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Average Ratings 11 Ratings

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Description

Document control made easy. You can create, review/approve and revise documents, as well as retire them. All transactions are recorded using e-signatures, timestamps, and stored in the Audit Trail. Audits from start-to-finish The SOLABS QM10 Audit APP allows you to track and document all aspects of your audits, from planning and preparation to closing. The SOLABS QM Essentials package offers advanced reporting capabilities and intuitive reporting. Trending and tracking are critical components of any quality management system. The dashboards and reports are easy-to-use, customizable, and can be shared in the most popular formats such as Excel, PowerPoint and PDF. You can share the reports and dashboards with anyone in your organization. In a matter of seconds, you can create, schedule, monitor, and assign training. Online assessments can be used to validate the learnings of your team. You can manage all aspects of training with the SOLABS QM Training section.

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

Jira No 

Integrations

Jira Yes 

Pricing Details

No price information available.
Free Trial Yes 
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 Yes 
iPad App Yes 
Android App Yes 
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) Yes 
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) Yes 
In Person Yes 

Types of Training

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

Vendor Details

Company Name

SOLABS

Founded

2002

Country

United States

Website

www.solabs.com

Vendor Details

Company Name

qmsWrapper

Country

Canada

Website

www.qmswrapper.com

Product Features

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 Yes 
ISO Standards Management Yes 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
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 

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