aligned elementsAligned AG
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Related Products
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About
Innovatum delivers a comprehensive, end-to-end labeling and regulatory-data management system for life-sciences companies, including pharmaceutical, medical-device, and biotechnology manufacturers. Its core platform, ROBAR, serves as an enterprise label-management system that supports all stages of the label lifecycle from master-data management (PIMS/MDM), artwork/version control (native management of Adobe files), and regulatory-data submissions (e.g., UDI/MDR/IVDR/Eudamed, GS1 data pool) to final label printing, print-inspection integration, and compliant archiving. It is configurable (rather than customized), meaning enhancements are incorporated into the base product so upgrades don’t require rework, and deployed via on-premises, hosted, or single-tenant cloud/SaaS setups, supporting a variety of IT-infrastructure preferences. Innovatum also offers an eLabeling (eIFU) module that links products, versions, and translations to electronic instructions for use.
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About
Aligned eQMS and Aligned Elements Design Control software are built specifically for medical device and IVD companies that need to meet global regulatory requirements without unnecessary complexity.
The platform supports compliance with ISO 13485, FDA QSMR, EU MDR, and IVDR, and is trusted by experts that want full control over quality, design, and regulatory processes across the entire product lifecycle.
Aligned products, designed for collaboration between quality, regulatory, R&D, and management teams, combines a complete electronic Quality Management System with deep Design Control functionality in one fully integrated environment. Design inputs, outputs, verification, validation, risk management, and change control are natively connected to the QMS, ensuring end to end traceability that stands up to audits and inspections.
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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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Platforms Supported
Windows
Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Pharmaceutical, biotech, and medical-device manufacturers seeking a solution to manage artwork, regulatory submissions, printing, and e-label distribution across complex supply chains
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Audience
Medical Device Manufacturers looking for a design control management solution
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Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Supported
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Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
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API
Offers API
Not Supported
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API
Offers API
Supported
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
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Pricing
€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Version
Not Supported
Free Trial
Supported
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Reviews/
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Reviews/
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Not Supported
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Supported
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Company InformationInnovatum
Founded: 1993
United States
www.innovatum.com
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Company InformationAligned AG
Founded: 2007
Switzerland
www.aligned.ch/
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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
Not Supported
Project Management
Not 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
Supported
Automated Test Generation
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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Integrations
Adobe Creative Cloud
Supported
Apache Subversion
Not Supported
Azure DevOps Server
Not Supported
GitHub
Not Supported
GitLab
Not Supported
HL7 FHIR
Supported
Jira Align
Not Supported
Redmine
Not Supported
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Integrations
Adobe Creative Cloud
Not Supported
Apache Subversion
Supported
Azure DevOps Server
Supported
GitHub
Supported
GitLab
Supported
HL7 FHIR
Not Supported
Jira Align
Supported
Redmine
Supported
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