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What is isoTracker Quality Management?

isoTracker Quality Management is a widely recognized cloud-based quality management software (QMS) that serves organizations globally in overseeing their compliance with various ISO standards such as ISO 9001, ISO 13485, ISO 22000, ISO 17025, and ISO 14001, among others. This versatile solution is designed as a modular platform, allowing businesses to tailor it according to their unique needs while maintaining a competitive pricing structure and providing exceptional customer support. Organizations can choose from a variety of modules, including Document Control, Complaints, CAPA, Audits, Training, Non-Conformance, and Risk, to create a customized quality management system that addresses all aspects of their operations effectively. By utilizing isoTracker, companies can enhance their quality management processes and ensure ongoing compliance with industry standards.

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

Integrations Supported

Atlassian Rovo
Confluence

API Availability

API Availability

Pricing Information

$17 USD/month/user
Recurring subscription pricing based on number of users and modules
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

Supported Platforms

SaaS

Customer Service / Support

Web-Based Support

Customer Service / Support

Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training

Training Options

Documentation Hub

Company Facts

Organization Name

isoTracker Solutions Ltd

Date Founded

2004

Company Location

United Kingdom

Company Website

www.isotracker.com

Company Facts

Organization Name

Clearlane Apps

Date Founded

2026

Company Location

France

Company Website

clearlaneapps.com/controlled-documents/

Categories and Features

CAPA

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

Document Control

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

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Risk Management
Training Management

Categories and Features

Document Control

Not specified

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