Elyse

Elyse

Silkwood Software
+
+

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About

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. The product is configured and ready to use out of the box. Setting up Elyse does not require a team of specialists. For multi-user production environment deployment the license is a low friction trust-based per-database instance perpetual license.

About

Orcanos is a medical device quality and development platform that unifies eQMS, ALM, design control, document control, and risk management in one system. It helps MedTech teams connect R&D and Quality workflows so requirements, risks, validations, documents, and audit evidence stay traceable. The platform supports compliance needs such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Orcanos includes customizable workflows, electronic signatures, document lifecycle automation, training tasks, audit trails, access controls, and centralized quality records. Its integrated ALM tools help teams manage design inputs, verification, validation, DHF readiness, impact analysis, and product development changes. With AI assistance, rapid deployment, and one source of truth for regulated product data, Orcanos helps medical device companies reduce compliance friction and accelerate innovation.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

All organizations who require a system for managing controlled documents, i.e. standards, policies, procedures etc.

Audience

Orcanos is best suited for medical device companies, MedTech startups, R&D teams, Quality teams, Regulatory Affairs teams, product development teams, and compliance leaders that need integrated eQMS, ALM, design control, risk management, document control, audit readiness, and traceability

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

$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 Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Silkwood Software
Founded: 2009
Australia
silkwoodsoftware.com

Company Information

Orcanos
Founded: 2004
Israel
www.orcanos.com

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Total Lean Management (TLM) Software

Lean & Mean Business Systems

Categories

Categories

Document Control Features

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

Application Lifecycle Management Features

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 Features

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

Integrations

Jira
Microsoft 365
Salesforce

Integrations

Jira
Microsoft 365
Salesforce
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