Enzyme QMS

Enzyme QMS: The Innovative Quality Management System for Life Sciences

What is Enzyme QMS? Enzyme QMS is a 21 CFR Part 11 compliant and validated quality management system designed for medical device, digital health, and biopharma companies. It is built to scale with your business, supporting the entire product lifecycle from premarket to postmarket.

Key Features and Benefits:

• Complete Solution: Enzyme QMS provides everything you need, from startup to IPO, covering all critical aspects of quality management.
• Versatile: Adapts to your existing workflows, integrating seamlessly with your preferred tools.
• Proactive: Continuously evolving to meet the changing needs of the life sciences industry.
• Intuitive Design: Created by quality and regulatory professionals, ensuring ease of use for similar professionals.

How to use Enzyme QMS?

Enzyme QMS integrates with Microsoft Office 365. This allows you to import your data and generate reports directly from the eQMS, streamlining your workflows.

Why is Enzyme QMS important?

Enzyme QMS helps companies streamline their quality processes and post-market compliance, ensuring adherence to cGMP, QSR, and ISO standards. Its flexibility and scalability make it suitable for both startups and large enterprises.

Customer Testimonials:

• Diego Rey, Chief Scientific Officer, Endpoint Health: "Comparing how we did QMS at GeneWEAVE without Enzyme and how we do things now is night and day."
• Enhao Gong, CEO, Subtle Medical: "The team at Enzyme has helped us streamline our quality process and post-market compliance, including our QMS process. Their level of professionalism and service has been outstanding."
• Judy Brimacombe, VP Clinical, QA, RA, DawnLight Technologies: "The care and thought the Enzyme team has put into designing and implementing the eQMS has made our lives one thousand times easier."

Where can I use Enzyme QMS?

Enzyme QMS is tailored for use in:

• Medical Device Companies
• Digital Health Companies
• Biopharma Companies

Connect with Enzyme:

Explore Enzyme's document control, change control, training, design control, risk management, supplier management, audit management, complaint management, nonconformance management, and CAPA functionalities. Contact Enzyme to learn more.