SimplerQMS Reviews & Ratings

SimplerQMS

3.0 out of 5 stars

Ratings and Reviews 2 Ratings

Total 3 out of 5 stars
ease 3 out of 5 stars
features 2.5 out of 5 stars
design 2.5 out of 5 stars
support 3.5 out of 5 stars

Ratings and Reviews 0 Ratings

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ease 0 out of 5 stars
features 0 out of 5 stars
design 0 out of 5 stars
support 0 out of 5 stars

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What is SimplerQMS?

SimplerQMS is a specialized electronic Quality Management System (eQMS) tailored specifically for organizations in the Life Sciences sector. Designed by industry experts, our eQMS ensures compliance with essential regulations such as FDA, ISO, and GxP by facilitating automated and audit-ready quality processes. The platform effectively centralizes and automates fundamental quality workflows within a fully validated, cloud-based system, allowing clients to minimize manual tasks, decrease errors, and maintain consistently organized records that are always inspection-ready. In contrast to standard QMS tools, SimplerQMS is pre-configured to meet the unique requirements of the Life Sciences industry, incorporating templates, workflows, and controls that align with FDA 21 CFR Part 11, 210/211, 820, EU Annex 11, ISO 13485:2016, and other relevant standards. Furthermore, clients benefit from a reliable partnership that provides extensive regulatory and quality knowledge, which includes access to audit-proven insights, advice from compliance experts, ongoing system validation, user training, round-the-clock global support, seamless implementation and data migration, along with dedicated Customer Success Experts. Our mission is to empower Life Science companies in efficiently managing quality and regulatory documentation, enabling organizations to thrive from initial growth stages to global operations while enhancing compliance, operational control, and fostering a robust quality culture. By leveraging our expertise, businesses can streamline their processes and ensure they meet the highest industry standards.

What is QUMAS EQMS?

To accelerate the launch of new products while ensuring compliance with international standards, businesses need to optimize and automate their processes for collecting, monitoring, analyzing data, and tackling associated issues. QUMAS EQMS, formerly known as ProcessCompliance, is a cloud-based solution crafted for Enterprise Quality and Process Management, providing comprehensive integrated tools for managing regulatory, quality, and compliance aspects within a validated Quality Management System (QMS) framework. Utilizing QUMAS’s data-driven approach, organizations can proficiently handle quality-related information and easily access valuable quality data, which guarantees a clear view into their quality environment. In addition, QUMAS offers interactive quality dashboards that summarize QMS performance across different business sectors and quality initiatives, enabling users to visualize progress effectively. The platform allows for the generation of reports that can be exported, shared through email, or scheduled for regular updates, making it a versatile tool for communication. Moreover, it supports secure, efficient, and compliant information sharing among departments involved in QMS, thus fostering collaboration and improving operational efficiency. Ultimately, QUMAS equips organizations to achieve their quality goals while adeptly managing the intricacies of regulatory compliance, positioning them for success in a competitive landscape.

Media

Media

Integrations Supported

Microsoft 365
Microsoft Entra ID

Integrations Supported

AssurX

API Availability

Has API

API Availability

Pricing Information

$17,500 / year
We offer subscription-based pricing with everything you need – integrated QMS modules, full implementation and onboarding, validation, user training, cloud hosting, QMS templates, data migration, and ongoing support. No hidden costs.
Free Trial Offered?

Pricing Information

Pricing not provided

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac

Supported Platforms

SaaS

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Online Training

Training Options

Documentation Hub
Webinars
On-Site Training

Company Facts

Organization Name

SimplerQMS

Date Founded

2017

Company Location

Denmark

Company Website

www.simplerqms.com

Company Facts

Organization Name

Dassault Systemes

Date Founded

1981

Company Location

France

Company Website

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

Categories and Features

Audit

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Forms Management
Issue Management
Mobile Access
Risk Assessment
Workflow Management

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Training Management

Compliance

Archiving & Retention
Audit Management
FDA Compliance
HIPAA Compliance
ISO Compliance
Risk Management
Version Control
Workflow / Process Automation

Document Control

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control

ISO Compliance

Not specified

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

Quality Management

Compliance Management
Corrective and Preventive Actions (CAPA)
Training Management

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