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Description
Elyse serves as a robust and highly secure controlled document database platform.
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 remains free and retains all functionalities.
Furthermore, the Elyse platform comes equipped with a fully operational Apache-licensed application layer that complements the proprietary Elyse database layer. This robust infrastructure provides a reliable and transparent base, enabling independent vendors, integrators, and internal teams to develop solutions effectively, fostering innovation and adaptability within organizations.
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
Integrations
Microsoft 365
Microsoft Entra ID
Pricing Details
$3,500 (+ applicable taxes)
Free Trial
Free Version
Pricing Details
$13,750/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
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
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
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
No Alternatives
