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ease
features
design
support

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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.

Description

An effective ALM tool significantly enhances the management of your product's application lifecycle. The premier ALM tools offer comprehensive traceability throughout the entire lifecycle, which is why development teams from various sectors opt for Perforce ALM (formerly Helix ALM). This versatile suite of ALM tools is designed to facilitate the tracking of requirements, testing, and issue management. Perforce ALM stands out as the top software for application lifecycle management, providing extensive traceability throughout the process. This means you will have clear visibility into whether requirements have been adequately tested and fulfilled, whether test executions were successful or not, and whether any issues have been addressed. Furthermore, should a requirement undergo changes, you will instantly know the test cases and issues that may be affected. Perforce ALM simplifies the creation of requirements and the sharing of related documents, allowing for seamless reviews and approvals directly within the application. Additionally, it offers the flexibility to reuse requirements across different projects, enhancing efficiency and collaboration. The collaborative features of Perforce ALM ensure that all team members stay informed and aligned throughout the lifecycle.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Jira
Helix QAC
HostAccess
Jira Work Management
Klocwork
Kovair QuickSync
Microsoft 365
OpsHub
P4 Plan
Rally Software
Salesforce

Integrations

Jira
Helix QAC
HostAccess
Jira Work Management
Klocwork
Kovair QuickSync
Microsoft 365
OpsHub
P4 Plan
Rally Software
Salesforce

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

Orcanos

Founded

2004

Country

Israel

Website

www.orcanos.com

Vendor Details

Company Name

Perforce

Founded

1995

Country

United States

Website

www.perforce.com/products/helix-alm

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

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

Bug Tracking

Backlog Management
Filtering
Issue Tracking
Release Management
Task Management
Ticket Management
Workflow Management

Issue Tracking

Assignment Management
Dashboard
Escalation Management
Issue Auditing
Issue Scheduling
Knowledge Base
Project Management
Recurring Issues
Scheduling
Task 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

Software Testing

Automated Testing
Black-Box Testing
Dynamic Testing
Issue Tracking
Manual Testing
Quality Assurance Planning
Reporting / Analytics
Static Testing
Test Case Management
Variable Testing Methods
White-Box Testing

Test Management

Automation Integration
Collaboration Tools
Pass/Fail Results Tabulation
Reporting / Analytics
Requirements Management
Test Scheduling
Test Tracking
Time/Budget Tracking

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