Enzyme

By offering the most robust Jira integration on the market, Enzyme QMS allows engineers to continue to work in the tools they know with appropriate documentation and oversight from the Quality team.

Curious what makes Enzyme different from other quality management system (QMS) solutions on the market? Our Director of Product Troy Michels shared two key things that distinguish Enzyme QMS from other QMS platforms: 💡 “Our system is built to be integrated with the tools that you already use. Your team shouldn't have to learn a lot of new things in order to incorporate quality into the processes you already have. You should be able to use your existing tools and then pull that data into record-keeping software with oversight from your Quality team. And that's what Enzyme QMS is really designed to do.” 💡 “If you really want a high-quality product to be produced by your team, you need understanding and participation from everyone. So, you need a tool that is easy-to-use and lightweight so that people are engaging with and actively using the tool. That’s why we’ve made Enzyme QMS intuitive and easy to learn.”

Not sure which QMS solution is right for you? Take our 2-minute quiz to receive three personalized recommendations on which QMS vendors are likely best suited for you (even if it’s not us). Take the quiz here: enzyme.com/quiz-whats-the…

At Enzyme, we’re thankful for all our amazing customers like Edward Ikeguchi at @akyrian_systems. Here’s what he had to say about one of his favorite Enzyme QMS features.

Attending the Combination Products Summit next week? Book a 30-minute session with our combination products expert Brian Intoccia to pick his brain on: 💡Product development strategy 💡Risk management 💡Systems engineering Not only will you get valuable feedback, but everyone who books a session will also get a free Pharma Device Development Life Cycle (D-DLC) SOP based on ISO 13485 (transition ready!). To schedule, email us at comboproducts@enzyme.com

The FDA draft rule for regulation of lab-developed tests (LDTs) would force clinical labs to conduct a major overhaul of their regulatory operations. The FDA’s timeline for this draft rule also appears highly ambitious. enzyme.com/blog/fda-draft…

Wondering if Enzyme QMS is right for you? Here’s what one of our customers had to say about his experience working with our quality management system software.

We asked our Director of Product Troy Michels what the biggest challenges are with QMS solutions today. Here's what he had to say. Do you agree or disagree?

At Enzyme, everything we build is guided by our product principles. This helps our whole team understand how to build products the Enzyme way, so that they’re innovative, integrated, and intuitive. Our product principles: 👉 We believe in empowering teams to use the best tools for the job rather than re-creating all tools within Enzyme. That’s why we offer an industry-leading number of integrations. 👉 We believe the best patient outcomes are achieved when Quality is owned by everyone. That’s why we build tools for the entire organization, not just the Quality team. 👉 We believe that we will only revolutionize life sciences product development by constantly evolving ourselves, which is why we prioritize innovation. 👉 We believe the best partners and best software meet you where you are. That’s why we build products that support teams at all different stages of the product and company life cycle.

At Enzyme, we want to help you find the best QMS solution for your company—even if it’s not us. That’s why we’ve created this list of questions to ask QMS vendors to help you make your decision. enzyme.com/blog/10-questi…

Our new integration with Microsoft Office 365 offers the best of both worlds: ✅ The collaboration potential of Google Docs ✅ The tried and tested software of Microsoft Office Learn more: enzyme.com/blog/new-micro…

Many life science companies depend on quality and regulatory consultants to help guide them. Here are some of the key benefits of working with consultants from our Director of Regulatory Michelle Rubin-Onur, PhD.

The FDA’s new draft guidance on use of clinical data in 510(k) submissions brings several critical questions into focus, such as the circumstances in which a change in the indication for use may require clinical testing. enzyme.com/blog/hazards-i…

With our new Microsoft Office 365 integration, documents no longer need to be downloaded & uploaded, checked in & out, or emailed in order to get reviewed. Now you can collaborate directly in Enzyme QMS in real-time.

Many times you know in advance, but all it takes is one horrendous audit to throw an organization into turmoil, and this can cost millions in remediation activities. It can also be a very public humiliation, as FDA inspection results get published.”

❌Not being audit-ready at all times. “Now that notified bodies can show up unannounced just like FDA, you don't have the luxury of having weeks, or at least days, to prepare.

Over the course of his career, Enzyme COO and Co-Founder Jacob Graham has helped oversee dozens of FDA and EU notified body, supplier, and internal audits. Here are some common mistakes he’s seen companies make: