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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 Quality Connect?

Cloud-based Enterprise Quality Management Software designed specifically for the life sciences industry is crucial for successfully navigating the complexities of today's operational environment. By placing technology at the center of operations, it enables quality assurance teams to be swiftly alerted to emerging issues, which cultivates a proactive management culture. Organizations that achieve a comprehensive understanding of their quality management system's performance in relation to operational conditions can effectively mitigate risks and sidestep costly delays. Montrium has developed its Enterprise Quality Management System (EQMS) with the specific aim of assisting life science companies in tackling their unique quality management hurdles, especially in the area of content management. Our SharePoint QMS modules are crafted with adaptability in mind; they can operate autonomously or integrate seamlessly into a unified quality management system. Accessible via our Montrium Connect Platform, these modules can be deployed either on-premises or through cloud-based solutions, making them particularly suitable for pharmaceutical companies, contract manufacturing organizations, and medical device manufacturers. Each module is carefully constructed to ensure adherence to Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP), thus helping organizations uphold the highest standards of quality. This all-encompassing approach not only boosts operational efficiency but also fortifies the integrity of the quality management process, reinforcing the commitment to excellence within the life sciences sector. As a result, companies can better navigate regulatory landscapes while achieving their business objectives.

Media

Media

Integrations Supported

Microsoft 365
Microsoft Entra ID

Integrations Supported

Montrium Connect

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
On-Prem

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
Online Training
On-Site Training

Company Facts

Organization Name

SimplerQMS

Date Founded

2017

Company Location

Denmark

Company Website

www.simplerqms.com

Company Facts

Organization Name

Montrium

Company Location

Canada

Company Website

www.montrium.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

Life Sciences

Not specified

Quality Management

Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
ISO Standards Management
Risk Management
Training Management

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