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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 QMS Manager PRO?

QMS Manager PRO is an independent, web-based quality management system tailored for small businesses, quality management experts, and ISO 9001 consultants. This all-inclusive tool encompasses eight vital modules—dashboard and KPIs, document management, training and competency, internal audits, nonconformities and CAPA, customer complaints, risks and opportunities, and management review—consolidated into a single local interface. Users can efficiently manage quality documentation, plan and carry out audits, track corrective actions and training programs, assess risks, and execute improvement plans. The software runs locally on Windows via Google Chrome, employs a local data structure for data storage, and provides functionalities such as CSV exports, PDF reporting, and backup and restore options. Offered as a one-time digital purchase, it eliminates the need for recurring subscription costs and is not designed for cloud collaboration or ISO certification services. This makes it a perfect option for organizations looking for a comprehensive and self-reliant quality management tool, ensuring they can maintain high standards without external dependency. Moreover, the user-friendly interface and extensive features empower small enterprises to enhance their quality assurance processes effectively.

Media

Media

Integrations Supported

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

Integrations Supported

API Availability

API Availability

Pricing Information

$799 per month
Free Version
Free Trial Offered?

Pricing Information

€95.59 one-time
The regular price is €95.59 as a one-time purchase, with no mandatory monthly subscription. The final price and applicable taxes are confirmed at Etsy checkout.

Supported Platforms

SaaS
Android
iPhone
iPad
Windows

Supported Platforms

Windows
On-Prem

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

Webinars

Company Facts

Organization Name

Qualcy Systems

Date Founded

2014

Company Location

United States

Company Website

www.qualcy.com

Company Facts

Organization Name

ToolsForQuality

Date Founded

2024

Company Location

Netherlands

Company Website

www.toolsforquality.com/qms-manager-pro

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

Quality Management

Not specified

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