Average Ratings 0 Ratings
Average Ratings 10 Ratings
Description
In the realm of life sciences manufacturing, prioritizing quality is essential for success. An efficient quality assurance process that enables swift business decisions, maintains regulatory compliance, and guarantees top-notch product quality necessitates a strong system. Assure-IQ is specifically built to meet these demands. When paired with Caliber's Document Management and Training and Learning Management systems, companies can experience an unparalleled quality management journey with Assure-IQ. This solution is crafted to optimize the entire quality assurance framework. With over 30 customizable modules available, you can tailor a platform that meets your specific needs. Additionally, quality processes, document management, and training management can be seamlessly integrated to oversee the entire product lifecycle. The solutions offered, whether on-cloud or on-premise, are developed using cutting-edge technology to adapt to the evolving requirements of the industry. A versatile Quality Management System (QMS) that integrates smoothly with your organization’s existing systems empowers you to establish your own standards for quality excellence. Embracing such a robust system can significantly enhance your operational efficiency and product reliability.
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
Pricing Details
No price information available.
Free Trial
No
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
Yes
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
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
Caliber Technologies
Founded
2001
Country
India
Website
caliberuniversal.com/solutions/quality-management-system/
Vendor Details
Company Name
qmsWrapper
Country
Canada
Website
www.qmswrapper.com
Product Features
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
No
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
No
Maintenance Management
Yes
Risk Management
Yes
Supplier Quality Control
No
Training Management
Yes
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