Qualcy QMS

Qualcy QMS

Qualcy Systems
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About

QFacts is a cloud-based Quality Management System for pharmacies, compounding facilities, and regulated industries. It covers the full quality lifecycle: controlled document management with version control and approval workflows, training and competency tracking with curriculum-based assignments, event and complaint handling, root cause investigations, CAPA management, and change control. All with complete audit trails. Built for GAMP 5 and European GMP/GDP compliance, QFacts enforces role-based access control across organisations, sites, and departments. Quality managers configure review workflows, track due dates, and monitor compliance through real-time dashboards. Every action is logged and traceable, giving inspectors and auditors a clear chain of accountability from document approval through training completion to corrective action closure.

About

Qualcy Bio-Med QMS Software has been designed for Bio-Medical companies (including Biotech, Pharma and Medical Device) to manage QMS records for ISO13485 and FDA requirements. * Designed for meeting the requirements for 21 CFR Part 820 * Has built in features for E-sign, audit trails and complies with 21 CFR part 11 requirements. This software helps manage the records for Doc. change control, complaints, audits, CAPA, NC Records, Training Records and more.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Quality managers, pharmacists, and compliance officers in GMP/GDP-regulated compounding pharmacies and healthcare organisations.

Audience

Bio-Medical companies (including Biotech, Pharma and Medical Device)

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

No images available

Screenshots and Videos

Pricing

$17/month/user
Free Version
Free Trial

Pricing

$799 per month
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Overall 5.0 / 5
ease 5.0 / 5
features 5.0 / 5
design 4.0 / 5
support 5.0 / 5

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

QFacts
Founded: 2024
Belgium
qfacts.be

Company Information

Qualcy Systems
Founded: 2014
United States
www.qualcy.com

Alternatives

Alternatives

Total Lean Management (TLM) Software

Total Lean Management (TLM) Software

Lean & Mean Business Systems
CAPA Manager

CAPA Manager

Adaptive Business Management Systems
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
isoTracker Quality Management

isoTracker Quality Management

isoTracker Solutions Ltd

Categories

Categories

Quality Management Features

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

Calibration Management Features

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

Integrations

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

Integrations

AWS Backup
AWS Cloud9
Gmail
Microsoft 365
Microsoft Azure
Microsoft Outlook
SAP Analytics Cloud
Claim QFacts and update features and information
Claim QFacts and update features and information
Claim Qualcy QMS and update features and information
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