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Ratings and Reviews 0 Ratings
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What is Qualis DMS?
The Qualis document management system provides a robust and secure solution for handling documentation, ensuring that users can access regulated and up-to-date materials efficiently. With its workflow-driven document approval process that includes features like revision tracking, users are guaranteed access to the latest approved versions, significantly reducing the risk of using outdated documents. This adaptable workflow can be customized to fit specific roles within the organization, allowing for the implementation of multiple workflows tailored to different types of documents. Additionally, the system promotes sustainability by reducing paper usage and storage requirements while also ensuring the secure storage and easy retrieval of documents. By limiting distribution to only those documents that have received approval, it effectively mitigates the risk associated with disseminating obsolete copies. Moreover, it strengthens regulatory compliance by offering controlled access and facilitating straightforward document searches. All associated metadata is consolidated in a flexible centralized database that is compatible with various systems, such as MS SQL, Oracle, and Postgre SQL. In summary, the Qualis DMS is an all-encompassing solution for document management and distribution within organizations, enhancing both efficiency and compliance throughout the process. Ultimately, this platform not only streamlines document oversight but also fosters greater collaboration among users, ensuring a cohesive approach to managing vital information.
What is Orcanos?
Orcanos is a unified eQMS and ALM platform designed specifically for medical device companies that need to manage regulated product development and quality operations together. The platform helps R&D, Quality, Regulatory, and Operations teams work from a single source of truth instead of relying on disconnected documents, spreadsheets, and siloed systems. Orcanos connects design control, quality management, document control, risk management, requirements, testing, validation, training, and audit evidence across the full medical device lifecycle. Its eQMS capabilities support quality processes such as document approvals, revision control, electronic signatures, training automation, CAPA, complaints, audits, nonconformances, and compliance records. Its ALM and design control tools help teams manage user needs, design inputs, risks, mitigations, verification, validation, DHF documentation, and automated impact analysis. Orcanos supports key medical device compliance needs, including ISO 13485, EU MDR, ISO 14971, FDA expectations, and 21 CFR Part 11 requirements. The platform is built for adaptive compliance, allowing teams to configure workflows, forms, fields, status flows, permission structures, and approval processes without heavy coding. Document control features help automate lifecycle routing, publishing, archiving, read-and-understand training tasks, and audit trails for every revision. Risk management becomes a live process by linking hazards, requirements, mitigations, design changes, and verification evidence in real time instead of maintaining static Excel files. Orcanos also includes Ask Paul, an AI-powered assistant designed to help users work more efficiently across regulated quality and development activities. With rapid implementation, traceability, configurable workflows, and centralized compliance data, Orcanos helps medical device teams reduce regulatory friction, stay audit-ready, and bring safer products to market faster.
Integrations Supported
Microsoft Excel
Microsoft Word
Oracle SQL Developer
PostgreSQL
SQL Server
API Availability
API Availability
Pricing Information
Pricing not provided
Pricing Information
Pricing not provided
Free Version
Free Trial Offered?
Supported Platforms
SaaS
Supported Platforms
SaaS
Android
Windows
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Standard Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
Agaram
Date Founded
1995
Company Location
India
Company Website
www.agaramtech.com/product/qualis-dms/
Company Facts
Organization Name
Orcanos
Date Founded
2004
Company Location
Israel
Company Website
www.orcanos.com
Categories and Features
Document Control
Not specified
Document Management
Not specified
Specification Management
Not specified
Categories and 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
Audit
Not specified
CAPA
Not specified
Compliance
Not specified
Document Control
Not specified
Medical Quality Management Systems
Not specified
Quality Management
Not specified
Regulatory Change Management
Not specified
Requirements Management
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes
Risk Management
Not specified