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What is Qualtrax?

Qualtrax is an advanced software solution designed for quality and compliance that facilitates the management and control of documentation, automates essential business processes, optimizes training management, oversees both internal and external audits, and guarantees adherence to vital industry regulations in real-time. This software proves to be an essential tool for organizations operating within tightly regulated sectors that must comply with standards like ISO 17025, 17020, 13485, 9001, TNI, GFSI, FDA, and FQS. By integrating these functionalities, Qualtrax not only enhances operational efficiency but also helps organizations mitigate risks associated with non-compliance.

What is Clearlane Controlled Documents?

Clearlane Controlled Documents provides a specialized document control system tailored for quality management frameworks within Confluence Cloud, effectively converting standard documentation such as SOPs, work instructions, and policies into regulated entries. Each document revision is verified by designated approvers who employ a distinctive personal signing password; this electronic signature is meticulously connected to the document content via a SHA-256 fingerprint, guaranteeing that any modifications during the review process will render the signature invalid. Upon securing the final signature, the revision is recognized as effective and is assigned a future review date. Readers can confirm that they are viewing the latest revision, and regular reviews trigger reminder notifications, while a comprehensive register tracks all documents within each designated space. Users can also generate a detailed evidence PDF, which encompasses signatures, revision histories, read confirmations, and an audit trail. This solution is ideal for teams operating in the pharmaceutical, biotech, medtech, and ISO 9001 quality sectors, and it is offered in English, French, and German. Furthermore, it supports compliance with regulations such as 21 CFR Part 11, EU GMP Annex 11, and ISO 13485 standards. Built on the Atlassian Forge platform, it ensures that data is securely stored within the client’s Atlassian environment, thus maintaining both compliance and data integrity. The application also features a user-friendly interface that facilitates the management of controlled documents for users in a variety of industries, making it an invaluable tool for maintaining regulatory standards and improving organizational efficiency.

Media

Media

Integrations Supported

Brandwatch
Microsoft 365

Integrations Supported

Atlassian Rovo
Confluence

API Availability

API Availability

Pricing Information

Pricing is determined on a per-user basis, with multiple license types available. Please contact us for a quote regarding your specific situation.
Free Trial Offered?

Pricing Information

$0
Free for up to 10 users. Larger teams pay per user, billed by Atlassian through the Marketplace.
Free Version
Free Trial Offered?

Supported Platforms

SaaS
Windows
Mac

Supported Platforms

SaaS

Customer Service / Support

Standard Support
24 Hour 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

Qualtrax

Date Founded

1993

Company Location

United States

Company Website

www.qualtrax.com

Company Facts

Organization Name

Clearlane Apps

Date Founded

2026

Company Location

France

Company Website

clearlaneapps.com/controlled-documents/

Categories and Features

Accreditation Management

Collaboration
Compliance Management
Document Management
Higher Education
Requirements Management
Self Assessment
User Access Permissions
Workflow Management

Audit

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Issue Management
Mobile Access
Risk Assessment
Workflow Management

Compliance

Archiving & Retention
Audit Management
Compliance Tracking
Environmental Compliance
FDA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Version Control
Workflow / Process Automation

Document Control

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

Document Management

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
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

Equipment Management

Not specified

ISO 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

Document Control

Not specified

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