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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 QualityKick?

QualityKick is an innovative cloud-based Quality Management System (QMS) specifically designed for the biological sciences industry, aimed at improving compliance and optimizing numerous quality management activities. It is equipped with various modules that tackle essential elements like document control, training, change management, incident tracking, CAPA (Corrective and Preventive Actions), risk assessment, qualification, along with audits for suppliers and equipment. As a web-based solution, it guarantees accessibility from any location and supports all mobile devices, including desktops, smartphones, and tablets. New users enjoy an automated guided tour during their first login, which helps to ease the onboarding process. The platform facilitates document editing through MS Word and offers a customizable review and approval workflow that boosts teamwork and efficiency. Users can tailor various event types, such as deviations, nonconformities, and customer complaints, to meet their specific organizational requirements. Moreover, it empowers users to create CAPA plans, document needed actions, and evaluate their effectiveness, providing a thorough solution for quality management in the pharmaceutical, biotechnology, and medical sectors. With its intuitive interface and comprehensive set of features, QualityKick is set to revolutionize how organizations address quality compliance and enhance their overall operational effectiveness. This innovative approach not only streamlines processes but also fosters a culture of continuous improvement within organizations.

Media

Media

Integrations Supported

Jira
Microsoft Word

Integrations Supported

Jira
Microsoft Word

API Availability

Has API

API Availability

Has API

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 Version
Free Trial Offered?

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

qmsWrapper

Company Location

Canada

Company Website

www.qmswrapper.com

Company Facts

Organization Name

SoftDoit

Company Location

Spain

Company Website

www.softwaredoit.es/qualitykick/qualitykick.html

Categories and Features

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident 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
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Categories and Features

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