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Description

Elyse® is a high-integrity controlled document management system that understands your data. Designed from the ground up to serve the people who use it, Elyse has a User-Centric data architecture that carefully mirrors the real world experience of how users expect controlled document management systems to behave. The result is: Users find what they need faster and experience less frustration. Administrators spend less time maintaining the system because there are fewer workarounds and customizations. Auditors have stronger evidence because foundational rules are hard wired. Organizations have a platform that is easier to validate and extend because it doesn't need program code to compensate for highly abstracted data. Your information is safeguarded through fully ACID-compliant data storage, integrated with a sophisticated security architecture. The system features role-based access control and detailed data permissions that facilitate scalability suitable for large enterprises. The document identifier namespace guarantees the uniqueness of document IDs right from the start, while also being format agnostic, which ensures smooth migration of existing data from legacy systems. For deployment in multi-user production environments, the licensing is designed to be low friction, offering a trust-based perpetual license per database instance without any recurring subscription or upgrade fees. Conversely, for single users or non-production scenarios, the product is free and retains all functionalities.

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 No 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Microsoft 365 No 
Microsoft Entra ID No 

Integrations

Microsoft 365 Yes 
Microsoft Entra ID Yes 

Pricing Details

$3,500
For multi-user production environment deployment the license is a low friction trust-based per-database instance perpetual license. There are no recurring subscriptions or upgrade fees. For single user or non-production use the product is free and fully featured.
Free Trial Yes 
Free Version Yes 

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 No 
On-Premises Yes 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
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 No 
Live Rep (24/7) No 
Online Support No 

Customer Support

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

Types of Training

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

Types of Training

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

Vendor Details

Company Name

Silkwood Software

Founded

2009

Country

Australia

Website

silkwoodsoftware.com

Vendor Details

Company Name

SimplerQMS

Founded

2017

Country

Denmark

Website

www.simplerqms.com

Product Features

Document Control

Archiving & Retention Yes 
Automated Routing No 
Change Management No 
Compliance Management Yes 
Electronic Signature No 
Escalation Management No 
Periodic Review Yes 
Version Control 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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