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What is Qualcy QMS?

Qualcy Biomed's quality management system (QMS) software is tailored specifically for biomedical enterprises, such as those in biotechnology and pharmaceuticals, to effectively handle QMS documentation in line with FDA and ISO 13485 standards. It ensures adherence to 21 CFR Part 820 and incorporates essential features like electronic signatures, audit trails, and compliance with 21 CFR Part 11. Additionally, the software facilitates the management of document change control, complaint handling, audits, corrective and preventive actions (CAPA), non-conformance records, and training records, among other critical functions, ensuring a comprehensive solution for quality management. This robust platform ultimately supports organizations in maintaining high standards of compliance and operational efficiency in their quality processes.

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

AWS Backup
AWS Cloud9
Gmail
Microsoft 365
Microsoft Azure
Microsoft Outlook
SAP Analytics Cloud

Integrations Supported

Atlassian Rovo
Confluence

API Availability

API Availability

Pricing Information

$799 per month
Free Version
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
Android
iPhone
iPad
Windows

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

Qualcy Systems

Date Founded

2014

Company Location

United States

Company Website

www.qualcy.com

Company Facts

Organization Name

Clearlane Apps

Date Founded

2026

Company Location

France

Company Website

clearlaneapps.com/controlled-documents/

Categories and Features

Calibration Management

Calibration Instructions
Calibration Schedules
Compliance Management
Due Date Tracking
Gage Management
Label Printing

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

Automated Routing
Change Management
Electronic Signature
Escalation Management
Periodic Review
Version Control

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