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
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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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
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Free Trial
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Pricing
€1300 per year
Free Version
Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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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
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control
Requirements Management Features
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
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Integrations
Adobe Creative Cloud
Apache Subversion
Azure DevOps Server
GitHub
GitLab
HL7 FHIR
Jira Align
Redmine
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Integrations
Adobe Creative Cloud
Apache Subversion
Azure DevOps Server
GitHub
GitLab
HL7 FHIR
Jira Align
Redmine
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