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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

Description

IBM Engineering Requirements Management DOORS Next offers a versatile platform designed to enhance communication and cooperation between teams and stakeholders, ultimately leading to increased productivity and quality outcomes. This solution allows users to effectively capture, trace, analyze, and manage modifications to requirements while ensuring adherence to relevant regulations and standards. By utilizing DOORS Next, organizations can enhance their ability to manage project scope and costs across their operations and supply chain. With deployment options available both on-premises and in the cloud, users can choose the setup that best suits their specific environment. Furthermore, the software promotes greater efficiency through advanced version and variant management features, while also fostering collaboration within diverse, multidisciplinary teams. Leveraging AI capabilities, such as the Requirements Quality Assistant, allows for further refinement of requirements, ensuring that users have the most effective tools at their disposal for comprehensive requirements management. Ultimately, this approach not only enhances transparency and minimizes rework but also significantly boosts the reusability of project components. Through these features, organizations can expect to achieve a more streamlined and efficient workflow.

Description

Orcanos is an integrated MedTech software platform built to help medical device companies manage quality, compliance, product development, and regulatory documentation from one connected workspace. It combines electronic quality management, application lifecycle management, design controls, document control, risk management, traceability, and audit readiness. The platform is designed to bridge the gap between R&D and Quality teams by connecting user needs, requirements, hazards, mitigations, tests, validations, complaints, and quality processes. Orcanos supports regulated frameworks and standards such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Its eQMS capabilities include document workflows, PDF publishing, revision control, electronic signatures, training automation, audit trails, CAPA support, and quality process management. ALM and design control features help teams maintain a live digital thread across development artifacts, risk files, verification activities, and design history documentation. Orcanos also offers customizable no-code workflows, configurable fields, granular permissions, and migration support for teams moving from spreadsheets or legacy tools. Its AI-powered assistant, Ask Paul, is positioned to help users navigate operations and improve efficiency. By unifying quality and development data, Orcanos helps medical device organizations stay audit-ready while reducing manual documentation work.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Codebeamer
Jira
Kovair QuickSync
Microsoft 365
OpsHub
Planview Hub
Planview Software Product Delivery
QVscribe
ReqView
Salesforce
SodiusWillert ReqXChanger
Syndeia
Trace.Space
VectorCAST
eQube®-DaaS

Integrations

Codebeamer
Jira
Kovair QuickSync
Microsoft 365
OpsHub
Planview Hub
Planview Software Product Delivery
QVscribe
ReqView
Salesforce
SodiusWillert ReqXChanger
Syndeia
Trace.Space
VectorCAST
eQube®-DaaS

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
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

IBM

Founded

1911

Country

United States

Website

www.ibm.com/products/requirements-management-doors-next

Vendor Details

Company Name

Orcanos

Founded

2004

Country

Israel

Website

www.orcanos.com

Product Features

Application Development

Access Controls/Permissions
Code Assistance
Code Refactoring
Collaboration Tools
Compatibility Testing
Data Modeling
Debugging
Deployment Management
Graphical User Interface
Mobile Development
No-Code
Reporting/Analytics
Software Development
Source Control
Testing Management
Version Control
Web App Development

Requirements Management

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

Product 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

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

Requirements Management

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

Risk Management

Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment

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