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What is QT9 QMS?

Streamline your quality processes with QT9's comprehensive cloud-based Quality Management System (QMS) Software Suite. Designed for ease of use, QT9 QMS features over 25 modules that offer unlimited scalability to meet your needs. Enhance your ISO and FDA compliance efforts with automated email alerts, task lists, and FDA 21 CFR Part 11 compliant electronic approvals. QT9 QMS empowers organizations in the Life Sciences, Biotechnology, Medical Device Manufacturing, and Pharmaceutical sectors to achieve digital transformation in their operations. Stay informed with real-time status updates and instantly visualize your quality metrics. The software includes essential features such as document control, revision management, corrective actions (CAPAs), and nonconformance tracking, among others. Additionally, it facilitates streamlined product releases with modules for Deviation Management, Engineering Change Orders, Failure Mode and Effects Analysis (FMEA), and Inspection Management. Transition to a paperless environment and automate your labor-intensive tasks effortlessly. QT9 QMS is ready for immediate use, allowing you to get started quickly. Experience it firsthand by signing up for a free product tour or beginning your free trial today at QT9qms.com. Embrace the future of quality management and elevate your organization's efficiency.

What is Clearlane CAPA?

Clearlane CAPA is a cutting-edge application designed for Jira Cloud, specifically aimed at teams working in quality and regulatory compliance across industries like medical devices, pharmaceuticals, and ISO 9001 manufacturing. This app enables teams to convert existing Jira work items—such as complaints, nonconformities, deviations, and audit findings—into CAPAs without requiring extra issue types, workflows, or fields. It streamlines a systematic approach that includes containment measures, a Five Whys root-cause analysis, the development of a signed action plan, links to Jira actions, and a planned effectiveness evaluation; if the effectiveness assessment is found lacking, it reverts to the root-cause analysis stage. Users can also examine associated CAPAs, leverage JQL for CAPA data inquiries, export data in CSV format, and generate PDF documentation that encompasses workflow history, actions taken, signatures, and a thorough audit trail. Moreover, CAPAs can be initiated directly from requests submitted via Jira Service Management, and a read-only Rovo agent is available to address questions about CAPA records. Built on the Atlassian Forge platform, this application guarantees that all records are securely housed within the customer's Atlassian environment, ensuring a seamless integration experience. By adopting this distinctive method, teams in regulated sectors can significantly boost the efficiency and effectiveness of their quality management processes, ultimately leading to improved compliance outcomes. The app's user-friendly interface further enhances its accessibility, making it a valuable tool for organizations striving to maintain high standards in quality assurance.

Media

Media

Integrations Supported

Microsoft Excel
Microsoft Outlook

Integrations Supported

Atlassian Rovo
Jira
Jira Service Management

API Availability

Has API

API Availability

Pricing Information

$10,000/year
Includes all 25+ Modules. Unlimited Training and Support Available. Get a quote today.
Free Trial Offered?

Pricing Information

$10/month
Plans start at $10/month for up to 10 users. Larger teams pay per user, billed monthly or yearly through Atlassian Marketplace. A free trial is available with every plan. There is no setup fee.
Free Trial Offered?

Supported Platforms

SaaS
Windows
On-Prem

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub

Company Facts

Organization Name

QT9 Software

Date Founded

2005

Company Location

United States

Company Website

qt9software.com/qms

Company Facts

Organization Name

Clearlane Apps

Date Founded

2026

Company Location

France

Company Website

clearlaneapps.com/capa/

Categories and 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
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
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

FMEA

Not specified

Inspection

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

ISO Compliance

Not specified

Life Sciences

Not specified

Product Compliance

Not specified

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

Categories and Features

CAPA

Not specified

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