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Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Description

Innovatum provides a thorough labeling and regulatory-data management solution tailored for companies in the life sciences sector, such as those involved in pharmaceuticals, medical devices, and biotechnology manufacturing. Central to their offering is the ROBAR platform, which acts as an enterprise-level label management system facilitating every phase of the label lifecycle, from master-data management (PIMS/MDM) and artwork/version control (with native capabilities for managing Adobe files) to regulatory-data submissions (including UDI/MDR/IVDR/Eudamed and GS1 data pool) and culminating in final label printing, print-inspection integration, and compliant archiving. The platform is designed to be configurable, allowing for enhancements to be added to the core product without necessitating rework during upgrades, and it can be deployed through on-premises, hosted, or single-tenant cloud/SaaS configurations, accommodating various IT infrastructure preferences. Additionally, Innovatum features an eLabeling (eIFU) module that connects products, their versions, and translations to electronic instructions for use, enhancing user accessibility and compliance. This comprehensive system not only streamlines processes but also ensures regulatory adherence for its users.

Description

Aligned provides a purpose built eQMS and design management solution created exclusively for medical device and in vitro diagnostic manufacturers. It addresses the demands of global regulatory compliance while removing the friction typically associated with traditional QMS tools. The system enables organizations to operate in line with key regulations and standards including ISO 13485, FDA QSMR, EU MDR, and IVDR. It is relied upon by experienced quality and development professionals who require transparency, control, and consistency across all stages of product development and post market activities. Aligned brings quality management and design control together in a single coherent platform that supports cross functional teamwork. Quality, regulatory, R and D, and leadership teams work within the same controlled environment, where requirements, design data, verification and validation activities, risk files, and changes are inherently linked. This built in connectivity delivers complete traceability and clear evidence for audits, inspections, and regulatory submissions.

API Access

Has API No 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Adobe Creative Cloud Yes 
Apache Subversion No 
Azure DevOps Server No 
GitHub No 
GitLab No 
HL7 FHIR Yes 
Jira Align No 
Redmine No 

Integrations

Adobe Creative Cloud No 
Apache Subversion Yes 
Azure DevOps Server Yes 
GitHub Yes 
GitLab Yes 
HL7 FHIR No 
Jira Align Yes 
Redmine Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Trial Yes 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Innovatum

Founded

1993

Country

United States

Website

www.innovatum.com

Vendor Details

Company Name

Aligned AG

Founded

2007

Country

Switzerland

Website

www.aligned.ch/

Product Features

Product Features

Application Lifecycle Management

Administrator Level Control Yes 
Defect Tracking Yes 
Iteration Planning No 
Project Management No 
Release Management Yes 
Requirements Review Yes 
Task Management Yes 
Test Case Tracking Yes 
User Level Management Yes 
Version Control Yes 

Requirements Management

Automated Functional Sizing No 
Automated Requirements QA Yes 
Automated Test Generation Yes 
Automated Use Case Modeling No 
Change Management Yes 
Collaboration Yes 
History Tracking Yes 
Prioritization Yes 
Reporting Yes 
Status Reporting Yes 
Status Tracking Yes 
Summary Reports Yes 
Task Management Yes 
To-Do List Yes 
Traceability Yes 
User Defined Attributes Yes 

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