Average Ratings 1 Rating

Total
ease
features
design
support

Average Ratings 1 Rating

Total
ease
features
design
support

Description

Arena PLM helps high-tech, medical device, life science, and aerospace and defense companies design, produce, and deliver innovative products quickly. Arena enables every participant throughout new product development (NPD) and new product introduction (NPI) to collaborate more effectively while ensuring regulatory compliance with FDA, ISO, ITAR, EAR, and environmental requirements.

Description

SimplerQMS is an expert-driven electronic Quality Management System (eQMS) purpose-built for Life Science organizations. Our eQMS is designed by professionals with deep industry experience and supports compliance with FDA, ISO, and GxP requirements through automated, audit-ready quality processes. The platform centralizes and automates core quality workflows within a cloud-based, fully validated system. Customers benefit from reduced manual work, fewer errors, and consistently organized, inspection-ready records. Unlike generic QMS tools, SimplerQMS comes pre-configured for Life Science needs, with built-in templates, workflows, and controls aligned with FDA 21 CFR Part 11, 210/211, 820, EU Annex 11, ISO 13485:2016, and other applicable standards. Beyond software, customers gain a trusted partner backed by deep regulatory and quality expertise. This includes: • Audit-proven insights • Guidance from compliance specialists • Continuous system validation • User training • 24/7 global support • Smooth implementation and data migration • Dedicated Customer Success Experts With a mission to help Life Science companies manage quality and regulatory documentation efficiently, SimplerQMS supports organizations from early-stage growth to global scale to strengthen compliance, operational control, and quality culture.

API Access

Has API Yes 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Allegro X Design Platform Yes 
Cofactr Yes 
Essenvia Yes 
Expandable Yes 
FlowEQ Yes 
IdoSell Yes 
Kenandy Yes 
Leverage Yes 
Manufacturo Yes 
Microsoft 365 No 
Microsoft Dynamics GP Yes 
Microsoft Entra ID No 
NetSuite Yes 
OrCAD X Yes 
Puntt AI Yes 
Rimsys Yes 
SOLIDWORKS Yes 
Sage 300 Yes 
Zendesk Yes 
xTuple Yes 

Integrations

Allegro X Design Platform No 
Cofactr No 
Essenvia No 
Expandable No 
FlowEQ No 
IdoSell No 
Kenandy No 
Leverage No 
Manufacturo No 
Microsoft 365 Yes 
Microsoft Dynamics GP No 
Microsoft Entra ID Yes 
NetSuite No 
OrCAD X No 
Puntt AI No 
Rimsys No 
SOLIDWORKS No 
Sage 300 No 
Zendesk No 
xTuple No 

Pricing Details

Contact vendor
Free Trial Yes 
Free Version No 

Pricing Details

$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 Yes 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App Yes 
iPad App Yes 
Android App Yes 
Windows Yes 
Mac Yes 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

Arena by PTC

Founded

2000

Country

United States

Website

www.arenasolutions.com

Vendor Details

Company Name

SimplerQMS

Founded

2017

Country

Denmark

Website

www.simplerqms.com

Product Features

Product Lifecycle Management

Change Management Yes 
Compliance Management Yes 
Cost Tracking Yes 
Design Management Yes 
Document Management Yes 
Product Data Management Yes 
Project Management Yes 
Requirements Management Yes 
Supplier Management Yes 

Product Features

Audit

Alerts / Notifications Yes 
Audit Planning Yes 
Compliance Management Yes 
Dashboard Yes 
Exceptions Management No 
Forms Management Yes 
Issue Management Yes 
Mobile Access Yes 
Multi-Year Planning No 
Risk Assessment Yes 
Workflow Management Yes 

CAPA

Audit Management Yes 
CAPA Planning Yes 
Change Management Yes 
Complaint Management Yes 
Incident Management Yes 
Nonconformance Tracking Yes 
Quality Control Yes 
Risk Management Yes 
Root Cause Analysis No 
Training Management Yes 

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking No 
Controls Testing No 
Environmental Compliance No 
FDA Compliance Yes 
HIPAA Compliance Yes 
ISO Compliance Yes 
Incident Management No 
OSHA Compliance No 
Risk Management Yes 
Sarbanes-Oxley Compliance No 
Surveys & Feedback No 
Version Control Yes 
Workflow / Process Automation Yes 

Document Control

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

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management Yes 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

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