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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 BlueKanGo?

Transform your operations into a digital format by focusing on security, environmental concerns, qualitative measures, and hygiene standards within your business framework. Streamline and centralize your processes while automating tasks to enhance efficiency. With a single tool, you can effectively oversee your organization’s sustainability and overall performance. Automated workflows serve as the backbone of safety and productivity in any enterprise. BlueKanGo stands out as the comprehensive digital EHSQ platform designed for efficient management of these processes. For nearly two decades, BlueKanGo has gained the trust of over 3,500 customers, proving its reliability and effectiveness. This platform allows for the digitization of various aspects such as quality control, audits, employee health and safety, environmental management, CMMS inspections, certification compliance, corporate social responsibility (CSR), regulatory monitoring, and strategic planning. Six key differentiators highlight what sets BlueKanGo apart from its competitors. With a robust history of 18 years, BlueKanGo is a boundaryless SaaS platform offering an innovative, scalable, and all-encompassing solution for modern businesses. By choosing BlueKanGo, you are investing in a future-ready system that adapts to your evolving needs.

Media

Media

Integrations Supported

Microsoft 365
Microsoft Entra ID

Integrations Supported

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
Free Trial Offered?

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac

Supported Platforms

SaaS
Android

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

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

BlueKanGo

Date Founded

1998

Company Location

France

Company Website

www.bluekango.com/en/

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

Accreditation Management

Collaboration
Compliance Management
Document Management
Requirements Management
Reviewer Portal
Self Assessment
User Access Permissions
Workflow Management

Audit

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management

Business Process Management

Access Controls / Permissions
Alerts / Notifications
Business Process Automation
Business Rules Management
Collaboration
Process Change Tracking
Process Mapping
Visual Workflow Management

CAPA

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

Compliance

Archiving & Retention
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Document Control

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

Document Management

Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Indexing
Document Retention
Electronic Signature
File Recovery
File Type Conversion
Offline Access
Optical Character Recognition
Version Control

EHS Management

Audit Management
Corrective / Preventive Actions
Incident Management
Industrial Safety Management
Inspection Management
OSHA Recordkeeping
Occupational Health Management
Safety Risk Assessment
Training Management

Environmental

Auditing
Compliance Management
Document Management
Emissions Inventory
Hazardous Materials Control
Sustainability Management
Waste Management

Forms Automation

Archiving & Retention
Collaboration
Drag & Drop
Full Text Search
Version Control

Inspection

Appointment Management
Customer Database
Dispatch Management
Equipment Tracking
Photos In Reports
Print on Site
Report Templates
Speech Recognition
Subcontractor Management

Permit to Work

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

Risk Management

Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Exceptions Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment

Safety Management

Audit Management
Corrective / Preventive Actions
Incident Management
Inspection Management
OSHA Recordkeeping
Training Management

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