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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 Read & Understood?

Clearlane Read & Understood is an application for Confluence Cloud that assigns standard operating procedures (SOPs), policies, and various documents to individuals or groups, mandating read confirmations by a specified deadline. This application carefully logs the identity of each reader, the date of their confirmation, the page version, and its SHA-256 fingerprint, necessitating new confirmations whenever updates are made to the document. It also includes optional multiple-choice quizzes to test comprehension, sends deadline reminders, provides a comprehensive overview of user statuses at the space level, and allows for personal reading lists, thereby aiding teams in tracking outstanding acknowledgments. Administrators can easily export data in CSV format and create per-page PDF training documents for auditing; they can also include a signing password to streamline workflows that adhere to 21 CFR Part 11 compliance. Primarily aimed at quality assurance and training teams in the pharmaceutical, biotechnology, medical device industries, and ISO 9001 compliant settings, the application supports multiple languages, including English, French, and German. Additionally, it functions effortlessly on the Atlassian Forge platform within the Confluence Cloud environment, making it a reliable tool for enhancing accountability and ensuring that critical documents are fully understood and reviewed by all necessary personnel. By integrating these features, the application significantly contributes to maintaining high standards of compliance and training efficacy.

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 through Atlassian Marketplace, billed monthly or yearly; the price varies by team size.
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/read-and-understood/

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

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