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Description
Our Quality Management System (QMS) encompasses comprehensive modules that cover every phase of the product life cycle, ranging from Design Control to Corrective and Preventive Actions (CAPA). We empower your entire workforce through training and are ready to assist you whenever necessary. Enzyme Consulting, LLC. specializes in tailoring and implementing your Quality System to meet your specific needs. Once you complete your onboarding process, our team remains accessible for follow-up discussions and to address any inquiries you may have. Created by seasoned industry professionals who were disillusioned with current QMS options, Enzyme's system is specifically designed for life science companies, with a strong focus on the unique hurdles of developing FDA-regulated software. With the support of our committed consultants, you can bring your product to market with assurance. Our consultants possess not only direct experience in the medical device sector but also a keen ability to evaluate risks accurately, allowing them to truly understand and relate to the challenges faced during the product development journey. This level of support ensures that you are not alone in navigating these complexities.
Description
ZenQMS is an electronic Quality Management System (eQMS) built for life sciences and GxP-regulated organizations, including biotech, pharma, CROs, and CMO/CDMO organizations. The cloud-based, AI-enabled, fully validated platform is designed for companies of all sizes to be easier to use, quicker to validate, and more effective at managing GxP activities. ZenQMS supports key quality processes, including:
Document management/document control
Training management and learning management
Corrective and Preventive Actions
Deviations, non-conformances, complaints, issues, and other quality events
Change controls
Audit management
Critical quality workflows
Supplier and vendor management
Electronic signatures with 21 CFR Part 11-compliance
Risk management
Quality metrics tracking and reporting
API Access
Has API
API Access
Has API
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Enzyme
Founded
2016
Country
United States
Website
www.enzyme.com
Vendor Details
Company Name
ZenQMS
Founded
2010
Country
United States
Website
www.zenqms.com
Product Features
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
Product Features
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management