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features
design
support

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Description

8Dflow is an innovative, online Quality Management System (QMS) tailored for manufacturing teams, integrating non-conformance management, root cause analysis, and the 8D problem-solving approach into a unified collaborative platform. Highlighted Features: • Comprehensive 8D report creation and tracking of non-conformances (NCR/SCAR). • Streamlined CAPA workflows with automated task assignments and containment monitoring. • Integrated root cause analysis tools, including the 5 Whys and Fishbone/Ishikawa methods. • Live analytics and dashboards for tracking defect resolution and cycle time metrics. • Preparedness for audits and compatibility with ISO 9001 and IATF 16949 standards. With a focus on quick implementation and user-friendly adoption, 8Dflow empowers quality engineers and plant managers to minimize recurring defects while enhancing continuous improvement initiatives across various facilities. Additionally, its collaborative nature fosters teamwork, enabling teams to tackle quality issues more effectively.

Description

SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry. SimplerQMS helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others. The system is fully validated according to GAMP5. The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more. SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel. Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.

API Access

Has API

API Access

Has API

Screenshots View All

No images available

Screenshots View All

Integrations

Microsoft 365
Microsoft Entra ID

Integrations

Microsoft 365
Microsoft Entra ID

Pricing Details

$299/month
Free Trial
Free Version

Pricing Details

$13,750/year
Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

8Dflow

Founded

2026

Country

Australia

Website

8dflow.com

Vendor Details

Company Name

SimplerQMS

Founded

2017

Country

Denmark

Website

www.simplerqms.com

Product Features

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

Product Features

Audit

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
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
Artificial Intelligence (AI)
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

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

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