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Average Ratings 0 Ratings

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features
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support

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Description

Designed specifically for pharmaceutical and other GxP-compliant organizations, this solution streamlines the digitization of production, quality, and compliance processes within manufacturing operations. Empower your data to guide decisions effectively. With real-time event monitoring, teams can swiftly respond to performance issues and tackle quality challenges as they arise. Equip operators with a user-friendly tool that enhances their ability to achieve accuracy on the first attempt. Navigating the complexities of manufacturing is challenging, especially with the added layer of GMP regulations. By providing your teams with the appropriate resources, you can address critical issues and unlock transformative advancements. Significantly cut down on the time and effort needed for batch reviews and approvals through a review-by-exception approach, eliminating the need for exhaustive reviews of complete batch records. Furthermore, automate tedious tasks such as data input and verification, managing paper records across the production floor, carrying out and double-checking calculations, and overseeing workflows, among others. This not only enhances efficiency but also allows teams to focus on more strategic initiatives.

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 

Screenshots View All

Screenshots View All

Integrations

Microsoft Excel No 
Microsoft Outlook No 

Integrations

Microsoft Excel Yes 
Microsoft Outlook Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

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 No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
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 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 Yes 
Webinars Yes 
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

BatchLine

Founded

2015

Country

Thailand

Website

batchline.com

Vendor Details

Company Name

QT9 Software

Founded

2005

Country

United States

Website

qt9software.com/qms

Product Features

Manufacturing Execution

Document Management No 
Forecasting No 
Quality Control No 
Quote Management No 
Resource Management No 
Supplier Management No 
Supply Chain Management No 
Traceability No 

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 

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