Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
No
API Access
Has API
No
Integrations
Codebeamer
Yes
Jira
No
Kovair QuickSync
Yes
Microsoft 365
No
OpsHub
Yes
Planview Hub
Yes
Planview Software Product Delivery
Yes
QVscribe
Yes
ReqView
Yes
Salesforce
No
Integrations
Codebeamer
No
Jira
Yes
Kovair QuickSync
No
Microsoft 365
Yes
OpsHub
No
Planview Hub
No
Planview Software Product Delivery
No
QVscribe
No
ReqView
No
Salesforce
Yes
Pricing Details
No price information available.
Free Trial
Yes
Free Version
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
Yes
Deployment
Web-Based
Yes
On-Premises
No
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
No
iPad App
No
Android App
Yes
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
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
Yes
Live Training (Online)
Yes
In Person
Yes
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
Yes
Code Assistance
No
Code Refactoring
No
Collaboration Tools
Yes
Compatibility Testing
No
Data Modeling
Yes
Debugging
Yes
Deployment Management
Yes
Graphical User Interface
No
Mobile Development
No
No-Code
No
Reporting/Analytics
Yes
Software Development
No
Source Control
No
Testing Management
No
Version Control
No
Web App Development
No
Requirements Management
Automated Functional Sizing
No
Automated Requirements QA
No
Automated Test Generation
No
Automated Use Case Modeling
No
Change Management
Yes
Collaboration
Yes
History Tracking
No
Prioritization
Yes
Reporting
Yes
Status Reporting
No
Status Tracking
Yes
Summary Reports
No
Task Management
No
To-Do List
No
Traceability
No
User Defined Attributes
No
Product Features
Application Lifecycle Management
Administrator Level Control
Yes
Defect Tracking
Yes
Iteration Planning
Yes
Project Management
Yes
Release Management
Yes
Requirements Review
Yes
Task Management
Yes
Test Case Tracking
Yes
User Level Management
Yes
Version Control
Yes
Audit
Alerts / Notifications
No
Audit Planning
No
Compliance Management
No
Dashboard
No
Exceptions Management
No
Forms Management
No
Issue Management
No
Mobile Access
No
Multi-Year Planning
No
Risk Assessment
No
Workflow Management
No
CAPA
Audit Management
No
CAPA Planning
No
Change Management
No
Complaint Management
No
Incident Management
No
Nonconformance Tracking
No
Quality Control
No
Risk Management
No
Root Cause Analysis
No
Training Management
No
Compliance
Archiving & Retention
No
Artificial Intelligence (AI)
No
Audit Management
No
Compliance Tracking
No
Controls Testing
No
Environmental Compliance
No
FDA Compliance
No
HIPAA Compliance
No
ISO Compliance
No
Incident Management
No
OSHA Compliance
No
Risk Management
No
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
Version Control
No
Workflow / Process Automation
No
Document Control
Archiving & Retention
No
Automated Routing
No
Change Management
No
Compliance Management
No
Electronic Signature
No
Escalation Management
No
Periodic Review
No
Version Control
No
Quality Management
Audit Management
No
Complaint Management
No
Compliance Management
No
Corrective and Preventive Actions (CAPA)
No
Defect Tracking
No
Document Control
No
Equipment Management
No
ISO Standards Management
No
Maintenance Management
No
Risk Management
No
Supplier Quality Control
No
Training Management
No
Requirements Management
Automated Functional Sizing
No
Automated Requirements QA
No
Automated Test Generation
No
Automated Use Case Modeling
No
Change Management
Yes
Collaboration
Yes
History Tracking
Yes
Prioritization
Yes
Reporting
Yes
Status Reporting
Yes
Status Tracking
Yes
Summary Reports
Yes
Task Management
Yes
To-Do List
Yes
Traceability
Yes
User Defined Attributes
Yes
Risk Management
Alerts/Notifications
No
Auditing
No
Business Process Control
No
Compliance Management
No
Corrective Actions (CAPA)
No
Dashboard
No
Exceptions Management
No
IT Risk Management
No
Internal Controls Management
No
Legal Risk Management
No
Mobile Access
No
Operational Risk Management
No
Predictive Analytics
No
Reputation Risk Management
No
Response Management
No
Risk Assessment
No