Enzyme offers an innovative eQMS that is 21 CFR Part 11 compliant and validated out-of-the-box. It includes multiple integrations and supports the full product lifecycle, making it ideal for life science companies.
Enzyme offers an innovative eQMS that is 21 CFR Part 11 compliant and validated out-of-the-box. It includes multiple integrations and supports the full product lifecycle, making it ideal for life science companies.
Enzyme is a next-generation eQMS designed to streamline quality management processes for life sciences companies. Validated out-of-the-box and 21 CFR Part 11 compliant, it offers unparalleled integration capabilities with existing tools. Enzyme scales as your business grows, supporting the entire product lifecycle. Key functionalities include Document Control, Design Control, Training, Supplier Management, Risk Management, Audits, Complaints, CAPA, and Nonconformance management. It was developed by industry veterans to address the complex regulatory needs of medical devices, biopharma, and other regulated industries.
Who will use Enzyme?
Medical Device Companies
Biopharma Companies
Drug Manufacturers
Biologic Companies
Digital Health Companies
How to use the Enzyme?
step1: Visit the Enzyme website.
step2: Schedule a demo to understand the features.
step3: Choose pricing plan based on your company's needs.
step4: Create an account on the Enzyme platform.
step5: Customize modules to fit your workflow.
step6: Upload and organize necessary documents.
step7: Set up user permissions and training modules.
step8: Use the platform to manage quality processes.
Platform
web
Enzyme's Core Features & Benefits
The Core Features of Enzyme
Document Control
Design Control
Training Management
Supplier Management
Risk Management
Audit Management
Complaint Handling
CAPA Management
Nonconformance Management
The Benefits of Enzyme
21 CFR Part 11 compliant
Validated out-of-the-box
Highly scalable
Supports full product lifecycle
Multiple integrations
Enzyme's Main Use Cases & Applications
Regulatory compliance management
Document management
Training record maintenance
Supplier quality management
Risk assessment
Internal and external audits
Complaint handling
Managing corrective and preventive actions
Nonconformance tracking
FAQs of Enzyme
What is Enzyme?
Enzyme is an advanced eQMS designed for life science companies, offering comprehensive quality management capabilities.
Is Enzyme compliant with regulatory standards?
Yes, Enzyme is 21 CFR Part 11 compliant and validated out-of-the-box.
What industries is Enzyme suitable for?
Enzyme is suitable for medical devices, biopharma, drug manufacturers, biologics, and digital health companies.