Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
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