Ratings and Reviews 11 Ratings

Total 4.5 out of 5 stars
ease 4.5 out of 5 stars
features 4.5 out of 5 stars
design 4 out of 5 stars
support 5 out of 5 stars

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features 0 out of 5 stars
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support 0 out of 5 stars

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What is qmsWrapper?

qmsWrapper is a connected Quality Management System (eQMS) designed specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, companies can start with Foundation and expand to Lifecycle and Vigilance as their quality system matures. Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper connects document control, training, CAPA, quality events, risk management, technical documentation, supplier quality, and traceability in one platform. AI assists users with quality processes while every action remains human-controlled and fully auditable. Start where the need is greatest. Keep everything you build. Grow your QMS without rebuilding or migrating to another system.

What is iPassport?

iPassport serves as a sophisticated software solution specifically designed for healthcare laboratories, with the goal of improving digitization, organization, and the management of quality and compliance on a daily basis. This platform includes a wide range of quality management modules that facilitate the oversight of various elements, from document control to employee training processes. All managed documents are centralized for convenience, equipped with specific access and editing rights, and feature complete revision histories for accountability. It contains all the essential tools required for effectively handling both internal and external audits. Users can document and track non-conformities, corrective measures, and incidents, while also overseeing staff training, competencies, tasks, meetings, and leave schedules. Furthermore, it boasts a comprehensive supplier database and auditing tool that features performance assessments. The system is adept at managing and monitoring assets and inventory, ensuring that detailed maintenance records for all equipment are maintained. By utilizing iPassport, healthcare laboratories can enhance their operational efficiency, uphold regulatory compliance, and facilitate a culture of continuous improvement. This ultimately enables laboratories to deliver higher quality care and improve patient outcomes.

Media

Media

Integrations Supported

Jira

Integrations Supported

API Availability

API Availability

Pricing Information

€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 Offered?

Pricing Information

Pricing not provided

Supported Platforms

SaaS
Windows
Mac
Linux

Supported Platforms

SaaS

Customer Service / Support

Web-Based Support

Customer Service / Support

Not specified

Training Options

Documentation Hub
Online Training

Training Options

Not specified

Company Facts

Organization Name

qmsWrapper

Company Location

Canada

Company Website

www.qmswrapper.com

Company Facts

Organization Name

Genial Genetic Solutions

Company Location

United Kingdom

Company Website

www.genialcompliance.com/products/ipassport/

Categories and Features

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Quality Management

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

Categories and Features

Medical Lab

Not specified

Quality Management

Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Document Control
Equipment Management

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