Best Qms Software For Medical Devices

Best Qms Software For Medical Devices – The way a company decides to establish and maintain its quality system has everything to do with its success. As the medical device industry and regulatory environment continue to evolve, there is an increasing focus on the capabilities of one’s quality system, including access to reliable quality data and the ability to demonstrate closed-loop traceability. Choosing to run your business with an inadequate quality system is a guaranteed waste of time, capital and other valuable resources. This guide is designed to give you a strong insight into the range of QMS solutions for medical device companies. It covers the necessary information to make a decision about how to approach your quality system and how your company can benefit strategically from your QMS. For two years and counting, it has been named a leader in quality management software by G2 Crowd, based on high customer satisfaction scores and large market presence. Table of Contents Compare the Best Medical Device QMS Solutions Paper and Ad Hoc Quality Systems Common QMS Software Types of Quality Management Systems Approaches Legacy Quality Management Approaches Modernize Your QMS The Best Medical Device QMS Software Solution: Unique Business Benefits Best QMS Software by Business Type High Potential Medical Device Startups Established companies selling devices internationally Companies growing in new regulatory markets Nimble, fast-moving teams Quality management as a competitive differentiator Overcoming challenges with quality management Quality management as an asset Compare the best medical device QMS software solutions Once you understand the impact your QMS has to your business, the next step is to choose the right QMS solution for your business. We’ve broken down the pros and cons of the different types of solutions available to medical device companies. Paper and ad hoc quality systems Using a paper-based process management system involves storing documents on physical paper and moving them manually through the QMS. The terms “paperless” and “paper-to-digital” refer to storing scanned images of these documents on a digital system or using tools such as Google Docs, Excel, SharePoint and Dropbox to manage files in a “digital storage box”. Typically, a paper system will be a combination of all of these methods. Although these systems are seen as a cheaper option and initially easy to set up, a paper-based system enables closed-loop traceability (CLT) of quality processes, such as design controls, changes, revisions, CAPA, customer feedback and more. , almost impossible. To sign documents, ad hoc and paper-based systems involve physically signing paper documents and then uploading them to storage using third-party signing software. Using this type of outdated system makes compliance with FDA’s related regulation, 21 CFR part 11, increasingly challenging. Because these tools are not built specifically for design control or design review, more time and resources are spent managing spreadsheets and disconnected systems. This is probably the most time-consuming part of medical device design and development, and project inputs alone can take up 30% of project time. When using paper and ad hoc systems, compiling a design history file (DHF) can take weeks, and design reviews can move particularly slowly. All of this results in a longer journey to bring a device to market, while also increasing the chance of things falling through the cracks and wasting capital along the way. Ensuring you have a closed quality system that automates the ability to link post-market quality data back into design activities will not only allow your team to focus on value-added activities, but will also eliminate the cumbersome paper-pushing that is the whole. error prone. Conclusion: When it comes to managing product development or quality processes, ad hoc and paper-based systems are outdated and prohibit companies from remaining competitive in the modern age. These systems are not sustainable or scalable, lack reliable data and will ultimately cause the QMS to be a bottleneck for business growth. General Quality Systems General purpose quality systems are a step up from paper-based solutions, but they are not without their own problems. Designed for quality process management, they typically have a less intuitive interface designed for generic use in many different industries. However, because they are not designed specifically for the medical device industry, they do not integrate regulatory standards, do not include industry-specific templates and best practices, and do not have proprietary expertise that can provide guidance in both using the software and navigating the medical device regulatory landscape. At the expense of efficiency, resources, and access to industry expertise, general-purpose quality systems can be used to manage traditional quality processes or document control workflows when they are supplemented by large configuration, consultant, and ongoing validation costs. These costs add up, of course. The lack of purpose-built capabilities to manage design controls, risks, and design reviews typically results in design history activities being documented offline and managed by disjointed processes within the quality system. Investing in a general purpose QMS solution allows you to manage quality, but does not prepare you to adapt to the rapidly changing medical device industry. And all that time and expense for a system that doesn’t fully integrate design control and risk and doesn’t lay the right foundation for closed-loop traceability? Conclusion: General quality system solutions are just that – general purpose. These solutions lack the purpose-built capabilities that medical device companies need to integrate their key QMS processes, maintain compliance with industry regulations, and achieve closed-loop traceability. They may cover the basics of a QMS, but configuring, implementing and managing them will cost you more time and money in the long run. Purpose-built quality systems A purpose-built quality management system was created exclusively for one industry. These systems are carefully designed to provide the necessary support that meets the unique needs of their users. Industry-specific workflows are interconnected within the quality system, covering the basics of each major product phase a company will go through. Purpose-built systems in the medical device industry are designed and constantly updated to ensure ongoing compliance with the latest regulations and standards, such as FDA 21 CFR Part 820 and ISO 13485:2016. This helps companies better manage and mitigate risk, accelerate time to market and pass audits/inspections in the best possible way. Everything is taken into account in a purpose-built quality management system, which ultimately simplifies and improves quality management for companies. A purpose-built quality management system for medical devices like , enables operational excellence and continuous improvement so you can focus on what really matters: making true quality medical devices that save and improve lives. Types of approaches to quality management Whether a company is implementing a QMS for the first time or wants to develop existing processes related to design control, risk, document control, etc. tools for quality management and product development activities against the adoption of modern solutions. Central to this decision is ensuring a solid understanding of how the approach you take to managing your QMS will support your ability to establish a quality culture, accelerate device release timelines, expand into new regulatory markets, and be able to scale effectively. and to be ahead of regulatory changes. Legacy Approaches to Quality Management Legacy approaches to managing medical device QMS operations typically involve paper, “digital paper,” or general-purpose office tools such as Word and Excel. These solutions are quickly falling out of fashion as they present major challenges to medical device companies that choose to use these legacy tools in an ad-hoc approach. Using legacy quality management tools makes it all too easy to lose documents or end up with different versions of the same document circulating among distributed teams, and moving through a bunch of binders is extremely cumbersome. It made sense to keep the device design file in physical three-ring binders in the late 1990s, but modern organizations are realizing that managing design and quality activities in ad-hoc ways fails and lacks real-time access to reliable design, risk data and quality that are highly correlated in a unique way for medical device companies. Key challenges with a legacy approach to a quality system include: the inability or cumbersome effort required to demonstrate closed-loop traceability between design controls, risk management, and quality activities. Difficulties with validating 21 CFR Part 11. Maintaining compliance as regulatory changes continue to evolve. reliable real-time quality data A key challenge with legacy QMS solutions is the time and effort required to achieve closed-loop traceability between design controls, risk management, design review and post-market surveillance activities throughout the product lifecycle. For example, understanding the relationship between how a corrective and preventive action (CAPA) investigation leads to the implementation of a change in device design results that affect validation, and thus further design reviews and risk management protocols is a difficult aspect of legacy. approaches that drive hidden costs, inefficiencies and risk to patients and business. Choosing a legacy approach will put your business at risk of falling behind – in more ways than one