Q.What stages of the product development lifecycle does Enzyme QMS cover?
A.Enzyme QMS covers all stages of the product development lifecycle, from Design Control to CAPA.
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Enzyme
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💲Paid
Enzyme QMS is a comprehensive quality management system tailored for life sciences companies, covering all stages of the product development lifecycle. It ensures compliance with key regulations and standards, supports integration with existing tools, and offers a scalable solution for startups to enterprises.
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Platform
web
21 CFR Part 11AuditsCAPAChange controlComplianceDesign controlDocument control
What is Enzyme?
Enzyme QMS is a quality management system software designed for life sciences companies, covering all stages of the product development lifecycle from Design Control to CAPA. It supports medical device, digital health, and biopharma companies, ensuring compliance with cGMP, QSR, ISO standards, and 21 CFR Part 11. The system is validated out-of-box, scalable, and integrates with existing tools, offering expert support and user-friendly features.
Core Technologies
- Quality Management System
- Regulatory Compliance
- Document Control
- Integration Capabilities
- User-Friendly Interface
Key Capabilities
- Compliance with industry standards
- Full product lifecycle support
- Scalable design
- Integration with existing tools
- Expert support team
Use Cases
- Streamlining quality processes for medical device companies
- Managing document control and training for biopharma firms
- Maintaining audit readiness for startups
Core Benefits
- Compliant with major industry standards
- Supports full product lifecycle
- Scalable for growing businesses
- Integrates with existing systems
- User-friendly interface with fast document loading
Key Features
- Document control
- Change control
- Training
- Design control
- Risk management
- Suppliers
- Audits
- Complaints
- Nonconformance
- CAPA
- 21 CFR Part 11 compliance
- Integrations
How to Use
- 1Integrate Enzyme QMS with existing tools to import data and generate reports.
- 2Select a plan (Core, Premarket, or Postmarket) based on company needs.
- 3Customize the system to meet specific regulatory and operational requirements.
- 4Leverage expert support for guidance through quality challenges and submissions.
Pricing Plans
Core
Document control, Training, eSignatures, Integrations
Premarket
Document control, Training, eSignatures, Integrations, Design control, Risk management, Suppliers
Postmarket
Document control, Training, eSignatures, Integrations, Design control, Risk management, Suppliers, Audits, Complaints, Nonconformance, CAPA
Frequently Asked Questions
Q.Is Enzyme QMS compliant with industry standards?
A.Yes, Enzyme QMS covers the key components of cGMP, the QSR, and ISO standards, and is 21 CFR Part 11 compliant.
Q.What types of companies does Enzyme QMS serve?
A.Enzyme QMS serves medical device, digital health, and biopharma companies.
Pros & Cons (Reserved)
✓ Pros
- Covers all stages of the product development lifecycle
- Compliant with key industry standards
- Scalable design to support growth
- Integrates with existing tools
- User-friendly system with rapid document loading
- Expert support team
✗ Cons
- Pricing not transparently listed on the website
- May require some configuration for complex enterprises
Alternatives
No alternatives found.