Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

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.

Description

TraxQM is a risk-oriented Quality Management System (QMS) aimed at assisting organizations in navigating regulatory compliance, optimizing quality workflows, and boosting operational effectiveness via a unified, AI-driven platform. This system empowers businesses to adopt a proactive stance toward compliance by digitizing their procedures and implementing structured approaches that comply with global standards like ISO and GxP. Featuring essential modules for managing documents, conducting risk assessments, overseeing Corrective and Preventive Actions (CAPA), implementing change control, executing audits, and facilitating training, TraxQM allows teams to handle the entire spectrum of quality operations within a single system. The platform ensures data integrity through features like automated version control, audit trails, and compliant electronic signatures, which guarantee traceability and adherence to regulatory mandates. Furthermore, TraxQM utilizes artificial intelligence to bolster decision-making by evaluating risks, proposing specific control measures, and recommending pertinent Key Performance Indicators (KPIs) aligned with the organization’s goals, thereby enhancing overall quality management capabilities. Ultimately, this comprehensive QMS not only streamlines processes but also empowers teams to foster a culture of continuous improvement in their quality practices.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Microsoft 365
Docusign
Microsoft Entra ID

Integrations

Microsoft 365
Docusign
Microsoft Entra ID

Pricing Details

$13,750/year
Free Trial
Free Version

Pricing Details

$403.97 per month
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

SimplerQMS

Founded

2017

Country

Denmark

Website

www.simplerqms.com

Vendor Details

Company Name

TraxQM

Country

United States

Website

www.traxqm.com

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

Alternatives

QEdge Reviews

QEdge

Sarjen Systems Pvt Ltd

Alternatives

isoTracker Quality Management Reviews

isoTracker Quality Management

isoTracker Solutions Ltd
Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences
SoftExpert EQM Reviews

SoftExpert EQM

SoftExpert
QualityPro by TecWork Reviews

QualityPro by TecWork

TecWork Global Business Solutions Pvt. Ltd.
Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences