aligned elements

aligned elements

Aligned AG
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+

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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 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

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

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 Supported
24/7 Live Support Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Pricing

€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Version Not Supported
Free Trial Supported

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

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 Supported
Webinars Not Supported
Live Online Supported
In Person Not Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported

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
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Kovair ALM-PLM CoE

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Kovair ALM

Kovair ALM

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Categories

Categories

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

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

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
Claim Innovatum and update features and information
Claim Innovatum and update features and information
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Claim aligned elements and update features and information