includes medical device experts who each have more than ten years of experience in validating systems.
We also invest in third-party resources to evaluate our system, helping to ensure objectivity. And whenever we design and develop a new feature, we put it through rigorous in-house user acceptance testing (UAT), as well as in-house IQ, OQ and PQ testing, before any sort of feature is a candidate for release. It can save our customers weeks or even months of time, whether they decide to accept our validations, or install their own protocols.
12. Greenlight Guru provides complete traceability.
We’re at a point today where traceability has become so important that it’s actually a requirement: it’s explicitly stated several times throughout ISO 13485:2016, and it’s a stated requirement during the design and development process. It’s important to understand that flow from a user need; from designing input and output, to design verification and validation, companies need to know how things are connected. From a business perspective, disconnected processes means it takes longer to gather the information needed to make critical decisions.
After a product is launched into the marketplace, companies receive information via customer feedback, in the form of complaints and different audit activities, which means your team has to be able to trace those events to the product. Greenlight Guru empowers customers to create and edit their traceability matrix, update the matrix in just minutes instead of days or weeks, and make related items traceable with automatic links. A platform that connects everything instantly doesn’t just streamline the process – it helps teams make more informed decisions, faster.
13. We provide your single source of truth.
Traceability is only possible when there’s a central location for all data, forms, and documentation. Many organizations rely on several electronic tools to store information, and, over time, that silo-type approach can lead to tacking on tools that don’t communicate with each other. A tech stack that doesn’t share information is inefficient, and leads to inaccurate data.
The Greenlight Guru platform connects all of your data and information into a single source. A closed loop quality system ensures that data is consistent throughout the process. Its end-to-end quality management system design also eliminates the need for working in programs like Excel, Word or Dropbox – all those systems can be replaced. And with a completely traceable platform like Greenlight Guru, companies can develop and maintain best practices, and improve processes, and significantly reduce non-compliance risk.
14. Greenlight Guru helps you save money.
Throughout this piece, we’ve talked about how Greenlight Guru helps companies save time and boost efficiency to generate more revenue. But companies can also save a significant amount of money as well. One of the reasons our platform is a money saver is that we can help reduce the need for more headcount – especially when it comes to document management. Traditional document control tools are often labor-intensive, relying on more people to increase throughput. But Greenlight Guru’s simplified workflows are built-in and tailor-made for medical devices to improve the user experience.
Companies can also see savings through the power of data and analytics. As part of the postmarket workflows, for example, there’s an analytics dashboard for customer feedback, performance, audits, CAPAs, and more. It automatically creates charts and graphs to help identify and track trends so companies can stay ahead. It even helps cut costs by eliminating the costs associated with generating and storing paper records: copying and filing of paper, the space to store it in, and the employees to maintain it.
15. QA/RA Experts act as an extension of your team.
No other eQMS solution has the customer success team that Greenlight Guru does. Every single one of our in-house, QA/RA experts has more than ten years of experience in the medical device industry. Every obstacle medical device companies face has been addressed by our customer success team – whether it’s going through ISO certification or preparing a 510(k) submission.
It’s a service we offer because, while it’s important for companies to develop expertise of their own, sometimes customers need an extra boost of productivity. Our customers can pick up the phone or open a web browser to chat with someone who has first-hand experience with their current challenges. We strive to offer tech-enabled support that goes above and beyond showing customers how to use the software. And, based on the positive feedback we’ve received, it’s one of the most valuable elements of Greenlight Guru.
The preceding 15 reasons medical device companies choose Greenlight Guru present just a fraction of the reasons our customers choose us to help them deliver the best medical devices on the market. We’re committed to providing quality management software specifically for the medical device industry, bolstered by the experience of our team, our dedication to quality, and our mission to building the best quality ecosystem available.
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