What is Enzyme?
Enzyme is a cutting-edge quality management system (QMS) software designed specifically for medical device, digital health, and biopharma companies. It provides unparalleled flexibility and scalability, helping organizations streamline regulatory tasks while reducing compliance risks and accelerating time-to-market.
How to use Enzyme?
First, configure the system to match your quality processes. Next, set up document control parameters and training tracking modules. Then implement audit management workflows and regulatory submission templates. Finally, customize dashboards to monitor real-time quality metrics and generate compliance reports.
Core features of Enzyme?
- Design history file management with version control
- Comprehensive risk management tools for proactive compliance
- Centralized document control with approval workflows
- Automated training tracking and competency management
- Real-time quality metrics with customizable reporting

