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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 No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Jira Yes 
Helix QAC No 
HostAccess No 
Jira Work Management No 
Klocwork No 
Kovair QuickSync No 
Microsoft 365 Yes 
OpsHub No 
P4 Plan No 
Rally Software No 
Salesforce Yes 

Integrations

Jira Yes 
Helix QAC Yes 
HostAccess Yes 
Jira Work Management Yes 
Klocwork Yes 
Kovair QuickSync Yes 
Microsoft 365 No 
OpsHub Yes 
P4 Plan Yes 
Rally Software Yes 
Salesforce No 

Pricing Details

No price information available.
Free Trial Yes 
Free Version Yes 

Pricing Details

No price information available.
Free Trial Yes 
Free Version 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 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac Yes 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
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 Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

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 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 

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 

Bug Tracking

Backlog Management No 
Filtering No 
Issue Tracking No 
Release Management No 
Task Management No 
Ticket Management No 
Workflow Management No 

Issue Tracking

Assignment Management No 
Dashboard No 
Escalation Management No 
Issue Auditing No 
Issue Scheduling No 
Knowledge Base No 
Project Management No 
Recurring Issues No 
Scheduling No 
Task Management No 

Requirements Management

Automated Functional Sizing No 
Automated Requirements QA No 
Automated Test Generation No 
Automated Use Case Modeling No 
Change Management No 
Collaboration No 
History Tracking No 
Prioritization No 
Reporting No 
Status Reporting No 
Status Tracking No 
Summary Reports No 
Task Management No 
To-Do List No 
Traceability No 
User Defined Attributes No 

Software Testing

Automated Testing No 
Black-Box Testing No 
Dynamic Testing No 
Issue Tracking No 
Manual Testing No 
Quality Assurance Planning No 
Reporting / Analytics No 
Static Testing No 
Test Case Management No 
Variable Testing Methods No 
White-Box Testing No 

Test Management

Automation Integration No 
Collaboration Tools No 
Pass/Fail Results Tabulation No 
Reporting / Analytics No 
Requirements Management No 
Test Scheduling No 
Test Tracking No 
Time/Budget Tracking No 

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