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Description
Qualcy Biomed QMS Software was designed for Bio-Medical businesses (including Biotech and Pharma) to manage QMS records in accordance with FDA and ISO13485 requirements. * Meets 21 CFR Part 820 requirements * Features include E-sign, audit trails, and compliance with 21 CFR part 11. This software manages Doc. Change control, complaints, audits CAPA, NC Records Training Records and many more.
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
Microsoft Azure
Yes
AWS Backup
Yes
AWS Cloud9
Yes
Gmail
Yes
Microsoft 365
Yes
Microsoft Outlook
Yes
Okta
No
Res_Q
No
SAP Analytics Cloud
Yes
Integrations
Microsoft Azure
Yes
AWS Backup
No
AWS Cloud9
No
Gmail
No
Microsoft 365
No
Microsoft Outlook
No
Okta
Yes
Res_Q
Yes
SAP Analytics Cloud
No
Pricing Details
$799 per month
Free Trial
Yes
Free Version
Yes
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
Yes
iPad App
Yes
Android App
Yes
Windows
Yes
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
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Qualcy Systems
Founded
2014
Country
United States
Website
www.qualcy.com
Vendor Details
Company Name
ZenQMS
Founded
2010
Country
United States
Website
www.zenqms.com
Product Features
Calibration Management
Calibration Instructions
Yes
Calibration Schedules
Yes
Compliance Management
Yes
Device History
No
Due Date Tracking
Yes
Gage Management
Yes
Label Printing
Yes
Measurement Readings
No
Multi-Station Management
No
Out-of-Tolerance Notification
No
Statistical Data Reporting
No
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
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