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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 QFacts?

QFacts is an all-encompassing cloud-driven Quality Management System tailored for pharmacies, compounding facilities, and other regulated industries. It manages the full spectrum of the quality lifecycle, offering features such as controlled document management with versioning and approval processes, training and competency tracking aligned with specific curricula, and comprehensive event and complaint management that includes root cause analysis, CAPA management, and change control, all while maintaining detailed audit trails. Designed to meet GAMP 5 requirements, it also adheres to European GMP and GDP regulations, utilizing role-based access controls that integrate across various organizations, locations, and departments. Quality managers benefit from customizable review workflows, the ability to monitor due dates, and compliance oversight through real-time dashboards. Every action within the system is logged meticulously, ensuring a transparent accountability chain for inspectors and auditors, from document approval to training completion and the resolution of corrective measures. This thorough level of oversight not only boosts operational efficiency but also instills greater reliability within quality management processes. As a result, QFacts positions itself as an essential tool for organizations striving to maintain high standards of quality and compliance.

Media

Media

No images available

Integrations Supported

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

Integrations Supported

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

API Availability

Has API

API Availability

Has API

Pricing Information

$799 per month
Free Trial Offered?
Free Version

Pricing Information

$17/month/user
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Qualcy Systems

Date Founded

2014

Company Location

United States

Company Website

www.qualcy.com

Company Facts

Organization Name

QFacts

Date Founded

2024

Company Location

Belgium

Company Website

qfacts.be

Categories and Features

Calibration Management

Calibration Instructions
Calibration Schedules
Compliance Management
Device History
Due Date Tracking
Gage Management
Label Printing
Measurement Readings
Multi-Station Management
Out-of-Tolerance Notification
Statistical Data Reporting

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

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

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