Quality ConnectMontrium
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Related Products
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About
Enterprise Quality Management Software in the cloud for the life sciences. In today’s complex operational environment, technology plays a vital role in ensuring that QA is made aware of the issues as they happen. Gaining insight into the performance of your quality management system and the current state of your operation helps you to be more proactive, which minimizes risk and eliminates costly delays. Montrium has designed its Enterprise Quality Management system (EQMS) to enable life science companies to tackle the quality challenges that they face in content management head-on. All of our SharePoint QMS modules can be used independently or together as a fully integrated quality management system. These modules are available as part of our Montrium Connect Platform and can be deployed on-premise or in the cloud. Perfect for pharmaceutical companies, contract manufacturing organizations, medical device companies. Built to achieve compliance with GMP and GCP requirements.
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About
qmsWrapper is a connected Quality Management System (eQMS) built specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, organizations can grow their QMS through three connected editions: Foundation, Lifecycle, and Vigilance.
Foundation helps companies move from paper forms, Word documents, and spreadsheets to controlled documents, workflows, training, and AI-assisted quality processes. Lifecycle adds CAPA, Quality Events, Change Control, Risk Management, Technical File management, Supplier Quality, and Smart Traceability Matrix. Vigilance extends the platform with post-market surveillance, regulatory oversight, audit readiness, and AI governance.
Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper helps companies scale their quality system without rebuilding or migrating to another platform.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Life science companies looking for an Enterprise Quality Management system (EQMS) to handle critical applications
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Audience
Medical Device Companies, MedTech Startups, SaMD, eQMS, ISO 13485, ISO 14971, FDA QMSR, EU MDR, Quality Management, Regulatory Affairs, Quality Assurance, CAPA, Risk Management, Technical File, Traceability
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Free Trial
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Pricing
€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
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Reviews/
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Reviews/
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Pros & Cons from Real UsersPros
Cons
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationMontrium
Canada
www.montrium.com
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Company InformationqmsWrapper
Canada
www.qmswrapper.com
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Categories |
Categories |
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Quality Management Features
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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Quality Management Features
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
CAPA Features
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
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