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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.

What is Grand Avenue Software?

An online software solution tailored for medical device manufacturers that streamlines their operations and eases adherence to regulatory standards. This suite features modules such as Audit Management, Corrective and Preventive Actions (CAPA), and Complaint Handling. It has been specifically developed to ensure compliance with ISO 13485 and 21 CFR Part 11 from the outset, providing a robust framework for quality management. Additionally, its user-friendly interface allows companies to efficiently navigate complex compliance requirements while maintaining high standards of product safety and effectiveness.

Media

No images available

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Has API

Pricing Information

$17/month/user
Free Trial Offered?

Pricing Information

Pricing not provided
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Online Training

Training Options

Documentation Hub
Webinars
Online Training

Company Facts

Organization Name

QFacts

Date Founded

2024

Company Location

Belgium

Company Website

qfacts.be

Company Facts

Organization Name

Grand Avenue Software

Date Founded

2002

Company Location

United States

Company Website

www.grandavenue.com

Categories and Features

Quality Management

Not specified

Categories and Features

Calibration Management

Calibration Instructions
Calibration Schedules
Due Date Tracking

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Training Management

Change Management

Approval Workflow
Audit Trail
Release Management
Task Management
Training Management

Complaint Management

Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Issue Tracking
Quality Assurance Management
Routing

Document Version Control

Access Controls/Permissions
Approval Process Control
Audit Trail
Revision History

Equipment Management

Not specified

Preventive Maintenance

Maintenance Scheduling
Reminders

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Vendor Management

Audit Management
Vendor Qualification Tracking

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