Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Average Ratings 10 Ratings

Total
ease
features
design
support

Description

To expedite the introduction of new products while adhering to international regulations, companies must streamline and automate their processes for gathering, monitoring, analyzing information, and addressing related challenges. QUMAS EQMS, previously known as ProcessCompliance, is a cloud-based platform designed for Enterprise Quality and Process Management, offering extensive integrated solutions for regulatory, quality, and compliance management within a validated Quality Management System (QMS) framework. By leveraging QUMAS’s data-centric methodology, organizations can adeptly manage quality-related content and easily access and repurpose quality data, ensuring thorough visibility into the quality landscape. Furthermore, QUMAS features interactive quality dashboards that provide an overview of QMS performance across various business sectors and quality initiatives. Users can generate reports that are easily exportable, shareable via email, or scheduled for regular updates. This platform also facilitates secure, efficient, and compliant information exchange among QMS departments in the cloud, enhancing collaboration and operational efficiency. Ultimately, QUMAS empowers organizations to meet their quality objectives while navigating the complexities of regulatory compliance.

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

AssurX Yes 
Jira No 

Integrations

AssurX 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 Yes 
Live Training (Online) No 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

Dassault Systemes

Founded

1981

Country

France

Website

www.3ds.com/products-services/biovia/products/life-sciences-quality-and-compliance/qumas-eqms/

Vendor Details

Company Name

qmsWrapper

Country

Canada

Website

www.qmswrapper.com

Product Features

Quality Management

Audit Management No 
Complaint Management No 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking No 
Document Control No 
Equipment Management No 
ISO Standards Management No 
Maintenance Management No 
Risk Management No 
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 

Alternatives

Alternatives

SoftExpert EQM Reviews

SoftExpert EQM

SoftExpert
Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences