Enzyme

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Discover Enzyme's 21 CFR Part 11 compliant eQMS, validated out-of-the-box, offering top integrations for seamless quality management in life sciences.

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May 03 2024

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Enzyme Product Information

What is Enzyme?

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

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's

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.

What core features does Enzyme offer?

Enzyme offers Document Control, Design Control, Training Management, Supplier Management, Risk Management, Audit Management, Complaint Handling, CAPA Management, and Nonconformance Management.

How do I get started with Enzyme?

Visit the Enzyme website, schedule a demo, choose a pricing plan, create an account, and customize the modules to fit your workflow.

What platforms does Enzyme support?

Enzyme supports the web platform.

Can Enzyme integrate with other tools?

Yes, Enzyme offers an industry-leading number of integrations to keep using the tools you love.

What are the benefits of using Enzyme?

The main benefits are regulatory compliance, scalability, full product lifecycle support, and multiple integrations.

Does Enzyme offer training management?

Yes, Enzyme includes comprehensive training management modules.

How can I contact Enzyme support?

You can contact Enzyme support via their website or their support email.

Enzyme Company Information

Website: https://www.enzyme.com
Company Name: Enzyme
Support Email: support@enzyme.com
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Enzyme's Main Competitors and alternatives?

MasterControl
Veeva Systems
Greenlight Guru
Qualio
Sparta Systems