SmartSolve eQMSIQVIA
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Related Products
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About
Orcanos is a medical device quality and development platform that unifies eQMS, ALM, design control, document control, and risk management in one system. It helps MedTech teams connect R&D and Quality workflows so requirements, risks, validations, documents, and audit evidence stay traceable. The platform supports compliance needs such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Orcanos includes customizable workflows, electronic signatures, document lifecycle automation, training tasks, audit trails, access controls, and centralized quality records. Its integrated ALM tools help teams manage design inputs, verification, validation, DHF readiness, impact analysis, and product development changes. With AI assistance, rapid deployment, and one source of truth for regulated product data, Orcanos helps medical device companies reduce compliance friction and accelerate innovation.
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About
Eliminate manual, repetitive tasks so you can focus on delivering safer, more effective products – faster. IQVIA’s SmartSolve Postmarket Surveillance is your complete, SaaS approach for postmarket surveillance (PMS) and provides best practices for centrally managing all post market surveillance activities. Fusion is a SmartSolve and RIM Smart user event that provides an in-depth education into timely and relevant quality and regulatory topics with actionable insights and practical tools that can be applied within any Life Sciences organization. Fusion started as a live SmartSolve user conference and has evolved over the past couple of years to include virtual and live events for both SmartSolve and RIM Smart users. Simplify, automate and integrate your compliance response times, accuracy, predictive planning and efficiency with IQVIA SmartSolve™ Regulatory Connector. Connected Intelligence is our innovative, interconnected approach that helps to drive operational efficiencies.
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Platforms Supported
Windows
Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Orcanos is best suited for medical device companies, MedTech startups, R&D teams, Quality teams, Regulatory Affairs teams, product development teams, and compliance leaders that need integrated eQMS, ALM, design control, risk management, document control, audit readiness, and traceability
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Audience
Companies searching for a solution to manage and improve their surveillance operations
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Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
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Support
Phone Support
Not Supported
24/7 Live Support
Supported
Online
Supported
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API
Offers API
Not Supported
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API
Offers API
Not Supported
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Supported
Free Trial
Supported
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Pricing
$542 one-time payment
Free Version
Not Supported
Free Trial
Not Supported
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Reviews/
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Reviews/
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Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Supported
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Not Supported
In Person
Supported
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Company InformationOrcanos
Founded: 2004
Israel
www.orcanos.com
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Company InformationIQVIA
Founded: 1982
United States
www.iqvia.com/solutions/integrated-global-compliance/quality-compliance/smartsolve-eqms
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Alternatives |
Alternatives |
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Categories |
Categories |
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Application Lifecycle Management Features
Administrator Level Control
Supported
Defect Tracking
Supported
Iteration Planning
Supported
Project Management
Supported
Release Management
Supported
Requirements Review
Supported
Task Management
Supported
Test Case Tracking
Supported
User Level Management
Supported
Version Control
Supported
Requirements Management Features
Automated Functional Sizing
Not Supported
Automated Requirements QA
Not Supported
Automated Test Generation
Not Supported
Automated Use Case Modeling
Not Supported
Change Management
Supported
Collaboration
Supported
History Tracking
Supported
Prioritization
Supported
Reporting
Supported
Status Reporting
Supported
Status Tracking
Supported
Summary Reports
Supported
Task Management
Supported
To-Do List
Supported
Traceability
Supported
User Defined Attributes
Supported
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Quality Management Features
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Not Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Supported
Document Control
Supported
Equipment Management
Supported
ISO Standards Management
Not Supported
Maintenance Management
Not Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
Document Management Features
Access Controls
Supported
Archiving & Retention
Supported
Collaboration Tools
Supported
Compliance Tracking
Supported
Document Archiving
Supported
Document Assembly
Supported
Document Capture
Not Supported
Document Conversion
Supported
Document Delivery
Supported
Document Indexing
Supported
Document Retention
Supported
Electronic Signature
Supported
Email Management
Not Supported
File Recovery
Supported
File Type Conversion
Supported
Forms Management
Not Supported
Full Text Search
Supported
Offline Access
Supported
Optical Character Recognition
Supported
Print Management
Not Supported
Version Control
Supported
Training Features
Academic / Education
Not Supported
Asynchronous Learning
Not Supported
Blended Learning
Not Supported
Built-In Course Authoring
Not Supported
Built-in LMS
Supported
Certification Management
Not Supported
Corporate / Business
Not Supported
eCommerce
Not Supported
Learner Portal
Supported
Mobile Learning
Not Supported
Simulation
Not Supported
Synchronous Learning
Not Supported
Training Companies
Not Supported
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Integrations
Indent
Not Supported
Jira
Supported
Microsoft 365
Supported
Salesforce
Supported
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Integrations
Indent
Supported
Jira
Not Supported
Microsoft 365
Not Supported
Salesforce
Not Supported
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