aligned elements

aligned elements

Aligned AG
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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.

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.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Pharmaceutical, biotech, and medical-device manufacturers seeking a solution to manage artwork, regulatory submissions, printing, and e-label distribution across complex supply chains

Audience

Medical Device Manufacturers looking for a design control management solution

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

€1300 per year
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

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Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Innovatum
Founded: 1993
United States
www.innovatum.com

Company Information

Aligned AG
Founded: 2007
Switzerland
www.aligned.ch/

Alternatives

Alternatives

ReqView

ReqView

Eccam
ARTWORKS

ARTWORKS

Resource Label Group
Kovair ALM-PLM CoE

Kovair ALM-PLM CoE

Kovair Software

Categories

Categories

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

Integrations

Adobe Creative Cloud
Apache Subversion
Azure DevOps Server
GitHub
GitLab
HL7 FHIR
Jira Align
Redmine

Integrations

Adobe Creative Cloud
Apache Subversion
Azure DevOps Server
GitHub
GitLab
HL7 FHIR
Jira Align
Redmine
Claim Innovatum and update features and information
Claim Innovatum and update features and information
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