Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
No
API Access
Has API
No
Integrations
GitHub
Yes
Jenkins
Yes
Jira
Yes
Microsoft Azure
No
Okta
No
Res_Q
No
Integrations
GitHub
No
Jenkins
No
Jira
No
Microsoft Azure
Yes
Okta
Yes
Res_Q
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
ZenQMS does not charge per seat license, allowing you to grow without sacrificing compliance. Our pricing is simple and transparent, and is based on the complexity of the account and initial migration/configuration activity. Contact ZenQMS today for more details.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
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
No
Complaint Management
No
Compliance Management
No
Corrective and Preventive Actions (CAPA)
No
Defect Tracking
No
Document Control
No
Equipment Management
No
ISO Standards Management
No
Maintenance Management
No
Risk Management
No
Supplier Quality Control
No
Training Management
No
Product Features
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
Yes
Maintenance Management
Yes
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes