Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Description

Streamline the processes involved in batch records, cleaning, environmental oversight, and inventory control. Enhance the production of advanced therapies using software tailored for Good Manufacturing Practice (GMP). This tool serves as an effective means to unify your workforce towards achieving ‘right-first-time manufacturing’. Eliminate the chaos of scattered paperwork by utilizing a single software solution that facilitates data collection, review and approval workflows, comprehensive reporting, and insightful analytics. Guarantee that your team adheres to the proper protocols promptly with engaging work instructions that guide them through each step. Enjoy peace of mind knowing that the software complies with 21 CFR part 11 and EU Vol 4 annex 11. Simplify the logging of information with features like barcode scanning, integrated data integrity measures, and automatic calculations. The system also includes built-in mechanisms for identifying out-of-spec conditions and ensuring thorough review and approval. Stay informed about the status of your samples throughout the testing phases, while efficiently organizing sample plans and automating trend analysis. Additionally, manage tasks related to maintaining cleanroom standards and monitor various stages of the production process to ensure optimal results. This comprehensive approach not only enhances efficiency but also fosters an environment of accountability and precision in manufacturing.

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

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Microsoft Excel
Microsoft Outlook

Integrations

Microsoft Excel
Microsoft Outlook

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

$10,000/year
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

MyCellHub

Founded

2019

Country

Belgium

Website

www.mycellhub.com

Vendor Details

Company Name

QT9 Software

Founded

2005

Country

United States

Website

qt9software.com/qms

Product Features

Manufacturing Execution

Document Management
Forecasting
Quality Control
Quote Management
Resource Management
Supplier Management
Supply Chain Management
Traceability

Product Features

Calibration Management

Calibration Instructions
Calibration Schedules
Compliance Management
Device History
Due Date Tracking
Gage Management
Label Printing
Measurement Readings
Multi-Station Management
Out-of-Tolerance Notification
Statistical Data Reporting

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Document Control

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control

Document Version Control

Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback

Inspection

Appointment Management
Customer Database
Dispatch Management
Equipment Tracking
Photos In Reports
Print on Site
Report Templates
Speech Recognition
Subcontractor Management

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

Alternatives

DELMIAworks Reviews

DELMIAworks

Dassault Systemes

Alternatives

isoTracker Quality Management Reviews

isoTracker Quality Management

isoTracker Solutions Ltd
Lockbox LIMS Reviews

Lockbox LIMS

Third Wave Analytics
SBS Quality Management Software Reviews

SBS Quality Management Software

Sunday Business Systems