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Average Ratings 10 Ratings

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support

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 

Screenshots View All

Screenshots View All

Integrations

EPIQ QMS by Caliber Yes 
Jira No 

Integrations

EPIQ QMS by Caliber No 
Jira Yes 

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 

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