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

Total 0 out of 5 stars
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 Enzyme QMS?

Our Quality Management System (QMS) features extensive modules that address every stage of the product life cycle, from Design Control to Corrective and Preventive Actions (CAPA). We provide your entire team with training and stand ready to support you whenever you need assistance. Enzyme Consulting, LLC. focuses on customizing and executing your Quality System to align with your unique requirements. After you finish the onboarding process, our team remains available for ongoing conversations and to answer any questions you might have. Established by experienced industry experts who were dissatisfied with existing QMS solutions, Enzyme's system is specifically crafted for life science companies, emphasizing the distinct challenges associated with developing FDA-regulated software. With the backing of our dedicated consultants, you can confidently bring your product to market. Our consultants not only have direct experience in the medical device industry but also excel in accurately assessing risks, which enables them to deeply understand the challenges encountered during product development. This comprehensive support ensures that you are not navigating these complexities on your own, allowing for a more seamless journey to successful product launch. Furthermore, our commitment to your success means we are continuously evolving our services to better meet your needs.

Media

Media

Integrations Supported

Microsoft 365
Microsoft Entra ID

Integrations Supported

GitHub
Jenkins
Jira

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

Web-Based Support

Training Options

Documentation Hub
Online Training

Training Options

Not specified

Company Facts

Organization Name

SimplerQMS

Date Founded

2017

Company Location

Denmark

Company Website

www.simplerqms.com

Company Facts

Organization Name

Enzyme

Date Founded

2016

Company Location

United States

Company Website

www.enzyme.com

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

Not specified

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