Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Create a simple, efficient Quality Management System (QMS). You can install on your local server, or use our Cloud QMS solution. ISO 9001:2015 requires risk-based thinking. Risk Assessment: Failure Modes Analysis (FMEA) Implement risk-based strategies for ISO 9001, ISO 14971. Identify failure modes for each item or process. Identify the effects and severity. Identify the causes and frequency. Identify current controls and detection levels. Multiple actions should be taken in response to this failure mode. Assign owners and due dates. Establish verification and validation criteria. Management approval can be obtained by electronic signature. User login: Define passwords and privileges. Rich set of reports. Track open actions and delinquent due date. Microsoft Access is free to download. To further analyze the data, export it to Excel. Common, easy-to-use software platform
Description
Unify quality processes with QT9's all-in-one cloud-based QMS Software Suite. QT9 QMS is a user-friendly quality management software that includes 25+ modules with unlimited scalability. Automate ISO & FDA Compliance with email alerts, To Do lists and FDA 21 CFR Part 11 Compliant Electronic Approvals.
QT9 QMS enables Life Sciences, Biotechnology Companies, Medical Device Manufacturers and Pharmaceutical Companies to digitally transform operations.
Get real-time status updates and visualize quality metrics up-to-the-minute. QT9 QMS comes with built-in document control, revision-level controls, corrective actions (CAPAs), Nonconforming products and more. Advance product releases with Deviation Management, Engineering Change Orders, FMEA, Inspection Management Modules Included.
Go paperless & put time-consuming tasks on autopilot. QT9 QMS comes ready-to-use. Get a free product tour! Start a Free Trial. Visit QT9qms.com
API Access
Has API
No
API Access
Has API
Yes
Integrations
Azure SQL Database
Yes
Microsoft 365
Yes
Microsoft Excel
No
Microsoft Outlook
No
Sunday Business Systems
Yes
Integrations
Azure SQL Database
No
Microsoft 365
No
Microsoft Excel
Yes
Microsoft Outlook
Yes
Sunday Business Systems
No
Pricing Details
$135.00/one-time
Multiple user licenses are available. Licensing based on concurrent users.
Free Trial
Yes
Free Version
Yes
Pricing Details
$10,000/year
Includes all 25+ Modules. Unlimited Training and Support Available. Get a quote today.
Free Trial
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
Yes
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
Yes
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
No
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
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Sunday Business Systems
Founded
2004
Country
United States
Website
sundaybizsys.com/fmea-database/
Vendor Details
Company Name
QT9 Software
Founded
2005
Country
United States
Website
qt9software.com/qms
Product Features
Risk Management
Alerts/Notifications
No
Auditing
No
Business Process Control
No
Compliance Management
Yes
Corrective Actions (CAPA)
Yes
Dashboard
No
Exceptions Management
No
IT Risk Management
No
Internal Controls Management
Yes
Legal Risk Management
Yes
Mobile Access
No
Operational Risk Management
Yes
Predictive Analytics
No
Reputation Risk Management
Yes
Response Management
Yes
Risk Assessment
Yes
Product Features
Calibration Management
Calibration Instructions
Yes
Calibration Schedules
Yes
Compliance Management
Yes
Device History
Yes
Due Date Tracking
Yes
Gage Management
Yes
Label Printing
Yes
Measurement Readings
Yes
Multi-Station Management
Yes
Out-of-Tolerance Notification
Yes
Statistical Data Reporting
Yes
CAPA
Audit Management
Yes
CAPA Planning
Yes
Change Management
Yes
Complaint Management
Yes
Incident Management
Yes
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
Yes
Root Cause Analysis
Yes
Training Management
Yes
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
Yes
Controls Testing
Yes
Environmental Compliance
Yes
FDA Compliance
Yes
HIPAA Compliance
No
ISO Compliance
Yes
Incident Management
Yes
OSHA Compliance
Yes
Risk Management
Yes
Sarbanes-Oxley Compliance
No
Surveys & Feedback
Yes
Version Control
Yes
Workflow / Process Automation
Yes
Document Control
Archiving & Retention
Yes
Automated Routing
Yes
Change Management
Yes
Compliance Management
Yes
Electronic Signature
Yes
Escalation Management
Yes
Periodic Review
Yes
Version Control
Yes
Document Version Control
Access Controls/Permissions
Yes
Approval Process Control
Yes
Archiving & Retention
Yes
Audit Trail
Yes
Commenting / Notes
Yes
Document Check-in / Check-out
Yes
For Engineering Documents
Yes
Revision History
Yes
Version Comparison
Yes
Version Rollback
Yes
Inspection
Appointment Management
Yes
Customer Database
Yes
Dispatch Management
Yes
Equipment Tracking
Yes
Photos In Reports
Yes
Print on Site
Yes
Report Templates
Yes
Speech Recognition
No
Subcontractor Management
Yes
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