Average Ratings 0 Ratings
Average Ratings 10 Ratings
Description
QFacts is a comprehensive cloud-based Quality Management System designed specifically for pharmacies, compounding facilities, and other regulated sectors. It encompasses the entire quality lifecycle, featuring controlled document management with versioning and approval workflows, training and competency tracking with curriculum-aligned assignments, as well as event and complaint management, root cause analysis, CAPA oversight, and change control, all accompanied by thorough audit trails. This system is built to comply with GAMP 5 and adhere to European GMP and GDP standards, employing role-based access controls that span organizations, locations, and departments. Quality managers can customize review workflows, keep track of due dates, and oversee compliance via real-time dashboards. Each action taken within the system is meticulously logged and traceable, providing inspectors and auditors with a transparent chain of accountability that extends from document approval through to the completion of training and the resolution of corrective actions. By ensuring such detailed oversight, QFacts significantly enhances the overall efficiency and reliability of quality management processes.
Description
qmsWrapper is a connected Quality Management System (eQMS) built for medical device startups and SMEs. It helps organizations move from paper forms, Word documents, and spreadsheets to a scalable, AI-enabled QMS that grows with their business through Foundation, Lifecycle, and Vigilance. Designed for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper connects documents, quality events, risk, training, CAPA, technical documentation, and traceability in one platform.
Best For:
- Medical device and SaMD companies implementing or modernizing an ISO 13485 QMS.
- Startups and SMEs that want to grow from controlled documents to connected quality workflows without replacing their QMS.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
No images available
Integrations
Jira
No
Pricing Details
$17/month/user
Free Trial
Yes
Free Version
No
Pricing Details
€3,499
Foundation starts at €3,499 per year with unlimited users. Lifecycle and Vigilance pricing is available on request. All editions are designed to grow with your quality management needs without requiring migration to a new platform.
Free Trial
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
Yes
Linux
Yes
Chromebook
No
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
QFacts
Founded
2024
Country
Belgium
Website
qfacts.be
Vendor Details
Company Name
qmsWrapper
Country
Canada
Website
www.qmswrapper.com
Product Features
Quality Management
Audit Management
No
Complaint Management
No
Compliance Management
No
Corrective and Preventive Actions (CAPA)
No
Defect Tracking
No
Document Control
No
Equipment Management
No
ISO Standards Management
No
Maintenance Management
No
Risk Management
No
Supplier Quality Control
No
Training Management
No
Product Features
CAPA
Audit Management
Yes
CAPA Planning
Yes
Change Management
Yes
Complaint Management
Yes
Incident Management
No
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
Yes
Root Cause Analysis
Yes
Training Management
Yes
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
No
ISO Standards Management
Yes
Maintenance Management
No
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes