Curious what it’s like to use Enzyme QMS? Here’s what one of our customers had to say.

When it comes to quality management system (QMS) solutions, there are significant differences across the life sciences regarding processes, needs, and requirements, so be sure to ask the following question when researching QMS vendors: ✅ What industries do you specialize in serving? Make sure the QMS solution you pick was designed with your particular industry in mind so you know it’s a good fit. Otherwise, that particular QMS software might be missing critical workflows and functions that you need for your business and/or you may be paying for modules and functions you don’t need.

“If we have a customer that’s not using any integrations, they’re using Enzyme wrong.” Our Director of Product Troy Michels shares some insights about why we offer an industry-leading number of integrations with Enzyme QMS.

Are you ready for a best-in-class document editing experience? With our new Microsoft Office 365 integration, you’ll enjoy the benefits of collaboration in the cloud combined with the Microsoft software you already know and use. https://www.enzyme.com/blog/new-microsoft-office-integration-enzyme-qms/

The new FDA guidance on the use of real-world data (RWD) and real-world evidence (RWE) is a long-anticipated playbook for how a drug manufacturer can employ a non-interventional study for regulatory decision-making. Here’s what you need to know. https://www.enzyme.com/blog/fda-guidance-rwd-rwe/

Did you know that a major barrier to successful implementation of QMS software is often the onboarding process? When trying to decide which QMS solution is right for you, make sure you ask potential vendors this question: ✅ How long does onboarding take? How much support do you provide? Many companies purchase a QMS solution and then fail to get it off the ground due to how long onboarding takes and/or how complicated the process is. Make sure you understand the vendor’s onboarding timeline and also how much support the company is going to provide along the way. If you think you’ll need more help than what the company includes with your package, find out what additional options are available and factor that cost and time into your decision.

We’re excited to announce our new integration with Microsoft Office 365! Customers can now edit Word, Excel, and PowerPoint files directly within the Enzyme platform with just one click.

We asked our Director of Regulatory Michelle Rubin-Onur, PhD, for tips on how regulatory professionals can stay up to date on the latest regulatory changes. Here are her three recommendations.

Every company and industry differs in what they need from their quality management system (QMS) software, so when you’re researching QMS solutions, make sure you ask this question: ✅ How configurable is your QMS software? It’s important to find out whether the vendor’s QMS software can be configured to meet your needs. Otherwise, you might be trying to fit a square peg in a round hole. The best option is to find a QMS solution that is validated out-of-the-box to save you time and money, but also configurable enough that it can adapt to your workflows and requirements.

We are currently in Phase 2 of the FDA’s 180-day transition plan for medical devices under enforcement discretion. Here’s what needs to be completed before the beginning of Phase 3 on November 7, 2023. ✅ A “Notification of Intent” needs to be submitted for certain reusable life supporting or life sustaining devices. ✅ If you intend to keep your device(s) on the market, the applicable marketing submission needs to be submitted and accepted for review prior to the beginning of Phase 3. If you have not submitted a marketing submission, had it accepted, or already received a negative decision on your submission, FDA expects that you will discontinue distribution of your device.

Want to know one of the most common regulatory mistakes companies make? Going through the whole FDA review process without a quality management system (QMS). Here’s why: Waiting to implement a QMS solution until after a device is cleared can be costly and inefficient. For most devices, it's actually against FDA regulations not to implement design controls and risk management processes — two aspects of QMS — during the development of your device. It can also make it very difficult to keep track of device changes, what was cleared, and how the device still complies with all the standards it complied to in the submission(s). It’s best to invest in a QMS solution early. Otherwise, you may jeopardize the regulatory standing of your product and/or burden your team with months of remedial documentation work.

This question will help you assess how much you and your team are going to have to change how you work in order to use the vendor's QMS software: ✅ What kind of integrations do you provide? The number of integrations a QMS provider offers tells you a lot about how flexible the system is. The more integrations there are, the more you’ll be able to keep using the tools you and your team already love. If the QMS software doesn’t integrate with your existing tools, you and your team are going to have to adapt the way you work to your QMS software instead of the other way around. Learning new tools and workflows on top of a new QMS solution is a burden a lot of teams would prefer to avoid.

In response to COVID-19, FDA released a number of enforcement discretion policies that allowed Americans to have access to medical devices that would traditionally undergo FDA review and clearance/approval without this review. However, now that the public health emergency has ended, FDA is transitioning these products back to being regulated again. Here’s what you need to know. https://www.enzyme.com/blog/end-of-fda-enforcement-discretion-policies/

We asked Michelle Rubin-Onur, PhD, Director of Regulatory at Enzyme, about the biggest challenge that regulatory teams are facing right now. Here’s what she had to say. (And stay tuned, we’ll have more on this topic later this week.)

If you’re an early-stage life sciences company, deciding what your regulatory strategy is going to be is one of the most important decisions you’ll make. Here’s one consideration you don’t want to overlook. 🎯Consider the cost of regulatory components. Different regulatory approaches have different financial considerations, such as clinical studies, specific types of testing, having a quality management system, and submissions. For example, if your device is a first-of-its-kind, it may be a De Novo submission. A De Novo submission for fiscal year 2024, even for a small business, is more than $30,000. That’s something you need to consider when you’re budgeting for the company and considering your regulatory path.

Don’t settle for QMS software that boxes you in, or consultants who can’t deliver. We’re here to help, whether it’s migrating your data from another QMS vendor to Enzyme or our consultants taking you from product inception through regulatory approval.

When selecting a quality management system (QMS) vendor for your company, it’s important to ask the right questions in order to ensure you make the right choice. Here’s one question that could save you from getting locked in with the wrong QMS provider. ✅ How do I export my data out of your QMS software? How difficult or easy is it to do this? The data being stored in your QMS platform is one of your most precious commodities. Make sure that what goes in can come back out so you’re not being held hostage by your QMS provider. If it’s difficult to export your data back out of the system, not only will it be challenging to analyze and leverage your data, but if you ever decide to switch to a different QMS solution, the migration will be a nightmare.

We asked Todd Etzel, Software Development Life Cycle Consultant at Enzyme, about the key updates in the new FDA guidance “Off-The-Shelf Software Use in Medical Devices.” Here’s what he had to say: 1) The procedure for OTS software risk assessment is the most noteworthy modification to the guidance. While the previous guidance emphasized a Level of Concern (LoC) partitioning system and a decision tree to establish OTS software risk and documentation levels, the updated guidance instead relies on the latest “Content of Premarket Submission for Device Software Functions” to determine the requisite documentation level. 2) The previous guidance outlined a highly specific methodology for conducting hazard analysis on OTS software. The updated guidance, however, mandates that manufacturers integrate the risk assessment of OTS software into their comprehensive risk management file, in alignment with the FDA's current perspective on adopting a 'least burdensome approach.’ Need help navigating these new changes? Todd and Enzyme’s consulting team are here to help.

When FDA uses the word “should” or “recommend” in its guidances, does that mean you have to do it? Here’s our answer: When FDA uses the term “should,” you really, really, really should consider it. If you don’t: ⚠ FDA may ask you questions about it. ⛔ It may result in a negative decision in your Premarket Submission. ⚠ It may result in a difficult conversation with FDA in a Pre-Submission. ⛔ You may not pass the administrative review of any sort of submission that you give FDA.