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

Aligned provides a purpose built eQMS and design management solution created exclusively for medical device and in vitro diagnostic manufacturers. It addresses the demands of global regulatory compliance while removing the friction typically associated with traditional QMS tools. The system enables organizations to operate in line with key regulations and standards including ISO 13485, FDA QSMR, EU MDR, and IVDR. It is relied upon by experienced quality and development professionals who require transparency, control, and consistency across all stages of product development and post market activities. Aligned brings quality management and design control together in a single coherent platform that supports cross functional teamwork. Quality, regulatory, R and D, and leadership teams work within the same controlled environment, where requirements, design data, verification and validation activities, risk files, and changes are inherently linked. This built in connectivity delivers complete traceability and clear evidence for audits, inspections, and regulatory submissions.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Microsoft 365
Microsoft Entra ID
Redmine

Integrations

Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Microsoft 365
Microsoft Entra ID
Redmine

Pricing Details

$13,750/year
Free Trial
Free Version

Pricing Details

€1300 per year
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

Aligned AG

Founded

2007

Country

Switzerland

Website

www.aligned.ch/

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

Product Features

Application Lifecycle Management

Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control

Requirements Management

Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

Alternatives

QEdge Reviews

QEdge

Sarjen Systems Pvt Ltd

Alternatives

isoTracker Quality Management Reviews

isoTracker Quality Management

isoTracker Solutions Ltd
ReqView Reviews

ReqView

Eccam
Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences
Kovair ALM-PLM CoE Reviews

Kovair ALM-PLM CoE

Kovair Software
QualityPro by TecWork Reviews

QualityPro by TecWork

TecWork Global Business Solutions Pvt. Ltd.