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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 Qualcy QMS?

Qualcy Biomed's quality management system (QMS) software is tailored specifically for biomedical enterprises, such as those in biotechnology and pharmaceuticals, to effectively handle QMS documentation in line with FDA and ISO 13485 standards. It ensures adherence to 21 CFR Part 820 and incorporates essential features like electronic signatures, audit trails, and compliance with 21 CFR Part 11. Additionally, the software facilitates the management of document change control, complaint handling, audits, corrective and preventive actions (CAPA), non-conformance records, and training records, among other critical functions, ensuring a comprehensive solution for quality management. This robust platform ultimately supports organizations in maintaining high standards of compliance and operational efficiency in their quality processes.

Media

Media

Integrations Supported

AWS Backup
AWS Cloud9
Gmail
Jira
Microsoft 365
Microsoft Azure
Microsoft Outlook
SAP Analytics Cloud

Integrations Supported

AWS Backup
AWS Cloud9
Gmail
Jira
Microsoft 365
Microsoft Azure
Microsoft Outlook
SAP Analytics Cloud

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

$799 per month
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

Qualcy Systems

Date Founded

2014

Company Location

United States

Company Website

www.qualcy.com

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

Calibration Management

Calibration Instructions
Calibration Schedules
Compliance Management
Device History
Due Date Tracking
Gage Management
Label Printing
Measurement Readings
Multi-Station Management
Out-of-Tolerance Notification
Statistical Data Reporting

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

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